Category Archives: Clinical Research Funding

Democrats align around a health policy platform

Posted on by • Posted in 2020 Election Issues, ACA, Centers for Disease Control & Prevention (CDC), Clinical Research Funding, COBRA Coverage, Health Policy, Medicaid, Medicare, Medicare for All, Surprise Bills • Leave a comment

https://mailchi.mp/86e2f0f0290d/the-weekly-gist-july-10-2020?e=d1e747d2d8

Abstract Word Cloud For Health Policy With Related Tags And Terms ...

 

Promising that “we are going to at last build the health care system the American people have always deserved”, a joint task force of health policy advisors from the Biden and Sanders campaigns this week released a unified set of proposals that will serve as part of the former Vice President’s campaign platform for the November election.

While the document does not include Sanders’ signature “Medicare for All” proposal, it does support a government-run public insurance option that would be available to all Americans, at income-adjusted, subsidized rates—including free coverage for those with low incomes. It also promises to expand Medicare benefits to include dental, vision, and hearing coverage, and to extend Medicare eligibility to those age 60 and above.

For those who lose their health coverage due to the COVID pandemic, the unity document endorses having the government pick up the tab for COBRA benefits and shifting enrollees into premium-free coverage on the Obamacare exchanges when their COBRA eligibility expires.

It also promises greater investment in public health resources, including increased funding for the CDC, and funding to recruit 100,000 contact tracers nationwide.

Other key components of the proposal include eliminating “surprise billing”, reducing drug costs, addressing racial and gender-based health inequities, and bolstering investment in scientific research.

This week’s document represents an important step in unifying the progressive and moderate wings of the Democratic party around key health policy principles. Should Biden win in November, and if Democrats gain control of the Senate, we’d expect quick action on many of these proposals.

Clearly the most difficult would be the public option and Medicare expansion, which would require lengthy negotiation with various industry groups to garner sufficient political support. Similar to the 2009 process that led to the Affordable Care Act, we would likely see a year’s worth of political horse-trading, leading to passage of some compromise legislation before the midterm elections in 2022.

All of that in the midst of an ongoing pandemic and likely prolonged economic downturn—both of which will probably allow for the passage of more far-reaching legislation than might otherwise be possible.

 

 

Whistleblower alleges Trump administration ignored coronavirus warnings

Posted on by • Posted in 2020 Election Issues, Clinical Research, Clinical Research Funding, Clinical Testing, Clinical Trials, Conflicts of Interest, Coronavirus, Credibility, Crisis, Crisis Management, Dept of Health and Human Services (HHS), Food and Drug Administration (FDA), Health Policy, Hydroxychloroquine, Misinformation, Mislead, Misleading, Mistake, Mistrust, Scientists, Transparency, Trust, Truth, U.S. Biomedical Advanced Research and Development Authority (BARDA) • Leave a comment

https://www.axios.com/coronavirus-rick-bright-whistleblower-f48cc9c6-8e6e-4662-a127-03e51f323288.html?stream=health-care&utm_source=alert&utm_medium=email&utm_campaign=alerts_healthcare

Whistleblower alleges Trump administration ignored coronavirus ...

Rick Bright, the former director of the U.S. Biomedical Advanced Research and Development Authority (BARDA), filed a whistleblower complaint Tuesday alleging that the Department of Health and Human Services failed to take early action to mitigate the threat of the novel coronavirus.

Flashback: Bright said last month he believes he was ousted after clashing with HHS leadership over his attempts to limit the use of hydroxychloroquine to treat the coronavirus.

What’s new: In his complaint, Bright claims he was excluded from an HHS meeting on the coronavirus in late January after he “pressed for urgent access to funding, personnel, and clinical specimens, including viruses” to develop treatments for the coronavirus should it spread outside of Asia.

  • Bright alleges it “became increasingly clear” in late January that “HHS leadership was doing nothing to prepare for the imminent mask shortage.”
  • Bright claims he “resisted efforts to fall into line with the Administration’s directive to promote the broad use of chloroquine and hydroxychloroquine and to award lucrative contracts for these and other drugs even though they lacked scientific merit and had not received prior scientific vetting.”
  • He adds that “even as HHS leadership began to acknowledge the imminent shortages in critical medical supplies, they failed to recognize the magnitude of the problem, and they failed to take the necessary urgent action.”

The White House declined to comment. HHS did not immediately respond to a request for comment.

https://www.documentcloud.org/documents/6882494-NEW-R-Bright-OSC-Complaint-Redacted.html

 

 

 

 

The world came together for a virtual vaccine summit. The U.S. was conspicuously absent.

Posted on by • Posted in 2020 Election Issues, Clinical Research, Clinical Research Funding, Clinical Testing, Clinical Trials, Coronavirus, Credibility, Crisis, Crisis Management, Leadership, Leadership Alignment, Solidarity, Vaccination, Vaccine, World Health Organization (WHO) • Leave a comment

https://www.washingtonpost.com/world/europe/the-world-comes-together-for-a-virtual-vaccine-summit-the-us-is-conspicuously-absent/2020/05/04/ac5b6754-8a5c-11ea-80df-d24b35a568ae_story.html?mkt_tok=eyJpIjoiTkdRelpUWXlNV1k0TW1WaSIsInQiOiJXSHJqUW1UV042bmt0Q1A5TUhJQ2dZOWFucFNYbmxtdTRsZUV2c0ltYzJmZkl5aU43NGJqbDdCZnB4Y0sxK0hJaXRzWjZmajAxN3V5aGZCbGQrS1wvcm1id2dVaGRZdld1TFpXMEt0VUkrMWtrMGJ6cko3VW5jVUZwZlpKR1d0eHEifQ%3D%3D

The world comes together for a virtual vaccine summit. The U.S. is ...

World leaders came together in a virtual summit Monday to pledge billions of dollars to quickly develop vaccines and drugs to fight the coronavirus.

Missing from the roster was the Trump administration, which declined to participate but highlighted from Washington what one official called its “whole-of-America” efforts in the United States and its generosity to global health efforts.

The online conference, led by European Commission President Ursula von der Leyen and a half-dozen countries, was set to raise $8.2 billion from governments, philanthropies and the private sector to fund research and mass-produce drugs, vaccines and testing kits to combat the virus, which has killed more than 250,000 people worldwide.

With the money came soaring rhetoric about international solidarity and a good bit of boasting about each country’s efforts and achievements, live and prerecorded, by Germany’s Angela Merkel, France’s Emmanuel Macron, Britain’s Boris Johnson, Japan’s Shinzo Abe — alongside Israel’s Benjamin Netanyahu and Turkey’s Recep Tayyip Erdogan.

“The more we pull together and share our expertise, the faster our scientists will succeed,” said Johnson, who was so stricken by the virus that he thought he might never leave the intensive care unit alive last month. “The race to discover the vaccine to defeat this virus is not a competition between countries but the most urgent shared endeavor of our lifetimes.”

A senior Trump administration official said Monday the United States “welcomes” the efforts of the conference participants. He did not explain why the United States did not join them.

“Many of the organizations and programs this pledging conference seeks to support already receive very significant funding and support from the U.S. government and private sector,” said the official, who spoke on the condition of anonymity under White House rules for briefing reporters.

Public health officials and researchers expressed surprise.

“It’s the first time that I can think of where you have had a major international pledging conference for a global crisis of this kind of importance, and the U.S. is just absent,” said Jeremy Konyndyk, who worked on the Ebola response in the Obama administration.

Given that no one knows which vaccines will succeed, he said, it’s crucial to back multiple efforts working in parallel.

“Against that kind of uncertainty we should be trying to position ourselves to be supporting — and potentially benefiting from — all of them,” said Konyndyk, a senior policy fellow at the Center for Global Development. “And instead we seem to be just focused on trying to win the race, in the hopes we happen to get one of the successful ones.”

Conference participants expressed a need for unity.

“We can’t just have the wealthiest countries have a vaccine and not share it with the world,” Canadian Prime Minister Justin Trudeau said.

“Let us in the international community unite to overcome this crisis,” Abe said.

Russia and India also did not participate. Chinese premier Li Keqiang was replaced at the last minute by Zhang Ming, Beijing’s ambassador to the European Union.

The U.S. official said the United States “is the single largest health and humanitarian donor in world. And the American people have continued that legacy of generosity in the global fight against covid-19.”

“And we would welcome additional high-quality, transparent contributions from others,” he said.

Asked three more times to explain why the United States did not attend, the official said he already had given an answer.

The U.S. government has provided $775 million in emergency health, humanitarian, economic and development aid for governments, international organizations and charities fighting the pandemic. The official said the United States is in the process of giving about twice that amount in additional funding.

There was one major American player at the virtual summit: the Bill and Melinda Gates Foundation, which promised to spend $125 million in the fight.

“This virus doesn’t care what nationality you are,” Melinda Gates told the gathering. As long as the virus is somewhere, she said, it’s everywhere.

Scientists are working around-the-clock to find a cure or treatment for the coronavirus. The World Health Organization says eight vaccines have entered human trials and another 94 are in development.

But finding an effective vaccine is only part of the challenge. When it’s discovered, infectious disease experts are predicting a scramble for limited doses, because there won’t be enough to vaccinate everyone on Day One. And deploying it could be difficult, particularly in countries that lack robust medical infrastructure.

Those that have begun human trials include a research project at Oxford University in England, which hopes to have its vaccine ready in the fall. The university started human trials on April 23. “In normal times,” British Health Secretary Matt Hancock said, “reaching this stage would take years.”

Other scientists are sprinting to create antiviral drugs or repurposing existing drugs such as remdesivir, which U.S. infectious diseases chief Anthony S. Fauci said he expected would be the new “standard of care.”

Other approaches now in trial include treatments such as convalescent plasma, which involves taking blood plasma from people who have recovered from covid-19 to patients who are fighting the virus, in the hope that the antibody-rich fluid will give the infected a helping hand.

Conference participants expressed hope that by working together, the world will find solutions more quickly — and they can then be dispersed to all countries, not only the wealthy, or those that developed vaccines first.

Many of the leaders stressed their support for the WHO. President Trump announced last month he was cutting off U.S. funding for the WHO because he said it had sided too closely with China, where the coronavirus arose. Trump says Chinese leaders underplayed the threat and hid crucial facts.

Public health analysts have shared some of those criticisms but have also criticized Trump for cutting off funding.

Peter Jay Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, said the United States has always been the primary funder of new products for global health. The country invested $1.8 billion in neglected diseases in 2018, according to Policy Cures Research, more than two-thirds of the worldwide total.

Hotez said the United States shoulders the burden of investing in global health technologies, while countries such as China do not step up.

“More than one mechanism for supporting global health technologies — that may not be such as a bad thing,” he said. “If it was all under one umbrella, you risk that some strong-willed opinions would carry the day and you might not fund the best technology.”

Hotez is working on a coronavirus vaccine that uses an existing, low-cost technology, previously used for the hepatitis B vaccine, precisely because he is worried about equitable distribution of the vaccine.

“I’m not very confident that some of the cutting-edge technologies going into clinical trials, which have never led to a licensed vaccine before, are going to filter down to low- and middle-income countries anytime soon,” Hotez said. “I’m really worried.”

 

 

 

 

How Long Will a Vaccine Really Take?

Posted on by • Posted in 2020 Election Issues, Clinical Research, Clinical Research Funding, Clinical Testing, Clinical Trials, Contact Tracing, Coronavirus, Expectations, Expert Opinion, Food and Drug Administration (FDA), Health Policy, Infection Control, Infectious Virus, Pandemic, Public Health, Public Safety, Quarantine, Social Distancing, Vaccine RNA • Leave a comment

Health - Digg

A vaccine would be the ultimate weapon against the coronavirus and the best route back to normal life. Officials like Dr. Anthony S. Fauci, the top infectious disease expert on the Trump administration’s coronavirus task force, estimate a vaccine could arrive in at least 12 to 18 months.

The grim truth behind this rosy forecast is that a vaccine probably won’t arrive any time soon. Clinical trials almost never succeed. We’ve never released a coronavirus vaccine for humans before. Our record for developing an entirely new vaccine is at least four years — more time than the public or the economy can tolerate social-distancing orders.

But if there was any time to fast-track a vaccine, it is now. So Times Opinion asked vaccine experts how we could condense the timeline and get a vaccine in the next few months instead of years.

Here’s how we might achieve the impossible.

Normally, researchers need years to secure funding, get approvals and study results piece by piece. But these are not normal times.

There are already at least 254 therapies and 95 vaccines related to Covid-19 being explored.

“If you want to make that 18-month timeframe, one way to do that is put as many horses in the race as you can,” said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine.

Despite the unprecedented push for a vaccine, researchers caution that less than 10 percent of drugs that enter clinical trials are ever approved by the Food and Drug Administration.

The rest fail in one way or another: They are not effective, don’t perform better than existing drugs or have too many side effects.

Fortunately, we already have a head start on the first phase of vaccine development: research. The outbreaks of SARS and MERS, which are also caused by coronaviruses, spurred lots of research. SARS and SARS-CoV-2, the virus that causes Covid-19, are roughly 80 percent identical, and both use so-called spike proteins to grab onto a specific receptor found on cells in human lungs. This helps explain how scientists developed a test for Covid-19 so quickly.

There’s a cost to moving so quickly, however. The potential Covid-19 vaccines now in the pipeline might be more likely to fail because of the swift march through the research phase, said Robert van Exan, a cell biologist who has worked in the vaccine industry for decades. He predicts we won’t see a vaccine approved until at least 2021 or 2022, and even then, “this is very optimistic and of relatively low probability.”

And yet, he said, this kind of fast-tracking is “worth the try — maybe we will get lucky.”

The next step in the process is pre-clinical and preparation work, where a pilot factory is readied to produce enough vaccine for trials. Researchers relying on groundwork from the SARS and MERS outbreaks could theoretically move through planning steps swiftly.

Sanofi, a French biopharmaceutical company, expects to begin clinical trials late this year for a Covid-19 vaccine that it repurposed from work on a SARS vaccine. If successful, the vaccine could be ready by late 2021.

As a rule, researchers don’t begin jabbing people with experimental vaccines until after rigorous safety checks.

They test the vaccine first on small batches of people — a few dozen during Phase 1, then a few hundred in Phase 2, then thousands in Phase 3. Months normally pass between phases so that researchers can review the findings and get approvals for subsequent phases.

But “if we do it the conventional way, there’s no way we’re going to be reaching that timeline of 18 months,” said Akiko Iwasaki, a professor of immunobiology at Yale University School of Medicine and an investigator at the Howard Hughes Medical Institute.

There are ways to slash time off this process by combining several phases and testing vaccines on more people without as much waiting.

Last week the National Academy of Sciences showed an overlapping timeline, describing it as moving at “pandemic speed.”

It’s here that talk of fast-tracking the timeline meets the messiness of real life: What if a promising vaccine actually makes it easier to catch the virus, or makes the disease worse after someone’s infected?

That’s been the case for a few H.I.V. drugs and vaccines for dengue fever, because of a process called vaccine-induced enhancement, in which the body reacts unexpectedly and makes the disease more dangerous.

Researchers can’t easily infect vaccinated participants with the coronavirus to see how the body behaves. They normally wait until some volunteers contract the virus naturally. That means dosing people in regions hit hardest by the virus, like New York, or vaccinating family members of an infected person to see if they get the virus next. If the pandemic subsides, this step could be slowed.

“That’s why vaccines take such a long time,” said Dr. Iwasaki. “But we’re making everything very short. Hopefully we can evaluate these risks as they occur, as soon as possible.”

This is where the vaccine timelines start to diverge depending on who you are, and where some people might get left behind.

If a vaccine proves successful in early trials, regulators could issue an emergency-use provision so that doctors, nurses and other essential workers could get vaccinated right away — even before the end of the year. Researchers at Oxford announced this week that their coronavirus vaccine could be ready for emergency use by September if trials prove successful.

So researchers might produce a viable vaccine in just 12 to 18 months, but that doesn’t mean you’re going to get it. Millions of people could be in line before you. And that’s only if the United States finds a vaccine first. If another country, like China, beats us to it, we could wait even longer while it doses its citizens first.

You might be glad of that, though, if it turned out that the fast-tracked vaccine caused unexpected problems. Only after hundreds or thousands are vaccinated would researchers be able to see if a fast-tracked vaccine led to problems like vaccine-induced enhancement.

“It’s true that any new technology comes with a learning curve,” said Dr. Paul Offit, the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “And sometimes that learning curve has a human price.”

Once we have a working vaccine in hand, companies will need to start producing millions — perhaps billions — of doses, in addition to the millions of vaccine doses that are already made each year for mumps, measles and other illnesses. It’s an undertaking almost unimaginable in scope.

Companies normally build new facilities perfectly tailored to any given vaccine because each vaccine requires different equipment. Some flu vaccines are produced using chicken eggs, using large facilities where a version of the virus is incubated and harvested. Other vaccines require vats in which a virus is cultured in a broth of animal cells and later inactivated and purified.

Those factories follow strict guidelines governing biological facilities and usually take around five years to build, costing at least three times more than conventional pharmaceutical factories. Manufacturers may be able to speed this up by creating or repurposing existing facilities in the middle of clinical trials, long before the vaccine in question receives F.D.A. approval.

“They just can’t wait,” said Dr. Iwasaki. “If it turns out to be a terrible vaccine, they won’t distribute it. But at least they’ll have the capability” to do so if the vaccine is successful.

The Bill and Melinda Gates Foundation says it will build factories for seven different vaccines. “Even though we’ll end up picking at most two of them, we’re going to fund factories for all seven, just so that we don’t waste time,” Bill Gates said during an appearance on “The Daily Show.”

In the end, the United States will have the capacity to mass-produce only two or three vaccines, said Vijay Samant, the former head of vaccine manufacturing at Merck.

“The manufacturing task is insurmountable,” Mr. Samant said. “I get sleepless nights thinking about it.”

Consider just one seemingly simple step: putting the vaccine into vials. Manufacturers need to procure billions of vials, and billions of stoppers to seal them. Sophisticated machines are needed to fill them precisely, and each vial is inspected on a high-speed line. Then vials are stored, shipped and released to the public using a chain of temperature-controlled facilities and trucks. At each of these stages, producers are already stretched to meet existing demands, Mr. Samant said.

It’s a bottleneck similar to the one that caused a dearth of ventilators, masks and other personal protective equipment just as Covid-19 surged across America.

If you talk about vaccines long enough, a new type of vaccine, called Messenger RNA (or mRNA for short), inevitably comes up. There are hopes it could be manufactured at a record clip. Mr. Gates even included it on his Time magazine list of six innovations that could change the world. Is it the miracle we’re waiting for?

Rather than injecting subjects with disease-specific antigens to stimulate antibody production, mRNA vaccines give the body instructions to create those antigens itself. Because mRNA vaccines don’t need to be cultured in large quantities and then purified, they are much faster to produce. They could change the course of the fight against Covid-19.

“On the other hand,” said Dr. van Exan, “no one has ever made an RNA vaccine for humans.”

Researchers conducting dozens of trials hope to change that, including one by the pharmaceutical company Moderna. Backed by investor capital and spurred by federal funding of up to $483 million to tackle Covid-19, Moderna has already fast-tracked an mRNA vaccine. It’s entering Phase 1 trials this year and the company says it could have a vaccine ready for front-line workers later this year.

“Could it work? Yeah, it could work,” said Dr. Fred Ledley, a professor of natural biology and applied sciences at Bentley University. “But in terms of the probability of success, what our data says is that there’s a lower chance of approval and the trials take longer.”

The technology is decades old, yet mRNA is not very stable and can break down inside the body.

“At this point, I’m hoping for anything to work,” said Dr. Iwasaki. “If it does work, wonderful, that’s great. We just don’t know.”

The fixation on mRNA shows the allure of new and untested treatments during a medical crisis. Faced with the unsatisfying reality that our standard arsenal takes years to progress, the mRNA vaccine offers an enticing story mixed with hope and a hint of mystery. But it’s riskier than other established approaches.

Imagine that the fateful day arrives. Scientists have created a successful vaccine. They’ve manufactured huge quantities of it. People are dying. The economy is crumbling. It’s time to start injecting people.

But first, the federal government wants to take a peek.

That might seem like a bureaucratic nightmare, a rubber stamp that could cost lives. There’s even a common gripe among researchers: For every scientist employed by the F.D.A., there are three lawyers. And all they care about is liability.

Yet F.D.A. approvals are no mere formality. Approvals typically take a full year, during which time scientists and advisory committees review the studies to make sure that the vaccine is as safe and effective as drug makers say it is.

While some steps in the vaccine timeline can be fast-tracked or skipped entirely, approvals aren’t one of them. There are horror stories from the past where vaccines were not properly tested. In the 1950s, for example, a poorly produced batch of a polio vaccine was approved in a few hours. It contained a version of the virus that wasn’t quite dead, so patients who got it actually contracted polio. Several children died.

The same scenario playing out today could be devastating for Covid-19, with the anti-vaccination movement and online conspiracy theorists eager to disrupt the public health response. So while the F.D.A. might do this as fast as possible, expect months to pass before any vaccine gets a green light for mass public use.

At this point you might be asking: Why are all these research teams announcing such optimistic forecasts when so many experts are skeptical about even an 18-month timeline? Perhaps because it’s not just the public listening — it’s investors, too.

“These biotechs are putting out all these press announcements,” said Dr. Hotez. “You just need to recognize they’re writing this for their shareholders, not for the purposes of public health.”

What if It Takes Even Longer Than the Pessimists Predict?

Covid-19 lives in the shadow of the most vexing virus we’ve ever faced: H.I.V. After nearly 40 years of work, here is what we have to show for our vaccine efforts: a few Phase 3 clinical trials, one of which actually made the disease worse, and another with a success rate of just 30 percent.

Researchers say they don’t expect a successful H.I.V. vaccine until 2030 or later, putting the timeline at around 50 years.

That’s unlikely to be the case for Covid-19, because, as opposed to H.I.V., it doesn’t appear to mutate significantly and exists within a family of familiar respiratory viruses. Even still, any delay will be difficult to bear.

But the history of H.I.V. offers a glimmer of hope for how life could continue even without a vaccine. Researchers developed a litany of antiviral drugs that lowered the death rate and improved health outcomes for people living with AIDS. Today’s drugs can lower the viral load in an H.I.V.-positive person so the virus can’t be transmitted through sex.

Therapeutic drugs, rather than vaccines, might likewise change the fight against Covid-19. The World Health Organization began a global search for drugs to treat Covid-19 patients in March. If successful, those drugs could lower the number of hospital admissions and help people recover faster from home while narrowing the infection window so fewer people catch the virus.

Combine that with rigorous testing and contact tracing — where infected patients are identified and their recent contacts notified and quarantined — and the future starts looking a little brighter. So far, the United States is conducting fewer than half the number of tests required and we need to recruit more than 300,000 contact-tracers. But other countries have started reopening following exactly these steps.

If all those things come together, life might return to normal long before a vaccine is ready to shoot into your arm.

 

 

 

 

 

What you need to know about the COVID-19 vaccine

Posted on by • Posted in Antibodies, Antigen, Clinical Research, Clinical Research Funding, Clinical Testing, Coronavirus, Crisis, Crisis Management, Efficacy, Food and Drug Administration (FDA), Health Policy, Infection Control, Infectious Virus, Pandemic, Public Health, Public Safety, Safety, Social Distancing, Vaccination, Vaccine, Vaccine DNA, Vaccine Inactivated, Vaccine Live, Vaccine RNA • 2 Comments

https://www.gatesnotes.com/Health/What-you-need-to-know-about-the-COVID-19-vaccine?WT.mc_id=20200430164943_COVID-19-vaccine_BG-FB&WT.tsrc=BGFB&linkId=87665504&fbclid=IwAR0SsBGe1GTcy-fOIXz86kImkScsdCGlRVgmDcPOgXMcaU7kdO39SyNpRSs

What you need to know about the COVID-19 vaccine | Bill Gates

Humankind has never had a more urgent task than creating broad immunity for coronavirus.

One of the questions I get asked the most these days is when the world will be able to go back to the way things were in December before the coronavirus pandemic. My answer is always the same: when we have an almost perfect drug to treat COVID-19, or when almost every person on the planet has been vaccinated against coronavirus.

The former is unlikely to happen anytime soon. We’d need a miracle treatment that was at least 95 percent effective to stop the outbreak. Most of the drug candidates right now are nowhere near that powerful. They could save a lot of lives, but they aren’t enough to get us back to normal.

Which leaves us with a vaccine.

Humankind has never had a more urgent task than creating broad immunity for coronavirus. Realistically, if we’re going to return to normal, we need to develop a safe, effective vaccine. We need to make billions of doses, we need to get them out to every part of the world, and we need all of this happen as quickly as possible.

That sounds daunting, because it is. Our foundation is the biggest funder of vaccines in the world, and this effort dwarfs anything we’ve ever worked on before. It’s going to require a global cooperative effort like the world has never seen. But I know it’ll get done. There’s simply no alternative.

Here’s what you need to know about the race to create a COVID-19 vaccine.

The world is creating this vaccine on a historically fast timeline.

Dr. Anthony Fauci has said he thinks it’ll take around eighteen months to develop a coronavirus vaccine. I agree with him, though it could be as little as 9 months or as long as two years.

Although eighteen months might sound like a long time, this would be the fastest scientists have created a new vaccine. Development usually takes around five years. Once you pick a disease to target, you have to create the vaccine and test it on animals. Then you begin testing for safety and efficacy in humans.

Safety and efficacy are the two most important goals for every vaccine. Safety is exactly what it sounds like: is the vaccine safe to give to people? Some minor side effects (like a mild fever or injection site pain) can be acceptable, but you don’t want to inoculate people with something that makes them sick.

Efficacy measures how well the vaccine protects you from getting sick. Although you’d ideally want a vaccine to have 100 percent efficacy, many don’t. For example, this year’s flu vaccine is around 45 percent effective.

To test for safety and efficacy, every vaccine goes through three phases of trials:

  • Phase one is the safety trial. A small group of healthy volunteers gets the vaccine candidate. You try out different dosages to create the strongest immune response at the lowest effective dose without serious side effects.
  • Once you’ve settled on a formula, you move onto phase two, which tells you how well the vaccine works in the people who are intended to get it. This time, hundreds of people get the vaccine. This cohort should include people of different ages and health statuses.
  • Then, in phase three, you give it to thousands of people. This is usually the longest phase, because it occurs in what’s called “natural disease conditions.” You introduce it to a large group of people who are likely already at the risk of infection by the target pathogen, and then wait and see if the vaccine reduces how many people get sick.

After the vaccine passes all three trial phases, you start building the factories to manufacture it, and it gets submitted to the WHO and various government agencies for approval.

This process works well for most vaccines, but the normal development timeline isn’t good enough right now. Every day we can cut from this process will make a huge difference to the world in terms of saving lives and reducing trillions of dollars in economic damage.

So, to speed up the process, vaccine developers are compressing the timeline. This graphic shows how:

In the traditional process, the steps are sequential to address key questions and unknowns. This can help mitigate financial risk, since creating a new vaccine is expensive. Many candidates fail, which is why companies wait to invest in the next step until they know the previous step was successful.

For COVID-19, financing development is not an issue. Governments and other organizations (including our foundation and an amazing alliance called the Coalition for Epidemic Preparedness Innovations) have made it clear they will support whatever it takes to find a vaccine. So, scientists are able to save time by doing several of the development steps at once. For example, the private sector, governments, and our foundation are going to start identifying facilities to manufacture different potential vaccines. If some of those facilities end up going unused, that’s okay. It’s a small price to pay for getting ahead on production.

Fortunately, compressing the trial timeline isn’t the only way to take a process that usually takes five years and get it done in 18 months. Another way we’re going to do that is by testing lots of different approaches at the same time.

There are dozens of candidates in the pipeline.

As of April 9, there are 115 different COVID-19 vaccine candidates in the development pipeline. I think that eight to ten of those look particularly promising. (Our foundation is going to keep an eye on all the others to see if we missed any that have some positive characteristics, though.)

The most promising candidates take a variety of approaches to protecting the body against COVID-19. To understand what exactly that means, it’s helpful to remember how the human immune system works.

When a disease pathogen gets into your system, your immune system responds by producing antibodies. These antibodies attach themselves to substances called antigens on the surface of the microbe, which sends a signal to your body to attack. Your immune system keeps a record of every microbe it has ever defeated, so that it can quickly recognize and destroy invaders before they make you ill.

Vaccines circumvent this whole process by teaching your body how to defeat a pathogen without ever getting sick. The two most common types—and the ones you’re probably most familiar with—are inactivated and live vaccines. Inactivated vaccines contain pathogens that have been killed. Live vaccines, on the other hand, are made of living pathogens that have been weakened (or “attenuated”). They’re highly effective but more prone to side effects than their inactivated counterparts.

Inactivated and live vaccines are what we consider “traditional” approaches. There are a number of COVID-19 vaccine candidates of both types, and for good reason: they’re well-established. We know how to test and manufacture them.

The downside is that they’re time-consuming to make. There’s a ton of material in each dose of a vaccine. Most of that material is biological, which means you have to grow it. That takes time, unfortunately.

That’s why I’m particularly excited by two new approaches that some of the candidates are taking: RNA and DNA vaccines. If one of these new approaches pans out, we’ll likely be able to get vaccines out to the whole world much faster. (For the sake of simplicity, I’m only going to explain RNA vaccines. DNA vaccines are similar, just with a different type of genetic material and method of administration.)

Our foundation—both through our own funding and through CEPI—has been supporting the development of an RNA vaccine platform for nearly a decade. We were planning to use it to make vaccines for diseases that affect the poor like malaria, but now it’s looking like one of the most promising options for COVID. The first candidate to start human trials was an RNA vaccine created by a company called Moderna.

Here’s how an RNA vaccine works: rather than injecting a pathogen’s antigen into your body, you instead give the body the genetic code needed to produce that antigen itself. When the antigens appear on the outside of your cells, your immune system attacks them—and learns how to defeat future intruders in the process. You essentially turn your body into its own vaccine manufacturing unit.

Because RNA vaccines let your body do most of the work, they don’t require much material. That makes them much faster to manufacture. There’s a catch, though: we don’t know for sure yet if RNA is a viable platform for vaccines. Since COVID would be the first RNA vaccine out of the gate, we have to prove both that the platform itself works and that it creates immunity. It’s a bit like building your computer system and your first piece of software at the same time.

Even if an RNA vaccine continues to show promise, we still must continue pursuing the other options. We don’t know yet what the COVID-19 vaccine will look like. Until we do, we have to go full steam ahead on as many approaches as possible.

It might not be a perfect vaccine yet—and that’s okay.

The smallpox vaccine is the only vaccine that’s wiped an entire disease off the face of the earth, but it’s also pretty brutal to receive. It left a scar on the arm of anyone who got it. One out of every three people had side effects bad enough to keep them home from school or work. A small—but not insignificant—number developed more serious reactions.

The smallpox vaccine was far from perfect, but it got the job done. The COVID-19 vaccine might be similar.

If we were designing the perfect vaccine, we’d want it to be completely safe and 100 percent effective. It should be a single dose that gives you lifelong protection, and it should be easy to store and transport. I hope the COVID-19 vaccine has all of those qualities, but given the timeline we’re on, it may not.

The two priorities, as I mentioned earlier, are safety and efficacy. Since we might not have time to do multi-year studies, we will have to conduct robust phase 1 safety trials and make sure we have good real-world evidence that the vaccine is completely safe to use.

We have a bit more wiggle room with efficacy. I suspect a vaccine that is at least 70 percent effective will be enough to stop the outbreak. A 60 percent effective vaccine is useable, but we might still see some localized outbreaks. Anything under 60 percent is unlikely to create enough herd immunity to stop the virus.

The big challenge will be making sure the vaccine works well in older people. The older you are, the less effective vaccines are. Your immune system—like the rest of your body—ages and is slower to recognize and attack invaders. That’s a big issue for a COVID-19 vaccine, since older people are the most vulnerable. We need to make sure they’re protected.

The shingles vaccine—which is also targeted to older people—combats this by amping up the strength of the vaccine. It’s possible we do something similar for COVID, although it might come with more side effects. Health authorities could also ask people over a certain age to get an additional dose.

Beyond safety and efficacy, there are a couple other factors to consider:

  • How many doses will it be? A vaccine you only get once is easier and quicker to deliver. But we may need a multi-dose vaccine to get enough efficacy.
  • How long does it last? Ideally, the vaccine will give you long-lasting protection. But we might end up with one that only stops you from getting sick for a couple months (like the seasonal flu vaccine, which protects you for about six months). If that happens, the short-term vaccine might be used while we work on a more durable one.
  • How do you store it? Many common vaccines are kept at 4 degrees C. That’s around the temperature of your average refrigerator, so storage and transportation is easy. But RNA vaccines need to be stored at much colder temperature—as low as -80 degrees C—which will make reaching certain parts of the world more difficult.

My hope is that the vaccine we have 18 months from now is as close to “perfect” as possible. Even if it isn’t, we will continue working to improve it. After that happens, I suspect the COVID-19 vaccine will become part of the routine newborn immunization schedule.

Once we have a vaccine, though, we still have huge problems to solve. That’s because…

We need to manufacture and distribute at least 7 billion doses of the vaccine.

In order to stop the pandemic, we need to make the vaccine available to almost every person on the planet. We’ve never delivered something to every corner of the world before. And, as I mentioned earlier, vaccines are particularly difficult to make and store.

There’s a lot we can’t figure out about manufacturing and distributing the vaccine until we know what exactly we’re working with. For example, will we be able to use existing vaccine factories to make the COVID-19 vaccine?

What we can do now is build different kinds of vaccine factories to prepare. Each vaccine type requires a different kind of factory. We need to be ready with facilities that can make each type, so that we can start manufacturing the final vaccine (or vaccines) as soon as we can. This will cost billions of dollars. Governments need to quickly find a mechanism for making the funding for this available. Our foundation is currently working with CEPI, the WHO, and governments to figure out the financing.

Part of those discussions center on who will get the vaccine when. The reality is that not everyone will be able to get the vaccine at the same time. It’ll take months—or even years—to create 7 billion doses (or possibly 14 billion, if it’s a multi-dose vaccine), and we should start distributing them as soon as the first batch is ready to go.

Most people agree that health workers should get the vaccine first. But who gets it next? Older people? Teachers? Workers in essential jobs?

I think that low-income countries should be some of the first to receive it, because people will be at a much higher risk of dying in those places. COVID-19 will spread much quicker in poor countries because measures like physical distancing are harder to enact. More people have poor underlying health that makes them more vulnerable to complications, and weak health systems will make it harder for them to receive the care they need. Getting the vaccine out in low-income countries could save millions of lives. The good news is we already have an organization with expertise about how to do this in Gavi, the Vaccine Alliance.

With most vaccines, manufacturers sign a deal with the country where their factories are located, so that country gets first crack at the vaccines. It’s unclear if that’s what will happen here. I hope we find a way to get it out on an equitable basis to the whole world. The WHO and national health authorities will need to develop a distribution plan once we have a better understanding of what we’re working with.

Eventually, though, we’re going to scale this thing up so that the vaccine is available to everyone. And then, we’ll be able to get back to normal—and to hopefully make decisions that prevent us from being in this situation ever again.

It might be a bit hard to see right now, but there is a light at the end of the tunnel. We’re doing the right things to get a vaccine as quickly as possible. In the meantime, I urge you to continue following the guidelines set by your local authorities. Our ability to get through this outbreak will depend on everyone doing their part to keep each other safe.

 

 

 

Melinda Gates: This is not a once-in-a-century pandemic.

Posted on by • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Clinical Research Funding, Clinical Testing, Clinical Trial Recruitment, Clinical Trials, Communication, Coronavirus, Crisis, Crisis Management, Emergency Preparedness, Food and Drug Administration (FDA), Health Policy, Herd Immunity, Infection Control, Infectious Virus, Intensive Care (ICU), Leadership, Leadership Cares, Leadership Trust, Mortality, National Strategy, Pandemic, Personal Protective Equipment (PPE), Public Health, Public Safety, Quarantine, Social Distancing, Vaccination, Vaccine • Leave a comment

https://www.businessinsider.com/melinda-gates-coronavirus-interview-vaccine-timeline-2020-4?linkId=87026774

Melinda Gates

‘We will absolutely have more of these.’ The billionaire philanthropist predicts a timeline for going back to normal.

  • Business Insider spoke with Melinda Gates about COVID-19, the prospect and timeline of making an effective vaccine, and how the world will be permanently changed by the coronavirus.
  • Gates said it would likely take about 18 months for a vaccine to become widely available, and that it should first go to healthcare workers to help them keep others safe.
  • She said this pandemic was not a once-in-a-century situation, like the Spanish flu. Because the world is now a global community, we’re likely to see other pandemics in our lifetimes, Gates said.
  • Even after things get back to normal, “our psyches are going to permanently changed … I hope we change to realize that we’re a global community.”

Melinda Gates is the cochair of the Bill & Melinda Gates Foundation, which has donated more than $45 billion to tackle some of the world’s toughest problems, including vaccination research and combating pandemics, from coronavirus to Ebola.

Gates and her husband have long been concerned about a pandemic and have warned that we need to be more prepared at a global level.

In a wide-ranging interview with Gates on Thursday afternoon, she gave her thoughts on the coronavirus pandemic, the inequality of it all, and how the world can go back to semi-normal. The highlights:

  • The world needs a vaccine delivered at mass scale to go back to “normal.” A realistic timeline is about 18 months, the same time it took to create an Ebola vaccine.
  • It is possible we won’t be able to find an effective vaccine for coronavirus, although Gates thinks that is highly unlikely.
  • The idea of herd immunity solving coronavirus is far-fetched. Gates said that would require more than half the population to get coronavirus (which isn’t anywhere close to happening) and a lot of death along the way.
  • To effectively roll out a vaccine, Gates believes you need to first give it to health workers, then to high-risk groups, then distribute it equitably to different countries and communities. The vaccine also has to cost very little with a fund to cover it for everyone. What the US is doing right now, pitting states against each other for supplies and allowing wealthy individuals to access tests first, would be disastrous for a vaccine rollout.
  • To prepare for the second wave of coronavirus this fall, or even a next pandemic, we need mass testing from the get-go, voluntary data sharing from people so that we can trace who has been tested and where they have been, and vaccine stockpiles so that you can distribute those as soon as you see signs of an outbreak.
  • Gates said there would “absolutely” be more pandemics in our lifetime. Coronavirus is not a once-in-a-century occurrence like the Spanish flu.
  • If you want to help vulnerable, poor communities survive coronavirus, Gates recommends giving to the WHO COVID Solidarity Fund, United Way, or America’s Food Fund.

We need a vaccine to be widely distributed before the world will start to feel normal again. Gates says we won’t get that for at least 18 months.

Alyson Shontell: How is it going in the Gates household?

Melinda Gates: Like all other families, it’s been a complete change of life for all of us. But we are also incredibly privileged, and we know that, and our kids know that. But yes, life has changed drastically. The kids are studying online. Bill and I are doing all of our meetings via video teleconference. I’m a terrible cook, so I’m heating things up a lot more, and everybody’s trying to pitch in to do what needs to get done in terms of things around the house.

And the other thing I would just say is every night, we’ve had this tradition for a long time of saying grace before meals. And what that looks like is that we all go around and say something we’re thankful for. Pretty much every night what comes up from the kids and us is we’re thankful for our health and for the fact that we’re not going hungry and the fact that we can still do our work and the kids can still learn. It’s kind of amazing.

Shontell: We heard Dr. Fauci say earlier this week that things probably won’t return to normal until we have a vaccine. What do you think is a realistic timeline for a wide distribution of a vaccine? Is anything faster than 18 months really safe?

Gates: I think it’s likely 18 months. Just from everything we know from working with our partners for many, many years on vaccines, you have to test the compounds. Then, you have to go into preclinical trials, then full-scale trials. And even though I’m sure the FDA will fast-track some of these vaccine trials like they did with Ebola, still by the time you get it through the trials safety- and efficacy-wise, then you have to manufacture the vaccine and manufacture at scale. I think it really is 18 months.

The good news that I’m seeing on that front, though, is so many scientists are coming forward, and I’m seeing CEOs come forward and say, “I have this platform we can use.” Pharmaceutical companies are coming together already to say, “How do we build up the manufacturing capacity so it’s there when we get a vaccine and we can basically just run it through the manufacturing process?” I’m seeing lots of good things come forward, but it’s a process that needs to run its full course, because you don’t want to put something in someone’s body that is harmful.

Shontell: Right. It seems like, in addition to creating something we’ve never had before, you do really have to do these human tests in a way that’s safe so that you’re not creating a vaccine that maybe cures coronavirus but gives you something else.

Gates: I’d add also that we need to know who it’s safe to give the vaccine to and in what dosages. We know COVID-19 is affecting people who are particularly vulnerable health-wise if they have diabetes, or a heart condition, or they have asthma. You have to make sure that, safety-wise, you’re not giving somebody a vaccine that’s going to affect their heart. So yeah, there are lots of issues there that have to be tested.

It’s possible we won’t be able to create a coronavirus vaccine, although Gates thinks that’s highly unlikely. Also, herd immunity is not the solution.

Shontell: If at the end of this 18-month period, or however long it is, we do feel like we’ve got a vaccine, what do you think that vaccine will actually look like? Is it possible that we actually won’t be able to create a vaccine at all? Could that be one scenario?

Gates: Well, it’s possible. We have to look at how far science has come even in the last five years. And the number of compounds we have, there’s something like 14,000 compounds that we, with our partners alone, have. And there are many, many, many others testing compounds that we’re looking at to see, “Is this promising?” Could that one be promising? And we have high throughput screening now of compounds. I really think we’re going to find a vaccine.

We found a vaccine for Ebola, right? And we did that in about an 18-month time frame, and that was hard. When I see the scientific community all coming together the way they are around the globe and sharing data and sharing information, we’re going to get a vaccine.

Shontell: OK, so you’d say that it’s a high likelihood.

Gates: High likelihood.

Shontell: That’s very, very good to know.

Gates: The other thing to think about is, in the meantime, there’s another whole strand of work going on, which is the therapeutics accelerator. Through the accelerator, we’re trying to find medicines so that if you get COVID-19, hopefully we can boost your immune system or tamp down the effect of the disease on you. So again, hopefully, we’ll come up with some medicines that will also help so people don’t get as sick as they’re getting and landing in the ICU, which is what’s truly tragic.

Shontell: Is there anything to this idea of herd immunity? Could we be closer than we think on that, or is that far-fetched thinking?

Gates: That’s still very far-fetched today. You don’t get herd immunity until you have a huge percent of your population that has had the disease. We know that from all the diseases in the past that humans have had. So no, we’re still a long way from herd immunity. And you can’t count on that because a lot of people are going to die in the meantime if you let the experiment run and you just let the disease run its course in communities. Sure, we could get herd immunity and we will get so much death. That’s why it’s so important to remind people the only tools we have today are physical distancing, handwashing, and wearing masks in public. We have to go with what we know works.

How to distribute a coronavirus vaccine to the masses: 1. Make it cheap and buy it for everyone. 2. Give it to healthcare workers. 3. Give it to the highest-risk people. 4. Come up with an equitable way for everyone else to get it (the US is screwing that up right now).

Shontell: Once we have a vaccine, what do you think is the best way to distribute it to the masses? Who should get it first? How would we do it on such a big scale?

Gates: We have to make sure that the vaccine is very low priced and that there’s a fund for buying it for everyone, whether you’re in a low-, middle-, or a high-income country. And that’s doable. We’ve done that with the Vaccine Alliance that exists today. That’s been in existence since 1990, so we know how to do that piece.

But we also have to distribute very carefully. The very first people that need to get this vaccine are healthcare workers, because if you can keep them safe, they can help keep others safe. Then you need to distribute it to the people who are the very most vulnerable. That is, they have underlying health conditions, some of the ones that we’ve talked about before. And from there, you then make it distributed completely equitably across society.

And even the United States is going to have to really work at that. COVID-19 is exposing all the inequities we have in our healthcare system. And so we need to look at, OK, does Mississippi get this vaccine at the same time California gets it and New York gets it? We can’t do this game that we’re playing right now where you have 50 different states competing for resources for masks and PPE, that makes zero sense. You need a national strategy that will equitably distribute this vaccine and we first look at the vulnerable populations.

Shontell: To touch on that point, as you mentioned, there are so many inequalities coming to light with this pandemic, from who has been able to get initial testing on to how it’s affecting different genders in different ways, to more African Americans in the US dying of this than other races. When you think about it, social distancing, stocking up on food, and handwashing are all privileges that some of the poorest communities don’t have.

You’ve done a lot of work on equality efforts, and you’ve said it’s the best way to fix everything in society is to level the playing field. How do we start leveling the playing field so the next time it’s better for everybody? How do we help the people who are in the poorest, most vulnerable communities right now?

Gates: We have to start by remembering that COVID-19 anywhere is COVID-19 everywhere. And if we keep that front and center in our minds, then we will start to think really deeply about these most vulnerable populations.

The thing that keeps me up at night — because I’ve traveled to Africa so many times and been in so many townships and slums — is if you are a person living in those conditions, you can’t begin to handwashing or social distance. In those situations, we need to start with food. People need to be able to feed themselves. And then if they feel like they have COVID symptoms, then they don’t have to go out of the house looking for food.

When I think forward about how we would do this, right now, we have to focus on the pandemic today right in front of us. We have to take the tools we have and try and distribute them as equitably as we possibly can. That means a national response that is thought out and strategic. So you start there.

When you plan for the future, you start to plan it out the way we did for other diseases that came into the world. You would create a vaccine stockpile. We’ve actually been quite involved with that for cholera, which we don’t get much in the United States anymore, but you get in a lot of places in the developing world or in refugee camps. And when there’s a stockpile of vaccine, then when you see an outbreak or a vulnerable population get it, it’s already basically paid for and you ship the vaccines out.

We have to have not a national stockpile of vaccines but an international stockpile of vaccines for something like COVID. We can predict some of these types of disease outbreaks; we just haven’t been planning it. We plan for things like an earthquake or a fire. We need to plan for disease. We are a global community. People travel. We’ve just learned that New York mostly got infected from people coming back from Europe. We have to plan for these things as a global community in the future.

How to be ready for the 2nd wave to hit this fall: Are you ready to give up your personal data and get tracked?

Shontell: Clearly, we were caught flat-footed and unprepared here in the US especially. There’s talk of a second wave of coronavirus potentially hitting in the fall. What are the things we need to do to plan for it? What has to be done by the end of the summer to put us all in a much better shape for it? And then I’m curious what we need to have in place to prevent something like this moving forward, if that’s even possible.

Gates: In terms of what we need to do to prepare ourselves this fall, first of all, all the way through this, we need to listen to the medical experts and the science experts. They know what’s real. We need to do the disease modeling to see where the outbreaks are going. We need to plan resources appropriately and share them in the United States with all the states in an equitable way.

And then we need to do massive testing. We have to have testing at wide scale so that you can get a test and you can know if you’re positive. And if you’re positive, then you self-isolate. Unless you get further disease, you then get telemedicine. You figure out if you need to go to the health system. And you have different tiers of the health system, places people can go for oxygen versus people who go to the ICU.

We can do that, kind of. You can do that triage of people if you have a test. To be frank, we also need to be able to share all that testing data so that eventually the US would be a place like South Korea, where I can literally prove on my phone “I took a test this morning — I’m COVID-free” or “Guess what? I had COVID before and I tested for antibodies in my system. I can be out in society working maybe now.” You could literally have a code on your phone that says, “Tested this morning” or “See? I have a COVID antibody.”

And so we can start to see who can be in society versus who needs to self-isolate. But without testing and contact tracing and some way of being able to prove to one another we’re safe, you can’t plan for a full eventual reopening of society. We need to do get that up and running at scale at a national level.

Preparing for the next epidemic is a whole different conversation. You’d have tests available from the get-go. You would have fought through the civil-liberties issues of people sharing their health information willingly or not willingly. Am I willing to share my health data so that you know if I got it?

Early on, people with COVID had symptoms we didn’t know to track. If we had known that from the get-go because they were able to share their information into a national database voluntarily, we would have known to tell people, “Look for these symptoms. Self-isolate just in case you have it.” We have to be able to start thinking through those types of systems as a country so that we’re prepared for whatever comes next.

Whose job is it to solve a pandemic, the elite’s or the government’s?

Shontell: Yes to all of that. Edelman put out on their annual Trust Barometer in January. They found that trust in media is really low right now. Trust in the government is really low too. But trust in business leaders is the highest group, and people seem to put the most faith in business leaders to solve some of society’s biggest problems.

You and Bill have done a tremendous amount with the foundation. You’re seeing Mark Zuckerberg giving a ton of money toward this. Sheryl Sandberg is doing the same. Jack Dorsey just pledged a big chunk of net worth to help fight COVID. Lots of people are stepping up. Bezos as well.

Is it the responsibility of business leaders to do this versus the government? Is this something we should come to expect? How do you kind of view the responsibility of the people who are in positions of the most privilege as we tackle something as wide-scale is this?

Gates: What I’m seeing is people stepping up. I sometimes wish people could see the number of emails we’re receiving daily at the foundation, not just Bill and me, but our scientists and our head of global health. We’re seeing CEOs come forward. We’re seeing philanthropists come forward. We’re seeing people who have knowledge and data saying, “Should we look at this? What should we do?” I am seeing the best of humanity come out right now in some of these leaders who are stepping forward and doing the right thing.

“Is this the responsibility of business?” was your question. It’s the responsibility of all of us. Business won’t be able to solve this. There’s no way business or philanthropy can solve this alone. It takes the government. It’s government who puts out huge amounts of money into our healthcare system to take care of everybody, to take care of the most vulnerable. It’s philanthropy and business and nonprofits coming together with government to have a national response. That is the only way we’re going to be able to care for all Americans.

But what I see is amazing scientists like Dr. Fauci stepping up and giving all the right messages. Those are the people we should be listening to, and I am seeing so many people come together behind the scenes to try and do the right thing. While the vulnerable is what keeps me up at night, one of the things that keeps me encouraged when I wake up in the morning is seeing so many people doing the right thing.

This is not just a once-in-a-century pandemic. ‘We are absolutely going to have more of these.’

Shontell: Is this a once-in-a-century pandemic like the Spanish flu, or do we need to expect to face more pandemics like this moving forward?

Gates: This is not a once-in-a-century pandemic. We are absolutely going to have more of these. This thing is highly infectious, COVID-19. But it is not nearly as infectious as measles. And we dealt with measles in the world. We know how to deal with measles. We’re going to see more, so we need to plan for them. And we haven’t planned for them as a global community.

Shontell: Why do you think we’ll see more pandemics?

Gates: We’ll see more because of all kinds of reasons, but mainly because we’re a global community and we travel and we spread disease.

Alyson: To end on a positive note, we are going to get through this, right? It will be hard, but we will get through this. I’m curious from your estimation: What timeline are we looking at for life to feel normal again? Or are we in a new normal, and are there things that we should expect to be permanently changed?

No one really knows when things will feel normal again. But be prepared for some permanent changes, including to your psyche.

Gates: I definitely think there are going to be things that are permanently changed. Our psyches are going to be permanently changed. We are learning some things about how to do more meetings online. We’re learning how to take care of each other online. People are reaching out to the elderly in their homes and doing video calls and sending emails or dropping a meal off. What’s going to change is our psyche, and I hope we change to realize that we’re a global community.

To the question of when does society reopen in what we think of as our normal form, nobody really knows the answer to that. It really is when we get a vaccine at scale.

Will we get, over time, probably some partial reopenings of society where you can do certain smaller group things or be out walking with one friend or two friends? I think we will start to see some partial reopenings.

We have to follow the data, though, of how is that working in Wuhan right now? How did it work in South Korea? How does it work in Germany? The places that are kind of ahead of us on both their response and when they got the disease? And then, we’ll start to be able to see, OK, where can we open up pockets of society over time? For right now, we need to be physically distant from one another.

Shontell: If the average person wants to give to help a vulnerable person or community, what’s the best way to do that other than social distancing? Is there some cause to give to or something that’s most helpful?

Gates: Yes. You could go globally. You could go to the WHO COVID Solidarity Fund. Locally, you could go to United Way. America’s Food Fund is another place you can go. I would give also to local domestic-violence organizations. We see domestic violence on the rise for many, many people, particularly women. Any of those would be amazing places to go and to give, even if you only give $10 — $10 or $100, it all makes a difference.

Shontell: I’m leaving this conversation very hopeful. Thank you for all efforts you and Bill and the foundation are doing in helping fight this. You were early to realizing the problems of pandemics, and we are grateful that you’re on it.

Gates: Thanks, Alyson. Be safe. Be well.

 

 

 

Bill Gates says the world is entering ‘uncharted territory’ because it wasn’t prepared for a pandemic like COVID-19

Posted on by • Posted in Centers for Disease Control & Prevention (CDC), Clinical Research, Clinical Research Funding, Clinical Testing, Clinical Trial Recruitment, Coronavirus, Dept of Health and Human Services (HHS), Economic Crisis, Economic Impact, Economic Stimulus, Economy, Failure, Health Policy, Infection Control, Infectious Virus, Intensive Care (ICU), Leadership Cares, Leadership Integrity, Leadership Respect, Leadership Trust, Pandemic, Public Health, Public Safety, Ventilators • Leave a comment

https://www.businessinsider.com/bill-gates-warns-world-is-entering-uncharted-territory-coronavirus-2020-4

5 Books Bill Gates Wants You to Read This Summer | Time

  • Microsoft cofounder Bill Gates said the world was entering into “uncharted territory” because it was not prepared for a pandemic like COVID-19, the disease caused by the novel coronavirus.
  • Speaking to “BBC Breakfast” by video chat on Sunday, Gates said the world should’ve invested more in mitigating a global health crisis.
  • “There is the period where the virus shows up in those first few months,” he said. “Were the tests prepared? Did countries think through getting their ICU and ventilator capacity up?”
  • He added that once the crisis is over “very few countries are going to get an A grade” for their handling of the outbreak.

Microsoft cofounder Bill Gates said the world was entering into “uncharted territory” because it was not prepared for a pandemic like COVID-19, the disease caused by the novel coronavirus.

Gates, who has been warning about the risk of a pandemic disease for years and who has poured millions into fighting the new coronavirus outbreak, told “BBC Breakfast” on Sunday that the world should have invested more into mitigating a global health crisis.

“Well, there was a period when I and other health experts were saying that this was the greatest potential downfall the world faced,” he told the BBC in an interview on Sunday, highlighting his previous warnings against the possibility of a deadly pandemic.

“So we definitely will look back and wish we had invested more,” he said, “so that we could quickly have all the diagnostics, drugs, and vaccines. We underinvested,” he said.

The 67-year-old billionaire warned that in the period before COVID-19 became a public-health crisis, countries could have better prepared their testing capabilities and made sure hospitals were stocked with ventilators and other necessary health supplies.

“There is the period where the virus shows up in those first few months,” he said. “Were the tests prepared? Did countries think through getting their ICU and ventilator capacity up?”

He added that once the crisis is over “very few countries are going to get an A grade” for their handling of the outbreak.

“Now, here we are, we didn’t simulate this, we didn’t practice,” he said. “So both in health policies and economic policies, we find ourselves in uncharted territory.”

Gates has become an outspoken advocate for preparing for a global health crisis like COVID-19.

Speaking to the Financial Times earlier this month, Gates said that COVID-19 was the “biggest event that people will experience in their entire lives” and world leaders and global policymakers have “paid many trillions of dollars more than we might have had to if we’d been properly ready.”

He told FT he was confident that lessons learned from this outbreak would encourage people to better prepare for next time but lamented that the cost this time around was too high.

“It shouldn’t have required a many trillions of dollars loss to get there,” he said. “The science is there. Countries will step forward.”

 

 

 

 

South Korea is winning the fight against covid-19. The U.S. is failing.

Posted on by • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Clinical Research Funding, Clinical Testing, Communication, Coronavirus, Crisis, Crisis Management, Denial, Emergency Preparedness, Health Policy, Indecision, Infection Control, Infectious Virus, Leadership, Public Health, Public Safety, Social Distancing, Trust, Truth, World Health Organization (WHO) • Leave a comment

https://www.washingtonpost.com/outlook/2020/04/10/south-korea-is-winning-fight-against-covid-19-us-is-failing/?fbclid=IwAR0Fizr7BiOZgPxJVjHpHcuetAnn_UcamZDfmY16V4_RG3xV52rOXryIepk&utm_campaign=wp_main&utm_medium=social&utm_source=facebook

Confucianism Isn't Helping South Korea Beat the Coronavirus

South Korea’s blueprint for victory.

As the coronavirus spreads rapidly around the world, killing thousands and leaving governments scrambling to deal with the fallout, one country has repeatedly drawn praise for its efficiency in dealing with it: South Korea. After the first cases appeared, the South Korean government ramped up testing at a speed almost unimaginable in the United States. Its swift response slowed the spread of the virus and saved thousands of lives. As of April 8, South Korea had suffered 200 deaths due to the virus (4 per 1 million of population) and the number of new cases has slowed, while the United States had suffered 13,000 deaths (39 per 1 million population) with new cases continuing to grow quickly.

How did this happen? For many it is baffling that a relatively small Asian country could succeed where much of the rest of the world tragically failed. Was it South Korea’s experience dealing with another respiratory epidemic illness, Middle East respiratory syndrome, in 2015? Its excellent and affordable health-care system? Its cultural values? Mask-wearing? Some of these factors doubtless accelerated South Korea’s rapid deployment of testing stations and its subsequent efforts to identify and treat patients.

But the efficient South Korean response also hinged on two historically rooted factors: the close cooperation between the state and the private sector, and the South Korean public’s willing and almost enthusiastic embrace of a large-scale medical intervention. The origins of both of these phenomena lie in the South Korean experience of rapid industrialization and nation-building during the Cold War.

After the first cases of covid-19 were reported in South Korea on Jan. 20, the government recognized the need for prompt and comprehensive action. According to Reuters, South Korean Health Ministry officials called a meeting with representatives from medical companies in January when only four cases of the virus had been confirmed. The health officials told the executives that the country needed to have tests ready in short order, and they promised rapid approval by the Korea Centers for Disease Control and Prevention. In scarcely one week, the government had approved a test kit developed by Kogene Biotech and would soon fast-track the approval of test kits developed by several other companies.

The endeavor was so successful that by March, 47 countries were seeking to import South Korean test kits. Compared with President Trump, who has squabbled with 3M and General Motors over the production of masks and ventilators, the government and private sector worked together seamlessly in South Korea. Companies responded quickly to the state’s demands while receiving strong government support.

The private companies’ swift response to an urgent government fiat followed a pattern of state-private sector partnership in the service of the nation that was pioneered by South Korea’s authoritarian ruler Park Chung Hee during the 1960s. When Park seized power in a military coup in 1961, South Korea was among the poorest countries in the world and, from the perspective of many U.S. officials who often called it a “rat hole,” it was hopeless. But Park was driven by an all-consuming determination to achieve double-digit economic growth rates and raise living standards in his impoverished country.

Although Park received much advice from the United States during his 19 years in power, the model of development he came up with did not emulate the American style of free-market capitalism at all. It bound South Korean conglomerates closely to the state, offering them special incentives if they followed state guidance and performed. During the 1960s, Park recognized that to achieve an economic takeoff, he needed to dramatically increase exports. His government made low-interest loans available to companies that were willing to test their mettle exporting textiles, wigs and other light-manufactured goods abroad. Those that succeeded were rewarded with even greater largesse from the state.

This development model had a dark side, of course. The cozy ties between the state and businesses facilitated corruption, strengthened Park’s grip on power and heightened repression. But from a purely economic standpoint, it worked. Exports increased, Korean firms captured a growing share of international markets, and per capita income rose.

Park never strayed far from his military roots. The managerial techniques and soldierly discipline he had learned in his years as an officer informed his approach to development. American aid officials were impressed by how his presentations seemed to come “straight out of the U.S. military briefing manuals.” South Korea’s rapid response to the coronavirus has contained echoes of this military ethos, although the country shifted to more democratic governance in the 1980s and 1990s. “We acted like an army,” one infectious-disease specialist in Korea told Reuters.

Cold War nation-building in South Korea brought not only state-led economic development, but also new kinds of government-led medical interventions. As historian John P. DiMoia has explained, during the 1950s, many South Koreans were still unfamiliar with Western medicine and did not initially welcome official health programs. This began to change under Park Chung Hee’s rule. The South Korean leader launched public health campaigns that fundamentally changed both the medical profession and the public’s attitude toward it. New professional standards were demanded of doctors and their support staff, while the public was encouraged — and at times coerced — to participate in family planning and other state-organized health interventions.

The swift rollout of coronavirus testing was not South Korea’s first large-scale effort to combat an infectious organism. During the 1960s, according to DiMoia, one of the biggest medical problems plaguing South Korea was parasite infestation. The Park government made a concerted effort to eradicate parasites through a national testing program that targeted elementary school students. For nearly two decades, collecting of stool samples for analysis was a routine part of life for South Korean children. The children that learned — at times grudgingly — to accept government testing for parasites during the 1970s and 1980s are now the adults who willingly line up to be tested for the coronavirus.

Today, the Moon Jae-in government’s response to the virus has not been without flaws and criticism. The South Korean media has blamed him for not moving quickly enough to ban Chinese tourists when the virus began spreading rapidly. Others have criticized the high degree of state surveillance that accompanied the rollout of testing. The government would have had far more difficulty carrying out contact tracing if it could not have closely followed the movement of its citizens through their smartphones and credit cards.

Here, too, there are faint echoes of South Korea’s authoritarian past, which was too often marked by the close monitoring of students, intellectuals and other dissidents by military regimes.

But Moon, who was imprisoned during the 1970s for protesting Park Chung Hee’s authoritarian rule, has been careful to keep his policies within the confines of democratic accountability. Conservative U.S. commentators who claim South Korea has succeeded because it is not a democracy have it wrong. In fact, South Korea has avoided the draconian lockdowns and travel restrictions imposed by the Communist Party of China. Through the use of technology and data, South Korean has been able to keep businesses open to a greater extent than most parts of the United States.

South Korea’s impressive management of the coronavirus only strengthens its rapidly growing cultural influence around the world, which is abundantly clear in the widespread popularity of K-pop and the unprecedented success of the Korean film “Parasite” at the Academy Awards.

The Moon government’s deft handling of a global pandemic that has taken on nightmarish proportions elsewhere has drawn praise from health experts and policymakers worldwide, with many citing it as a model. “Let’s not follow Italy, let’s follow South Korea,” Sen. Mitt Romney (R-Utah) said recently when talking about how the United States should deal with its own swiftly escalating crisis.

Unfortunately, it is too late for the United States to emulate South Korea and avert thousands of deaths. But we could learn from its example, by encouraging better public-private partnerships in manufacturing needed medical equipment and protective gear and by encouraging Americans to embrace public health initiatives, including widespread testing, to save lives.

 

 

 

Trump considering suspending funding to WHO

Posted on by • Posted in 2020 Election Issues, Accusations, Blame, Centers for Disease Control & Prevention (CDC), Clinical Research Funding, Clinical Testing, Coronavirus, Crisis, Crisis Management, Excuses, Health Policy, Incoherent, Indecision, Infection Control, Infectious Virus, Pandemic, World Health Organization (WHO) • Leave a comment

https://thehill.com/homenews/administration/491671-trump-considering-suspending-funding-to-who?utm_source=&utm_medium=email&utm_campaign=28856

WHO declares the outbreak of the new coronavirus is a pandemic ...

President Trump said Tuesday that he would consider placing a hold on funding for the World Health Organization (WHO), expressing grievances with its handling of the novel coronavirus.

“They missed the call. They could have called it months earlier. They would have known, and they should have known, and they probably did know,” Trump told reporters at a White House press briefing, suggesting the WHO failed to sufficiently warn the global community about the virus.

“We’re going to be looking into that very carefully, and we’re going to put a hold on money spent to the WHO,” Trump continued. “We’re going to put a very powerful hold on it, and we’re going to see. It’s a great thing if it works, but when they call every shot wrong, that’s not good.”

Pressed later by a reporter on whether it was a good idea to put a hold on funding during a global pandemic, the president clarified that he was considering suspending funding to the WHO.

“I’m not going to say I’m going to do it,” Trump said. “We will look at ending funding.”

The United States is the largest contributor to the WHO’s budget. The president’s fiscal 2021 budget request proposed slashing funding to the WHO, a body of the United Nations responsible for international public health, from $122 million to about $58 million.

The president said the WHO seemed to be “very biased towards China” and accused the organization of disagreeing with his travel restriction on flights coming in from China. He suggested the organization was blind to the extent of the outbreak in Wuhan, the capital of China’s Hubei province, where the virus originated.

The WHO said in early February that widespread travel bans that interfere with international travel and trade were not necessary to prevent the spread of COVID-19, days after the Trump administration announced it would restrict travel coming into the U.S. from China. It did not take particular issue with the president’s travel restriction.

“They actually criticized and disagreed with my travel ban at the time I did it, and they were wrong. They’ve been wrong about a lot of things. They had a lot of information early, and they didn’t — they seemed to be very China-centric. We have to look into it,” Trump told reporters.

When a reporter asked Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, to answer a question on the WHO, Trump interjected before he answered, saying Fauci “respects the WHO, and I think that’s good.”

“But they did give us some pretty bad play-calling,” Trump said.

The remarks, expanding on a critical tweet he sent earlier Tuesday, come amid growing criticism among conservatives of the WHO’s handling of the coronavirus outbreak. Some have accused the organization of leaving other nations unprepared for the virus.

Sen. Martha McSally (R-Ariz.) last week called on WHO Director-General Tedros Adhanom Ghebreyesus to resign, after reports emerged that the U.S. intelligence community had concluded China underreported its count of coronavirus cases. McSally accused the WHO of helping China conceal the extent of the outbreak.

Trump has faced criticism for at first downplaying the threat from the coronavirus, and his administration has been scrutinized for early delays in testing that hampered the overall response. Trump has often pointed to his early action restricting travel from China as a sign his administration was quick to confront the outbreak.

Ezekiel Emanuel, a special adviser to the director general of the WHO, was critical of Trump’s remarks on the coronavirus at the end of February, saying he found much of what Trump said at his first press briefing on the domestic virus outbreak to be “incoherent.”

 

 

 

 

How Epidemics of the Past Changed the Way Americans Lived

Posted on by • Posted in Clinical Research, Clinical Research Funding, Communication, Epidemic, Health Policy, Pandemic, Public Debate, Public Discourse, Waste Management • Leave a comment

https://www.smithsonianmag.com/history/how-epidemics-past-forced-americans-promote-health-ended-up-improving-life-this-country-180974555/?fbclid=IwAR1_2pHlIidRC01Bjxr7IFOpUBq1ShM8xXXGBkPFT8J6ZK1PtGgtNh9NJ0s

How Epidemics of the Past Changed the Way Americans Lived ...

Past public health crises inspired innovations in infrastructure, education, fundraising and civic debate.

At the end of the 19th century, one in seven people around the world had died of tuberculosis, and the disease ranked as the third leading cause of death in the United States. While physicians had begun to accept German physician Robert Koch’s scientific confirmation that TB was caused by bacteria, this understanding was slow to catch on among the general public, and most people gave little attention to the behaviors that contributed to disease transmission. They didn’t understand that things they did could make them sick. In his book, Pulmonary Tuberculosis: Its Modern Prophylaxis and the Treatment in Special Institutions and at Home, S. Adolphus Knopf, an early TB specialist who practiced medicine in New York, wrote that he had once observed several of his patients sipping from the same glass as other passengers on a train, even as “they coughed and expectorated a good deal.” It was common for family members, or even strangers, to share a drinking cup.

With Knopf’s guidance, in the 1890s the New York City Health Department launched a massive campaign to educate the public and reduce transmission. The “War on Tuberculosis” public health campaign discouraged cup-sharing and prompted states to ban spitting inside public buildings and transit and on sidewalks and other outdoor spaces—instead encouraging the use of special spittoons, to be carefully cleaned on a regular basis. Before long, spitting in public spaces came to be considered uncouth, and swigging from shared bottles was frowned upon as well. These changes in public behavior helped successfully reduce the prevalence of tuberculosis.

As we are seeing with the coronavirus today, disease can profoundly impact a community—upending routines and rattling nerves as it spreads from person to person. But the effects of epidemics extend beyond the moments in which they occur. Disease can permanently alter society, and often for the best by creating better practices and habits. Crisis sparks action and response. Many infrastructure improvements and healthy behaviors we consider normal today are the result of past health campaigns that responded to devastating outbreaks.

In the 19th century, city streets in the U.S. overflowed with filth. People tossed their discarded newspapers, food scraps, and other trash out their windows onto the streets below. The plentiful horses pulling streetcars and delivery carts contributed to the squalor, as each one dropped over a quart of urine and pounds of manure every day. When a horse died, it became a different kind of hazard. In “Portrait of an Unhealthy City,” Columbia University professor David Rosner writes that since horses are so heavy, when one died in New York City, “its carcass would be left to rot until it had disintegrated enough for someone to pick up the pieces. Children would play with dead horses lying on the streets.” More than 15,000 horse carcasses were collected and removed from New York streets in 1880. Human waste was a problem, too. Many people emptied chamber pots out their windows. Those in tenement housing did not have their own facilities, but had 25 to 30 people sharing a single outhouse. These privies frequently overflowed until workers known as “night soil men” arrived to haul away the dripping barrels of feces, only to dump them into the nearby harbor.

As civic and health leaders began to understand that the frequent outbreaks of tuberculosis, typhoid and cholera that ravaged their cities were connected to the garbage, cities began setting up organized systems for disposing of human urine and feces. Improvements in technology helped the process along. Officials began introducing sand filtration and chlorination systems to clean up municipal water supplies. Indoor toilets were slow to catch on, due to cost, issues with controlling the stench, and the need for a plumbing system. Following Thomas Crapper’s improved model in 1891, water closets became popular, first among the wealthy, and then among the middle-class. Plumbing and sewage systems, paired with tenement house reform, helped remove excrement from the public streets.

Disease radically improved aspects of American culture, too. As physicians came to believe that good ventilation and fresh air could combat illness, builders started adding porches and windows to houses. Real estate investors used the trend to market migration to the West, prompting Eastern physicians to convince consumptives and their families to move thousands of miles from crowded, muggy Eastern cities to the dry air and sunshine in places like Los Angeles and Colorado Springs. The ploy was so influential that in 1872, approximately one-third of Colorado’s population had tuberculosis, having moved to the territory seeking better health.

Some of this sentiment continues today. While we know that sunshine doesn’t kill bacteria, good ventilation and time spent outside does benefit children and adults by promoting physical activity and improving spirits—and access to outdoor spaces and parks still entices homebuyers. This fresh-air “cure” also eventually incited the study of climate as a formal science, as people began to chart temperature, barometric pressure and other weather patterns in hopes of identifying the “ideal” conditions for treating disease.

Epidemics of the past established an ethos of altruism in the U.S. During the 1793 yellow fever epidemic, Philadelphians selflessly stepped up to save their city. With no formal crisis plan, Mayor Matthew Clarkson turned to volunteers collect clothing, food and monetary donations; to pitch a makeshift hospital; and to build a home for 191 children temporarily or permanently orphaned by the epidemic. Members of the Free African Society, an institution run by and for the city’s black population, were particularly altruistic, providing two-thirds of the hospital staff, transporting and burying the dead and performing numerous other medical tasks.

A 20th-century diphtheria outbreak in a small region in the Alaska Territory inspired a national rally of support—and created the Iditarod, the famous dog sled race. When cases of “the children’s disease” began to mount in Nome, Alaska, in January 1925, the town was in trouble. Diphtheria bacteria produces a toxin, making it especially deadly, unless the antitoxin serum is administered. This serum had been readily available for decades, but Nome’s supply had run short, and the town was inaccessible by road or sea in the winter. Leaping into action, 20 of the area’s finest dogsled teams and mushers carried a supply of the serum all the way from Fairbanks—674 miles—in record time, facing temperatures of more than 60 degrees below zero. Their delivery on February 2nd, plus a second shipment a week later, successfully halted the epidemic, saving Nome’s children from suffocation. Newspapers across the country covered the rescue. It was also memorialized in movies (including the animated Balto), with a Central Park statue—and, most notably, with the annual Iditarod race. The significant challenges of delivery by dogsled also sparked investigation into the possibilities of medical transport by airplane, which takes place all the time in remote areas today but was still in its infancy at the time.

Diseases fueled the growth of fundraising strategies. The polio epidemic of 1952 sickened more than 57,000 people across the United States, causing 21,269 cases of paralysis. The situation became so dire that at one point, the Sister Kenny Institute in Minneapolis, a premier polio treatment facility, temporarily ran out of cribs for babies with the disease. In response, the National Foundation of Infantile Paralysis (NFIP), which had been founded in 1938 by President Franklin D. Roosevelt and later came to be known as the March of Dimes, distributed around $25 million through its local chapters. It provided iron lungs, rocking chairs, beds and other equipment to medical facilities, and assigned physicians, nurses, physical therapists, and medical social workers where they were needed. The March of Dimes success has served as the gold standard in public health education and fundraising since its heyday in the 1940s and 1950s.

Public health emergencies have inspired innovations in education. Starting in 1910, Thomas Edison’s lab, which had invented one of the first motion picture devices in the 1890s, partnered with anti-TB activists to produce short films on tuberculosis prevention and transmission—some of the first educational movies. Screened in public places in rural areas, the TB movies were also the first films—of any type—that viewers had ever seen. The anti-tuberculosis crusade was also a model for later NFIP efforts to combat polio that relentlessly put that disease at the front of public agenda until an effective vaccination was developed and implemented, and set a standard for future public health campaigns.

Past epidemics fueled the growth of civic debate and journalism in the U.S., too. As far back as colonial times, newspapers built their audiences by providing an outlet for debate on controversial issues, including disease. Founders of the New England Courant—the first paper in Colonial America to print the voices and perspectives of the colonists—launched their paper as a vehicle to oppose smallpox inoculation during the 1721 Boston epidemic. As smallpox ravaged the city, a Boston doctor named Zabdiel Boylston began using inoculation, a practice in which people are intentionally infected with a disease, to produce milder cases and reduce mortality risk. Backed by those opposed to the practice, James Franklin started the Courant to serve as a tool to fight it. Inoculation’s success was demonstrated in 1721 and later smallpox epidemics, eventually convincing even staunch opponents of its value—but by inspiring an outlet to air their concerns, the anti-inoculation camp had made an important contribution to public discourse.

Since colonial times, newspapers, pamphlets, and a host of other outlets have continued to thrive and evolve during outbreaks—updating the public on believed transmission and remedies, announcing store closing and quarantine restrictions, advertising outbreak-related job openings (florists, nurses, grave diggers, coffin makers, to name a few), and serving as spaces for public debate. The cycle continues today, as media powers and regular citizens flock to social media to discuss COVID-19—disseminating information, speculating on its origins, expressing fear of its unknowns.