A key safety milestone for the vaccine candidate is expected to occur in the second half of November.
An mRNA-based vaccine candidate against the SARS-CoV-2 being developed by Pfizer and BioNTech has shown promising results in people that weren’t previously infected by the virus. The findings from the first interim report of the vaccine candidate’s efficiency revealed that the BHT162b2 experimental COVID-19 vaccine was over 90 percent effective in preventing the infection. The analysis was conducted on 8 November 2020 by an independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.
A comparison between vaccinated participants and those who received the placebo shows a vaccine efficacy rate above 90 percent, at 7 days after the second dose. In other words, the experimental COVID-19 shot offered protection 28 days after the 2-dose schedule was begun. However, with the Phase 3 study still ongoing, the vaccine efficacy percentage is still open to change.
The Phase 3 study of the BHT162b2 experimental shot enrolled 43,538 volunteers, and no major safety concerns were noted in any of them. More safety and additional efficacy data will be collected over the remainder of the Phase 3 trial. The participants will also be monitored for long-term protection and safety for two additional years after the second dose, the release said.
A key safety milestone for the vaccine candidate is expected to occur in the third week of November, as per the press release. After this, the company plans to submit it to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA).
“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 ,” Dr Albert Bourla, Pfizer Chairman and CEO, was quoted as saying in the release. “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.”
Pfizer also shared projection for volume, assuming the candidate clears the Phase 3 trials. It plans to make 50 million vaccine doses in 2020, and up to 1.3 billion doses in 2021, as per the release. Both Pfizer and BioNTech have said they will submit data from the full Phase 3 trial for scientific peer-review publication once the study is concluded.
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