FDA authorizes updated Covid-19 boosters to protect against omicron this fall and winter - MedCity News

Covid-19 booster vaccines modified to protect against the omicron variant are on the way. The FDA has authorized updated versions of messenger RNA vaccines from Moderna and partners Pfizer and BioNTech.

Wednesday’s announcement amends the booster vaccination section of emergency use authorizations to allow a single dose of the new booster at least two months after a person received the primary vaccination or a previous booster vaccine. Renewed boosters are bivalent. In addition to protecting against the original SARS-CoV-2 strain, they also include components that protect against omicron’s BA.4 and BA.5 lines. Those versions of the virus that have mutations that make them highly transmissible are the ones currently causing Covid-19 cases in the US. The FDA said those lines are also projected to result in cases this fall and winter.

“As we move into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose of the bivalent Covid-19 vaccine to provide better protection against the currently circulating variants.” , FDA Commissioner Robert Califf said in an agency release.

Moderna’s bivalent booster is approved for immunizing individuals over 18 years of age. The authorization for Pfizer and BioNTech’s bivalent booster covers persons 12 years of age and older. With the changes announced by the FDA, anyone age 12 and older may no longer receive monovalent mRNA vaccines as a booster. The FDA said it will evaluate the use of bivalent boosters in other age groups as it receives supporting data and requests from vaccine manufacturers.

The FDA cleared the new bivalent boosters without clinical data for versions of the injections designed to protect against the BA.4 and BA.5 subvariants. Pfizer and BioNTech have clinical data on a bivalent vaccine that protects against the original strain and the BA.1 subvariant. In June, an FDA advisory committee voted to recommend that vaccine manufacturers include an omicron component in their booster vaccines.

After the advisory vote, the FDA manual issued to vaccine manufacturers, instructing them to include a BA.4 and BA.5 component in their bivalent vaccines to address the omicron subvariants that have become dominant in the US. The agency added that clinical data for bivalent injections designed to address BA.1 would be sufficient to seek approval for shots designed to protect against BA.4 and BA.5. Last week, Pfizer and BioNTechas well as Moderna, finished respectively divalent boosters to the FDA.

The FDA’s approval of the bivalent boosters comes one day before a scheduled meeting of the Centers for Disease Control and Prevention’s Vaccine Practices Advisory Committee. The agenda includes discussion of the two bivalent booster shots, followed by a committee vote. CDC Director Rochelle Wolensky can then sign off on the updated boosters, clearing the way for them to become available early next week.

picture: wikimedia commons

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