AstraZeneca vaccine up to 90% effective and easily transportable, company says

Coronavirus vaccine by AstraZeneca and Oxford up to 90 percent effective -  The Washington Post

AstraZeneca on Monday became the third pharmaceutical company to announce remarkable results from late-stage trials of a coronavirus vaccine, saying that its candidate, developed by Oxford University, is up to 90 percent effective.

This is the third straight week to begin with buoyant scientific news that suggests, even as coronavirus cases surge to devastating levels in many countries, an end to the pandemic is in sight.

Pfizer and its German partner BioNTech and Moderna have each reported vaccines that are 95 percent effective in clinical trials. A direct comparison to the Oxford-AstraZeneca vaccine is complicated, due to the trial design, but the vaccine may be a more realistic option for much of the world, as it is likely to be cheaper and does not need to be stored at subzero temperatures.

Peter Piot, director of the London School of Hygiene & Tropical Medicine, who was instrumental in the battle against AIDS, said the positive results from three vaccine candidates cannot be overestimated.

“2020 will be remembered for the many lives lost from covid-19, lockdowns and the U.S. election. Science should now be added to this list,” said Piot, adding, “the only way to stop covid-19 in its tracks is having multiple effective and safe vaccines that can be deployed all around the world and in vast quantities.”

“I’m totally delighted,” said Hildegund C.J. Ertl, a vaccine expert at the Wistar Institute in Philadelphia. Adding to the results from Pfizer and Moderna, “what it tells me is this virus can be beaten quite easily: 90 to 95 percent efficacy is something we’d dream about for influenza virus, and we’d never get it.”

The Oxford-AstraZeneca team said in a video conference with journalists that its candidate offered 90 percent protection against the virus when a subject received a half-dose, followed with a full dose one month later. Efficacy was lower — 62 percent — when subjects received two full doses a month apart. The interim results, therefore, averaged to 70 percent efficacy.

Andrew Pollard, chief investigator of the Oxford trial, said the findings showed the vaccine would save many lives.

“Excitingly, we’ve found that one of our dosing regimens may be around 90 percent effective, and if this dosing regimen is used, more people could be vaccinated with planned vaccine supply,” he said.

Britain has preordered 100 million doses — which at a dose and a half per person would cover most of its population. The United States has ordered 300 million.

The results have yet to be peer-reviewed or published, and will be scrutinized by regulators. Many questions remain, including whether the vaccine can reduce transmission of the virus by people without symptoms, which would have repercussions for how soon people could stop wearing masks. It is also unclear how long the immunity from the vaccine lasts — a crucial question.

Sarah Gilbert, a lead Oxford researcher, cautioned that the dose-and-a-half regimen would have to be more closely studied to be fully understood. But she said the first half-dose might be priming a person’s immune system just enough, and that the second booster then encourages the body to produce a robust defense against sickness and infection.

AstraZeneca and Oxford have been conducting Phase 3 clinical trials worldwide, with the most recent data coming from an interim analysis based on 131 coronavirus infections in Britain and Brazil among 10,000 volunteers, with half getting the vaccine and half getting a placebo.

The company said it would present the results to Britain’s health-care products regulators immediately and would seek approval to fine-tune its clinical trials in the United States, to further assess the half-dose shot followed by a booster.

Because the vaccine is already in production, if approved, the first 4 million doses could be ready in December, and 40 million could be delivered in the first quarter of 2021, company executives said. By the spring, the company and its global partners in India, Brazil, Russia and the United States could be cranking out 100 million to 200 million doses a month.

British Health Secretary Matt Hancock said “should all that go well, the bulk of the rollout will be in the new year.”

In a statement to Parliament, Prime Minister Boris Johnson said that vaccines were “edging ever closer to liberating us from the virus, demonstrating emphatically that this is not a pandemic without end. We can take great heart from today’s news, which has the makings of a wonderful British scientific achievement.”

World markets have rallied on optimistic vaccine news, though shares in AstraZeneca were down Monday on the London stock exchange.

No participants who received the vaccine developed severe cases or required hospitalization, AstraZeneca said Monday. The drugmaker also said that no “serious safety events” were reported in connection with the vaccine, which was typically “well tolerated” by participants regardless of their dosing levels or ages.

The vaccine uses a harmless cold virus that typically infects chimpanzees to deliver to the body’s cells the genetic code of the spike protein that dots the outside of the coronavirus. That teaches the body’s immune system to recognize and block the real virus.

Although the reason the regimen with an initial half-dose worked better remains to be teased out, Ertl said that it could be related to the fact that the body’s immune system can develop a defense system to block the harmless virus that’s used to deliver the spike protein’s code. Giving a smaller initial dose may lessen those defenses, and make the vaccine more effective.

Several other vaccines in late-stage development use a similar technology, harnessing a harmless virus to deliver a payload that will teach the immune system how to fight off the real thing — including the Johnson & Johnson vaccine, the Russian vaccine being developed by the Gamaleya Research Institute and the vaccine made by CanSino Biologics in China.

While the results released by AstraZeneca indicate somewhat lower efficacy than Pfizer and Moderna, the vaccine can be stored and transported at normal refrigerated conditions for up to six months. That could make it significantly easier to roll out than Pfizer’s vaccine, which has to be stored at minus-70 degrees Celsius, or Moderna’s, which is stable in refrigerated conditions for only 30 days and must be frozen at minus-20 degrees Celsius after that.

The Oxford-AstraZeneca vaccine was first developed in a small laboratory running on a shoestring budget by Gilbert at Oxford and her team. The university kicked in 1 million pounds ($1.3 million) and then sought a manufacturing partner, before settling on AstraZeneca.

“We wanted to ensure there wouldn’t be any profiteering off the pandemic,” said Louise Richardson, the university’s vice chancellor, so that their vaccine would be widely distributed “and wouldn’t just be for the wealthy and the first world.”

The scientists said that although it appeared to be a race, or a competition, among the front-running vaccine developers, no one company could produce by itself the millions of doses needed to end the pandemic.

“We don’t have enough supply for the whole planet,” Pollard said, adding that the important message is that today there are at least three highly effective, safe vaccines, that also appear to work well among the elderly, and that they are produced using different technologies, ensuring the quickest route to manufacture the billions of doses that will be necessary.

Pollard said it is “unclear why” the different vaccines were producing different results, and he said he and the scientific community awaited full data sets from all the clinical trials to fully understand what is going on. He said different studies were also using different end points to describe efficacy.

“At this moment we can’t fully explain the differences,” Pollard said. “It’s critical to understand what everyone is measuring.”

What will the world look like after COVID-19?

Home | Bill Gates

Like a lot of people, I have really gotten into listening to podcasts over the last year. They’re such an immersive way to learn about the world, and I like how the format lets you dive as deep on a topic as you want. So, I was inspired to start one of my own—but I knew I couldn’t do it on my own.

I couldn’t ask for a better partner on this project than Rashida Jones. A mutual friend suggested that the two of us might have a lot to talk about, and it turned out he was right. I already knew she was a talented actor, but I was impressed by her thoughtful perspective on the world. So, we decided to start a podcast that lets us think through some of today’s most pressing problems together. In our first episode, Rashida and I explore a big question that is top of mind for many people: what will the world look like after COVID-19?

I know it’s hard to imagine right now while new cases are surging around the world, but there will come a time when the COVID-19 pandemic is behind us. I think it’s safe to assume that society will be changed forever, given how disruptive the virus has been to virtually every part of our lives.

Unfortunately, we still have a long way to go before life truly gets back to “normal.” Rashida and I were joined by Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, to discuss what to expect in the months to come. I’ve had the opportunity to work with Dr. Fauci on a number of global health issues over the years, including the quest for an HIV vaccine and cure. He’s such a quiet and unassuming guy normally, so it’s been wild to watch him become a huge celebrity.

Dr. Fauci and I are both optimistic that a vaccine will bring an end to the pandemic at some point in the near future. But what the world looks like after that is a lot less clear. I suspect that some of the digitization trends we’ve seen—especially in the areas of online learning, telemedicine, and remote work—will become a regular part of our lives. I hope this episode leaves you hopeful about the future and curious about what comes next.

What do Pfizer’s and Moderna’s COVID-19 vaccine announcements mean for you?

https://www.politifact.com/article/2020/nov/12/what-does-pfizers-covid-19-announcement-mean-you/

COVID vaccine: What the second shot in the Moderna trial was like

IF YOUR TIME IS SHORT

  • If all goes according to plan, health care workers and individuals at high risk for severe illness from COVID-19 could be vaccinated as early as December.
  • Experts predict that the broader public could start being vaccinated in April.
  • The distribution of the vaccine could present some challenges for state and federal governments. That or any other unexpected events could delay the vaccine’s distribution.

When drugmaker Pfizer announced that its new vaccine was highly effective at preventing COVID-19, it raised hopes that the coronavirus pandemic could be nearing its end. 

In a Nov. 9 press release, the company and its partner BioNTech claimed that an early analysis of clinical trial data found that inoculated individuals experienced 90% fewer cases of symptomatic COVID-19 than those who had received a placebo. 

These results surpassed expectations. For months, experts have warned that a new vaccine might only be 60% effective. If Pfizer’s analysis is accurate — and it has yet to produce official scientific documentation —  the new vaccine would offer a level of protection equal to that of highly effective vaccines for diseases such as measles

Experts told us that Pfizer’s announcement is cause for optimism. However, the country, and the world, still have a way to go before coronavirus vaccines become available to ordinary Americans. 

Here’s what we know about when the vaccine might be distributed and what that process could look like. What’s next for Pfizer’s vaccine?

If the information in the press release is accurate, Pfizer will likely be the first company to come up with a vaccine that meets the Food and Drug Administration’s requirements for distribution. 

To get approval from the FDA, Pfizer has to gather two months of safety data on clinical trial participants to gauge whether the treatment has any negative side effects. The company will reach the two-month benchmark in the third week of November. Barring any unexpected developments, it will then submit its vaccine to the FDA for emergency use authorization, a special provision allowing the use of an unapproved product during a state of emergency.  

After Pfizer submits its data to the FDA, the agency will analyze it to see if it’s sufficient to begin distribution. After approval from the FDA, the vaccine would be assessed by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. The Advisory Committee will then issue a recommendation to the CDC, which will make the final ruling about whether to distribute the vaccine.  

This might sound intricate, but James Blumenstock, the chief program officer for health security at the Association of State and Territorial Health Officials, said that the vaccine could probably be approved by the FDA and the CDC in a matter of days rather than weeks. 

“Both agencies are standing ready and will give these requests and this assessment the highest level of priority just for expediency’s sake,” he said. 

What this means is that high-priority Americans, such as health care workers, could be vaccinated as early as December. What a vaccine rollout might look like.

Pfizer predicts that it will be able to manufacture only 50 million doses for global consumption by the end of the year, enough to vaccinate 25 million people. (The world’s population is about 7.8 billion.)

With a limited number of doses available, the eventual rollout of a vaccine would likely consist of two phases. During the first phase, U.S. health care workers, emergency responders and individuals at higher risk of severe illness would be eligible for vaccination. If all goes according to plan, the first phase will commence sometime in December. 

During the second phase, the vaccine would become available to the broader public. Most experts told us that they expect the second phase to start sometime in April, although the date would vary depending on Pfizer’s vaccine production rates and whether other companies get their vaccines greenlit by the FDA and CDC. The state of other vaccines

As of early July, there were roughly 160 vaccine projects under way worldwide, according to the World Health Organization

Pfizer’s announcement bodes well for other vaccine candidates, said Matthew B. Laurens, an associate professor of pediatrics at the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health. 

Pfizer’s vaccine uses genetic material, known as mRNA, that provides the instructions for a body to produce coronavirus proteins, known as antigens, in the hope that these could prime the human immune system to fight the virus. The biotechnology company Moderna is also manufacturing a vaccine that uses mRNA and is set to receive trial data by the end of November. 

Other companies in the United States and Europe producing a vaccine include Novavax, which plans to start clinical trials in the U.S. and Mexico by the end of November; Johnson & Johnson, which recently resumed testing its vaccine candidate after a brief pause; and AstraZeneca, which expects to have clinical trial data by the end of the year. 

The more companies there are that are able to produce a vaccine, the quicker the vaccine will become widely available, experts say.

Vaccine presents potential distribution hurdles

The CDC will be in charge of the distribution process, with involvement from the U.S. Defense Department, said Dr. Litjen Tan, chief strategy officer for the Immunization Action Coalition, which distributes information about vaccines to try to increase vaccination rates. 

Vaccines would be manufactured and then transported to states, which will then pass the vaccine on to providers, such as hospitals. The McKesson Corp., which has received a federal contract to distribute the treatment, will assist pharmaceutical companies and the government with the shipping process. 

Shipping the doses will present some challenges. Pfizer’s vaccine has complex and ultra-cold storage requirements that many hospitals, particularly those in hard-to-reach areas, won’t be able to meet. 

The cold chain requirement “is an issue for Pfizer, but manufacturing and distribution are issues for all vaccines,” said Robert Finberg, a physician and infectious disease specialist at the University of Massachusetts Medical Center.

To surmount this hurdle, Pfizer plans to transport the vaccine in thermal shippers that can keep the vaccine at the necessary temperature of minus 70 degrees Celsius for about two weeks. However, the shippers themselves present additional problems for distribution, Tan said. Each shipment consists of five trays containing 975 doses of vaccine, and reducing the size of the shipment could dramatically raise the cost of distribution. 

As a result, the states might initially prioritize shipping the vaccine to major hospitals rather than rural hospitals that service fewer patients in order to avoid waste. 

Blumenstock told us that state and federal governments are working hard to make sure that all regions of the U.S. receive proportionate amounts of vaccine. However, he acknowledged that hospitals in remote areas that don’t service many patients could initially take longer to get the vaccine than a well-trafficked hospital in a heavily populated area.

“Outskirt hospitals won’t be ignored or marginalized, even if it takes more time and effort to get them the vaccine,” he said. “One of the primary principles will be equitable distribution, even when that means you need to take extraordinary measures for logistics, transportation, and handling.” 

Overall, experts said that Pfizer’s announcement is a significant step forward. “I’m optimistic that we have a vaccine that’s safe and effective,” said Tan. “And I’m glad that what we’re dealing with now is the problem of how to get it to the public.”

Moderna’s coronavirus vaccine found to be nearly 95 percent effective in a preliminary analysis

Moderna says its COVID-19 vaccine is 94.5 percent effective | US & Canada |  Al Jazeera

Biotechnology firm Moderna announced Monday that a preliminary analysis shows its experimental coronavirus vaccine is nearly 95 percent effective at preventing illness, including severe cases — a striking initial result that leaves the United States with the prospect that two coronavirus vaccines could be available on a limited basis by the end of the year.

The news comes a week after pharmaceutical giant Pfizer and its German partner BioNTech lifted the stock market and people’s hopes with the news that their coronavirus vaccine was more than 90 percent effective. The announcement sent stocks up again, with the Dow Jones industrial average and S&P 500 up about 1 percent in midmorning trading. Moderna’s share price rose more than 6 percent.

At a briefing Monday, government officials predicted that if the two vaccines receive a regulatory greenlight, the first shots could be given in December, with enough to vaccinate 20 million people that month — and more becoming available into 2021 as production ramps up and other vaccine candidates may be successful.

“It’s extremely good news. If you look at the data, the numbers speak for themselves,” said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, who was one of three people briefed on the data by an independent committee Sunday morning. “I describe myself as a realist, but I’m fundamentally a cautious optimist. I felt we’d likely get something less than this. … I said certainly a 90-plus-percent effective vaccine is possible, but I wasn’t counting on it.”

Moderna’s vaccine, co-developed with Fauci’s institute, is being tested in 30,000 people. Half received two doses of the vaccine, and half received a placebo. To test how well the vaccine works, physicians closely monitored cases of covid-19 to see whether they predominantly occurred in people who received the placebo.

Of the 95 cases of covid-19, the disease caused by the virus, 90 were in the group that received the placebo. There were 11 severe cases reported — all in people who received the placebo. With cases of covid-19 confined almost exclusively to trial participants receiving a placebo, that sends a strong signal that the vaccine is effective at thwarting the virus.

The data have not yet been published or peer reviewed, and the overall effectiveness of the vaccine may change as the study continues. But Fauci said the data on severe cases was “quite impressive” and effectively answers a question that has lingered: whether a vaccine measured by its success in preventing any case of covid-19 can prevent the most urgent cases, too.

An independent data committee, convened by the National Institutes of Health, analyzed the results Sunday morning. Stéphane Bancel, chief executive of Moderna, said in an interview that he spent the morning trying to distract himself from wondering about the results by working at his home in Boston, but instead he found himself constantly checking his phone and email. When he learned the results later in the morning, the evidence that the vaccine prevented severe disease stood out as most consequential.

“In this pandemic, what has been awful from a public health standpoint, an economic standpoint, is the worry people have to get so sick they have to go to the hospital — so sick they have to get to the ICU and have a high risk of dying,” Bancel said. “If a [vaccine] could prevent 95 percent of people to not get disease, but to not get severe disease, that would be a game-changer: the impact on hospitals, the impact on people’s psyche and the impact on deaths.”

Many questions about details remain. How long will the protection last? Will results be similar across all subgroups? Does the vaccine decrease the infectiousness of the virus in people without symptoms?

But the early successes show the power and speed of a new vaccine technology never before used in an approved medical product that delivers a strip of genetic material called messenger RNA to teach the body to defend against the virus. The messenger RNA carries the blueprint for the distinctive spike protein that dots the outside of the coronavirus, instructions that the body’s cells follow to build the spike protein.

“It is extremely encouraging,” said Stanley Plotkin, inventor of the rubella vaccine. “This and the earlier result shows that the platform really works, and this bodes very well for other diseases, where this platform could be used — and considering the speed with which the platform was put into operation. It’s an excellent result.”

Moderna has committed to completing its trial before applying for emergency-use authorization — which means waiting until there are 151 cases of covid-19 in the study. A previous projection showed that the trial might end sometime early next year, but it is instead expected to reach its endpoint in seven to 10 days, Bancel said, because of surging coronavirus cases in the United States. The explosion of virus cases translates into an expedited ability to ascertain whether a vaccine works.

The company will have enough safety data to support an application shortly before Thanksgiving. Bancel anticipates a vaccine might begin to become available to those at high risk in the second half of December.

Unlike Pfizer, which invested $2 billion of its own money in researching and developing a vaccine, Moderna is part of Operation Warp Speed, the government initiative designed to erase the financial risk of vaccine and therapeutics development by providing upfront funding to companies and helping coordinate the trials. Moderna received nearly $1 billion from the U.S. government to support research and development. The companies both have contracts to sell 100 million doses to the U.S. government.

Moderna projects it can produce 20 million doses by the end of the year — enough for 10 million people to get both shots. The company aims to produce at least 500 million doses next year, with the possibility of scaling up to 1 billion doses depending on the availability of raw materials.

The side effects of the two-dose vaccine were mostly mild or moderate, including pain at the injection site, fatigue, headache and muscle pain, according to the company’s news release.

Regulators at the Food and Drug Administration must review the evidence for the Moderna and Pfizer vaccines, but the robust early indication of success suggests both vaccines might become available to high-risk populations before the end of this year.

Fauci predicted that people such as health-care workers or people with conditions that raise their risk of developing severe disease could begin receiving doses before the end of the year. It could take about four months to vaccinate people in high-risk groups, and in April, the vaccine could expand to the rest of the population.

The two successes could have ripple effects that influence the ongoing trials and in future coronavirus vaccine trials. People currently in the Moderna and Pfizer trials do not know whether they received the real vaccine or placebo, and at some point, those who received a placebo may be crossed over to receive the real thing. But the decision to do that will mean a loss of follow-up and valuable data.

“Given these products will be given to potentially billions of people, you have to be careful to make sure they’re safe and effective, and there’s no easy way around that issue,” said Ira Longini, a biostatistics expert at the University of Florida, who said a year of follow-up on participants would be ideal.

The focus on vaccines will now shift to the daunting logistics of manufacturing and distribution.

The Pfizer vaccine requires ultracold storage conditions — minus 70 degrees Celsius — not widely available in typical vaccination settings. The company has been working to overcome that limitation.

Moderna announced Monday that its vaccine can be stable at refrigerator temperatures for a month and frozen for up to six months. It will not require dilution at the point of care, unlike the Pfizer vaccine.

What You Need To Know About Pfizer’s Covid-19 Vaccine

Pfizer's Covid-19 Vaccine Is 90% Effective, But Has Storage & Shipping  Issues | Boomers Daily

On Monday, Pfizer announced preliminary results from the phase 3 trial of the vaccine that it has developed with German company BioNTech, suggesting that it may be up to 90% effective at preventing Covid-19 with no serious safety concerns. The vaccine, which represents a new way to make a vaccine, might be ready for an Emergency Use Authorization from the FDA by the end of the year. 

BioNTech’s vaccine is an mRNA (as in “messenger RNA,” which might ring a faint bell from high school biology class) vaccine, similar to one being developed by Boston-based Moderna as well as Translate Bio, which is partnered with pharmaceutical giant Sanofi. This type of vaccine has been in the works for other diseases, including the flu, but none have been approved for use by any regulatory body yet. Success with this platform has the potential to accelerate the development of vaccines for new diseases, a process which can typically take close to a decade. 

Here’s what you need to know.  

Pfizer’s vaccine is based on a new kind of technology

Traditional vaccines are made from dead or weakened versions of an infectious virus. This new type of vaccine is different. To develop it, the genes of the SARS-CoV-2 virus, which causes Covid-19, were first analyzed to locate the part that codes its “spike” protein, which is what enables the virus to infect people. The codes for that protein are then isolated and copied as mRNA fragments, which is what cells use as instructions for making proteins. Those fragments are packaged up into special molecules, then injected into the patient’s cells.

Within the cells, the mRNA comes into the body’s protein factories, called ribosomes. The ribosomes “read” the mRNA, and follow its instructions to make copies of the spike protein. Those copies of the spike protein can’t, by themselves, cause harm. But they’ll trigger the body to make antibodies against the virus. Those antibodies, in turn, will protect patients from a Covid-19 infection. At least, that’s the idea. 

The vaccine still needs to be approved by the Food and Drug Administration

Before the vaccine can be distributed, it has to first be approved by appropriate regulatory bodies. In the United States, that’s the FDA. Pfizer has said that it intends to seek an Emergency Use Authorization from the FDA to enable distribution and administration of the vaccine in late November, at which point the company will have an average of two months’ worth of safety data for each patient. That’s because most bad reactions to vaccines happen shortly after infection. Additionally, Pfizer will continue to monitor the patients in its study for two years after the vaccine administration. 

Distributing this vaccine is more complicated than for a typical vaccine

Although one advantage of mRNA vaccines is that they’re potentially faster to develop than traditional vaccines, their administration and distribution is scads more complicated. For example, the Pfizer vaccine is currently being tested on a two-dose schedule, 21 days apart, unlike the single dose of a typical vaccine for diseases like the flu. The 21-day separation has raised some concerns about the patient compliance needed for vaccines to work.

For long-term storage, the vaccine has to be kept at very cold temperatures—around –70° Celsius (–94° Fahrenheit), which requires a specialized freezer. (Flu vaccines, by contrast, can usually be stored in a refrigerator.) The company has developed a specialty thermal shipping container, which can be kept cold with dry ice and be used to store the vaccine doses for up to 15 days. If long-term storage isn’t required, Pfizer’s vaccine can be stored in a refrigerator, but only for up to five days. 

Pfizer footed the bill for its own part of vaccine development

Several companies, such as Moderna, have received federal funding and support for the development of their vaccines and treatments through the research and development process. Pfizer opted out of that, choosing instead to spend $1 billion of its own money to move the vaccine forward. “A billion dollars is not going to break us,” CEO Albert Bourla told Forbes earlier this year. 

That said, BioNTech did receive a $442 million grant from the German government to help develop the vaccine. And in July, the two companies signed an agreement to sell at least 100 million doses to the U.S. Department of Health and Human Services (HHS) for $1.95 billion. The country of Spain has initially secured 20 million doses of the vaccine as well. 

Biden’s 7 point plan for the pandemic

https://www.beckershospitalreview.com/hospital-management-administration/biden-s-plan-for-the-pandemic-7-things-to-know.html?utm_medium=email

Trump's And Biden's Coronavirus Plans: Vaccines, Testing : NPR

President-elect Joe Biden and Vice President-elect Kamala Harris have released a seven-point plan regarding the COVID-19 pandemic.

The Biden administration’s seven pandemic plans:

1. Ensure all Americans have access to regular, reliable and free testing by doubling the number of drive-thru testing sites, investing in next-generation testing, developing a pandemic testing board to produce and distribute tests, and establishing a U.S. Public Health Jobs Corps.

2. Provide all states, cities, tribes and territories with critical supplies. Efforts will include full use of the Defense Production Act, building American-sourced and manufactured capabilities. 

3. Provide clear, consistent and evidence-based guidance for how communities should navigate the pandemic. Planned resources will be tailored to the needs of schools, small businesses and families.

4. Plan for effective and equitable distribution of treatments and vaccines. The administration intends to invest in a $25 billion manufacturing and distribution plan to guarantee every American can receive the vaccine for free. The administration also said it will work to ensure that politics won’t play a role in determining the safety and efficacy of vaccines.   

5. Protect older Americans and other high-risk groups. Efforts will include establishing a COVID-19 racial and ethnic disparities task force and a nationwide pandemic dashboard that can be checked in real-time to gauge local transmission.

6. Rebuild and expand defenses to prevent and mitigate pandemic threats, including the restoration of the White House National Security Council Directorate for Global Health Security and Biodefense and the nation’s membership with the World Health Organization.

7. Implement nationwide mask mandates.

President-elect Biden announces coronavirus task force made up of physicians and health experts

Joe Biden Live Updates: President-Elect Talks Mask Wearing, Pandemic - The  New York Times

President-elect Joe Biden on Monday announced the members of his coronavirus task force, a group made up entirely of doctors and health experts, signaling his intent to seek a science-based approach to bring the raging pandemic under control.

Biden’s task force will have three co-chairs: Vivek H. Murthy, surgeon general during the Obama administration; David Kessler, Food and Drug Administration commissioner under Presidents George H.W. Bush and Bill Clinton; and Marcella Nunez-Smith, associate dean for health equity research at the Yale School of Medicine. Murthy and Kessler have briefed Biden for months on the pandemic.

Biden will inherit the worst crisis since the Great Depression, made more difficult by President Trump’s refusal to concede the election and commit to a peaceful transition of power. The Trump administration has not put forward national plans for testing, contact tracing and resolving shortages in personal protective equipment that hospitals and health-care facilities are experiencing again as the nation enters its third surge of the virus.

“Dealing with the coronavirus pandemic is one of the most important battles our administration will face, and I will be informed by science and by experts,” Biden said in a statement. “The advisory board will help shape my approach to managing the surge in reported infections; ensuring vaccines are safe, effective, and distributed efficiently, equitably, and free; and protecting at-risk populations.”

The United States is recording more than 100,000 new coronavirus cases a day and, on many days, more than 1,000 deaths, a toll expected to worsen during the crucial 10-week stretch of the transition. It remains unclear whether Trump or his top aides will oversee and lead a robust response to the pandemic during the transition, which could further exacerbate the crisis Biden and Vice President-elect Kamala D. Harris inherit.

The 13-member task force also includes former Trump administration officials, including Rick Bright, former head of the Biomedical Advanced Research and Development Authority, who, after being demoted, spoke out against the administration’s approach to the pandemic. Luciana Borio, director for medical and biodefense preparedness on Trump’s National Security Council until 2019, is also on the panel.

The group includes several other prominent doctors:

· Ezekiel Emanuel, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania.

· Atul Gawande, a surgeon at Brigham and Women’s Hospital and a professor at Harvard Medical School who is a prolific author.

· Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

· Eric Goosby, global AIDS coordinator under President Barack Obama and professor of medicine at the University of California at San Francisco School of Medicine.

· Celine R. Gounder, clinical assistant professor of medicine and infectious diseases at New York University’s Grossman School of Medicine.

· Julie Morita, executive vice president of the Robert Wood Johnson Foundation, a philanthropy focused on health issues.

· Loyce Pace, president and executive director of the Global Health Council, a U.S.-based nonprofit organization dedicated to global health issues.

· Robert Rodriguez, professor of emergency medicine at the UCSF School of Medicine.

Rebecca Katz, director of the Center for Global Health Science and Security at Georgetown University Medical Center, and Beth Cameron, director for global health security and biodefense on the White House National Security Council during the Obama administration, are serving as advisers to the transition task force.

Task force members will work with state and local officials to craft public health and economic policies to address the virus and racial and ethnic disparities, while also working to reopen schools and businesses, the transition team said in a news release.

While the makeup of the task force garnered widespread praise, Peter Hotez, dean of the National School of Tropical Medicine at the Baylor College of Medicine, said the group needs more geographic diversity.

“They are all from the Acela corridor or the [San Francisco] Bay Area,” he said. “Who is going to be the field marshal or the supreme allied commander who goes into middle of the country and get this done? The coasts are doing okay but the red states are being hammered and the deaths are going to be extraordinary. There needs to be a frank reckoning between leaders of the two parties, to say we cannot let this happen.”

Public health experts said Biden should use the transition to provide leadership as the pandemic continues through a deadly stretch and begin communicating a strong national message.

“Clearly from the election outcomes, half the country doesn’t believe we’re in a crisis,” said Kavita Patel, a fellow at the Brookings Institution who worked on health policy in the Obama administration. Biden and Harris “have an incredible platform that can be used for communication. The country needs clear daily briefings that we thought we’d get from the White House coronavirus task force. They have an incredible platform, if not an official platform.”

Biden plans to call Republican and Democratic governors to ask for their help in developing a consistent message from federal and state leaders, according to three Biden advisers who spoke on the condition of anonymity because they were not authorized to speak publicly about these matters. He will urge governors to adopt statewide mask mandates and to provide clear public health guidance to their constituents, including about social distancing and limiting large gatherings.

The task force will have subgroups that focus on issues related to the response, including testing, vaccine distribution and personal protective equipment, according to two people familiar with the plans who spoke on the condition of anonymity to reveal plans that were not yet public.

In his victory speech Saturday, Biden addressed challenges in bringing the pandemic under control.

We cannot repair the economy, restore our vitality or relish life’s most precious moments — hugging a grandchild, birthdays, weddings, graduations, all the moments that matter most to us — until we get this virus under control,” Biden said. “That plan will be built on a bedrock of science. It will be constructed out of compassion, empathy and concern. I will spare no effort — or commitment — to turn this pandemic around.”

Yet the plans Biden laid out on the campaign trail are set to collide with political realities. That includes a deeply divided nation in which more than 71 million people voted for Trump and the possibility of having to navigate a Republican-controlled Senate disinclined to support a greater federal role in testing and contact tracing, among other responsibilities now left mostly to the states.

Biden’s most ambitious plans will require significant congressional funding. Senate Majority Leader Mitch McConnell (R-Ky.) has said he would like to pass new coronavirus relief measures during Congress’s lame-duck session, and Congress faces a Dec. 11 government funding deadline. Biden and his team are poised to begin engaging with congressional Democrats on their priorities.

Biden’s plans include dramatically expanding testing and building a U.S. public health jobs corps to have 100,000 Americans conduct contact tracing. They also include ramping up production of personal protective equipment and implementing a vaccine distribution plan.

Murthy, who served as the 19th U.S. surgeon general, is a physician whose nomination was stalled in the Senate for more than a year because of his view that gun violence is a public health issue. Three months into the Trump administration, he was replaced as “the nation’s doctor” with more than two years left on his four-year term.

In 2016, he wrote a landmark report on drug and alcohol addiction, which put that condition alongside smoking, AIDS and other public health crises that previous surgeons general addressed. The report called the addiction epidemic “a moral test for America.” Murthy’s office sent millions of letters to doctors asking for their help to combat the opioid crisis.

The son of immigrants from India, he earned medical and MBA degrees at Yale before joining the faculty at Harvard Medical School, where his research focused on vaccine development and the participation of women and minorities in clinical trials.

After leaving his post as surgeon general, he wrote a book on loneliness and social isolation, including their implications for health, that grew out of his conversations with people in clinical practice and as surgeon general.

Several public health officials celebrated Nunez-Smith’s leadership role on the task force. Her research focuses on promoting health and health-care equity in marginalized populations, according to her Yale biography. She has also studied discrimination that patients endure in the health-care system — expertise that many said was welcome in an epidemic that is disproportionately affecting people of color.

Kessler was FDA commissioner from 1990 to 1997, during the George H.W Bush and Clinton administrations. He is well-known for his attempts to regulate cigarettes — an effort that resulted in a loss in the Supreme Court, which ruled that the agency did not have the authority. That prompted Congress to pass a law, enacted in 2009, that explicitly gave the agency that power.

Kessler, a pediatrician and lawyer, worked at the FDA to accelerate AIDS treatments and on food and nutrition issues. He oversaw the FDA’s development of standardized nutrition labels and notably ordered the seizure of orange juice labeled “fresh” because it was made from concentrate. He has written several books on diet, mental illness and other topics, and has served as dean of the medical schools at Yale and UCSF.

COVID response leads voters’ healthcare concerns

https://mailchi.mp/f2794551febb/the-weekly-gist-october-23-2020?e=d1e747d2d8

The upcoming election has huge implications for healthcare, far beyond how COVID is managed, ranging from how care is covered to how it’s delivered. The graphic above shows a continuum of potential policy outcomes of the November 3rd vote.

If President Trump wins a second term and Republicans control at least one house of Congress, there will likely be more attempts to dismantle the ACA, as well as continued privatization of Medicare coverage.

 If Democrats win the presidency and sweep Congress, actions to expand the Affordable Care Act (ACA), or even create a national public option, are on the table—although major healthcare reform seems unlikely to occur until the second half of a Biden term.

In the short term, we’d expect to see more policy activity in areas of bipartisan agreement, like improving price transparency, ending surprise billing and lowering the cost of prescription drugs, regardless of who lands in the White House.
 
While healthcare emerged as the most important issue for voters in the 2018 midterm elections, the COVID pandemic has overshadowed the broader healthcare reform platforms of both Presidential candidates heading into the election. As shown in the gray box, many Americans view the election as a referendum on the Trump administration’s COVID response. Managing the pandemic is one of the most important issues for voters, especially Democrats, who now rank the issue above reducing the cost of healthcare or lowering the cost of drugs. 

In many aspects, the COVID policies of Biden and Trump are almost diametrically opposed, especially concerning the role of the federal government in organizing the nation’s pandemic response.

The next administration’s actions to prevent future COVID-19 surges, ensure safe a return to work and school, accelerate therapies, and coordinate vaccine delivery will remain the most important aspect of healthcare policy well into 2021.

Trump claims COVID “will go away,” Biden calls his response disqualifying

https://www.axios.com/trump-biden-debate-coronavirus-14b6e962-e968-4547-933d-6d7105df24b9.html

The Final Presidential Debate: The Moments That Mattered - WSJ

President Trump repeated baseless claims at the final presidential debate that the coronavirus “will go away” and that the U.S. is “rounding the turn,” while Joe Biden argued that any president that has allowed 220,000 Americans to die on his watch should not be re-elected.

Why it matters: The U.S. is now averaging about 59,000 new coronavirus infections a day, and added another 73,000 cases on Thursday, according to the Covid Tracking Project. The country recorded 1,038 deaths due to the virus Thursday, the highest since late September.

What they’re saying: “More and more people are getting better,” Trump said. We have a problem that’s a worldwide problem. This is a worldwide problem. But I’ve been congratulated by the heads of many countries on what we’ve been able to do … It will go away and as I say, we’re rounding the turn. We’re rounding the corner. It’s going away.”

  • Trump later disputed warnings by public health officials in his administration that the virus would see a resurgence in the winter, claiming: “We’re not going to have a dark winter at all. We’re opening up our country.”

Biden responded: “Anyone responsible for that many deaths should not remain as president of the United States of America.”

  • “What I would do is make sure we have everyone encouraged to wear a mask all the time. I would make sure we move in the direction of rapid testing, investing in rapid testing.”
  • “I would make sure that we set up national standards as to how to open up schools and open up businesses so they can be safe and give them the wherewithal, the financial resources, to be able to do that.”

The bottom line: Biden and Trump are living in two different pandemic realities, but Biden’s is the only one supported by health experts.

Go deeper: The pandemic is getting worse again

The first presidential debate: 7 healthcare takeaways

https://www.beckershospitalreview.com/hospital-management-administration/the-first-presidential-debate-7-healthcare-takeaways.html?origin=CFOE&utm_source=CFOE&utm_medium=email&oly_enc_id=2893H2397267F7G

5 key takeaways from Joe Biden and Donald Trump's 1st presidential debate -  ABC News

President Donald Trump and former Vice President and Democratic presidential nominee Joe Biden sparred over the future of the ACA, the COVID-19 pandemic and health insurance during a 90-minute debate in Cleveland Sept. 29.

Seven takeaways for healthcare leaders:

The ACA

1. Moderator and Fox News host Chris Wallace opened the debate with the topic of President Trump’s nomination of Judge Amy Coney Barrett of the U.S. Court of Appeals for the 7th Circuit to the U.S. Supreme Court. In the first few minutes of the debate, the discussion turned to the future of the ACA should Ms. Coney Barrett join the Supreme Court. A week after the November presidential election, the Supreme Court is set to hear a lawsuit, supported by the Trump administration, that seeks to overturn the ACA. 

2. If the Supreme Court overturns the ACA, Mr. Biden said 22 million Americans would lose insurance and 100 million would lose protections for preexisting conditions. HHS said in 2017 as many as 133 million Americans have preexisting conditions, and a KFF analysis estimates 54 million Americans have conditions serious enough to lead to coverage denials if the ACA is overturned.

3. Mr. Wallace questioned the president about his promise to repeal and replace the ACA, adding that President Trump hadn’t released a comprehensive plan to replace the health law despite pledges to do so. The president disagreed with that, saying he had gotten rid of the individual mandate. Mr. Wallace said eliminating the mandate was not a comprehensive plan. Mr. Wallace called President Trump’s recent executive orders on preexisting conditions and surprise billing “largely symbolic.” President Trump disagreed, but did not tell how the executive orders would be implemented.

Drug prices 

4. The president said drug prices would be coming down “80 or 90 percent.” The president highlighted insulin, which he said he’s getting so inexpensively, “it’s like water.” Insulin continues to retail for about $300 per vial, according to STAT, but cheaper insulin prices could be coming for some seniors. CMS recently said it is expanding the number of Medicare Advantage plans that provide insulin for a $35 or less monthly copay.

Public option

5. In an exchange with Mr. Biden, President Trump accused the Democratic Party of wanting “socialist medicine,” and claimed Mr. Biden wants to end private insurance. Mr. Biden denied those claims and said his health plan, which includes expanded ACA subsidies and a public option, would allow employees to keep their private health insurance. He has not supported Medicare-for-All proposals.

COVID-19

6. On the topic of the pandemic, Mr. Wallace asked President Trump about differing timelines for a vaccine that have been presented by him versus federal scientists like CDC Director Robert Redfield, MD. The president said he has spoken with Pfizer, Moderna and Johnson & Johnson, who’ve said “they can go faster” on a vaccine, but “it’s a very political thing.” He added that the military is already set up to distribute vaccines. Mr. Biden questioned Americans’ trust in the process. A Sept. 29 poll from the Axios/Ipsos Coronavirus Index found 8 in 10 Americans wouldn’t likely get a first generation COVID-19 vaccine if the president said it was safe.

7. President Trump and Mr. Biden took different stances on masks. Mr. Biden cited Dr. Redfield’s renewed call to wear masks, and said masking up and social distancing would save 100,000 lives between now and January. President Trump responded by saying, “They’ve said the opposite.” He alluded to early in the pandemic when public health experts, including Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, were slow to recommend widespread mask-wearing before scientists better understood how the virus spreads. The CDC currently recommends that every American wear a mask.