WASHINGTON, D.C. – Pfizer and BioNTech asked on Thursday for approval from the Food and Drug Administration (FDA) to issue an emergency authorization for children aged 5 to 11 to be able to receive the COVID-19 vaccine developed in tandem by the two companies.
Announced on Twitter by Pfizer, the pharmaceutical giant said that the move was needed due to the rate of infections among Americans still being at a high level.
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” the tweet said.
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Last week, Pfizer-BioNTech had submitted clinical trial data to the FDA from a COVID-19 vaccine study they had conducted on 2,268 children aged 5 to 11, with the companies saying that the two-dose inoculation administered to the test subjects – which were smaller (10 micrograms) than typical adult doses (30 micrograms) – were tolerated well and had side effects generally comparable to those observed in participants 16 to 25 years of age.
In anticipation of Pfizer-BioNTech’s eventual request for emergency vaccine authorization for children aged 5 to 11, acting FDA Commissioner Dr. Janet Woodcock issued a press release in early October, stating that the organization would thoroughly evaluate the clinical data and make a final determination based on safety factors.
“We know from our vast experience with other pediatric vaccines that children are not small adults,” she said. “We will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults.”
Pfizer-BioNTech also stated that they would have data available from a study conducted with children aged 6 months to 5 years by the fourth quarter of 2021.