FDA: Omicron variants should be included in fall boosters

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The Food and Drug Administration (FDA) recommended COVID vaccine manufacturers modify the next round of COVID-19 booster shots to target the extremely contagious Omicron subvariants BA.4 and BA.5.

FDA officially advised the manufacturers to “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.”

Biotechnology companies – including Pfizer, Moderna, and Novavax – are already working on boosters targeting these variants.

Pfizer’s CEO stated on Sunday that Pfizer’s revamped shots will be available for use as soon as the FDA authorizes them.

However, the FDA believes the primary vaccination series should remain the same for now. They said “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.”

The FDA’s recommendation comes after the independent experts on its Vaccine and Related Biological Products Advisory Committee (VRBPAC), as we previously reported, “voted in favor of including Omicron variants in the COVID booster vaccines for the fall.”

According to the Centers for Disease Control and Prevention’s (CDC) COVID data tracker, the Omicron subvariants BA.4 and BA.5 are dominant in the U.S. accounting for 52% of cases and are expected to rise.

U.S. secures 105 million doses for fall

The U.S. Department of Health and Human Services (HHS) announced that the U.S. signed an agreement securing an additional 105 million doses of Pfizer-BioNTech COVID jabs to distribute to Americans this fall.

HHS Secretary Xavier Becerra said they’re “committed to doing everything we can to continue to make vaccines free and widely available to Americans – and this is an important first step to preparing us for the fall.”

The $3.2 billion deal, according to the HHS release, includes vaccines for babies, young children, teens, and adults but may also include the new Omicron-specific boosters.

Delivery should begin in late summer and continue into the fourth quarter of 2022.

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