US regulators, experts take up vaccine issues
Outside advisers weigh in on approval guidelines
WASHINGTON – The U.S. regulators who will decide the fate of COVID-19 vaccines took an unusual step Thursday: asking outside scientists if their standards are high enough.
The Food and Drug Administration may have to decide by year’s end whether to allow use of the first vaccines against the coronavirus. Thursday, a federal advisory committee began pulling back the curtain on that decision process, debating whether the guidelines FDA has set for vaccine developers are rigorous enough.
“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 as they began the daylong deliberation.
How much information FDA needs to be sure a vaccine is safe and effective is a key question for the advisers, and one key vaccine developer, Moderna Inc., announced Thursday it has finished enrollment in its final testing of its shot.
The FDA is requiring manufacturers to do studies of at least 30,000 people to prove whether 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 people with other health problems.
The FDA has said any vaccine must
be at least 50% effective. And while the studies are designed to run for two years, companies may get enough evidence the shots are protective – in at least some people – to stop the trials early and seek an “emergency use authorization” for wider vaccinations.
Despite White House objections, the FDA told vaccine makers earlier this month not to seek that speedier review until they’ve tracked at least half their trial volunteers for two months.
That’s not long enough, said the head of the nonprofit ECRI Institute, which reviews medical technology for hospitals and insurers. ECRI’s Dr. Marcus Schabacker said FDA should require six months of follow-up.
“Doing any less would simply risk too much, and the consequences may be severe,” he wrote. “A weak vaccine that
loses public trust could poison the well for epidemic control for many years.”
A tougher question: If the FDA allows emergency use of a vaccine before final testing is finished, will that destroy chances of ever learning just how well that shot – and maybe others still being studied – really worked?
“We can’t lose sight of the fact that it is in our societal interest to see these trials to completion,” said Dr. Luciana Borio, a former FDA acting chief scientist. Borio said allowing emergency use of a vaccine is not the same as having full proof the shot works.