Drug Discovery and Development

FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall

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Picture of COVID-19 vaccine or COVID-19 booster

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The first-generation COVID-19 vaccines remain potent tools in protecting against severe COVID-19, but their effectiveness in protecting against infections from SARS-CoV-2 has slipped as the virus evolves. While boosters improve protection, their effectiveness wanes over time.

FDA today followed the lead of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) in backing the inclusion of an omicron component in future COVID-19 vaccines.

In particular, the agency recommended that vaccine makers develop bivalent COVID-19 vaccines with an omicron BA.4/5 spike protein component combined with the current vaccine composition.

FDA expects the updated vaccines to be used as a booster in “early to mid-fall 2022,” but the current formulation of vaccines will still be used for the primary series.

Moderna and Pfizer have already shared data from clinical trials featuring vaccine candidates with a BA.1 component. FDA has instructed them to submit data from those experimental products to help it evaluate modified boosters with an omicron BA.4/5 component.

The agency will also request manufacturers to conduct clinical trials with modified vaccines with an omicron BA.4/5 component.

Pfizer (NYSE:PFE) saw its share price increase almost 3% to $52.43, while its partner BioNTech (Nasdaq:BNTX) ticked up 5% to $149.10. Moderna (Nasdaq:MRNA) shares were mostly flat, ticking up 0.028% to $142.85.

Filed Under: Infectious Disease
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About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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