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The US authorizes the use of double-variant covid-19 vaccine boosters

The US Food and Drug Administration has authorized the use of versions of Moderna and Pfizer/BioNTech covid-19 vaccines that target both the original virus and two omicron subvariants.

Health


September 1, 2022

Pfizer/BioNTech and Moderna have received authorization to launch new covid-19 boosters

Hannah Beier/Bloomberg via Getty Images

The US Food and Drug Administration (FDA) granted emergency use authorization on August 31 to covid-19 vaccines that target two different variants of coronavirus. 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 received their initial doses of the COVID-19 vaccine or received their most recent booster at least two months ago will now be eligible for the new Pfizer/BioNTech booster if they are 12 years of age or older and the updated Moderna booster if they are 18 years or older. older. A press release from Moderna said that reinforcements from the company should be available. in the days to come at vaccination sites in the US; Pfizer/BioNTech announced that they will begin sending their reinforcements following the instructions of the US government.

“The updated boosters are expected to provide further protection against currently circulating omicron variants,” he said. peter marks, director of the FDA’s Center for Biological Evaluation and Research, during a news conference on August 31. “Ongoing studies will provide information on the specific level of strength of protection.”

Currently, there are no data on the safety and efficacy of these boosters in humans. Rather, the FDA made its decision based on data from animal studies, which found 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 sub-variant. This vaccine is very similar to those targeting BA.4 and BA.5, FDA commissioner said Roberto Caliph at a press conference. The main difference is that the updated boosters contain genetic material to make antibodies against BA.4 and BA.5 instead of BA.1, she 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 confident that what we have is very similar to what we’ve done in the past with flu strain switching where we don’t have clinical trials,” Marks said.

The FDA chose to license the bivalent BA.4 and BA.5 vaccines instead of the BA.1 version because these subvariants represent virtually all new cases in the US. “This gives us a [booster] that’s the most up-to-date,” Marks said.

The FDA will no longer authorize the use of the original COVID-19 vaccines as a booster for people over 12 years of age. However, it will continue to be used as the first and second dose for people who have not received both injections and will be available as a booster for those under 12 years of age.

“The more up-to-date you are on 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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