Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time.


A normally backwater committee meeting of a Food and Drug Administration advisory group held Thursday highlighted the extreme importance of getting COVID-19 vaccines right.

The meeting was unlike others held by the Vaccines and Related Biological Products Advisory Committee, a group of outside experts who advise FDA on whether or not to approve drugs, therapeutics and vaccines after they have gone through FDA’s rigorous approval process.

Thursday’s meeting featured excruciatingly detailed presentations by FDA and Centers for Disease Control and Prevention on what’s known about COVID-19 and what requirements must be met for a vaccine to be approved. 

The question of when to approve a vaccine is of enormous importance. It must be both safe and effective because it will be given to healthy individuals.

At the same time, as Marion Gruber, director of CDC’s office of Vaccines Research & Review noted, 700 Americans are dying of COVID-19 each day.

Some have been concerned an emergency use authorization (EUA) for a COVID-19 vaccine  may mean the vetting process for the vaccine won’t be as thorough as the FDA’s usual licensing process. 

By the time agency officials finished their presentations, committee members seemed to be less worried.

“I’m reassured,” said Dr. Paul Offit, a committee member, director of the Vaccine Education Center and an attending physician at Children’s Hospital of Philadelphia. The EUA process FDA described was “much much much closer” to the full licensing process than he had thought, he said. 

The committee did not vote on a specific vaccine Thursday but discussed FDA’s guidance and requirements to seek either a license or an emergency use authorization for one.

VRBPAC (pronounced verb-pack) meetings are generally little-noticed outside of pharmaceutical circles but Thursday’s meeting was closely watched and heavily attended online as the committee discussed COVID-19 vaccines. It was streamed live from FDA’s website.

The 15 committee members — all distinguished physicians, scientists and doctors — discussed FDA’s current guidance to COVID-19 vaccine manufacturers and what kinds of data they hope to see when Phase 3 clinical trials for each vaccine are completed. 

Generally, the committee meets once FDA has approved a drug or a vaccine. It goes over the application and votes whether it also thinks it should be approved.

FDA officials have said that once a COVID-19 vaccine or vaccines have been presented to the agency for approval — which will not happen for several weeks or months — it will ask the committee to consider the applications. 

Thursday’s meeting allowed the group to give feedback to FDA in the middle of the complex and very rapid COVID-19 vaccine development and testing press. 

“Note how FDA mentioned several times that an EUA vaccine could reach millions — FDA wants to be real sure it does due diligence,” said John Grabenstein, general manager of Vaccine Dynamics and editor for the Immunization Action Coalition.