Ayyyeee… What’s Goodie Everyone. So I got some tea and it involves the FDA and coronavirus vaccine.
Two vaccine candidates appeared to be on the verge of clearing the final U.S. regulatory hurdles. An advisory panel convened Thursday morning to decide whether to recommend that the Food and Drug Administration approve the Pfizer BioNTech vaccine.
If all goes as expected, 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’s 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.
The FDA tipped its hand to the public about its view of the experimental coronavirus vaccine by pharmaceutical giant Pfizer and German biotech firm BioNTech, when it released its evaluation of safety and effectiveness data. On Tuesday that was in preparation for Thursday’s meeting 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 that an 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 United States, angering Trump in the process.
If the advisory committee gives the go ahead in a formal vote 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 potentially lifesaving vaccine won’t immediately change the pandemic outlook. Vaccinating most Americans will take several months, even if the vaccine is widely accepted. With more than 280,000 dead, even grimmer days lie ahead, with deaths potentially rising to 3,000 or 4,000 a day, experts say.
The all day remote meetingis happening on Thursday and 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 23 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 Vaccines and Related Biological Products Advisory Committee, also includes a consumer representative and a nonvoting member who represents the pharmaceutical industry.
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, and 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.
FDA officials and some panel members have said the two months standard is appropriate, given 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.
One 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 who is 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 who is the 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 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.
The biggest moment will come at the end of the day being told 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.
The following week, the process starts over for Moderna. On December 15, the agency will post its view of the vaccine, in preparation for a December 17 advisory committee meeting.