The US government has placed an order worth $1.95bn to Pfizer and BioNTech to procure 100 million doses of their BNT162 vaccine candidate for Covid-19.
BNT162, which is being developed for giving protection against SARS-CoV-2, the virus that causes Covid-19, was recently given the fast track designation by the US Food and Drug Administration (FDA). The vaccine candidate is currently in a phase 1/2 clinical trial.
Pfizer and BioNTech, which are jointly developing the vaccine programme, have signed the supply agreement with the US Department of Health and Human Services (HHS) and the Department of Defense.
The agreement undertaken by the US government is said to be in line with its Operation Warp Speed programme, which aims to start delivering 300 million doses of a vaccine for Covid-19 in 2021.
The government will receive the agreed doses of the BNT162 vaccine after Pfizer is successful in manufacturing and also in getting either approval or emergency use authorisation from the FDA.
There is also an option for the US government to procure an additional 500 million doses of the potential Covid-19 vaccine.
HHS Secretary Alex Azar said: “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.
“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.”
The BNT162 vaccine programme has been developed based on BioNTech’s mRNA technology and is backed by Pfizer’s capabilities in global vaccine development and manufacturing.
The two firms entered into a collaboration agreement in March 2020 for the joint development of four vaccine candidates as part of the programme. Out of these, BNT162b1 and BNT162b2 are the vaccines to get the FDA fast track status.
Pfizer and BioNTech expect to begin a phase 2b/3 safety and efficacy clinical trial later this month, and will look to seek a review from the FDA as early as October 2020. The pharma companies aim to manufacture up to 100 million doses of the vaccine across the world by the year-end, and potentially over 1.3 billion doses by the end of next year.
Pfizer chairman and CEO Albert Bourla said: “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.
“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.”