Pfizer Will Submit Coronavirus Vaccine to FDA on November 20, Requesting Emergency Use Authorization

Researchers Say Pfizer’s SARS-CoV-2 (COVID-19) Coronavirus Vaccine Just Around the Corner

New York, N.Y. (PPD) — Pfizer, Inc. (PFE) plans to submit an application to the Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its coronavirus vaccine on November 20. People’s Pundit Daily (PPD) spoke exclusively with sources at the company with knowledge of the nation’s coronavirus vaccine development efforts, who spoke on the condition of anonymity because they were not authorized to speak on the record.

Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) grants FDA Commissioner Stephen Hahn the authority to facilitate the availability and uses of medical countermeasures, or MCMs, needed during public health emergencies. EUA authority allows FDA to approve MCMs to treat conditions associated with chemical, biological, radiological, or nuclear (CBRN) threats, or emerging infectious diseases.

The November 20 date is a fluid target, but Pfizer also intends to start pediatric and maternal protocols by January, according to one source directly involved with the effort. However, sources tell PPD the damage done by those politicizing vaccine development is on par with the anti-vaccination lobby.

Former Vice President Joe Biden has amassed a long history of casting doubt on the coronavirus vaccine. Mr. Biden, the 2020 Democratic presidential nominee, questioned whether the vaccine will be “real” and whether it would be distributed with “any degree of equity and realization”.

Kamala Harris, his vice presidential running mate, said she may not take a coronavirus vaccine developed under the Trump Administration.

Developers say such remarks are irresponsible, undermine their work and what will inevitably be a massive effort to distribute the vaccine to an already vaccine-skeptical public.

Over the summer, the Trump Administration launched Operation Warp Speed aimed at delivering 300 million doses of a safe, effective, and authorized vaccine for SARS-CoV-2 (COVID-19) by the end of the year. Efforts resulting from Operation Warp Speed “have been working with remarkable efficiency,” according to The New York Times.

While three vaccine candidates showed promise during trials — Pfizer, AstraZeneca (AZN) and Moderna (MRNA) — Pfizer has the furthest global reach. In July, the Trump Administration struck a historic deal with the company to secure 100 million vaccine doses — with the potential for nearly half a billion more to follow — as soon as it is FDA approved and manufactured.

Per the agreement, Pfizer will begin delivering the doses to the American people at no cost. The Trump Administration simply directs the company to the locations for distribution.

“I would not hesitate for a moment to take the vaccine myself and recommend it to my family,” Dr. Anthony Fauci, a member of the White House Coronavirus Task Force and head of the National Institute of Health (NIH), said in response to Mr. Biden’s and Ms. Harris’ remarks casting doubt on the safety of the vaccine. NIH colleague Dr. Francis Collins added, “The safety and the effectiveness will be not compromised.”

Sources at Pfizer said the application submitted to the FDA will naturally include safety and efficacy data, and noted the company previously submitted six amendments with supporting data. Adverse event monitoring for the vaccine candidates developed by Pfizer is reportedly much lower juxtaposed to other candidates.

“We will do our job to assess the safety and the efficacy of a vaccine candidate,” Commissioner Hahn said in a previous statement addressing the process for reviewing applications. “Science and data are really going to guide this decision, and nothing else.”