Despite the Covid-19 death count in the United States rapidly accelerating, a startlingly high percentage of health care professionals and frontline workers throughout the country—who have been prioritized as early receipts of the coronavirus vaccine—are reportedly hesitant or outright refusing to take it, despite clear scientific evidence that the vaccines are safe and effective.
Earlier this week, Ohio Gov. Mike DeWine said he was “troubled” by the relatively low numbers of nursing home workers who have elected to take the vaccine, with DeWine stating that approximately 60% of nursing home staff declined the shot.
Dr. Joseph Varon, chief of critical care at Houston’s United Memorial Medical Center, told NPR in December more than half of the nurses in his unit informed him they would not get the vaccine.
Roughly 55 percent of surveyed New York Fire Department firefighters said they would not get the coronavirus vaccine, the Firefighters Association presidentsaid last month.
The Los Angeles Times reported Thursday that hospital and public officials in Riverside, Calif., have been forced to figure out how best to allocate unused doses after an estimated 50% of frontline workers in the county refused the vaccine.
Fewer than half of the hospital workers at St. Elizabeth Community Hospital in Tehama County, Calif., were willing to be vaccinated, and around 20% to 40% of L.A. County’s frontline workers have reportedly declined an opportunity to take the vaccine.
Dr. Nikhila Juvvadi, the chief clinical officer at Chicago’s Loretto Hospital, said that a survey was administered in December, and 40% of the hospital staff said they would not get vaccinated.
A recent survey by the Kaiser Family Foundation found that 29% of healthcare workers were hesitant to receive the vaccine, citing concerns related to potential side effects and a lack of faith in the government to ensure the vaccines were safe.Frontline workers in the United States are disproportionately Black and Hispanic. The pandemic has taken an “outsized toll” on this segment of the population, which has reportedly accounted for roughly 65% of fatalities in cases in which there are race and ethnicity data. A study published by the journal The Lancet over the summer found “healthcare workers of color were more than twice as likely as their white counterparts” to test positive for the coronavirus. According to a Pew Research Center poll published in December, vaccine skepticism is highest among Black Americans, as less than 43% said they would definitely/probably get a Covid-19 vaccine. Dr. Juvvadi told NPR that “there’s no transparency between pharmaceutical companies or research companies — or the government sometimes — on how many people from” Black and Latino communities were involved in the research of the vaccine. Dr. Varon said that “the fact that [President] Trump is in charge of accelerating the process bothers” those individuals who refuse to be immunized, adding “they all think it’s meant to harm specific sectors of the population.” In an op-ed published in the New York Times earlier this week, emergency physicians Benjamin Thomas and Monique Smith wrote that “vaccine reluctance is a direct consequence of the medical system’s mistreatment of Black people” and past atrocities, such as the unethical surgeries performed by J. Marion Sims and the Tuskegee Syphilis Study, best exemplifies “the culture of medical exploitation, abuse and neglect of Black Americans.”
“I’ve heard Tuskegee more times than I can count in the past month — and, you know, it’s a valid, valid concern,”said Dr. Juvvadi.
WHAT TO WATCH FOR:
Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said in a Friday interview that it’s “quite possible” the Covid-19 vaccine could be required for international travel and to attend school at some point in the future.
40 million. In early December, government officials said they planned to have 40 million doses available by the end of 2020, which would be enough to fully vaccinate 20 million Americans. However, according to the Centers for Disease Control and Prevention, less than 3 million Americans have received the first dose of the vaccine, with 14 million doses have been distributed.
Atul Gawande is outlandishly accomplished. The son of Indian immigrants, he grew up in Athens, Ohio, and was educated at Athens High School, Stanford, Oxford, and Harvard, where he studied issues of public health. Before working as a surgeon at Brigham and Women’s Hospital, in Boston, he advised such politicians as Jim Cooper and Bill Clinton. He teaches at Harvard and is the chairman of Ariadne Labs, which works on innovation in health-care delivery and solutions, and he recently spent two years as the C.E.O. of a health-care venture called Haven, which is co-owned by Amazon, JPMorgan Chase, and Berkshire Hathaway.
Since the beginning of the coronavirus pandemic, Gawande has been sharp in his criticism of the Trump Administration and, like Anthony Fauci and other prominent figures in public health, insistent on clear, basic measures to reduce levels of disease. After the election in November, President-elect Biden formed a covid-19 advisory board and included Gawande among its members. Earlier this week, I spoke with Gawande for The New Yorker Radio Hour. In the interview, which has been edited for length and clarity, Gawande says that President Trump’s relative silence on the issue after the election might be a blessing (considering the alternative). He suggests that the development of vaccines promises great things down the line, a return to relative normalcy some months from now. But, before that happens, he says, we may not only see terrible rates of illness and death—we will also experience an almost inevitably contentious rollout of the vaccine. Questions of who gets the vaccine and when will test a deeply divided society. As Gawande put it, “The bus drivers never came before the bankers before.”
We currently have one of the highest death and transmission rates of covid-19 in the world. What went wrong?
There’s so many things that went wrong, but you can boil it down to the difficulty of pulling together. One of the most critical things you have in the toolbox in public health is communications. It’s your ability to have clear priorities and communication about those priorities to your own public and to all of the players who get stuff done. We didn’t get testing started early. We weren’t calling the laboratories together to get testing built and created right from the get-go. And then fast-forward to where we are today. We still are in a world where we have not had clear communications from the top of the government around whether we should be wearing masks and having an actual national strategy to fight the virus. I would boil down what went wrong to not committing to communicating clearly and with one voice about the seriousness of what we’re up against and what the measures are to solve it.
When this began, I read “The Great Influenza,” John M. Barry’s book about 1918 and the horrendous flu that killed millions worldwide, and many hundreds of thousands in the United States. I thought to myself, Well, it’s not possible that we would repeat these mistakes, because, after all, we learn from history, even if the President of the United States does not. How is it possible that we made these same mistakes on such a mass scale? Do you lay it all at the feet of the President?
There’s a big part of this that I lay at the feet of the President. Imagine Pearl Harbor happened, and then we spent seven or eight months deciding whether or not we were going to fight back. And then, seven or eight months into it, a new President is going to come in who says, O.K., we are going to fight now. But you now have substantial parts of the country already arrayed against the idea that fighting it is worthwhile. In the meantime, some states have fought the attack and other states have not, and they’ve had to compete with each other for supplies. That’s the mess we have.
In May, I got to write about this in The New Yorker: the hospitals learned how to bring people to work and have them succeed. It was a formula that included masks, included some basic hygiene, some basic distancing, and testing. That’s been the formula, and is the formula still, for making it possible for people to resume a normal life. But we did not have a commitment from the very top to make this happen on a national basis. And we are continuing to litigate that issue to this very day.
You are now on President-elect Biden’s advisory board on covid-19, and I wonder what kind of coöperation you’re getting from the Trump Administration’s own advisory board.
Well, remember: up until just a few days ago, there was no contact allowed at all between any Administration officials and the Biden-Harris transition team. So only in the last few days have there started to be the contacts that would allow for basic information to be passed. I think it’s too early to say how well those channels of communication are turning out.
I’m sorry to interrupt, Atul, but, just to be clear here: we’re in a public-health emergency. Are you saying that the President’s theories, ill-founded and fantastical theories about the election, held up any communication whatsoever between President Trump’s advisory board and President-elect Biden’s board?
Absolutely. And I want to put a pin in what that means, in concrete fact. Here, we had a vaccine trial that came out three weeks ago showing a successful, effective vaccine, followed, just a few days later, by another vaccine trial. We did not have access to the information they were getting about the status of those trials. We did not have access to information about supplies. So, at the beginning of the year, with Operation Warp Speed, the target was three hundred million vaccines produced by the end of the year. Instead, what we’re seeing is reportedly thirty million or so by the end of [December]. We’re seeing in the press some backtracking from that as well. What were the bottlenecks that meant that this couldn’t be done? Is it a shortage of raw ingredients? Are they having stockpile problems? Is it a problem with the actual production processes?
Here’s another one when I’m talking to colleagues around the country who are going to be involved in distributing the vaccine: We hear about everything from shortages of gloves, uncertainty about supplies of needles and syringes for three hundred and thirty million people to get two rounds of doses. There’s no information yet on how many vaccines will be allocated to a given state or a given big pharmacy company like CVS or Walgreens—places that are an important part of the distribution chain. So there’s a lot of basic information that hasn’t been known. That discovery process is just starting.
The Biden Administration-to-be’s covid-19 task force has got a seven-point plan to stop the pandemic. What are the crucial elements of that plan?
It’s the same story that we’ve known since April: It’s mandating masks—that’s one of the most important tools we have for driving transmission down. It’s testing and being able to make sure that there’s widespread availability of testing. It’s supplies for the places that are going to need proper gloves, masks, et cetera. It’s continuing, based on the level of spread in a given community, to tune how much capacity restriction you have on indoor environments, whether it’s bars and restaurants or weddings or other gatherings that are seen to be currently driving transmission. Those are all critical elements. I’m firmly in agreement with where the President-elect is going on heeding the advice from public-health people that schools can be opened. But, in order for kids to be back in schools, especially elementary and middle schools, there’s still a lot of work to do to insure they have the supplies that they need to maintain distancing, to have the right ventilation.
Thanksgiving was a week ago. Anthony Fauci says that what he fears is a spike on top of a spike, a leap on top of a leap. Do you share that fear?
I do. A lot of people heeded the C.D.C. advice to not travel during Thanksgiving and to limit the size of family get-togethers. And I think that will help a great deal. But clearly large numbers of people did not heed that advice. And that’s the reason for the fear of the spike on top of a spike. We saw that, during the Thanksgiving weekend, we had the highest level of hospitalizations at any time in this pandemic, including the darkest days of spring. That’s going to have consequences in the days to come. I’m concerned that we’ll go into the Christmas holiday week with even higher spikes that will make that holiday all that much more challenging. Spike upon spike upon spike is the fear in this six-week-long period.
One of the signal disasters, as you said earlier, in the Trump Administration was communications, both what the President said about the pandemic and how he said it, the language he couched it in and the attitude he took toward it. Since the election, Trump doesn’t even talk about it on a daily basis.
No, he’s, he’s been awol. He had said in his statements: You know, it’s covid, covid, covid; all they want to talk about is covid. But watch, he said, the news will go away the day after the election. Instead, he’s the one who went away the day after the election. He has hardly spoken on what we’re up against, how bad things are, and what is going to be required. It’s interesting, however. In some ways, that is preferable to his coming in and constantly undermining the public-health messaging. So you have seen the C.D.C. and F.D.A. be able to step up. I can only surmise that what he’s clearly been focussed on is figuring out how to hold on to power. The irony is it’s left the field clear.
President-elect Biden is saying very clearly that this should be thought of as a war. We have to be on a war footing and understand how grave this is. Now you’re getting a unified message that’s coming across, and it’s coming from the President-elect on down and from the career scientists. In the face of the rising levels of disease in the country, you now have some Republican governors who had [opposed] a mask mandate now implementing the mask mandate. And they’re not getting contradicted by the President in that process. So, ironically, look, if I have to have President Trump on the airwaves contradicting everybody, or being awol, I’d rather have him be awol.
Thankfully, we can look forward to a vaccine, but that presents enormous logistical challenges. What are the challenges, and how do you view that rolling out?
Well, this is an undertaking on another scale from anything we’ve been doing in the last year. We have deployed north of a hundred and twenty million coronavirus tests in the course of eight months.This is going to be three hundred and thirty million vaccinations, done twice, and hoping to accomplish it in the course of six months or less. This is with vaccines that are new and that haven’t been produced at this volume before. Their clinical data is just undergoing review for approval by the F.D.A. The task is muddied by the fact that we don’t have a clear understanding of what the supply situation is that we have inherited from the Trump Administration. We also don’t know even what the prioritization is.
I’m concerned that what will happen when the new Administration starts is that they will inherit a lot of public confusion, because each state is now coming to its own conclusion about how they’re going to prioritize things. There’s going to be such demand. People are going to clamor for this vaccine. And, if they think that the system is rigged, we will have even more trouble.
After health-care workers and nursing homes, who gets the vaccine next? It’s almost like some terrible philosophical, moral, ethical conundrum that philosophers are faced with all the time. What are your discussions like when it comes to those next levels?
There are eighty-seven million essential workers who are at heightened risk of exposure. They are, say, meatpackers who are exposed to co-workers, or grocery-store workers or bus drivers who are exposed. You’ll be able to go to your local pharmacy and get a vaccine, but what they need to know is, how do they identify who’s the bus driver and who’s not?
Will the government be able to guarantee us that wealthy people, connected people, won’t be able to jump the line?
I think this is one of the critical tests—and an opportunity. The chance to prove that the system is not rigged should not be underestimated. It’s hard. Think about it. The bus drivers never came before the bankers before. You’re going to have Zoom workers who want to go back to normal, and I cannot blame the number of people who will say, You know, thank God I can finally not be in fear. Let me get the vaccine. What do you mean, I have to wait five months? I can imagine a million ways [of jumping the line], people paying someone twenty-five hundred bucks to get your work I.D. tag. This is all about rallying people together. It can’t just be about the rules. It has to be about how we all understand this and work together to say, These are the folks most at risk. They make our subways work. They make our buses work. They get our food supply to us. They make it possible for me to go grocery shopping, and I’ll just have to wait three or four months for my turn.
What you’re talking about is community and common interest and fairness. Many people are very good about that on the level of rhetoric, but, when it comes to their health and their children’s health or their parents’ health, that’s where rubber meets the road.
The mass debate and antagonism we’ve had over the last few months is nothing compared to the splits we will see over “I want my family to be vaccinated.” You know, one person in the family might get vaccinated. Another person might not because they have an illness profile or they have a job that fits in that way. You’ll have children who some families will want to have vaccinated and others will not want to have vaccinated. Pediatric clinical trials have only just gotten under way, and we won’t see those results for a while.
I have a child with severe autism, and so I pay very close attention to the anti-vaxxer movement. And the statistics, the numbers of people who say they will not be vaccinated, is enormous. Doesn’t that have serious implications not only for them but for our over-all effort?
It does. It seems, if we can get around seventy per cent or so of people vaccinated, that would stop the transmission just through vaccination alone. Now if, once people start getting vaccinated, they start throwing their masks away and you can’t get them to do anything else like distancing, then you’re really relying on vaccination as the sole prong of the strategy come three, four months from now. I think there are lots of things that are pushing in the direction of keeping the numbers of people who resist vaccination smaller than those surveys indicate.
What are the numbers?
The numbers suggest that it’s up to as much as forty per cent, even up to fifty per cent, who have said that they are not ready to take the vaccine [even] if the F.D.A. approves it. Part of the reason it’s good that health-care workers would go first is just demonstrating that we ourselves are willing to get vaccinated. Health-care workers are everywhere, which means we’re all going to know people who got vaccinated, and we’re going to see that they did all right.
The reality is that there are memes around anti-vaccination, like: the vaccine will change your D.N.A., or people are injecting a location transmitter into you, a conspiracy to be tagging everybody in the country. We’ll have to be able to combat crazy conspiracy theories. I’ll just summarize by saying this will be contentious, but I’m quite hopeful that we will get to large enough levels of vaccination so that we will be able to get this under control and return to a significant degree of normalcy.
Has there ever been any kind of distribution effort like this in American history?
I draw on things like the polio campaigns, which, you know, took polio from being an annual summer pandemic, in the early fifties, that left kids paralyzed, to essentially being gone a few years after the vaccines came out. Then you had H1N1, where we were in position to vaccinate seventy-million-plus people. So I think there is some precedent. We have not tried to say, Let’s eradicate this disease in one year. Smallpox took a couple of decades. I think we can get [the coronavirus] under control without necessarily eradicating it.
What would it take to eradicate it—or are we never going to eradicate it?
You don’t have to vaccinate every single human being in order to eradicate it. You need to get enough people vaccinated so that the disease stops spreading and dies out. I’m hopeful that we can get it under control here, but, to get eradication, to go back to global travel like before, you would have to get the whole world vaccinated. And that will take years. If we are well vaccinated here, we will feel comfortable over time lifting our restrictions on travel in the United States. And we will become freer to travel to many places around the world. And we will begin to realize what a lot of public-health people like me have been saying, which is that this can’t just be about distribution of vaccine in the United States. This is also going to need to be about enabling global vaccination.
At what point do you think you will be comfortable eating in crowded restaurants, flying on planes, living the life that you lived a year ago?
I think it will be after I get vaccinated [and we have enough data to know the vaccines are stopping transmission]. I’m actually a trial participant. One of the things that’s running through my brain is when I’m going to feel comfortable—when I find out whether I got a placebo or I got the vaccine.
What trial are you in?
I’m in the Moderna trial. After the booster shot, I got a fever, and I had the whole reaction that you would have expected. So I’m going to guess that I got the vaccine. But I won’t feel comfortable that I got it until I actually get that confirmation. But this isn’t about me. I want to see the evidence that the vaccine is lasting. What is the story three months from now? Are the antibodies showing indications that it lasts? I suspect that we’ll really feel comfortable, that we’re able to largely return to normal, maybe in about six months’ time. But, you know, we’re going to go through this gray-zone period where a lot of people have been vaccinated, and I will feel among them. I’m so desperate to go to a concert! Live music is the thing I’ve missed the absolute most.
Dr. Fauci has been a paragon. At the same time, he said, it could be a year and a half for a vaccine to be deployable. Why was the timeline so much faster in the end?
It was insane, some of the timelines that the scientists hit. For example, from the moment that the genome for the virus got sequenced to the moment when the N.I.H.-Moderna team actually was producing the vaccine, it was days. I think it was like a week or something like that. That’s just beyond belief.
What was the science, the discoveries, that made that possible?
Well, it was years of work to build the platform that could deliver the genetic information. Those first few days of success were built on years of work that folks like Dr. Fauci get credit for, because he’s been contributing to the creation of that kind of platform for some years now, as have many biotech companies and many university labs and the government.
Atul, we’re sitting here and watching the year 2020 end—and not a moment too soon. What do you expect will be our situation in December, 2021?
Well, for one thing, I think we’ll be having normal holiday experiences. We’ll be able to get together with our families and spend time. It’s harder for me to predict from my vantage point with as much confidence, but I think that if that’s happening, we will be on better economic terms as well. Right now, airlines, hotels, and any face-to-face service industry—bars, restaurants, child care, health care—I think all of those things are coming back.
On Monday, at Long Island Jewish Medical Center in New York City, critical care nurse Sandra Lindsay rolled up her sleeve andbecame the first American to receive Pfizer and BioNTech’s newly approved COVID vaccine, opening a new front in the nation’s battle with the coronavirus pandemic.
By Friday, nearly 50,000 doses of the vaccine had been administered nationwide, with millions more expected before year’s end. Amid a complex rollout that has already raised questions about the timely distribution of doses, the Food and Drug Administration (FDA) confirmed that it was safe to use every last drop of the Pfizer vaccine, including the excess amount used to fill the five-dose vials of the precious medicine—meaning many vials may have enough to immunize a sixth person.
Based on Thursday’s recommendation from a key panel of experts, the FDA is expected to approve a similar vaccine from Moderna as soon as Friday evening, with doses of that vaccine beginning to be administered by next week. The Moderna vaccine comes in smaller packages with less-demanding storage requirements, making it suitable for a wider distribution across smaller settings and remote areas.
Pharmacy chains CVS and Walgreens were set to begin administering shots to nursing home residents in Ohio, Connecticut, and Florida on Friday, as part of an agreement with the US government to vaccinate staff and residents in 75,000 long-term care facilities nationwide.
In an interview this week, Secretary of Health and Human Services (HHS) Alex Azar said that the vaccine could be widely available to the general public as soon as late February or early March. While it’s surely tempting to fixate on every setback, second guess every decision about prioritization and distribution, and fret over every isolated report of an adverse vaccine reaction, it will be important in the coming weeks to keep the big picture in mind: we are on the way to beating back the coronavirus. The end is nigh.
Britain’s medicine regulator said anyone with a history of anaphylaxis to a medicine or food should not get the Pfizer-BioNTech COVID-19 vaccine, giving fuller guidance on an earlier allergy warning about the shot.
Starting with the elderly and frontline workers, Britain began mass vaccinating its population on Tuesday, part of a global drive that poses one of the biggest logistical challenges in peacetime history.
The Medicines and Healthcare Products Regulatory Agency (MHRA) said there had been two reports of anaphylaxis and one report of a possible allergic reaction since rollout began.
“Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine,” MHRA Chief Executive June Raine said in a statement.
“Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks… You can be completely confident that this vaccine has met the MHRA’s robust standards of safety, quality and effectiveness.”
Anaphylaxis is an overreaction of the body’s immune system, which the National Health Service describes as severe and sometimes life-threatening.
The fuller guidance, clarifying that the main risk was from anaphylaxis specifically, was issued after consulting experts on allergies. The MHRA had initially advised anyone with a history of a “significant allergic reaction” not to take the shot.
Pfizer and BioNTech said they were supporting the MHRA’s investigation.
Last week, Britain’s MHRA became the first in the world to approve the vaccine, developed by Germany’s BioNTech and Pfizer, while the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) continue to assess the data.
A top U.S. official said on Wednesday that Americans with known severe allergic reactions may not be candidates for Pfizer’s COVID-19 vaccine until more was understood about what had happened.
Canada’s health ministry said it would look at the reported adverse reactions in Britain, but said adverse events were to be expected and would not necessarily change the risk/benefit of the shot, after the country approved the vaccine.
MHRA chief Raine told lawmakers such allergic reactions had not been a feature of the Pfizer’s clinical trials.
Pfizer has said people with a history of severe adverse allergic reactions to vaccines or the candidate’s ingredients were excluded from their late stage trials, which is reflected in the MHRA’s emergency approval protocol.
However, the allergic reactions may have been caused by a component of Pfizer’s vaccine called polyethylene glycol, or PEG, which helps stabilise the shot and is not in other types of vaccines.
Imperial College London’s Paul Turner, an expert in allergy and immunology, who has been advising the MHRA on their revised guidance, told Reuters: “As we’ve had more information through, the initial concern that maybe it affects everyone with allergies is not true.”
“The ingredients like PEG which we think might be responsible for the reactions are not related to things which can cause food allergy. Likewise, people with a known allergy to just one medicine should not be at risk,” Turner told Reuters.
The EMA said in an email that all quality, safety and efficacy data would be taken into account in assessing the vaccine, including data generated outside the EU.
In the United States, the FDA released documents on Tuesday in preparation for an advisory committee meeting on Thursday, saying the Pfizer vaccine’s efficacy and safety data met its expectations for authorization.
The briefing documents said 0.63% of people in the vaccine group and 0.51% in the placebo group reported possible allergic reactions in trials, which Peter Openshaw, professor of experimental medicine at Imperial College London, said was a very small number.
“The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well,” he said.
However, Gregory Poland, a virologist and vaccine researcher with the Mayo Clinic in Rochester, Minnesota, said that the MHRA and NHS had overreacted initially.
“I would not have broadened to the degree they did,” he said.
“It’s reasonable to let the world know about this, and to be aware of it in terms of people who have had reactions like this to vaccines. I think to say medicines, foods or any other allergies is past the boundary of science.”
Americans have made no secret of their skepticism of COVID-19 vaccines this year, with fears of political interference and a “warp speed” timeline blunting confidence in the shots. As recently as September, nearly half of U.S. adults said they didn’t intend to be inoculated.
But with two promising vaccines primed for release, likely within weeks, experts in ethics and immunization behavior say they expect attitudes to shift quickly from widespread hesitancy to urgent, even heated demand.
“People talk about the anti-vaccine people being able to kind of squelch uptake. I don’t see that happening,” Dr. Paul Offit, a vaccinologist with Children’s Hospital of Philadelphia, told viewers of a recent JAMA Network webinar. “This, to me, is more like the Beanie Baby phenomenon. The attractiveness of a limited edition.”
Reports that vaccines produced by drugmakers Pfizer and BioNTech and Moderna appear to be safe and effective, along with the deliberate emphasis on science-based guidance from the incoming Biden administration, are likely to reverse uncertainty in a big way, said Arthur Caplan, director of the division of medical ethics at New York University School of Medicine.
“I think that’s going to flip the trust issue,” he said.
The shift is already apparent. A new poll by the Pew Research Center found that by the end of November 60% of Americans said they would get a vaccine for the coronavirus. This month, even as a federal advisory group met to hash out guidelines for vaccine distribution, a long list of advocacy groups — from those representing home-based health workers and community health centers to patients with kidney disease — were lobbying state and federal officials in hopes their constituents would be prioritized for the first scarce doses.
“As we get closer to the vaccine being a reality, there’s a lot of jockeying, to be sure,” said Katie Smith Sloan, chief executive of LeadingAge, a nonprofit organization pushing for staff and patients at long-term care centers to be included in the highest-priority category.
Certainly, some consumers remain wary, said Rupali Limaye, a social and behavioral health scientist at the Johns Hopkins Bloomberg School of Public Health. Fears that drugmakers and regulators might cut corners to speed a vaccine linger, even as details of the trials become public and the review process is made more transparent. Some health care workers, who are at the front of the line for the shots, are not eager to go first.
“There will be people who will say, ‘I will wait a little bit more for safety data,” Limaye said.
But those doubts likely will recede once the vaccines are approved for use and begin to circulate broadly, said Offit, who sits on the FDA advisory panel set to review the requests for emergency authorization Pfizer and Moderna have submitted.
He predicted demand for the COVID vaccines could rival the clamor that occurred in 2004, when production problems caused a severe shortage of flu shots just as influenza season began. That led to long lines, rationed doses and ethical debates over distribution.
“That was a highly desired vaccine,” Offit said. “I think in many ways that might happen here.”
Initially, vaccine supplies will be tight, with federal officials planning to ship 6.4 million doses within 24 hours of FDA authorization and up to 40 million doses by the end of the year. The CDC panel recommended that the first shots go to the 21 million health care workers in the U.S. and 3 million nursing home staff and residents, before being rolled out to other groups based on a hierarchy of risk factors.
Even before any vaccine is available, some people are trying to boost their chances of access, said Dr. Allison Kempe, a professor of pediatrics at the University of Colorado School of Medicine and expert in vaccine dissemination. “People have called me and said, ‘How can I get the vaccine?’” she said. “I think that not everyone will be happy to wait, that’s for sure. I don’t think there will be rioting in the streets, but there may be pressure brought to bear.”
That likely will include emotional debates over how, when and to whom next doses should be distributed, said Caplan. Under the CDC recommendations, vulnerable groups next in line include 87 million workers whose jobs are deemed “essential” — a broad and ill-defined category — as well as 53 million adults age 65 and older.
“We’re going to have some fights about high-risk groups,” said Caplan of NYU.
The conversations will be complicated. Should prisoners, who have little control over their COVID exposure, get vaccine priority? How about professional sports teams, whose performance could bolster society’s overall morale? And what about residents of facilities providing care for people with intellectual and developmental disabilities, who are three times more likely to die from COVID-19 than the general population?
Control over vaccination allocation rests with the states, so that’s where the biggest conflicts will occur, Caplan said. “It’s a short fight, I hope, in the sense in which it gets done in a few months, but I think it will be pretty vocal.”
Once vaccine supplies become more plentiful, perhaps by May or June, another consideration is sure to boost demand: requirements for proof of COVID vaccination for work and travel.
“It’s inevitable that you’re going to see immunity passports or that you’re required to show a certificate on the train, airplane, bus or subway,” Caplan predicted. “Probably also to enter certain hospitals, probably to enter certain restaurants and government facilities.”
But with a grueling winter surge ahead, and new predictions that COVID-19 will fell as many as 450,000 Americans by February, the tragic reality of the disease will no doubt fuel ample demand for vaccination.
“People now know someone who has gotten COVID, who has been hospitalized or has unfortunately died,” Limaye said.
“We’re all seeing this now,” said Kempe. “Even deniers are beginning to see what this illness can do.”
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.”
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.
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.
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.
The United States surpassed 10 million coronavirus cases on Monday, just 10 days after hitting 9 million. The average number of daily new infections has exceeded 100,000, and public health experts warn the country is entering the pandemic’s worst phase yet.