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

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.



Source

Moderna cuts high end of 2025 revenue outlook on vaccine shipment delay in U.K.
Health

Moderna cuts high end of 2025 revenue outlook on vaccine shipment delay in U.K.

Moderna logo is seen in Warsaw, Poland on April 9, 2025. Jakub Porzycki | Nurphoto | Getty Images Moderna on Friday lowered the high end of its 2025 revenue outlook due to a delay in vaccine shipments to the U.K., but beat Wall Street’s expectations for the second quarter as it works to cut costs. […]

Read More
Trump says he asked 17 drugmakers to take steps to cut U.S. prices within 60 days
Health

Trump says he asked 17 drugmakers to take steps to cut U.S. prices within 60 days

U.S. President Donald Trump, U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., Dr. Mehmet Oz, Administrator for the Centers for Medicare & Medicaid Services, David Sacks, AI & Crypto Czar and Amy Gleason, Acting Administrator, Department of Government Efficiency (DOGE) attend the “Making Health Technology Great Again” event in the East Room […]

Read More
Eli Lilly’s Mounjaro shows heart health benefits in head-to-head trial with older diabetes drug Trulicity
Health

Eli Lilly’s Mounjaro shows heart health benefits in head-to-head trial with older diabetes drug Trulicity

Mounjaro manufactured by Eli Lilly and Company packaging is seen in this illustration photo taken in a pharmacy in Krakow, Poland on April 9, 2024. Nurphoto | Nurphoto | Getty Images Eli Lilly on Thursday said its blockbuster diabetes drug Mounjaro showed heart health benefits in a late-stage trial directly comparing it to the company’s […]

Read More