Session Summary
Updated keynote presentation by Andreas Kuhn, Senior Vice President, RNA Biochemistry & Manufacturing at BioNTech RNA Pharmaceuticals GmbH
Summarized by biotech researcher and writer Catarina Carrao
Dr. Andreas Kuhn, Senior Vice President, RNA Biochemistry & Manufacturing at BioNTech RNA Pharmaceuticals GmbH, gave an update on the development of a vaccine against SARS-CoV-2, BNT162 (COMIRNATY®), which met all primary efficacy endpoints in the global Phase 3 trial. 43,661 participants had been enrolled and 41,135 received a 2nd dose of the vaccine 21 days after the first shot. The primary efficacy objective of the trial was efficacy against confirmed COVID-19 in participants without evidence of infection before vaccination; and, efficacy against confirmed COVID-19 in participants with or without evidence of infection before vaccination. The primary efficacy analysis demonstrated 95% vaccine efficacy beginning 28 days after the first dose. There was an observed >94% vaccine efficacy in adults over 65 years of age, with 41% of global participants between 56 and 85 years old. Ten severe COVID-19 cases were observed in the trial, with 9 occurring in the placebo group. The vaccine was well tolerated across all populations. The cumulative incidence of COVID-19 after the first dose clearly shows that the curve between the vaccinated and the placebo group takes place 12 days after the first shot, giving proof that there is already some protection with the first dosage of the vaccine.
On November 9th, 2020, based on 94 confirmed cases of COVID-19 in trial participants, an efficacy above 90% at seven days after the second dose was observed in the interim analysis for COMIRNATY®. On November 18th, 2020, the final analysis, based on 170 confirmed cases of COVID-19 in trial participants indicates an efficacy of 95% (p<0.0001), across age, gender, race and ethnicity demographics.
As of now, authorization for emergency use or temporary use or conditional approval has been obtained in > 45 countries. mRNA technology is poised to revolutionize immunotherapy and displace traditional modalities.