For a nation ravaged by the pandemic, this week marks a pivotal moment – the final push by federal regulators to clear the first experimental coronavirus vaccine for a besieged populace.
If all goes well over the next few days, the Food and Drug Administration could give emergency authorization to the vaccine as early as week’s end, triggering the start of an unprecedented effort to inoculate enough Americans to confer individual immunity and eventually stop the virus’ spread. That next chapter, however, is filled with herculean challenges, including ramping up production to tens of millions of doses, shipping them in specially designed boxes packed with dry ice to keep them ultracold and vaccinating people in every corner of the United States.
“It’s staggering where we find ourselves,” said Robert Wachter, chairman of the department of medicine at the University of California at San Francisco. “And this remarkable week will either put us on a path to getting out of this in six months, or if people lose trust in the process, put us back by months, or a year.”
The regulatory drama kicks off early Tuesday. The Food and Drug Administration tips its hand to the public for the first time about its view of experimental coronavirus vaccine by pharmaceutical giant Pfizer and German biotech BioNTech, when it releases its evaluation of the safety and effectiveness data. That’s in preparation for a meeting two days later of the agency’s vaccine advisory committee – independent experts who will debate that data and whether the FDA should clear the vaccine, a decision many hope will eventually change the course of the crisis.
The agency sees Thursday’s open committee meeting, which includes time for the general public to speak, as a critical part of its effort to be transparent and convince people to take the vaccine. Its commitment to holding a public session is one reason Britain managed to authorize the vaccine before the U.S., angering President Donald Trump.
“We feel it’s our responsibility to make it happen as fast as possible,” said Peter Marks, director of the Center for Biologics Evaluation and Research. But, he added, “We want to show that we really thought this all through carefully.”
If the advisory committee gives the thumbs’ up in a formal vote on Thursday, the FDA is expected to authorize the vaccine within days, clearing the way for its almost-immediate distribution to all 50 states. Operation Warp Speed, the White House-led initiative to develop and distribute vaccines, has said it plans to begin shipping the vaccine within 24 hours of an FDA authorization. But if an unexpected problem should emerge, or the advisory panel raises concerns, the process could be slowed.
Even if all goes as hoped, a new, potentially lifesaving vaccine won’t immediately change the pandemic outlook. Vaccinating most Americans will take several months, even if the vaccine is widely accepted. And, with more than 280,000 dead, even grimmer days lay ahead, with deaths potentially rising to 3,000 or 4,000 a day, experts say.
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What happens first this week?
Public health experts hope that documents released by the FDA and Pfizer on Tuesday will provide many more details about the vaccine, as well as the agency’s opinion about it. If there are any surprises that could slow or derail an authorization, they could pop up here.
“For now, all we have is this press release with a big efficacy number,” said Jason Schwartz, assistant professor of health policy and management at the Yale School of Public Health, referring to Pfizer’s press statements that its vaccine is a remarkable 95 percent effective overall and 94 percent in people over 65. It hasn’t released information on other subgroups, and the data has not yet been published in a peer-reviewed journal.
Also Tuesday, the White House is having a “Covid-19 Vaccine Summit” to tout the vaccine development effort, and inviting governors, federal officials, and executives of pharmaceutical companies and drugstore chains. The goal appears to be to give Trump, who called the FDA part of the “deep state” and accused Pfizer of trying to hurt his reelection prospects, a chance to claim credit for the vaccine.
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Can I watch the advisory committee meeting?
The all-day remote meeting on Thursday will be carried online by the FDA, YouTube and Facebook. University of Michigan epidemiologist Arnold Monto, the temporary chairman of the panel, is shoring up his spotty home WiFi. Meanwhile, teams of FDA staffers are poring over Pfizer data and the quality of the manufacturing process. Manufacturing vaccines can be notoriously difficult, and quality is paramount. In 1955, tainted polio vaccine made by Cutter Laboratories caused five deaths.
The independent panel has a core group of 15 voting members, including all-star experts on immunology, virology and infectious diseases. They include Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and the co-developer of a rotavirus vaccine. The panel, whose official name is the Vaccine and Related Blood Products Advisory Committee, also includes a consumer representative and a nonvoting member who represents the pharmaceutical industry.
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What does the FDA want from the meeting?
Agency officials will be looking for the panel to say the Pfizer safety and efficacy data justifies an emergency use authorization for the vaccine. They are likely to consider a broad “label,” saying the vaccine should be used to prevent covid-19, the disease caused by the coronavirus, in people from ages 16 and up. Pfizer has started to test the shots in children as young as 12, but more data is needed.
Emergency authorizations are temporary approvals used to accelerate the availability of medical products during a public health emergency. They require less data than full approvals. The FDA has said, however, it will apply rigorous criteria because millions of healthy people are expected to receive the vaccine.
Panel members are sure to drill down on the safety data. In a general vaccine meeting on Oct. 22, some members said the FDA’s requirement that vaccine developers provide two months’ follow-up on half the trial participants wasn’t stringent enough.
“How much oxygen do those concerns get at this meeting?” said Schwartz. “If there are serious concerns, that would complicate the effort to assure the public that this process is every bit as rigorous as we would expect this vaccine to be.”
FDA officials and some panel members have said the two months’ standard is appropriate, given that most serious complications occur in the first six weeks after inoculation. Waiting longer can’t be justified, they said, considering the pandemic’s horrific daily toll, now up to a seven-day average of more than 2,000 deaths daily.
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What else will be discussed?
A critical issue will be the longer-term safety program the FDA and Pfizer have set up to ensure they catch any serious complications caused by the vaccine after it is on the market. “Once you roll something out to hundreds of thousands and millions of people, safety problems can emerge,” said Lawrence Gostin, a public health expert at Georgetown Law School.
The panel also might ask how long the vaccine’s protection will last. The information is important because once people are vaccinated, they are likely to change their behavior – eschewing masks, for example – said Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. But officials say it’s too soon to know the duration of protection.
The committee also is likely to wrestle with the ethical issue of whether Pfizer should offer the vaccine to people in the placebo group, once the shots are cleared. The company has said that it plans to do so, but the FDA is worried such “unblinding” of the trial will make it difficult to continue to collect long-term data on safety and duration of protection.
Michael Tovar, a participant in the Pfizer trial, predicted a “mass exodus” of enrollees if the placebo group is not offered the vaccine. “For most of us, the possibility of receiving a vaccine early was one of the main reasons for joining the trial,” he said in a comment filed to the public docket on the meeting. “Were it not for the bravery and commitment of trial participants, this historic moment would not be happening.”
But if those participants are not in high-risk priority groups, they might not be able to get the vaccines outside the trial.
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What’s the most important part of the meeting?
The biggest moment will come at the end of the day – probably 5 p.m. or later – when the panel will vote on questions posed by the FDA. The key one will be on whether to authorize the vaccine.
Does the FDA have to follow the panel’s advice?
No, the advice isn’t binding. But the FDA often follows the recommendations of its advisers. And in this case, with all the controversy and political wrangling that has surrounded the vaccine, experts say it would be hard for the agency to ignore the committee, which is partly designed to boost public confidence in the shots.
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What happens then?
Marks, of the FDA, said the agency could authorize the Pfizer vaccine “within a week” of a favorable recommendation from the advisory committee. Some think the decision would be even sooner than that.
The following week, the process starts over for Moderna. On Dec. 15, the agency will post its view of the vaccine, in preparation for a Dec. 17 advisory committee.