Pfizer, BioNTech start their COVID-19 vax phase 3, squaring off with Moderna

Pfizer and German biotech partner BioNTech have on the same day as rival Moderna kick-started a late-stage effort for their “best” attempt at an mRNA pandemic vaccine.

Moderna announced early Monday that, alongside a near half-billion extra in Biomedical Advanced Research and Development Authority dollars, it has started a boosted 30,000-patient phase 3 for its vaccine; not to be left out, Pfizer and BioNTech announced after-hours that they too were starting a late-stage attempt.

Unlike Moderna, however, the partners have four shots on target; we’ve already seen early data out from one, which showed an immune response and a manageable safety profile, but now the partners are putting forward a new shot on goal, which they think is better.

Specifically, it’s the pair’s nucleoside-modified messenger RNA (modRNA) candidate, known as BNT162b2, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein.

The vaccine will be given at a 30-µg dose level in a two-dose regimen in a phase 2/3 study of up to 30,000 participants aged 18 to 85 years. It has started in the U.S. and is expected to include around 120 sites globally, with a focus on those with a high prevalence of the disease still in the community.

Like Moderna, they are hoping for a quick turnaround and say that, should this test win out, it’s “on track to seek regulatory review as early as October 2020 and, if regulatory authorization or approval is obtained, plan to supply up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021.” Unlike Moderna's study, U.S. Vice President Mike Pence did not formally announce the start of the Pfizer trial.

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The trial’s primary endpoints will be prevention of COVID-19 in those who have not been infected by SARS-CoV-2 as well as the prevention of COVID-19 regardless of whether they have previously had the virus. Secondaries include prevention of severe COVID-19 in those groups.

Ugur Sahin, M.D., CEO and co-founder of BioNTech, said: “Today, we are starting our late-stage global study, which will include up to 30,000 participants. We selected BNT162b2 as our lead candidate for this Phase 2/3 trial upon diligent evaluation of the totality of the data generated so far.

“This decision reflects our primary goal to bring a well-tolerated, highly effective vaccine to the market as quickly as possible, while we will continue to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio. Many steps have been taken towards this important milestone and we would like to thank all those involved for their extraordinary commitment.”

BioNTech’s shares were up 5% after-hours, while Pfizer, which reports its second-quarter financials today, was also up nearly 2%. Pfizer has a pact to sell the winning vaccine for 50 million people to the U.S. government for around $2 billion, should it pass through the clinical hurdles.