The US Food and Drug Administration has approved the use of versions of Moderna and Pfizer/BioNTech covid-19 vaccines targeting both the parent virus and two ommicron subvariants
September 1, 2022
The U.S. Food and Drug Administration (FDA) granted emergency approval on Aug. 31 for Covid-19 vaccines targeting two different coronavirus variants. These updated “bivalent” vaccine boosters from Moderna and Pfizer/BioNTech target both the parent strain of the virus and the highly contagious BA.4 and BA.5 omicron subvariants.
People who have had their first Covid-19 vaccine doses or received their most recent booster at least two months ago are now eligible for the new Pfizer/BioNTech booster if they are 12 years of age or older and Moderna’s updated booster if they are 18 years of age or older. older. A press release from Moderna said the company’s boosters should be available the next few days at vaccination sites in the US; Pfizer/BioNTech has announced that they will ship their boosters as directed by the US government
“The updated boosters are expected to provide better protection against the currently circulating omicron variants,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, at a press conference on Aug. 31. “Ongoing research will provide insight into the specific level of security robustness.”
Currently, there is no data on the safety and efficacy of these boosters in humans. Instead, the FDA made its decision based on data from animal studies, which showed that the new vaccines elicited an immune response. The agency also used safety data from previous Covid-19 vaccines, including a bivalent one approved for use in the UK, but not in the US, which is designed to target the BA.1 omicron subvariant. This vaccine is very similar to those targeting BA.4 and BA.5, FDA commissioner said Robert Califf at a press conference. The main difference is that the updated boosters contain genetic material for producing antibodies against BA.4 and BA.5 instead of BA.1, he said.
Both Marks and Califf said the approval without human trial data is similar to how the FDA approves annual flu shots.
“We’re pretty sure what we have is very similar to what we’ve done in the past with changing strains of influenza where we don’t have clinical trials,” Marks said.
The FDA has chosen to allow the bivalent vaccines BA.4 and BA.5 instead of the BA.1 version because these subvariants are responsible for virtually all new cases in the US. “This gives us a [booster] that’s the most up-to-date,” says Marks.
The FDA will no longer allow the use of the original Covid-19 vaccines as a booster for people 12 years and older. However, it will still be used as the first and second dose for people who have not had both injections and will be available as a booster for people under the age of 12.
“The more informed you are about the vaccine, the more likely you are to be protected,” Califf said. “We have to be one step ahead or at least try to be one step ahead [of covid-19].”
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