- Biopharma News
Pfizer and BioNTech COVID vaccine proves 90% effective10 Nov 2020
Results from a Phase III clinical study found Pfizer and BioNTech's mRNA-based vaccine candidate, BNT162b2, is more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection, the companies announced Monday.
This outcome is based on the first interim efficacy analysis conducted on 8 November 2020 by an external, independent Data Monitoring Committee (DMC).
“Today is a great day for science and humanity. The first set of results from our Phase III COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr Albert Bourla, Pfizer Chairman and CEO.
Prof. Ugur Sahin, BioNTech co-founder and CEO, described this milestone as a "victory for innovation, science and a global collaborative effort".
The Phase III study, which began on 27 July and has enrolled 43,538 participants to date, is designed to determine whether the companies' vaccine candidate is safe and effective in preventing COVID-19 disease, when compared to placebo.
Participants had a 50% chance of receiving either the vaccine candidate or a placebo (randomized, placebo-controlled), which was given as two doses, three weeks apart.
The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose.
To date, the DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned.
The two companies are continuing to accumulate safety data and currently estimate that a median of 2 months of safety data following the second (and final) dose of the vaccine candidate – the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization – will be available by the third week of November.
In addition, participants will continue to be monitored for long-term protection and safety for an additional 2 years after their second dose.
Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.
Based on current projections, Pfizer and BioNTech expect to produce globally up to 50 million vaccine doses by the end of the year and up to 1.3 billion doses in 2021.
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