Waterloo Region Record

Pfizer says its vaccine for kids is 90.7% effective

U.S. FDA advisory panel meets Tuesday to discuss approving the rollout

TONY OWUSU

Pfizer and BioNTech told the U.S. Food and Drug Administration that their COVID-19 vaccine is 90.7 per cent effective for children 5 to 11 years old.

The companies said that the vaccine was effective at preventing symptomatic COVID-19 in a study of children in this age group and was found to be safe and tolerable.

The FDA is expected to post its own written assessment of the study data soon, according to The Wall Street Journal.

Pfizer and BioNTech in early October asked the FDA to approve the children’s vaccine.

The Vaccines and Related Biological Products Advisory Committee, a panel of vaccine experts advising the FDA, is scheduled to meet on Tuesday and could be discussing the new data and whether to recommend its authorization.

Nearly 5.9 million children have been infected with COVID-19 since the pandemic started, according to the American Academy of Pediatrics.

Pfizer is the only fully approved FDA vaccine for individuals 16 and over, and is also authorized for emergency use in children aged 12 to 15.

On Thursday, Pfizer and BioNTech reported 95.6 per cent efficacy for its COVID vaccine booster shot.

The companies said those results are “from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a booster dose of the PfizerBioNTech COVID-19 vaccine in more than 10,000 individuals 16 years of age and older.”

The companies plan to give the data to the FDA, the European Medicines Agency and other regulators worldwide.

At last check shares of Pfizer, the New York health-care group, were little changed at $42.83 (U.S.) while BioNTech shares dropped 4.3 per cent to $274.13.

BUSINESS

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2021-10-23T07:00:00.0000000Z

2021-10-23T07:00:00.0000000Z

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