Coronavirus: Pfizer and BioNTech to supply vaccine candidate to U.S. government

The U.S. government has entered an agreement with Pfizer and BioNTech to supply millions of doses of an MRNA-based vaccine candidate aimed at battling the COVID-19 coronavirus pandemic.

According to a news release, the U.S. Department of Health and Human Services (HHS) has placed an initial order for 100 million doses of the vaccine candidate BNT162, which was developed jointly by Pfizer and BioNTech, for $1.95 billion after it is manufactured and either obtains approval or emergency use authorization from the Food and Drug Administration (FDA).

The federal government will also be able to acquire up to an additional 500 million doses and American patients will receive the vaccine free, according to the release.

“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,” Albert Bourla, MD, Pfizer chairman and CEO, says in the release. “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. We are honored to be a part of this effort to provide Americans access to protection from this deadly virus.”

“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,” HHS Secretary Alex Azar says in the release. “Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of this vaccine to the American people.”

There are currently four BNT162 vaccine candidates which are currently undergoing clinical trials and are not approved yet for distribution. Preliminary data from the most advanced of the four vaccine candidates, BNT162b1, shows that it is able to produce neutralizing antibodies at relatively low dose levels, the release says.

If the ongoing studies are successful, the companies plan to seek Emergency Use Authorization as early as October 2020, according to the release.