FILE PHOTO: COVID-19 vaccinations in New York By Manojna Maddipatla
(Reuters) – The debate over whether Americans should receive a booster dose of the Pfizer/BioNTech COVID-19 vaccine moves to a panel of independent expert advisers to the U.S. Food and Drug Administration on Friday.
While U.S. health officials, some other countries and vaccine makers have said boosters are needed, many scientists and vaccine experts disagree.
The FDA staff said in documents https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-says-third-covid-19-shot-warranted-fda-document-2021-09-15 prepared for the committee this week that the vaccine Pfizer Inc developed with Germany’s BioNTech SE is still very effective at preventing severe illness and death and that the evidence is mixed on whether its efficacy declines over time.
Pfizer, which is arguing for broad use of a third shot, submitted data from an analysis of over 300 participants in its late stage clinical trial showing that the vaccine’s efficacy diminished by around 6% every two months after the second dose, and that an additional shot boosted immunity.
The FDA’s Vaccines and Related Biological Products Advisory Committee will also consider data from Israel, which has been administering booster doses of the Pfizer/BioNTech vaccine.
The effectiveness of the second dose of the vaccine waned six months after administration, making a booster necessary, Israeli health officials had said.
It began offering a COVID-19 booster https://www.reuters.com/world/middle-east/israel-offers-covid-19-booster-shots-all-vaccinated-people-2021-08-29 to people as young as age 12 last month, expanding a campaign that began in July for people over 60.
A new analysis by Israeli scientists published on Wednesday in the New England Journal of Medicine found that among 1.1 million people age 60 or older who had been fully vaccinated at least 5 months earlier, those who received a booster were less likely to be infected or become severely ill than those who did not get the third shot.