The Centers for Disease Control and Prevention and the Food and Drug Administration are pushing back at Pfizer’s claims that a COVID-19 booster shot is needed at this time.
The two federal agencies issued a joint statement on Thursday as Pfizer prepared to seek emergency authorization for a third dose of its COVID-19 vaccine.
"The United States if fortunate to have highly effective vaccines that are widely available for those aged 12 and up," the statement read. "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 (the National Institutes of Health) 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."
A copy of the statement was tweeted out by Sara Cook of CBS News.
It came as Pfizer said it would ask the FDA for emergency use authorization for a booster in August.
Pfizer's Dr. Mikael Dolsten told The Associated Press that initial data compiled by the company's booster study indicates antibody levels increase five- to 10-fold after a third dose, compared to their second dose months earlier.
And Pfizer, in a statement to CNN, said: "As seen in real world data released from the Israel Ministry of Health, vaccine efficacy in preventing both infection and symptomatic disease has declined six months post-vaccination, although efficacy in preventing serious illnesses remains high.
"Additionally, during this period the Delta variant is becoming the dominant variant in Israel as well as many other countries. These findings are consistent with an ongoing analysis from the Companies' Phase 3 study.
"While protection against severe disease remained high across the full six months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected. Based on the totality of the data they have to date, Pfizer and BioNTech believe that a third dose may be beneficial within 6 to 12 months following the second dose to maintain highest levels of protection."
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