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Company ‘days’ away from submitting data to FDA – Colorado Springs, Colorado

Colorado Springs, Colorado 2021-09-27 11:05:04 –

Pfizer’s CEO said Sunday that he was “a few days” away from submitting data to the FDA, hoping that the COVID-19 vaccine would be approved by children up to the age of five.

In a speech at ABC News on Sunday, Albert Bourla said the company was “days, not weeks” away from submitting final data.

“I think we’ll submit this data soon,” Bourla said. “It’s a matter of days, not weeks, so it’s up to the FDA to review the data and reach better conclusions.”

When Pfizer submits the data to the FDA, authorities will review the data. Within a few weeks, it is widely expected that the authorities’ Vaccine and Related Biopharmaceutical Advisory Board will meet to vote on whether to recommend that children make the vaccine available on an emergency use basis.

last week, From Phase 2/3 trials, Pfizer has released data showing that low-dose vaccines are safe and effective for children aged 5-11 years. The data showed that participants developed antibodies that fight the virus. vaccination.

The Pfizer vaccine is fully approved by the FDA and the Centers for Disease Control and Prevention for people over the age of 16. The vaccine is also available for children aged 12 to 15 years for emergency use.

The Pfizer vaccine is the first vaccine approved by the FDA for use in children. National health officials believe that approval of vaccines for children will help keep communities nationwide safe from COVID-19, especially in the middle of the school year, with the spread of delta variants nationwide.

Company ‘days’ away from submitting data to FDA Source link Company ‘days’ away from submitting data to FDA

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