The departments of Health and Human Services and Defense yesterday announced an agreement to purchase at least 105 million doses of a Pfizer omicron-specific COVID-19 vaccine for use this fall if the Food and Drug Administration authorizes and the Centers for Disease Control and Prevention recommend the vaccine. An FDA advisory committee this week recommended including an omicron component in COVID-19 vaccine boosters beginning this fall. HHS said the $3.2-billion contract with Pfizer includes a combination of adult and pediatric doses, with a portion of the adult doses provided as single-dose vials, a first for COVID-19 vaccines.

“HHS has been working with vaccine manufacturers to offer single-dose vials as an option to minimize instances of wastage,” the agencies said. “Pending FDA authorization of the vaccine and a recommendation by the Centers for Disease Control and Prevention, HHS could expect to receive first deliveries of the new vaccine in the early fall.”

Peter Marks, M.D., director of FDA’s Center for Biologics Evaluation and Research, today said FDA has advised manufacturers seeking to update their COVID-19 vaccines to add an omicron BA.4/5 component to their current vaccine to create a booster for potential use this fall.

“As we expect this coming year to be a transitional period when this modified booster vaccine may be introduced, we have not advised manufacturers to change the vaccine for primary vaccination, since a primary series with the FDA-authorized and approved COVID-19 vaccines provides a base of protection against serious outcomes of COVID-19 caused by circulating strains of SARS-CoV-2,” he said.
 

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