FDA Authorizes Moderna and Pfizer's Updated COVID Booster Shots

The Food and Drug Administration (FDA) announced on Wednesday, August 31, that it has authorized updated versions of Moderna and Pfizer-BioNTech's COVID booster shots that target the highly contagious BA.5 omicron subvariant.

The federal agency authorized Pfizer's modified booster for people ages 12 and up, while Moderna's shot was authorized for those 18 and older, according to NBC News.

FDA said in a statement that people who have received the two-dose primary series of either COVID vaccine and those who have received the initial two doses plus one or two boosters are eligible for the updated shots as long as a couple of months have passed since their last shots.

Boosters to provide increased protection against BA.5

The FDA's signoff was not the last step, as the decision went to the Centers for Disease Control and Prevention (CDC) and its advisory committee, which recommended how the booster shots should be used.

CDC's Advisory Committee on Immunization Practices voted on the matter on Thursday. Dr. Rochelle Walensky, the agency's director, signed off on the boosters shortly after the meeting, and COVID vaccinations could begin widely after Labor Day, according to CNBC.

Dr. Peter Marks, the FDA's top vaccine regulator, told reporters during a call on Wednesday that health officials expect the updated COVID boosters will provide increased protection against the highly infectious BA.5 omicron subvariant.

According to the CDC, BA.5 makes up nearly 90 percent of all new COVID cases in the United States. Marks said that the FDA had taken great care to ensure that these updated boosters meet their rigorous safety, effective and manufacturing quality standards for emergency use authorization.

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U.S. government buys millions of doses from Pfizer and Moderna

Marks added that the FDA's two-month gap recommendation for getting the updated shots is meant to ensure enough time for the shots to build a good immune response. He also said that the two-month gap should reduce the risk of a rare heart inflammation called myocarditis.

Both Moderna and Pfizer's first iterations of the COVID vaccines have been linked to a small but increased risk of the heart condition, particularly among young men. According to Marks, a wider gap between doses reduces the risk of the heart condition.

The U.S. government agreed to purchase 66 million doses of Moderna's vaccine and 105 million doses of Pfizer's vaccine. Both modified boosters target not only the BA.4 and BA.5 omicron subvariants but also the original coronavirus strain in a single shot.

The FDA revealed on Wednesday that moving forward; the modified boosters will be the only booster available for adults and teens in the U.S. The agency did not consult its advisory committee again before Wednesday's authorizations.

The Biden administration prepares to distribute the updated boosters to teens and adults as part of its fall vaccine campaign.

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