Nearly three weeks after Pfizer and BioNTech released data purporting to show that their COVID jab is safe and effective for children between the ages of 5 and 11, the two companies confirmed Thursday that they had officially asked the FDA to approve their jab for emergency use for children in that age group.
According to the NYT, should the FDA grant this approval, it would make another 28MM Americans (all young children) eligible for the jab. The FDA has reassured Pfizer that it will "move quickly" on the request. A meeting has been tentatively scheduled for Oct. 26 to review the data and consider the emergency approval. A decision on emergency approval is expected some time between Halloween and Thanksgiving.
Parents across the country are waiting on the FDA's decision. Now that California has become the first state in the country to require children to be vaccinated to attend school (be it private or public), the FDA's approval could spur similar measures from other states.
Per the NYT, whether the emergency authorization is extended will depend not only on the strength of the clinical trial data, but on whether they could prove to regulators that they are properly manufacturing a new pediatric formulation of the vaccine. This new formulation would only include about one-third of the adult dosage. Producing this new formulation will require Pfizer to add more diluent to the jab.
Dr. Janet Woodcock, the acting FDA commissioner, said last week that children might require “a different dosage or formulation from that used in an older pediatric population or adults.”
The FDA will also have to examine the purity and stability of mass-produced pediatric doses to ensure that the "quality" and potency matches that of the doses given to children during the trials.
While one in every six Americans infected with COVID was under the age of 18, even the NYT acknowledges that "children rarely become severely ill" from COVID.
Pfizer's submission coincides with the release of new study data which appears to confirm that the protection provided by the Pfizer jab starts to wane after a couple of months - even earlier than many experts had expected.
It also comes as three northern European countries have restricted use of the Moderna jab - which, like Pfizer's jab, is based on mRNA technology - among younger patients amid worries that the threat of rare side effects might outweigh the benefit of whatever protection is provided by the jab.