Pfizer will present new data to outside advisers to the Food and Drug Administration (FDA) Friday showing that its COVID-19 vaccine diminishes in efficacy over time and a booster dose is safe and effective at stopping the virus and its variants.
The company says that data from both the United States and Israel indicates breakthrough infections of COVID-19 are more common in individuals who are further removed from their vaccination, and that the increased breakthroughs are caused by declining vaccine efficacy, not the Delta variant. Pfizer’s data suggests that the reduced vaccine efficacy against infection over time may be followed by a reduction in efficacy against serious disease, particularly in vulnerable and elderly populations.
The @Pfizer @US_FDA booster documents https://t.co/KMb2pfKLAv
reviews all data on effectiveness (VE) vs infection
—waning immunity not related to Delta, just a matter of time, 6% reduction of VE every 2 months
—restoration to 95% VE by 3rd shot
—recommends booster for all age 16+ pic.twitter.com/CO5EqVON5v
— Eric Topol (@EricTopol) September 15, 2021
The meeting of the FDA’s Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee will also feature presentations from the Centers for Disease Control and Prevention, researchers from Israel and the United Kingdom and FDA staff.
The committee will be presented with data on real-world vaccine effectiveness and Israeli data on the protection afforded by booster shots against infection and serious disease. Pfizer says Israeli data shows booster doses are highly effective in areas where the Delta variant is dominant. Pfizer’s final-stage trial of booster doses given six months after initial vaccination found no signs of new, unexpected side effects. (RELATED: Nearly Half Of All Hospitalized Patients With COVID-19 Had Only Mild Or Asymptomatic Cases, Study Shows)
The FDA has already approved booster doses of the Pfizer vaccine in the U.S. for immunocompromised individuals. However, as the Biden administration has promised that booster doses will soon be available to the general public, two top vaccine officials at the FDA are resigning after they wrote in a letter that booster doses for the general population are not currently needed based on the available science.