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Pfizer, BioNTech identify and advance lead COVID-19 vaccine candidate

Companies pick the most promising candidate to take into phase 2/3


Pfizer and BioNTech have identified the lead candidate in their COVID-19 vaccine programme to take forward into a large-scale phase 2/3 study.

The partners have identified the lead candidate, BNT162b2, from among four different candidates that were being evaluated in the programme.

Each candidate is mRNA-based; this type of technology is relatively new in the field of vaccine research, with a number of companies, including Moderna, developing mRNA candidates.

An mRNA vaccine tricks the body into producing some of the targeted viral proteins, which in turn can be detected by the immune system which begins to produce antibodies against them. Because the technology is so new,  there are currently no mRNA vaccines approved for any infectious disease.

At the beginning of July, Pfizer and BioNTech revealed early positive data from their vaccine programme, revealing that initial clinical data for another candidate, BNT162b1, demonstrated dose-dependent immunogenicity.

According to Pfizer, BNT162b2 encodes an optimised SARS-CoV-2 full length spike glycoprotein, which is the optimum target of virus neutralising antibodies. The company also added that the candidate demonstrated a favourable overall tolerability profile compared to BNT162b1.

Now that the companies have identified a lead candidate, a phase 2/3 study will begin which is set to include up to 30,000 participants aged 18 to 85. If all goes to plan in this trial and the vaccine proves effective, Pfizer and BioNTech expect to seek regulatory reviews as early as October 2020.

If the companies receive regulatory approval, they then plan to supply up to 100 million doses by the end of 2020 with a further 1.3 billion doses by the end of 2021.

“Our selection of the BNT162b2 vaccine candidate and its advancement into a phase 2/3 study are the culmination of an extensive, collaborative and unprecedented R&D programme involving Pfizer, BioNTech, clinical investigators and study participants with a singular focus of developing a safe and effective COVID-19 RNA vaccine,” said Kathrin Jansen, senior vice president and head of vaccine research and development at Pfizer.

Last week, the US government placed an initial order for 100 million doses of Pfizer and BioNTech’s COVID-19 vaccine, fronting $1.95bn for the first batch. The deal was made as part of the government’s Operation Warp Speed, which is aiming to deliver 300 million doses of a COVID-19 vaccine by January 2021, free of charge, to American citizens.

Article by
Lucy Parsons

28th July 2020

From: Research



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