FDA greenlights updated mRNA Covid vaccines

The FDA on Monday cleared two updated mRNA Covid-19 shots from Pfizer-BioNTech and Moderna, paving the way for an early fall rollout. It will be the first updated shots offered to the public in a year and since the public health emergency ended in May.

The new shots target the XBB.1.5 subvariant of Omicron, following the FDA's June recommendation. Both companies said their shots generate substantial antibodies against the XBB subvariants of the virus, as well as the newer EG.5 and FL.1.5.1 subvariants, which now make up more than 30 percent of cases in the U.S.

Pfizer-BioNTech and Moderna said their updated shots provide additional neutralizing antibodies against BA.2.86, a variant the World Health Organization is monitoring because the variant's high number of mutations could mean it can evade existing immunity. The variant was first detected in Denmark in July and in the U.S. in August.

The FDA approved shots from Pfizer-BioNTech for those 12 years and older as a single shot rather than the two-dose regimen approved previously. It also approved Moderna's shot for those 18 and older as a single dose, when it had previously consisted of two doses.

The agency also updated authorizations for shots from both Moderna and Pfizer so that a child 5 years old and older can receive either shot in a single dose, as long as it has been two months since their previous shot. Children 6 months through 4 years old who have been previously vaccinated can receive one or two doses of an updated vaccine, depending on their last shot, and those who have never been vaccinated can receive three doses of the Pfizer-BioNTech shot, or two doses of the Moderna shot.

"Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

Novavax asked the FDA to authorize its updated shot earlier this summer, but has not yet received a decision from the FDA. The company said it has received shipments of the vaccine in the U.S. that are ready to go. If it receives authorization, it will be the only non-mRNA vaccine option available.

What's next: The CDC's Advisory Committee on Immunization Practices will meet on Tuesday to discuss endorsing and deciding who should receive the updated shots. The panel will also hear from all three vaccine manufacturers, as well as updates on current Covid spread and data on vaccine effectiveness.

Once the agency's director, Mandy Cohen, signs off on ACIP's recommendations for the two shots just approved, they have a clear path to reach the public. Makers of all the shots have said they're prepared to deliver shots in the coming weeks.