FDA Approves Updated COVID-19 Booster Shots

The Food and Drug Administration (FDA) announced its authorization of two updated coronavirus booster shots to combat the Omicron variant on Wednesday.

Without human testing, the FDA put its stamp of approval on the Moderna and Pfizer-BioNTech vaccines. These bivalent boosters target both the BA.4 and BA.5 lineages of the Omicron strain as well as the original COVID-19 virus.

The BA.5 Omicron strain now accounts for roughly 90% of new U.S. cases, and health officials expect another surge in the fall and winter.

The boosters are described as updates and have been tested on mice.

FDA Commissioner Robert Califf warned that as seasons change and the nation heads indoors, “we strongly encourage anyone who is eligible” to get the new booster dose. He said it will protect against the current circulating variants, particularly Omicron.

Wednesday’s action marks the first FDA authorization since the original shots were approved in December 2020. The Health and Human Services Department said that the nation has secured 171 million doses of the Pfizer and Moderna updated boosters.

Pfizer’s new booster is approved for ages 12 and older, and Moderna’s is authorized for adults 18 and over.

The FDA said the original vaccines will no longer be used as boosters for those ages 12 and up with the authorization of the new boosters that are updated for the latest strains.

The original shots were designed to go after the COVID-19 strain that emerged from Wuhan, China, in 2019. That strain, however, has mutated many times since then to the point where the first doses offer little protection from the new variants.

Health officials stress that, although the first doses are still effective against severe disease, their effectiveness against infection and mild illness has declined rapidly. There is also a greater chance of hospitalization with only the original vaccines as protection.

The Biden administration is expected to start a major push for getting Americans boosted before cooler weather arrives, and doses are expected to begin rolling out the week after Labor Day.