FDA says findings affirm its decision to approve the booster without human testing based on experience with a similarly tweaked vaccine
FRIDAY, Nov. 4, 2022 (HealthDay News) — Getting an updated booster for COVID-19 is likely to boost protection substantially, according to a new study released by drug company Pfizer on Friday.
The news affirms a decision by the U.S. Food and Drug Administration to approve the bivalent booster without first requiring human testing, the Associated Press reported. The booster was tweaked to target the now dominant omicron variant along with the original virus and was cleared based on studies of a similar shot targeting an earlier variant, according to the AP.
The new data “reassures us that this was a good decision to move to this bivalent vaccine,” FDA vaccine chief Peter Marks, M.D., told the AP. “Right now is the time for people to consider going out and get the updated” booster.
To study the new booster, Pfizer compared results for adults who received it to those who received a fourth dose of its original COVID-19 vaccine. The new booster combines vaccines for the original COVID-19 strain and the now-dominant omicron BA.5 strain.
The results showed that people 55 years and older who received the new Pfizer bivalent vaccine had antibody levels four times as high as those who were given another dose of the original vaccine, the AP reported. Those 55 years and older who received the new booster had antibody levels 13 times higher than before getting the shot. Younger adults who had not received a vaccine in about 11 months also saw improved antibodies, about a 9.5-fold increase.
Pfizer said it is too soon to know how much real-world protection the antibodies provide and how long the protection will last. The study is continuing.
Associated Press Article
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