Pfizer and BioNTech’s COVID-19 vaccine shows 90% efficacy in interim analysis

pharmafile | November 10, 2020 | News story | Manufacturing and Production, Research and Development BioNTech, COVID-19, Pfizer, Vaccine 

Pfizer and BioNTech have ignited a wave of hope with the announcement of positive Phase 3 data demonstrating that their mRNA-based SARS-CoV-2 vaccine, BNT162b2, showed high levels of efficacy in the first independent analysis of any COVID-19 vaccine in Phase 3 trials so far.

On 8 November, an independent Data Monitoring Committee (DMC) conducted an interim efficacy analysis into the study, triggered once the evaluable count of COVID-19 cases in the patient population hit 96. According to the two drug firms, Phase 3 studies of the candidate have so far enrolled 43,538 healthy participants in six countries since they began in July, with 38,955 of this number having received the second vaccine dose at the time of the interim review.

It was found that the vaccine had an efficacy rate above 90% seven days following the second dose, 28 days after initial treatment.

Importantly, given the virus’ established severity in specific minority groups, the companies pointed out that “42% of global participants and 30% of US participants have racially and ethnically diverse backgrounds”.

No serious safety concerns were reported and the DMC recommended that the trial continue. Despite the promising findings, the developers were keen to stress that the final efficacy rate of the vaccine will likely change as the study continues.

Dr Albert Bourla, Pfizer Chairman and CEO, said the release of the findings was “a great day for science and humanity,” adding: “The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19.”

Under their current projections, Pfizer and BioNTech plan to manufacture and deliver 50 million doses of the vaccine before the end of the year, and up to 1.3 billion doses in 2021.

Matt Fellows

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