Pfizer, BioNTech request emergency use approval for COVID-19 vaccine

Coronavirus

WASHINGTON (WPRI) — Top U.S. government officials say “hope and help are on the way,” especially with one company applying for emergency use of its coronavirus vaccine.

Pharmaceutical companies Pfizer and BioNTech said they have submitted their requests seeking emergency approval for their vaccine.

Earlier this week, the companies reported the vaccine candidate was 95% effective and did not present any major safety concerns.

The application and clinical trial data will be reviewed by an independent board of scientists before an approval is granted.

In addition to submitting to the U.S. Food and Drug Administration (FDA), the companies have already initiated rolling submissions across the globe including in Australia, Canada, Europe, Japan and the U.K., and plan to submit applications immediately to other regulatory agencies around the world.

General Gustave Perna, the chief operation officer for Operation Warp Speed, said once the emergency use authorization comes, vaccines will be distributed as soon as 24 hours later, and will be ready to administer.

Based on current projections, Pfizer and BioNTech expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

“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. 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,” said Dr. Albert Bourla, Pfizer Chairman and CEO.

Earlier this week, Pfizer announced Rhode Island was one of four states chosen to take part in a pilot vaccine delivery program.

The designation does not mean Rhode Island gets the vaccine sooner. The program is intended to help refine a plan for the delivery, deployment, and administration of the vaccine.

At a White House Coronavirus Task Force briefing Thursday afternoon, Dr. Anthony Fauci said the speed in which these vaccines are being developed did not compromise safety or scientific integrity.

“It was a reflection of the extraordinary scientific advances in these types of vaccines which allowed us to do things in months that actually took years before,” Fauci said. “So, I really want to settle the concern that people have about that.”

Massachusetts-based Moderna is also expected to file for emergency approval for its own vaccine candidate in the coming weeks.

The company recently reported its vaccine was 94.5% effective.

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