FDA says benefits outweigh risks for Pfizer/BioNTech COVID-19 vaccine in children
Scientists at the US Food and Drug Administration (FDA) said on Friday that the likely benefits of giving the Pfizer (PFE.N)/BioNTech COVID-19 vaccine to 5 to 11 year olds clearly outweigh the risks of rare cases of heart inflammation.
KATHMANDU, June 23: Children aged between 5 to 12 years are being administered Pfizer BioNTech COVID-19 vaccine from today (Thursday) across the country.
WASHINGTON, Oct. 22: Pfizer and BioNTech announced Thursday that a large-scale trial of their COVID-19 vaccine booster showed it restored full protection against the disease.
In a Phase 3 randomized, controlled trial, a Pfizer-BioNTech booster dose was administered to more than 10,000 individuals 16 years of age and older, who previously received the Pfizer-BioNTech primary two-dose series.
It showed a relative vaccine efficacy of 95.6 percent when compared to those who did not receive a booster.
These are the first efficacy results from any randomized, controlled COVID-19 vaccine booster trial.
"These results provide further evidence of the benefits of boosters as we aim to keep people well-protected against this disease," said Albert Bourla, Pfizer chairman and chief executive officer.
Last month, the U.S. Food and Drug Administration authorized the booster shots for the Pfizer-BioNTech COVID-19 vaccine, allowing a single booster dose of the Pfizer-BioNTech vaccine be administered at least 6 months after completion of the primary series to individuals 65 years of age and older, and 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
The European Union’s drug regulator gave its backing Monday to administering booster shots of the Pfizer-BioNTech COVID-19 vaccine for people 18 and older.
The government is set to receive 100,000 doses of Pfizer–BioNTech COVID-19 vaccine to be delivered under the COVAX sharing scheme for poorer countries.
Apart from the two Chinese vaccines, WHO has previously listed the COVID-19 vaccine developed by Pfizer/BioNTech, two versions of AstraZeneca/Oxford vaccine, the Janssen vaccine, and the Moderna vaccine for emergency use.
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