Pfizer has launched trials in Knoxville and Nashville to test a third booster shot for the COVID-19 vaccine, marketed as an “updated version.” Alliance for Multispecialty Research (AMR) Knoxville’s Volunteer Research Group is conducting the Knoxville study, and Clinical Research Associates is conducting the Nashville study. Pfizer claimed in a press release earlier this month that a third dose of the COVID-19 vaccine would more effectively provide immunization, especially against the Delta variant.
In response to Pfizer’s claims, CDC and FDA asserted in a joint statement that any additional booster shots are unnecessary.
The United States is fortunate to have highly effective vaccines that are widely available for those aged 12 and up. People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta. People who are not vaccinated remain at risk. Virtually all COVID-19 hospitalizations and deaths are among those who are unvaccinated. We encourage Americans who have not yet been vaccinated to get vaccinated as soon as possible to protect themselves and their community.
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. 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. (emphasis added)
Until Tuesday, the CDC also asserted that fully vaccinated individuals didn’t need to wear masks. When it changed its guidance on Tuesday, they cited the Delta variant as a reason for reversing course on masks for fully vaccinated individuals.
#DeltaVariant surging in U.S. New data show Delta much more contagious than previous versions of #COVID19. Unvaccinated people: get vaccinated & mask until you do. Everyone in areas of substantial/high transmission should wear a mask, even if vaccinated. https://t.co/tt49zOEC8N
— CDC (@CDCgov) July 27, 2021
The Tennessee Star asked AMR and the FDA for comment on this trial, in light of the CDC and FDA joint statement. Neither AMR or FDA spokespersons responded by press time.
– – –