Pfizer and BioNTech to supply up to 600 million doses of COVID-19 vaccine to US

Pfizer and BioNTech have announced an agreement with the US Department of Health and Human Services and the Department of Defense to meet the US government’s Operation Warp Speed programme goal to begin delivering 300 million doses of a COVID-19 vaccine in 2021.

Under the agreement, the US government will receive 100 million doses of BNT162, the COVID-19 vaccine candidate jointly developed by Pfizer and BioNTech, after Pfizer successfully manufactures and obtains approval or emergency use authorisation (EUA) from the US Food and Drug Administration (FDA).

The country’s government will pay the companies $1.95 billion upon the receipt of the first 100 million doses, following FDA authorisation or approval. It will also be able to acquire up to an additional 500 million doses.

The BNT162 programme 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. 

The US population will receive the vaccine for free, consistent with the US government’s commitment for available access for COVID-19 vaccines. 

“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, Chairman and Chief Executive Officer (CEO) of Pfizer. “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 EUA is granted. We are honoured to be a part of this effort to provide Americans access to protection from this deadly virus.”

“We are pleased to have signed this important agreement with the US 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 a 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,” said Dr Ugur Sahin, CEO and Co-founder of BioNTech.

According to the companies, if the ongoing studies are successful, they expect to be ready to seek EUA or some form of regulatory approval as early as October 2020.