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Pfizer and BioNTech said Monday they submitted an application to the FDA for an updated COVID-19 booster that targets the Omicron BA.4 and BA.5 subvariants.
The big picture: The Biden administration has been pressing to have updated boosters widely available by mid-September.
- But it's still unclear whether an invigorated booster campaign cuts through months of public apathy and confusion and can prime the public for potentially more COVID-19 waves this fall.
What they said: The companies said the data supports emergency use authorization of a 30-microgram booster dose for individuals 12 years of age and older.
- The "bivalent" shot contains mRNA encoding the original COVID spike protein that's present in the current Pfizer-BioNTech vaccine, along with mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants.
- Preclinical data showed a booster dose "generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain."
- The companies plan to launch a clinical study in individuals 12 and older this month.
Background: FDA vaccine advisors in June recommend an Omicron-specific update to COVID-19 booster vaccines.