Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN’s Jim Sciutto on Wednesday he hopes Covid-19 vaccines will receive full FDA approval “very soon,” and that the FDA will work “as expeditiously as possible” on approval applications for coronavirus vaccines as they come in.
Progressing from authorized to approved would allow manufacturers to market and directly distribute their vaccines. It could also have an impact on vaccine mandates — and perhaps sway skeptics hesitant to get the vaccines now.
Currently, the three Covid-19 vaccines distributed in the United States — made by Pfizer/BioNTech, Moderna and Johnson & Johnson — are authorized, but not approved.
CNN has contacted Pfizer/BioNTech, Moderna and Johnson & Johnson — the most recent Covid-19 vaccine to be authorized — about their plans to apply for full approval of their vaccines. None provided a timeline.
The FDA also requires vaccine manufacturers to submit data to support their manufacturing processes, facilities, product characterization and demonstration that the vaccine can be produced reliably and consistently.
Once all of that is complete — both the clinical trials and manufacturing details — companies can submit a Biologics License Application or BLA to the FDA.
“FDA evaluates the data to determine whether the safety and effectiveness of the vaccine has been demonstrated and whether the manufacturing and facility information assure product quality and consistency. After its evaluation, FDA decides whether to approve (also known as to license) the vaccine for use in the United States.”
After all, as spread of the virus is reduced, the nation may no longer be under an emergency situation and the vaccines will need a different type of green light under the FDA.
The agency is “the gold standard of a safety and regulatory organization throughout the world,” said Fauci, chief medical adviser to President Biden. “I hope they do it quickly.”
‘It will help show skeptics that the authorized Covid vaccines are safe’
A concern around authorized-but-unapproved vaccines hinges on vaccine hesitancy.
If history is any indication, skepticism — if not outright mistrust — about an unapproved vaccine is nothing new.
The researchers, from the University of Pittsburgh and the University of Georgia, found that about 77% of respondents would be moderately, very or extremely worried if offered an unapproved vaccine; some 63% said they would not take it.
But the study also found that there were some other key factors that would convince respondents that a vaccine authorized under an EUA was safe to use.
If the vaccine were administered by a public health professional, 55% of respondents said they would take it.
If it came with a fact sheet, just over 57% of those surveyed said they would get it.
If their own health care provider administered the vaccine, that number shot up to 68%.
“We should also pursue full Food and Drug Administration approval and expand covid vaccinations to youths,” Adams wrote in part.
“The individuals who got vaccinated early on were generally high risk and willing to take a vaccine authorized for emergency use. But many people who are lower risk understandably ask if the benefits justify taking a medication that has not received the full and traditional FDA stamp of approval,” he wrote. “As vaccine manufacturers complete further studies, which will eventually lead to expanded eligibility among minors, it will help show skeptics that the authorized covid vaccines are safe.”
Plans to require vaccines
Some organizations say they expect to require the vaccine, but have opted not to while it’s authorized and not yet fully approved.
“People, when they hear it’s still emergency use, they still have a little concern about how far you can go with it,” Fauci said on CNN Wednesday.