Category Archives: Clinical Trials

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.

 

 

 

 

 

Murky data fragments about a coronavirus drug

Posted on by • Posted in Clinical Failure, Clinical Research, Clinical Testing, Clinical Trials, Coronavirus, Pandemic, Remdesivir, Scientists • Leave a comment

https://www.axios.com/newsletters/axios-vitals-d53939d5-90fb-4aef-a87d-30cf2b0ceebf.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

Fact Check: Politicians on both sides make misleading claims about ...

Depending on the study, remdesivir is either a clinical failure or a godsend for treating the novel coronavirus, Axios’ Bob Herman reports.

The big picture: The grim reality of the coronavirus pandemic has the world itching to know which experimental treatments actually work, but we’re not necessarily getting any smarter from these incremental drips of incomplete information.

Driving the news: Remdesivir — an antiviral drug that some experts have seen as a promising coronavirus treatment — “was not associated with clinical or virological benefits” for coronavirus patients, according to a summary of a clinical trial in China, viewed by STAT and the Financial Times.

Between the lines: The truth is we still don’t really know how effective the drug is in fighting this virus.

  • The Chinese trial has a randomized control group, so it is by far the most reliable study. However, the trial has not gone through peer review, and Gilead said the results were “inconclusive” because the trial had to be terminated early.

The bottom line: Science is slow for a reason, and the deluge of poorly designed trials and early drafts of studies is sowing confusion instead of creating clarity.

What’s next: A more rigorous report from Gilead’s Chinese trial is expected at the end of this month, and data from other trials is expected in late May.

 

 

 

 

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.