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There is no data from human trials on the new BA.5 boosters, so it’s unclear how they will perform in the real world. The CDC and FDA used human data from clinical trials for shots targeting the original version of omicron, BA.1, which triggered a stronger immune response than the old vaccines.
Pfizer and Moderna were originally developing omicron boosters to target BA.1, but the FDA asked the companies to switch gears in June and develop BA.5 shots instead after the subvariant became dominant. The decision to focus on BA.5 did not leave enough time to wait for data from human trials ahead of a fall vaccine rollout.
The lack of human data for the BA.5 shots has caused some controversy, but Dr. Peter Marks, a senior FDA official, said the agency followed the same process used for years with strain changes for flu vaccines. Marks said on Wednesday that flu vaccine strains are also changed without human clinical data.
https://www.cnbc.com/2022/09/01/cdc-pane...-week.html
Pfizer and Moderna were originally developing omicron boosters to target BA.1, but the FDA asked the companies to switch gears in June and develop BA.5 shots instead after the subvariant became dominant. The decision to focus on BA.5 did not leave enough time to wait for data from human trials ahead of a fall vaccine rollout.
The lack of human data for the BA.5 shots has caused some controversy, but Dr. Peter Marks, a senior FDA official, said the agency followed the same process used for years with strain changes for flu vaccines. Marks said on Wednesday that flu vaccine strains are also changed without human clinical data.
https://www.cnbc.com/2022/09/01/cdc-pane...-week.html
