malaymail.com 04 May, 2021 05:00 am

NYT: US FDA set to authorise Pfizer Covid-19 shot for ages 12-15 early next week

NYT: US FDA set to authorise Pfizer Covid-19 shot for ages 12-15 early next week
NEW YORK, May 4 — The US Food and Drug Administration is preparing to authorise Pfizer Inc and German partner BioNTech SE’s Covid-19 vaccine for adolescents aged between 12 and 15 years by early next week, the New York Times reported on Monday, citing federal officials familiar with the...

NEW YORK, May 4 — The US Food and Drug Administration is preparing to authorise Pfizer Inc and German partner BioNTech SE’s Covid-19 vaccine for adolescents aged between 12 and 15 years by early next week, the New York Times reported on Monday, citing federal officials familiar with the agency’s plans.An approval is highly anticipated after the drugmakers said in March that the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year-olds in a clinical trial.If an approval for the 12-15 year olds is granted, the CDC’s vaccine advisory panel will likely meet the following day to review the clinical trial data and make recommendations for the vaccine’s use in adolescents, the report added.The US Centers for Disease Control (CDC) Director Rochelle Walensky said earlier in April that the vaccine could be approved by mid-May.

Both companies have said they hope to be able to vaccinate children under 11 as soon as early 2022.Responding to a Reuters request for comment, the FDA said its review of expanding the vaccine’s emergency use authorisation is ongoing, but did not provide further details.

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