Pfizer and BioNTech announced a positive development in their latest findings from their COVID-19 vaccine candidate, BNT162b2. According to their final results, the vaccine is 95 percent effective.
Their phase 3 clinical trials began in July and included 43,538 participants who received either two doses of the vaccine or a placebo. The two doses were given 21 days apart, and the assessment of 94 confirmed cases of COVID-19 from the pool of vaccinated and placebo groups indicated an efficacy rate of more than 90 percent at 7 days after the second dose. They performed the final efficacy check when the confirmed infection cases reach 170 participants of which 162 cases of the virus were found in the placebo group and 8 in the group that received the vaccine.
As of November 13, 41,135 participants have received a second dose of the vaccine. The two pharmaceutical giants will be seeking emergency use authorization from the U.S. Food and Drug Administration (FDA) after further monitoring and collection of around two months of safety data following the second dose, as specified by the FDA in its guidance. They have met the safety requirements as of this week.
Should a participant develop any severe reactions to the vaccine, it is likely to occur within six weeks of receiving it. So far, the side effects are reportedly only mild to moderate, with pain mostly around the injection site, as well as the presence of fatigue and aching muscles for about a day or two.
Besides this, Pfizer and BioNTech have also begun preparing safety and manufacturing data to allow for mass-market production. They expect to supply the global market up to 50 million vaccine doses before the end of this year and 1.3 billion doses in 2021. They are planning to present this information to the FDA before the end of November.
Pfizer CEO Dr. Albert Bourla shared their enthusiasm for this new milestone 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,” he said. “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.”
Pfizer added that they will also be studying the effects of the vaccine on patients who were infected previously and whether the vaccine can provide long-term protection against the COVID-19 disease for those with severe infection cases.
The BNT162b2 vaccine leverages the mRNA immunotherapy process used by BioNTech in its cancer research program. This means that unique bioinformatic profiles of mutation patterns are created to develop a drug candidate that mirrors the immune system in order to counteract resistance mechanisms. BioNTech has been using this computational approach to create on-demand individualized immunotherapies for commercial consumption for the likes of mutation detection and cancer genomics. The goal is to maximize the biological potential of the immune system itself.
The COVID-19 vaccine will contain mRNA encased in tiny particles that are transported into our cells. It will then stimulate the immune system to create antibodies against the virus.
For more information about BioNTech’s immunotherapy work, visit https://biontech.de/how-we-translate/biontech-approach.
For more news and stories, check out how this 14-year-old discovered a potential COVID-19 blocker here.