Pfizer asked the Food and Drug Administration on Thursday to approve its COVID-19 vaccine on an emergency basis for the 28 million American children ages 5-11.
The FDA said a panel will meet on October 26th to evaluate the request. If they offer a green light, then the Centers for Disease Control and Prevention must weigh in. A final decision will likely come some time in November, although Dr. Scott Gottlieb, who sits on Pfizer’s board and was a former commissioner of the FDA, told CNBC last week, “I wouldn’t foreclose the possibility that this could be out in October.”
CNBC adds:
Last month, Pfizer released new data that showed a two-dose regimen of 10 micrograms — a third of the dosage used for teens and adults – is safe and generates a “robust” immune response in a clinical trial of young children. It said the shots were well tolerated and produced an immune response and side effects comparable with those seen in a study of people ages 16 to 25.
The Wall Street Journal reports:
School districts and public-health officials have begun preparations for vaccinations, though the work remains in early stages. Health and vaccine experts expect the vaccines to be administered at certain schools, pediatrician offices and some pharmacies.
Schools and public-health departments are experienced with childhood vaccines unrelated to Covid-19 because they routinely administer them, although the cold-storage requirements of the Pfizer-BioNTech vaccine may pose some challenges, according to the experts.
According to a recent Kaiser Family Foundation report, about a third of parents who have children 5 to 11 say they would vaccinate their kids as soon as possible.
For the week ending September 30, children were 26.7% of reported weekly COVID-19 cases, according to the American Academy of Pediatrics, which noted that children under age 18 make up 22.2% of the US population.
Since the outset of the pandemic, nearly six million children have been infected with the virus.
