Pfizer submits data to U.S. FDA for COVID-19 vaccine in children 5 and older
Posted Sep 28, 2021 7:44 am.
Last Updated Sep 28, 2021 9:00 am.
Pfizer-BioNTech has submitted initial trial data to the U.S. Food and Drug Administration to clear their COVID-19 vaccine for children aged five to 11.
The drugmaker says a formal request for emergency use authorization is expected in the coming weeks.
The vaccine has already been authorized for emergency use in youth 12 to 15 and is fully approved for people 16 and older in the U.S.
The companies said last week that the vaccine was shown to have a strong immune response in younger children during a clinical trial with 2,268 participants.
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In Canada, the Pfizer and Moderna mRNA vaccines are currently approved for those 12 and older, with Health Canada confirming the “safety and effectiveness in people younger than 12 years of age have not yet been established.”
A number of Ontario health units recently announced they are developing plans for the vaccination of younger children once COVID-19 shots are approved for them.
Toronto Public Health said Monday that it had formed a planning group that includes health partners, school boards, community representatives and the province, while health officials for Peel Region, Middlesex-London, Hamilton, Ottawa and York Region also said they were making arrangements.
Toronto Mayor John Tory said plans are being made now so that young children can be vaccinated as soon as possible after Health Canada authorizes a COVID-19 shot for them.
With files from the Canadian Press
