Moderna and Pfizer ask FDA to OK more boosters

Pfizer and Moderna are both requesting Food and Drug Administration (FDA) emergency use authorization for a second booster shot of their mRNA vaccines against COVID-19, according to announcements made last week.

Pfizer and BioNTech, makers of the vaccine called COMIRNATY, said in a March 15 press release that they are asking the FDA for emergency authorization of a second booster shot for their COVID-19 vaccine for individuals aged 65 and up.

Moderna announced on March 17 that it would seek broader emergency use authorization to give a second booster to all adults, over age 18, for its SPIKEVAX vaccine.

Pfizer and BioNTech said they sent their submission to the FDA along with “real world data” that was collected in Israel, where second booster shots have already been approved.

“Clinical and real-world data continue to show that people who are vaccinated, particularly those who have received a booster, maintain a high level of protection, particularly against severe disease and hospitalization. The companies remain vigilant and continue to collect data to explore new vaccine approaches and regimens to reduce the risk of infection and the risk of severe COVID-19 disease,” the press release said.

Funding an issue

Government funding for a fourth dose may be lacking. “Senior administration officials said they do not have the money for a potential fourth shot for all Americans following last week’s collapse of a $15.6 billion plan to fund vaccines and other coronavirus countermeasures,” The Washington Post reported.

“We are working right now very intensively,” Pfizer’s chief executive Albert Bourla told The Washington Post. “I think our data suggests that [fourth doses] are protecting — they are improving dramatically the protection, the fourth dose compared to the third for omicron after some time, after, let’s say, three to six months.”

“Federal health officials have said they are concerned about waning potency of the booster shot that was authorized for both Moderna and Pfizer in the fall. But although there are indications that regulators could move swiftly on Pfizer’s request, it is unclear how favorably they will view Moderna’s more sweeping application,” The New York Times reported.

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