Pfizer to seek FDA sign-off today for emergency COVID-19 vaccine usage
The Pfizer-BoiNTech vaccine has 95% efficacy
Pfizer and partner BioNTech confirmed they will seek approval from the Food and Drug Administration on Friday for emergency usage of their new COVID-19 vaccine, a major step forward in a fight against a pandemic that has killed more people in the U.S. than any other nation.
"Hope and help are on the way," Health and Human Services Secretary Alex Azar, a point person in the Trump administration's push to develop a safeguard against the disease, said the night before.
“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally," Dr. Albert Bourla, Pfizer Chairman and CEO, said in a statement.
"Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential," he added.
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| MRNA | MODERNA INC. | 44.26 | +1.20 | +2.79% |
| PFE | PFIZER INC. | 25.82 | -0.39 | -1.49% |
Pfizer and BioNTech are currently in Phase 3 trials on the vaccine, which is 95% effective, as is rival pharmaceutical giant, Moderna.
"Two vaccines, each with 95% efficacy, rivaling the 98% efficacy of our measles vaccine," Azar said during a coronavirus task force briefing at the White House on Thursday. "Produced in some of the largest vaccine clinical trials ever conducted in history."
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The secretary emphasized the rapidity with which the vaccines were created -- in a 10-month period, a product of the administration's Operation Warp Speed plan.
Azar is joining 'Mornings With Maria" on Friday.
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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 get our vaccine did not get any severe disease, which is, of course, a gamechanger," Bancel told "Mornings with Maria" on Monday.
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.