Pfizer’s COVID-19 vaccine finally reaches its last step: FDA committee vote. Most vaccines never get that far. – USA TODAY
We asked you to tell us your biggest questions about the COVID-19 vaccines. Here are some answers. USA TODAY
A committee crucial for clearing a COVID-19 vaccine will hold an all-day meeting Thursday, and depending on how it votes, the nation's first doses could ship as early as Friday.
The external expert committee will review data from Pfizer and German startup BioNTech on their vaccine, called BNT162b2, and by day's end will vote whether the U.S. Food and Drug Administration should authorize the countrys first COVID-19 vaccine.
The companies are requesting an emergency use authorization, shy of a full approval. While they have compiled as much short-term safety and effectiveness data as is typical with any vaccine, the process has been compressed. But corners, FDA says, have not been cut.
If the independent Vaccines and Related Biological Products Advisory Committee recommends that authorization, the FDA is expected to sign off on the vaccine, possibly as soon as late Thursday.
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Another committee, convened by the U.S. Centers for Disease Control and Prevention, will meet Friday and Sunday to officially determine who should receive the first doses. Depending on timing, the first Americans could start to be vaccinated by the weekend, though more likely Monday.
The VRBPAC meeting (pronounced verb-pack), is one of the final pieces in a process that began in January when workbegan on a vaccine to help end the global coronavirus pandemic. Just 10 months later, on Nov. 20, Pfizer and BioNTechbecame the first tosubmittheir application to FDA for general use in the U.S.
Another COVID-19 vaccine, developed by Cambridge, Massachusetts-based Moderna, will go through the same approval processnext week. Its candidate goes before the FDA committee Dec. 17.
No fully vetted vaccinehas ever been developed more quickly. The previous record was four years for one against the mumps.Vaccine developers saved time by conducting steps at the same time that are usually done in sequence.
Despite the swift pace, experts stress the process has been painstaking and methodical, and FDA's scientific experts will comb the data submitted by the companies.Everything is double-checkedand nothing is taken for granted.
They even go through it line by line and check all the math, do all the statistical analyses over again, saidDr. Gregory Poland, director of the Mayo Vaccine Research Group and editor-in-chief of the journal Vaccine.
"They're really making sure that no stone left goes left unturned in terms of evaluating the safety and the efficacy of these vaccines," said Dr. William Moss, an epidemiologist with the International Vaccine Access Center.
A vial of the COVID-19 candidate vaccine developed by BioNTech and Pfizer is displayed at the headquarters in Puurs, Belgium.(Photo: AP Images)
The unprecedented speed at which the COVID-19 vaccines have beenbrought to market belies the truth about vaccine development: Most efforts fail.
Only about 1 in 6 make it all the way through approval. Decades of tedious work can be upended by spectacular failuresand the most promising paths can turn into dead ends.
Nature gives up its secrets slowly and grudgingly. Its a constant struggle to prove that a product you think saves lives actually does, said Dr. Paul Offit,director of the Vaccine Education Center at Children's Hospital of Philadelphiaand a professor of vaccinology at the Perelman School of Medicine at the University of Pennsylvania.
Vaccines take years and sometimes decades to develop for a reason. There are so many hoops to jump thatits hard to even count the hundreds of points where something could go wrong and knock a candidate out of the running.
Getting a vaccine has been a huge undertaking. How all 50 states scramble to dole them out is the next massive challenge.
Everyone who works in the field knows they should never get their hopes up.
The nature of vaccine development is there are always surprises, said Poland. After four decades working the field, his advice is expect the unexpected.
Vaccines are first tested in cellsthen in animals.If things go well in animals, the company or researchers working on the vaccine apply to the FDA to test it in a very small number of humans to make sure it doesnt hurt people.
Those first humantests are wheremost vaccine creators hopes and dreams end. What works in animals, theyve learned the hard way, usually doesnt work in people.
The Phase 1 trial is where 90% of vaccines die, said Dr. Corey Casper, CEO of the Infectious Disease Research Institute in Seattle and a professor of global health at the University of Washington.
If a vaccine clears Phase 1, it still can be rejected in larger Phase 2 and the much larger Phase 3 human trials, which are guided by external expert committees with the power of life and death over the process.
Almost 15% of candidate vaccines get bad news when trials expand,according to research by the Massachusetts Institute of Technology.
Its one of the most dejecting feelings. Its like getting a holiday present and theres nothing in the box, said Casper. You feel horrible. Youve done all this work, youve spent all this and youve gotten people to volunteer their time and their bodies and they didnt benefit."
The frontrunning COVID-19vaccines got lucky.
Data fromPfizer/BioNTech's Phase 3 trial showed itprevented 95% of people from becoming sick. Moderna's vaccine, based on the same messenger RNA technology, showed similar effectiveness. The findings bode well for their FDA blessing.
Phil Dormitzer, chief science officer for Pfizers viral vaccine research and development division, received the good news Nov. 9.
He wasat home in Nyack, New York, when he opened his email at 6:15 a.m.and saw the subject line.
Ill be honest with you, it was somewhat overwhelming. I was stopped in my tracks, it was a real rush of emotion, he said.
Later in the day his team held a brief celebratory teleconference but then they went back to work.
To actually get this vaccine authorized, manufactured and distributed," he said, "theres still a huge amount that has to be done."
Contact Elizabeth Weise at eweise@usatoday.com
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