The Pfizer/BioNTech COVID-19 vaccine confirmed 90.7% efficacy in opposition to the coronavirus in a scientific trial of youngsters 5 to 11 years previous, the U.S. drugmaker stated on Friday.
Sixteen kids within the trial who had acquired a placebo acquired COVID-19, in contrast with 3 who had been vaccinated, Pfizer stated in briefing paperwork submitted to the U.S. Meals and Drug Administration.
As a result of greater than twice as many kids within the 2,268-participant trial got the vaccine than placebo, that equates to raised than 90% efficacy.
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Pfizer’s scientific trial in these 5 to 11 years previous was not primarily designed to measure efficacy in opposition to the virus. As a substitute, it in contrast the quantity of neutralizing antibodies induced by the vaccine within the kids to the response of older recipients of their grownup trial.
Based mostly on these outcomes, Pfizer and BioNTech stated final month that their COVID-19 vaccine induced a strong immune response within the kids.
Outdoors advisors to the FDA are scheduled to fulfill on Tuesday to vote on whether or not to advocate that the company authorize the vaccine for that age group.
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The Pfizer/BioNTech vaccine already has U.S. regulatory authorization for people who find themselves no less than 12 years previous, together with full FDA approval in August for these 16 and up.
Round 190 million folks in the US are absolutely vaccinated, together with greater than 11 million who’re 12 to 17 years previous which have acquired the Pfizer vaccine.
If the FDA authorizes the vaccine for kids 5 to 11 years previous, a gaggle of advisors to the U.S. Facilities for Illness Management and Prevention will meet on Nov. 2 and three to make suggestions to the company on how the photographs needs to be administered. Most states await the CDC to log out on suggestions for vaccines earlier than they start administering photographs.
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