Docsun Biomed Report on Pfizer-BioNTech COVID-19 Vaccine

By: WHO, CDC and FDA
 
JHUBEI CITY, Taiwan - Jan. 5, 2022 - PRLog -- U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to:
  • Expand the use of a single booster dose to include use in individuals 12 through 15 years of age.
  • Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months.
  • Allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age.
Boosters are now authorized for people 12 years of age and older
  • A single booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include its use in individuals as young as 12 years of age.
  • The agency has determined that the protective health benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death, outweigh the potential risks in individuals 12 through 15 years of age.
  • The FDA reviewed real-world data from Israel, including safety data from more than 6,300 individuals 12 through 15 years of age who received a booster dose of the vaccine at least 5 months following completion of the primary two-dose vaccination series.

Booster interval updated to five months for people 12 years of age and older

The FDA is also authorizing the use of a single booster dose five months after completion of the primary vaccination series of the Pfizer-BioNTech COVID-19 Vaccine.
  • Since Pfizer initially submitted safety and effectiveness data on a single booster dose following primary vaccination, additional real-world data have become available on the increasing number of cases of COVID-19 with the omicron variant in the U.S.
  • No new safety concerns have emerged from a population of over 4.1 million individuals 16 years of age and older in Israel who received a booster dose at least five months following completion of the primary vaccination series.
  • Additionally, peer-reviewed data from multiple laboratories indicate that a booster dose of the Pfizer-BioNTech COVID-19 Vaccine greatly improves an individual's antibody response to be able to counter the omicron variant.
  • While today's action applies to the Pfizer-BioNTech COVID-19 Vaccine, the FDA continues to review data concerning all available vaccines and will provide additional updates as appropriate.
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Original links to the article: - https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-multiple-actions-expand-use-pfizer-biontech-covid-19-vaccine

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