NEW YORK & MAINZ, Germany—So, how fast does the COVID-19 pandemic have infectious disease researchers moving these days? Well, our November issue of DDN only recently arrived in people’s mail with news of an mRNA vaccine candidate from Pfizer Inc. and BioNTech SE and its strong showing in preclinical results in mouse and primate models—a paper about which was still under peer review for publication—and we already have even more promising news from the companies about an interim analysis from a Phase 3 human trial.
And those results are quite impressive so far for the mRNA-based vaccine candidate, BNT162b2, with a reported 90- percent effectiveness in preventing COVID-19 in participants without evidence of prior SARS-CoV-2.
After discussion with the FDA, the companies had recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases.
According to the companies, 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. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a two-dose schedule. No serious safety concerns have yet cropped up.
Although this is an impressively high prevention figure, both companies do note that as the study continues, the final vaccine efficacy percentage may vary. Still, despite that caveat their enthusiasm was obvious, as Pfizer Chairman and CEO Dr. Albert Bourla said, “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.
“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.”
Added Prof. Ugur Sahin, BioNTech’s co-founder and CEO: “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. 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. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued.”
In addition to primary prevention, the overall study, which began in July, also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease.