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Updated August 30th, 2021 at 21:33 IST

Pfizer's COVID-19 vaccine likely to get authorisation for kids by Oct, says Ex-FDA head

The former head of the US FDA has said on August 29 that the drug company’s COVID-19 vaccine could be available for children younger than 12 by early winter. 

Reported by: Aanchal Nigam
COVID-19
IMAGE: AP | Image:self
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The former head of the US Food and Drug Administration and a member of Pfizer’s board of directors, Dr Scott Gottlieb said on Saturday, 29 August 2021, that the drug company’s COVID-19 vaccine could be available for children younger than 12 by early winters. Suggesting a crucial development in the immunisation efforts in the United States, in an interview with CBS News, Gottlieb said that Pfizer will be in a position to file data with US FDA anytime next month. Then the US-based drug company will submit its application to expand its emergency use authorisation for its jabs among five-year-olds and older as early as October. 

"The agency will be in a position to make an authorization, I believe, at some point, late fall, probably early winter," Gottlieb told ‘Face the Nation’ while adding "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."

He also revealed that “The data on kids two to five is going to be available in November.” Gottlieb’s remarks came after US FDA in May authorised the two-dose vaccine made by Pfizer for emergency use among children 12 to 15. Meanwhile, the drugmaker has been conducting clinical trials of its jabs in children ages two or older.  If US FDA decided to approve the Pfizer vaccine against COVID-19 for kids between the ages five and 11 in November or December, ex-FDA head said, it “puts you on a timeframe that you could start rolling out these vaccinations before the end of the year."

Canada Approves Moderna For 12 To 17-Year-Olds

His remarks came after Canada on August 27 approved Moderna’s COVID-19 vaccine for adolescents 12 years of age and older. The government said in a statement on Friday, “Following Health Canada's authorization of the Moderna COVID-19 vaccine for adolescents 12 years of age and older, the National Advisory Committee on Immunization (NACI) released updated recommendations on the use of mRNA COVID-19 vaccines in adolescents 12 to 17 years of age.”

It also noted that in May 2021, NACI had recommended vaccination of adolescents with Pfizer-BioNTech COVID-19 vaccine after regulatory approval and from Friday, it would also include the Moderna jabs mRNA-based jabs. The official statement added, “Clinical trial findings suggest the Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines provide very good protection against symptomatic COVID-19 infection and have a favourable benefit versus risk profile in adolescents 12 years of age and older.”

IMAGE: AP

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Published August 30th, 2021 at 21:33 IST

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