Full FDA approval of Covid-19 vaccines could help fight vaccine hesitancy, officials say – CNN

These vaccines have been in use since mid-December under emergency use authorizations, known as EUAs. During the pandemic, real-world data have shown the vaccines are effective against the coronavirus that causes Covid-19.

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."

If history is any indication, skepticism -- if not outright mistrust -- about an unapproved vaccine is nothing new.

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Full FDA approval of Covid-19 vaccines could help fight vaccine hesitancy, officials say - CNN