Pfizer's COVID Vaccine for Young Adults Expected to Get FDA Approval in Coming Days

As Canada becomes the first country to approve the Pfizer COVID-19 vaccine for children age 12 to 15, the U.S. Food and Drug Administration is set to approve the vaccine for that age group soon.

In late March, Pfizer released preliminary results from a vaccine study of 2,260 U.S. volunteers age 12 to 15 showing there were no cases of COVID-19 among fully vaccinated adolescents compares with 18 among those given dummy shots. The vaccine was previously authorized for anyone 16 or older.

The FDA is expected to authorize Pfizer's vaccine for young people by next week, setting up shots for many before the beginning of the next school year, according to the Associated Press.

Dr. Supriya Sharma, the chief medical adviser at Health Canada, said the evidence shows the vaccine is safe for those age 12 to 15.

She added that while most kids don't experience serious illness from COVID-19, the vaccine helps protect their friends and family who may be at higher risk of complications.

"It will also support the return to a more normal life for our children, who have had such a hard time over the past year,″ she said.

For more reporting from the Associated Press, see below.

Teens COVID Vaccine
A group of teenagers serving as "Covid-19 Student Ambassadors" joined Michigan Governor Gretchen Whitmer to receive a dose of the Pfizer COVID vaccine at Ford Field during an event to promote and encourage Michigan residents to go and get their vaccines on April 6, 2021, in Detroit. The FDA is set to approve the Pfizer vaccine for ages 12 to 15 next week. Matthew Hatcher/Getty Images

Sharma said the evidence is there that the vaccine is safe and effective in that age group. It is the first vaccine approved for children in Canada.

Sharma said about one-fifth of all cases of COVID-19 in Canada have occurred in children and teenagers, and having a vaccine for them is a critical part of Canada's plan.

Kids studied had side effects similar to young adults, the company said, mainly pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.

"Today's expansion of our authorization represents a significant step forward in helping the Canadian government broaden its vaccination program and begin to help protect adolescents before the start of the next school year," Fabien Paquette, vaccines lead for Pfizer Canada, said in a statement.

Health Canada said it will require Pfizer-BioNTech to continue providing information to it on the safety, efficacy and quality of the vaccine in this younger age group to ensure its benefits.

Vaccinations have ramped in Canada in recent months and the government expects to receive at least 10 million vaccines this month. More than 34% of Canadians have received at least one dose.

"It's fantastic and unsurprising," Dr. Andrew Morris, a professor of infectious diseases at the University of Toronto and the medical director of the Antimicrobial Stewardship Program at Sinai-University Health Network, said of the new approval. "We need to get as many people as possible vaccinated as soon as possible. We know older kids are higher transmitters than younger, so this will help everyone."

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Canada COVID Vaccine Children
Canada Prime Minister Justin Trudeau speaks during a news conference in Ottawa on April 23, 2021. Canada recently announced it approved the use of the Pfizer COVID-19 vaccine for ages 12 to 15. Sean Kilpatrick/The Canadian Press via AP