Pfizer
The meeting with the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and other officials on Monday, according to the Associated Press, comes only days after Pfizer said it was starting to see waning immunity from its two-dose messengerRNA (mRNA) vaccine, developed in partnership with BioNTech
"As seen in real world evidence release from the Israel Ministry of Health, vaccine efficacy has declined six months post-vaccination, at the same time that the Delta variant is becoming the dominant variant in the country," Pfizer and BioNTech said in a joint statement on Thursday.
"These findings are consistent with an ongoing analysis from the companies' Phase 3 study," the companies said. "That is why we have said, and we continue to believe that it is likely, based on the totality of the data we have to date, that a third dose may be needed within 6 to 12 months after full vaccination."
After Pfizer's announcement, the FDA and CDC released a joint statement saying: "Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary."
This process takes into account laboratory data, clinical trial data, and cohort data - which can include data from specific pharmaceutical companies, but does not rely on those data exclusively," the federal agencies added. "We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed."
An individual is considered fully vaccinated two weeks after their second dose of either vaccine developed by Pfizer-BioNTech or Moderna
Those invited to the meeting included White House chief medical advisor Dr. Anthony Fauci, Driver of the National Institutes of Health Dr. Francis Collins, CDC Director Dr. Rochelle Walensky, and action FDA Commissioner Dr. Janet Woodcock, according to The Washington Post.
Currently, only 48% of the U.S. population is fully vaccinated, according to CDC data. The U.S. is also still missing President Joe Biden's goal of administering at least one of vaccine to 70% of U.S. adults by early July, standing at about 68% at this time.
In some parts of with low immunization rates the Delta variant, which first emerged in India, is surging. The White House stated last week that virtually all COVID related hospitalizations and deaths are now among unvaccinated Americans.
