KALAMAZOO, MI (WKZO AM/FM) — Monday, officials with Pfizer and BioNTech announced that an in-development vaccine may be more that 90 percent effective in preventing COVID-19.
According to the announcement, analysis of the data included an evaluation of 94 total confirmed cases in trial participants who had tested positive for COVID-19. Officials add the study has enrolled 43,538 participants, and that no serious safety concerns have been observed. 38,955 participants have received a second dose of the vaccine candidate as of November 8.
Officials say the case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90% percent at seven days after the second dose.
In other words, officials say protection is achieved 28 days after the initiation of the vaccination, which consists of a two-dose schedule. As the study continues, the final vaccine efficacy percentage may vary.
“Today is a great day for science and humanity. 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,” Pfizer Chairman and CEO Dr. Albert Bourla said in a statement. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. 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.”
The Phase 3 clinical trial for the vaccine began in late July, and will continue until 164 cases have been accrued, according to the announcement. The study will also evaluate the potential for the vaccine to provide protection against COVID-19 in those who have had prior exposure.
“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,” BioNTech co-founder and CEO Professor Ugur Sahin said in a statement. “When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality.”
The companies have posted an updated version of the study protocol, which can be viewed online at this link.
Both companies currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate will be available by the third week of November. The FDA specifies in its guidelines that two months of safety data is required for potential Emergency Use Authorization.
Using this data, the companies are working to submit their findings to the FDA. Officials add that participants in the study will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Based on current projections, officials expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
The announcement drew praise from Michigan Governor Gretchen Whitmer on Monday, who also reminded residents that the vaccine will take time to distribute once it has been approved.
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