Ex-FDA chief : Pfizer Covid vax may be authorised for 5-yr-olds by Oct

Insight Online News

Washington, Aug 30 : US drug maker Pfizer’s Covid-19 vaccine is likely to get authorisation for providing vaccines to children aged between 5 to 12 by October, according to Scott Gottlieb, former head of the Food and Drug Administration (FDA).

Currently of the three Covid-19 vaccines used in the US, only the Pfizer-BioNTech vaccine has been granted the emergency use authorisation for children aged 12 and older.

Pfizer along with Moderna and Johnson and Johnson are conducting clinical trials to evaluate the safety and efficacy of the vaccines in children under 12.

Results of the Pfizer vaccine for children are expected 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 News.

Pfizer has also been conducting clinical trials of its Covid-19 shot in children ages 2 and older. The results will be available in November.

If the FDA authorises Pfizer’s vaccine in kids between the ages of 5 and 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 would be crucial as the highly contagious Delta variant is driving cases, particularly among the children.

According to Gottlieb, there are roughly 300 kids being hospitalised each day with Covid-19, and infection rates among children have spiked with schools reopening.

The two “best things” schools can do, Gottlieb said, is testing students twice a week and keeping them in geographic or social pods to cut down on intermingling among the full student body.

Gottlieb also advocated for students to wear face masks and schools to improve ventilation, as well as vaccinated those who are currently eligible.


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