Vaccine manufacturers Pfizer and BioNTech have submitted an application to the Food and Drug Administration (FDA) seeking to expand the approval of their COVID-19 shots to individuals aged between 12 and 15, citing trial data, the company announced on Thursday. In a statement, the companies said their application to the FDA includes updated longer-term follow-up data from their Phase 3 clinical trial of the vaccine focusing on 2,228 participants ages 12 to 15 years. The companies said their two-dose series of the Pfizer-BioNTech COVID-19 vaccine had been 100 percent effective during the trial and had a “favorable safety profile”. The results of the trial participants were measured seven days through to four months after they had received the second shot. “Among 30 confirmed symptomatic cases of COVID-19 in the trial with and without evidence of prior infection with SARS-CoV-2, all cases of COVID-19 were in the placebo group (n=1,129) and no cases were in …
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