Dr. Scott Gottlieb, former FDA head and member of Pfizer’s board of directors, predicted on Sunday that the drug company’s COVID-19 vaccine could be available to children under the age of 12 by early winter, a critical development in the nation’s vaccination efforts as students return to school.
According to Scott Gottlieb, former head of the Food and Drug Administration, Pfizer’s Covid-19 vaccine is likely to receive approval for providing vaccines to children aged 5 to 12 by October (FDA).
Only one of the three Covid-19 vaccines currently used in the United States, the Pfizer-BioNTech vaccine, has been granted emergency use authorization for children aged 12 and older.
Pfizer, Moderna, and Johnson & Johnson are conducting clinical trials in children under the age of 12 to assess the safety and efficacy of the vaccines.
The Pfizer vaccine for children is expected to produce results in September.
“Pfizer will be in a position to file data with the FDA at some point next month, and then submit its application to expand its emergency use authorisation for its vaccine in children 5 years and older as early as October,” Gottlieb was quoted as saying in an interview on CBS News on Sunday.
“The agency (FDA) will be in a position to make an authorisation, I believe, at some point, late fall, probably early winter.
“And probably they’re going to base their decision on what the circumstances around the country, what the urgency is to get to a vaccine for kids,” Gottlieb, who is also a member of Pfizer’s board of directors, told CBC New
Pfizer has also been testing its Covid-19 shot in children as young as two years old. The findings will be made public in November.
If the FDA approves Pfizer’s vaccine in children aged 5 to 11 in November or early December, “that, again, puts you on a timeframe that you could start rolling out these vaccinations before the end of the year”, Gottlieb noted.
Vaccinating younger children against Covid is critical because the highly contagious Delta variant is causing cases, especially among children.
According to Gottlieb, approximately 300 children are hospitalised each day with Covid-19, and infection rates among children have increased with the reopening of schools.
Gottlieb believes that testing students twice a week and keeping them in geographic or social pods to reduce intermingling among the entire student body are the two “best things” schools can do.
Gottlieb also advocated for students to wear face masks and for schools to improve ventilation, as well as for those who are currently eligible to be vaccinated.