Pfizer asks FDA to authorize Covid booster shots that target omicron BA.5 for people ages 12 and older

In this photo illustration, vials and a medical syringe seen in front of the Food and Drug Administration (FDA) of the United States and Pfizer Pharmaceutical company logos. FDA approves Pfizer/BioNTech the COVID-19 coronavirus vaccine for emergency use in the US, reportedly by media.

Pavlo Gonchar | AP

Pfizer and its German partner BioNTech on Monday asked the Food and Drug Administration to authorize Covid booster shots that target the omicron BA.4 and BA.5 subvariants for people ages 12 and older.

The U.S. is preparing for a fall vaccination campaign using updated vaccines that target the dominant omicron subvariants. Public health officials expect another wave of infection this fall as as immunity from the currently authorized shots wanes off and people head indoors to escape the colder weather.

The updated vaccines would target the original strain of the virus that first emerged in Wuhan, China in 2019 as well as omicron. Scientists and public health officials hope the new shots will provide broader and more durable protection against infection and mild illness.

The currently authorized shots were developed to target the version of Covid that first emerged in China. Though the original vaccines are still preventing severe disease, they are not providing substantial protection against infection and mild illness.

Dr. Ashish Jha, the White House Covid response coordinator, has said the new shots will become available to the public by early to mid-September. Pfizer said it can ship the omicron BA.4/BA.5 boosters as soon as the FDA authorizes them. The U.S. government has secured 105 million doses of Pfizer’s updated shots and 66 million doses of Moderna’s new vaccine.

Omicron BA.5 is the dominant strain of Covid circulating in the U.S. right now, making up about 90% of new infections, according to the Centers for Disease Control and Prevention. The omicron BA.4 and BA.4.6 subvariants represent a little more than 10% of new infections taken together. These versions of omicron are more contagious than past variants of Covid.

Pfizer was originally developing a booster that targets the original version of omicron, BA.1, that caused the massive wave of infection over the winter. But omicron has continued to mutate, and the FDA asked the vaccine makers this summer to switch gears and focus on BA.4 and BA.5.

This is breaking news. Please check back for updates.

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