Pfizer, BioNTech File for FDA Approval of Updated Booster

Yesterday, Pfizer and BioNTech submitted their application to the FDA for emergency use authorization of their bivalent Covid-19 vaccine for use in people ages 12 and older. The updated formula will combine the original vaccine with one that targets the omicron subvarients Ba.4 and Ba.5 and will be administered as a 30 microgram dose. The companies are following guidance from the FDA and are including critical data of their bivalent BA.1 vaccine and pre-clinical and manufacturing data from the bivalent BA.4 and 5 vaccine for the submission. The updated booster should be available to the public early to mid September but the FDA will need to give the green light before that can happen.