- The FDA's independent experts voted to include a SARS-CoV-2 omicron component in COVID-19 vaccines that would be used for boosters in the U.S. beginning in fall 2022.
- The panel has advised manufacturers to develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two-component (bivalent) booster vaccine.
- The agency said that the vaccine manufacturers need not change the vaccine for primary vaccination, saying "this coming year to be a transitional period when this modified booster vaccine may be introduced."
- Yesterday, Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) announced a $3.2 billion contract to supply more COVID vaccine doses to the U.S., which may include adult omicron-adapted COVID-19 vaccines, subject to the FDA authorization.
- The FDA said vaccine manufacturers have already reported data from trials containing modified vaccines containing an omicron BA.1 component.
- Related: Pfizer/BioNTech's Updated Omicron-Based COVID-19 Shots Show Improved Response Against Variant.
- The agency has asked the companies to submit these data before any potential authorization of a modified vaccine containing an omicron BA.4/5 component.
- Manufacturers will also be asked to begin trials with modified vaccines containing an omicron BA.4/5 component, as these data will be of use as the pandemic further evolves.
- Photo by Johaehn from Pixabay
Get all your news in one place.
100’s of premium titles.
One app.
Start reading
One app.
Get all your news in one place.
100’s of premium titles. One news app.
FDA Expert Panel Favors COVID-19 Boosters Targeting Omicron BA.4, BA.5 Subvariants
Sign up to read this article
Read news from 100’s of titles, curated specifically for you.
Already a member?
Sign in here
Top stories on inkl right now
One subscription that gives you access to news from hundreds of sites
Already a member?
Sign in here
Related Stories
Top stories on inkl right now
One subscription that gives you access to news from hundreds of sites
Already a member?
Sign in here
Our Picks