A new study by Pfizer and its partner BioNTech shows their COVID-19 vaccine is over 90% effective in children ages 5-11 as the companies seek an emergency use authorization.
The Food and Drug Administration released a briefing document Friday showing the vaccine, which received full approval for people 16 and older in August and an emergency use authorization for those ages 12-15, was 90.7% effective against symptomatic COVID-19 when the two-dose regimen was administered to children ages 5-11.
"Given all the above, the benefits of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 given as a two-dose, 10 μg dose level, primary series in children 5 to <12 years of age outweigh the known or potential risks," the document stated.
While no cases of myocarditis, a rare heart condition that was diagnosed in some adolescents who received Moderna's coronavirus vaccine, were found among the patients, "the number of participants in the current clinical development program [was] too small to detect any potential risks of myocarditis associated with vaccination," the document said. As a result, five post-authorization safety studies looking into the long-term safety of the COVID-19 vaccine among children will be conducted.
The FDA will discuss this research and other related biological products in a meeting to be held on Tuesday.
Pfizer and BioNTech submitted data to the FDA showing their COVID-19 vaccine was safe for children ages 5-11 on Sept. 28 before filing an application on Oct. 7 seeking the emergency use authorization.
Among those in the United States ages 12-17, 58.6% have received their first COVID-19 vaccine dose, with 48.8% fully vaccinated. In the U.S. as a whole, 66.3% have received at least one COVID-19 vaccine dose, with 57.4% fully vaccinated, according to the Mayo Clinic.
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Original Author: Asher Notheis