Infectious Disease

CDC, FDA say booster doses are not required as a Pfizer eye approval

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Pfizer and BioNTech announced positive initial results from an ongoing study evaluating a booster dose of their COVID-19 vaccine and planned to file the data with the FDA soon.

However, federal health officials said a COVID-19 vaccine booster program was not yet needed and fully vaccinated people would be protected from serious illness from all SARS-CoV-2 viruses, including variants.

Vial of COVID19 vaccine

Pfizer and BioNTech move forward with a COVID-19 vaccine booster program.
Source: Adobe Stock.

“Americans who have been fully vaccinated currently don’t need a booster vaccination,” the CDC and FDA said in a joint statement, adding that federal health officials “are under a scientifically-based, rigorous process to see if or.” when a refresher “may be necessary.”

“We continue to check all new data since [they become] available and will keep the public informed, “said the CDC and FDA. “We are prepared for booster doses when science shows they are needed.”

In addition to pushing a booster program, Pfizer and BioNTech have developed an updated COVID-19 vaccine specifically targeting the highly transmissible Delta variant that the CDC said this week was the most dominant SARS-CoV 2 virus in. has become the United States. Clinical trials of the updated intake are expected to begin in August.

Data on the effectiveness of a booster has not been peer-reviewed, but Pfizer and BioNTech said they would soon publish “more definitive data” and publish it in a peer-reviewed journal. According to a press release issued by the companies, a booster dose of the original vaccine given 6 months after the second dose showed “a consistent tolerability profile while maintaining high neutralization titers against the wild-type and beta variant” – 5 to 10 times higher than after the first two cans.

The CDC and FDA said the US is “fortunate enough to have highly effective vaccines that are widely available to those ages 12 and older”.

“People who are fully vaccinated are protected from serious illness and death, including the variants currently circulating in the country like Delta,” they wrote. “People who are not vaccinated remain at risk. Virtually all COVID-19 hospital admissions and deaths are from those who are not vaccinated. We encourage Americans who have not yet been vaccinated to get vaccinated as soon as possible to protect themselves and their community. “

References:

BioNTech. Pfizer and BioNTech give an update on the booster program in view of the Delta variant. https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-provide-update-booster-program-light-delta. Accessed July 9, 2021.

HHS. Joint CDC and FDA statement on vaccine boosters. https://www.hhs.gov/about/news/2021/07/08/joint-cdc-and-fda-statement-vaccine-boosters.html. Accessed July 9, 2021.

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