The Covid-19 vaccine is currently under development and the agreement with the UK government is subject to clinical success and receipt of regulatory approval

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Pfizer world headquarters in Manhattan, New York. (Credit: Coolcaesar/Wikipedia.)

Pfizer and BioNTech reached an agreement with the UK Government to supply 30 million doses of their mRNA-based vaccine candidate against SARS-CoV-2, which causes Covid-19 disease.

The companies have been jointly working on the BNT162 programme, with BioNTech leveraging its mRNA technology and Pfizer providing its global vaccine development and manufacturing capabilities. The initial data from the German Phase ½ study of the BNT162b1 was also released.

The potential Covid-19 vaccine under BNT162 programme is currently under development and the agreement with the UK government is subject to clinical success and receipt of regulatory approval. The financial terms of the agreement will be based on the timing of delivery and the volume of doses.

Pfizer chairman and chief executive officer Albert Bourla said: “In the face of this global health crisis, Pfizer’s purpose, breakthroughs that change patients’ lives, has taken on even greater urgency.

“Consequently, we’re harnessing our scientific expertise, and we’re marshalling our manufacturing resources to ensure that the vaccine would be available as soon as possible if our clinical trials prove successful and regulatory approval is granted.

“This agreement is a testament to our shared goal to have millions of doses of a vaccine against Covid-19 available before the end of the year. We would like to thank the U.K. government for its commitment and support in helping to protect the people of the United Kingdom from this deadly virus.”

BNT162 vaccines represent a combination of mRNA format and target antigen

The BNT162 vaccine development programme is designed to evaluate four experimental vaccines, representing a combination of messenger RNA (mRNA) format and target antigen.

The preliminary data from studies evaluating BNT162b1 showed that the vaccine has produced neutralising antibodies at equal or increased levels observed in the plasma from patients who have recovered from Covid-19, with no serious adverse events reported.

Also, two of the four investigational vaccine candidates BNT162b1 and BNT162b2 have been granted the US Food and Drug Administration (FDA) Fast Track designation recently, based on the ongoing preliminary data from Phase 1/2 studies in the US and Germany.

Data from the clinical trials will be used to select a lead candidate among the four vaccine candidates in BNT162 programme, along with dose level for an anticipated large, global Phase 2b/3 study.

Apart from its agreement with the UK government, Pfizer and BioNTech will also supply their vaccine to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and World Health Organization (WHO).

BioNTech CEO and co-founder Ugur Sahin said: “I would like to thank the UK government for its support and putting trust in us. This agreement is part of our commitment to address the pandemic by creating a global supply. We are in advanced discussions with multiple other government bodies and hope to announce additional supply agreements soon.”