The U.S. government has signed an agreement worth $1.95 billion with Pfizer and BioNTEch to produce and deliver 100 million doses of their Covid-19 vaccines. It is the largest such deal between the government and companies racing to develop a coronavirus vaccine.
The U.S. Dept. of Health and Human Services, along with the U.S. Defense Dept., agreed to the large-scale production and delivery deal once Pfizer’s vaccine is successfully manufactured and approved. In addition to the 100 million Covid-19 vaccine doses, the U.S. government will be able to acquire an additional 500 million doses. This will be after Pfizer obtains approval or emergency use authorization from the U.S. Food and Drug Administration (FDA).
Americans will receive the coronavirus vaccine for free.
“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.”
“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 HHS Secretary Alex Azar.
The companies previously said they expect to begin a large Covid-19 vaccines trial with up to 30,000 participants later this month if they receive regulatory approval.
The BNT162 Vaccine under development is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world.
BioNTech is the market authorization holder worldwide and will hold all trademarks for the potential product.
There are four different vaccines under evaluation, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen. The most advanced of them is BNT162b1. The early data shows BNT162b1’s ability to produce neutralizing antibodies in humans at or above the levels observed in the plasma from patients who have recovered from COVID-19, and this was shown at relatively low dose levels. No serious adverse events were reported.
Recently, two of the companies’ four investigational vaccine candidates (BNT162b1 and BNT162b2) received Fast Track designation from the FDA. This was granted based on the progress made and data shown from Phase 1/2 studies that are currently ongoing in the United States and Germany as well as animal immunogenicity studies. If the ongoing studies are successful, Pfizer and BioNTech expect to be ready to seek Emergency Use Authorization or some form of regulatory approval as early as October 2020.
Questioned about the supply chain mechanism and how it would be distributed to the receivers, Alex Azar of HHS said that was not a worry as the government had bolstered the supply chain.“We’re not concerned about supply chain,” he said. “We’ve secured that to be able to ensure that we’ll be able to vaccinate the American people once we get vaccines that are demonstrated safe and effective to the FDA’s gold standard of approval or authorization.”
As part of the Warp Speed Program the government has announced a $1.6 billion agreement with Novavax, a $456 million investment in Johnson & Johnson’s vaccine candidate, $486 million for Moderna’s vaccine, and up to $1.2 billion for AstraZeneca vaccine being developed with the Oxford University.