Pfizer and BioNTech have signed an agreement with the US Department of Health and Human Services and the Department of Defence to supply their mRNA-based Covid-19 vaccine BNT162 to the US.

The agreement is part of the US government’s Operation Warp Speed programme, which is aimed at delivering 300 million doses of Covid-19 vaccine in 2021.

Under the agreement, the companies will initially supply 100 million doses of their Covid-19 vaccine, following the manufacturing and receiving the US Food and Drug Administration (FDA) emergency use authorisation for the vaccine.

The US government is committed to paying $1.95bn, after receiving the first 100 million doses, and also has an option to acquire an additional 500 million doses of the mRNA vaccine against Covid-19.

American citizens are expected to receive the vaccine at free of cost, pursuant to the US government’s commitment for free access for Covid-19 vaccines.

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 Authorisation is granted.”

Pfizer and BioNTech are working together on the BNT162 programme to develop mRNA vaccine against Covid-19

BNT162 programme has been jointly developed by Pfizer and BioNTech, by leveraging BioNTech’s unique mRNA technology and Pfizer’s global vaccine development and manufacturing capabilities.

Under the BNT162 vaccine development programme, the companies are evaluating at least four experimental vaccines, each representing a distinct combination of messenger RNA (mRNA) format and target antigen.

In addition, two of the four vaccine candidates BNT162b1 and BNT162b2 have received FDA Fast Track designation, based on the preliminary data from the ongoing Phase 1/2 clinical trials, conducted in the US and Germany.

Once the clinical trials are completed, the companies intend to seek FDA emergency use authorisation or regulatory approval by October 2020, manufacture up to 100 million doses by the end of 2020 and produce more than 1.3 billion doses expected by the end of 2021.

BioNTech co-founder and CEO Ugur Sahin said: “We are pleased to have signed this important agreement with the U.S. government to supply the initial 100 million doses upon approval as part of our commitment to address the global health threat. This agreement is one of many steps towards providing global access to safe and efficacious vaccines for Covid-19.

“We are also in advanced discussions with multiple other government bodies and we hope to announce additional supply agreements soon. Our goal remains to bring a safe and effective Covid-19 vaccine to many people around the world, as quickly as we can.”