FDA Panel Supports Rollout of Tweaked Booster Shots From Moderna, Pfizer This Fall
Advisory panel approval speeds the process by which FDA regulators will push for updated booster formulations
WEDNESDAY, June 29, 2022 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel recommended on Tuesday that updated COVID-19 booster shots be used this fall to protect against omicron and its highly contagious subvariants.
Because the virus mutates so quickly, the FDA may approve the new vaccine formulations, since COVID-19 cases are expected to surge again this winter. Tuesday's advisory panel approval speeds the process by which FDA regulators will push for updated booster formulations.
According to The New York Times, the panel discussed various formulations of the Pfizer-BioNTech and Moderna vaccine boosters as possible candidates, but did not decide on which might work best. The agency has been leaning towards a combination of the existing COVID-19 vaccine and one targeting two omicron subvariants, BA.4 and BA.5. Data from the U.S. Centers for Disease Control and Prevention now show those subvariants together making up half of all new infections in the United States.
Manufacturers must work "very rapidly" to produce reformulated shots that would be ready for an autumn rollout, Peter Marks, M.D., head of the FDA's vaccine division, told The Times. Given how fast the virus changes, lengthy human trials may have to be abandoned in favor of more laboratory tests and animal tests, The Times added. That is because human trials can take up to five months, which can make the vaccine obsolete before it is even released to the public.
Both Pfizer and Moderna have been testing updated booster shots that target the omicron variant, with early trial results showing the tweaked shots boost protection against omicron. But since then, subvariants of omicron have surfaced and are spreading.