Pfizer In Clinical Trial Of Coronavirus Vaccine
PEARL RIVER, NY — Pfizer Inc., whose vaccine research operation is located in Pearl River, began a global clinical study last week to evaluate a candidate from their vaccine program against the new coronavirus.
If the Food and Drug Administration authorizes the vaccine for use, the federal government announced that it will pay $1.95 billion to Pfizer and partner BioNtech to secure the first 100 million doses of the experimental SARS-CoV-2 vaccine. Americans will receive the vaccine for free.
Part of the agreement would give the federal government the option to buy up to an additional 500 million doses. The agreement comes as part of the government's Operation Warp Speed program that aims to secure 300 million doses of coronavirus vaccines by 2021.
"Our selection of the BNT162b2 vaccine candidate and its advancement into a Phase 2/3 study are the culmination of an extensive, collaborative and unprecedented R&D program involving Pfizer, BioNTech, clinical investigators, and study participants with a singular focus of developing a safe and effective COVID-19 RNA vaccine," said Kathrin Jansen, senior vice president and head of Vaccine Research & Development at Pfizer Inc. "The initiation of the Phase 2/3 trial is a major step forward."
The two companies expect to seek emergency use authorization from the FDA or other regulatory approval by October if ongoing clinical trials are successful.
Pfizer and BioNTech worked together on the vaccine. BioNTech used its proprietary mRNA technology to develop the vaccine and Pfizer lended its manufacturing capabilities and global vaccine development expertise. The experimental mRNA process is being used by a few companies to develop vaccine candidates at an unprecedented pace.
Both companies are evaluating at least four experimental vaccines and the agreement with the federal government is for the most advanced of the candidates.
Up to 100 million doses could be produced globally by the end of 2020 and potentially more than 1.3 billion doses can be produced by the end of 2021, according to a statement from both companies.
News of the deal was somewhat a surprise since Pfizer didn't receive funding for research from the federal government, unlike other pharmaceutical companies including Moderna, Johnson & Johnson and AstraZeneca, according to the New York Times.
"We've been committed to making the impossible possible by working tirelessly to develop and produce in record time a safe and effective vaccine to help bring an end to this global health crisis," said Dr. Albert Bourla, Pfizer chairman and CEO. "We made the early decision to begin clinical work and large-scale manufacturing at our own risk to ensure that product would be available immediately if our clinical trials prove successful and an Emergency Use Authorization is granted."
Early data shows that the vaccine produces antibodies against the coronavirus at or above levels produced by people who are infected with the actual virus, according to a joint statement from both companies.
"Expanding Operation Warp Speed's diverse portfolio by adding a vaccine from Pfizer and BioNTech increases the odds that we will have a safe, effective vaccine as soon as the end of this year," said federal Health and Human Services Secretary Alex Azar.
By Rich Scinto, Patch Staff. Patch editor Lanning Taliaferro contributed to this report.
This article originally appeared on the Pearl River Patch
