Pfizer said in the release that it will submit to the US Food and Drug Administration for emergency use authorization in the near future. FDA officials have said that when the data is submitted, the drug agency could authorize a vaccine for this younger group of children in the next few weeks, according to the article.
The trial had nearly 2,700 participants ranging between 5 and 11 years old who used a two-dose regimen of the vaccine administered 21 days apart, according to the article. This trial used a 10-microgram dose — much smaller than the 30-microgram dose that is contained in the vaccine for individuals 12 and older.
“The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age,” Pfizer said in a news release.
A Pfizer spokesperson also confirmed that were no instances of myocarditis, a form of heart inflammation connected with mRNA vaccines.
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