Pharmaceutical company Pfizer announced Thursday that it has requested the green light from the Food and Drug Administration (FDA) for emergency use of its anti-Covid vaccine, developed with the German BioNTech, for elderly children from 5 to 11 years old in the United States.
This request was expected after assurances given by the American laboratory that clinical trials have proven that the vaccine is reliable and safe for this age group. In its trials, Pfizer tested a dose for children, almost a third of the amount used in adults. At the end of September, the biotechnology firm announced positive results from its studies, indicating a “favorable safety profile and robust neutralizing antibody responses”.
“Based on our extensive experience with other pediatric vaccines, we know that children are not little adults, and we will conduct a comprehensive evaluation of the submitted clinical trial data to support the safety and efficacy of the vaccine. ‘efficacy of the vaccine used in a younger pediatric population, which may need a different strength or formulation than that used in an older pediatric population or in adults,’ said Acting FDA Commissioner Janet Woodcock, during the advisory committee meeting. No anti-Covid vaccine has so far been available for children under 12.
The FDA has previously said it will move quickly to review the clearance request. An advisory committee of the Agency meets to examine the authorization request on October 26th. According to the American Academy of Pediatrics, although children generally do not become seriously ill from COVID-19 as much as the elderly, nearly 175,000 cases have been identified among children in the week ending September 30. Between 0.1% and 1.9% of COVID-19 cases in children have resulted in hospitalization, according to the same source.