Pfizer Applies to FDA for COVID-19 Vaccine Authorization For Children Ages 5 to 11
12:43 GMT 07.10.2021 (Updated: 13:43 GMT 07.10.2021)
COVID-19 infections in the US have soared among children, hitting their highest point in the pandemic in early September, according to data from the American Academy of Pediatrics.
Pfizer Inc have asked the US Food and Drug Administration to approve the emergency use of the COVID-19 vaccine for children aged 5 to 11.
The FDA has warned that once Pfizer's request is made, the process could still take "a few weeks" until the first shots can actually be administered. The agency said last week it had scheduled a meeting of its advisory committee to review the data on 26 October. The latter will have to give its opinion before the authorisation is then officially granted.
Pfizer / BioNTech has conducted clinical trials on more than 2,000 children aged 5 to 11. The companies indicated by presenting these results that the vaccine was well tolerated in these children, and elicited a "robust" immune response, "comparable" to that observed in 16 to 25 year-olds.
The dosage has been adjusted to 10 micrograms per injection, compared to 30 micrograms for the older groups. For the moment in the United States, Pfizer is fully authorised for those aged 16 years and over, and authorised in urgent cases for 12-15 year-olds.
Pfizer’s COVID-19 vaccine for children aged 5-11 could be authorized for emergency use by federal health regulators by late November, White House COVID Response Coordinator Jeff Zients said in an interview broadcast by CNN on Thursday.
“Again, it's up to the FDA [Food and Drug Administration] and CDC [Centers for Disease Control and Prevention] and scientific processes,” Zients said when asked whether the approval could be granted by Thanksgiving in the US. “But yes, it could and we will be ready as soon as the FDA and CDC give the go-ahead."