The Atlanta Journal-Constitution
Leaders seek clarity as vaccine nears
U. S. regulators ask outside scientists to weigh in on standards.
WASHINGTON — With vaccines against COVID- 19 inching closer, U. S. regulators took an unusual step Thursday in asking outside scientists: Are the government’s standards high enough to adequately judge the shots?
About the concerns
The Food and Drug Administration may have to decide by year’s end whether to allow use of the fifirst vaccines against the coronavirus, amid growing public fears that politics are overriding science. Thursday, a federal advisory committee pulled back the curtain on that decision process in daylong discussions to be sure corners aren’t cut.
“Vaccine development can be expedited. However, I want to stress that it cannot — and must not — be rushed,” Dr. Marion Gruber, director of FDA’s vaccine research office, told the advisers.
Gruber said the public scrutiny “is critical to build trust and confifidence” in whichever vaccines emerge.
Exactly how much data FDA needs to be sure a vaccine is safe and effective is a key question for the advisers, and one looming as a key vaccine developer, Moderna Inc., announced Thursday the fifinal study of its shot has completed enrollment.
An even tough er question: If the FDA allows emergency use of a vaccine before fifinal testing is fifinished, will that destroy chances of ever learning just howwell those shots — and maybe competitors still being studied — really work?
What we still don’t know
Any vaccine allowed for emergency use will still be experimental. It may not be clear if the fifirst vaccines prevent people from spreading the coronavirus or just from getting seriously ill, for example. And with multiple shots in the pipeline — made with different technologies — the fifirst may not be the best.
FDA’s Dr. Doran Fink made clear the agency wants vaccine makers to keep as many volunteers enrolled in their studies for as long as possible to determine long- term vaccine safety and effectiveness.
“Once a decision is made to unblind an ongoing placebo- controlled trial, that decision cannot be walked back and that controlled follow- up is lost forever,” Fink said. Asked howto avoid losing crucial information, he added: “I don’t have any specific remedies to offfer at this time.”
The meeting wasn’t to evaluate particular shots. The FDA has pledged to reconvene advisers to publicly analyze every vaccine before the agency decides its fate.
It was an opportunity for the FDA to assure the public that science-driven vetting of COVID- 19 vaccines is happening despite political pressure.
What evidence is needed?
The FDA is requiring studies of at least 30,000 people to prove if a vaccine protects and how safe it is. Those studies must include adequate numbers of people at highest risk from COVID- 19 — older adults, minorities and anyone with other health problems.
A vaccine must be at least 50% effective. While the studies are designed to run for two years, companies may get enough evidence to stop the trials and seek what’s called an “emergency use authorization” for wider vaccinations.
Despite White House objections, the FDA told vaccine makers this month not to seek the speedier review until they’ve tracked at least half their trial volunteers for two months.