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Pfizer, BioNTech’s COVID-19 vaccine prevents 90% of infections in initial late-stage study data

Preliminary results could warrant regulatory approval soon

Pfizer and BioNTech have announced preliminary results from a phase 3 study of their COVID-19 vaccine candidate, which shows the vaccine prevented over 90% of infections in vaccinated individuals.

Not only are the results the first from a late-stage COVID-19 vaccine study, but the data is also particularly promising given prior warnings from experts that the first vaccines for the virus could only be 60-70% effective.

The interim analysis was conducted after 94 participants in the study contracted COVID-19, and the study is set to continue until 164 cases have occurred in total.

According to the partner companies, the case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, seven days after the second dose of the vaccine, BNT162b2.

Pfizer and BioNTech did add that the final vaccine efficacy percentage could change as the study continues, but even an initial efficacy of over 90% is promising.

However, additional key data will be needed to fully understand the effectiveness of Pfizer and BioNTech’s vaccine, including whether it prevents severe cases of COVID-19.

It is also still currently unknown if the vaccine prevents individuals from carrying the SARS-CoV-2 without presenting symptoms.

The phase 3 BNT162b2 study’s data monitoring committee (DMC) has not reported any serious safety concerns and has recommended that the study should continue to collect additional safety and efficacy data.

If subsequent data read-outs continue to demonstrate efficacy, Pfizer and BioNTech will head to the US Food and Drug Administration (FDA) to seek approval for the vaccine.

The FDA currently requires a minimum of two months safety data before it can grant emergency approval to a potential COVID-19 vaccine.

Pfizer and BioNTech expect to have a median of two months of safety data, following the second dose of BNT162b2, available by the third week of November.

In addition to this minimum safety data, participants will be monitored for long-term protection and safety for an additional two years after their second dose.

The companies added that, based on current projections, they expect to produce up to 50 million vaccine doses globally in 2020, with up to an additional 1.3 billion doses forecast for 2021.

“We are reaching this critical milestone in our vaccine development programme at a time when the world needs it most, with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen,” said Albert Bourla, chairman and chief executive officer of Pfizer.

“With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks,” he added.

“The first interim analysis of our global phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” said Ugur Sahin, co-founder and chief executive officer of BioNTech.

Article by
Lucy Parsons

9th November 2020

From: Research



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