The U.S. Food and Drug Administration on Wednesday gave the green light to updated COVID booster shots from both Pfizer and Moderna that target Omicron variants, paving the way for the shots to get into American arms within a few days. This is the first time updated COVID-19 vaccines have received emergency use authorization in the United States.
“The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in an agency news release announcing the emergency approval.
“We sought input from our outside experts on the inclusion of an Omicron component in COVID-19 boosters to provide better protection against COVID-19. We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently. The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations,” Marks added.
Why new boosters are needed
FDA Commissioner Dr. Robert Califf urged Americans to get the new boosters.
Despite that, U.S. health officials haven’t managed to convince most Americans that they need more shots at this point in the pandemic. Only about two-thirds of the population has had the primary series of two shots, and far fewer have received booster doses.
The main target of the new shots? The BA.5 variant, which now accounts for nearly 90% of all new U.S. cases.
“We have really got to do better to protect the American public,” Dr. Anthony Fauci, President Biden’s chief medical adviser, said. “We are in the middle of a BA.5 outbreak here, and we are nowhere near where we want to be.”
“As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent [targets both the original virus and the Omicron variants] COVID-19 vaccine to provide better protection against currently circulating variants,” he said in the news release.
The hope is that the modified boosters will blunt yet another winter surge — and help with the BA.5 Omicron relative that continues to spread widely.
Until now, COVID-19 vaccines have solely targeted the original coronavirus strain, even as