Pfizer, Moderna to file FDA COVID-19 vaccine emergency usage as soon as Friday

FAN Editor

“Hope and help are on the way” to combat the coronavirus pandemic, according to Health and Human Services Secretary Alex Azar, who said Thursday that Pfizer and its partner BioNTech “intend to file for emergency use authorization at the FDA” for its COVID-19 vaccine on Friday.

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Pfizer and BioNTech are currently in Phase 3 trials on the vaccine as is fellow pharmaceutical giant, Moderna.

“Two vaccines, each with 95% efficacy, rivaling the 98% efficacy of our measles vaccine. Produced in some of the largest vaccine clinical trials ever conducted in history. Over 40,000 patients in each of these clinical trials demonstrating good safety profiles,” Azar said during the White House’s Coronavirus task force briefing Thursday.

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The secretary emphasized the importance of the speed with which the vaccines were created — “10 months!”

As for when Moderna will follow Pfizer in the application process, Azar said, “We would expect to see Moderna filing soon.”

PFIZER’S COVID-19 VACCINE: WHAT TO KNOW

Azar will join ‘Mornings With Maria” on Friday in the 8 AM ET hour.

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MODERNA’S COVID-19 VACCINE: WHAT TO KNOW

Earlier this week, Moderna CEO Stephane Bancel said his company’s coronavirus vaccine has demonstrated a “gamechanger” safety record in ongoing studies, along with 94.5% effectiveness in preventing COVID-19.

“People who did got our vaccine did not get any severe disease, which is, of course, a gamechanger,” Bancel told “Mornings with Maria” Monday. “We’re very excited to announce this morning that the vaccine at this first interim analysis of phase three, the real test … has shown 94.5% efficacy.”

Earlier this week, Azar said that the US could distribute 40 million doses of the Pfizer and Moderna vaccines by the end of the year.

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