


The FDA on Monday cleared two updated mRNA Covid-19 shots from Pfizer-BioNTech, Moderna and Novavax, 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.
Novavax asked the FDA to authorize its updated shot earlier this summer, but has not yet received a decision from the FDA. The company has received shipments of the vaccine in the U.S. 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, Dr. Mandy Cohen, signs off on ACIP’s recommendations, the shots have a clear path to reach the public. Makers of all three shots have said they’re prepared to deliver shots in the coming weeks.