The U.S. Food and Drug Administration (FDA) advised COVID-19 vaccine manufacturers on June 30 that any modifications to booster shots for fall will need to target Omicron subvariants BA.4 and BA.5, which account for more than half of new virus cases in the U.S.
“There is a way that seems right to a man,
But its end is the way of death.” Proverbs 14:12
The FDA’s announcement came a day after the Biden administration said it had already entered into a $3.2 billion deal with Pfizer to purchase 105 million doses of its COVID-19 vaccine for a fall vaccination campaign. The announcement said these vaccines will include supplies of new unauthorized bivalent boosters containing the original Wuhan variant and BA.4 and BA.5 Omicron subvariants.
In a press release, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said manufacturers seeking to update current COVID-19 vaccines were advised they should “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 so that the modified vaccines can potentially be used starting in early to mid-fall 2022.”
Vaccine manufacturers already reported data from clinical trials using Omicron BA.1 but will have to submit their data to the FDA prior to its evaluation of any potential authorization of a modified vaccine containing the omicron BA.4 and BA.5 components.
Although there have been no clinical trials to date testing modified vaccines with Omicron subvariants in humans, Marks said manufacturers “will also be asked to begin clinical trials with modified vaccines containing an omicron BA.4/5 component, as these data will be of use as the pandemic further evolves.”
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