What you should know:
– Pfizer Inc. (NYSE: PFE) i BioNTech SE (Nasdaq: BNTX) announced the start of a clinical trial to evaluate the safety, tolerability, and immunogenicity of an Omicron-based candidate vaccine in healthy adults 18 to 55 years of age.
– The study will have three cohorts examining different regimes of the current Pfizer-BioNTech Covid-19 vaccine or an Omicron-based vaccine. The study will be based on some participants in the companies’ Phase 3 COVID-19 booster study and is part of their ongoing efforts to address Omicron and determine the potential need for variant-based vaccines.
Overview of the clinical trial study
The study will evaluate up to 1,420 participants in the three cohorts:
– Cohort # 1 (n = 615): He received two doses of the current Pfizer-BioNTech COVID-19 vaccine 90-180 days prior to enrollment; in the study, participants will receive one or two doses of the Omicron-based vaccine
– Cohort # 2 (n = 600): He received three doses of the current Pfizer-BioNTech COVID-19 vaccine 90-180 days prior to enrollment; in the study, participants will receive a dose of the current Pfizer-BioNTech COVID-19 vaccine or Omicron-based vaccine
– Cohort # 3 (n = 205): Participants without vaccination will receive three doses of the Omicron-based vaccine
Clinical and real-world data continue to find people who are vaccinated, especially those who have received reinforcement, maintain a high level of protection against Omicron, especially against serious illness and hospitalization. Companies have previously announced that they expect to produce four billion doses of the Pfizer-BioNTech COVID-19 vaccine by 2022, and that capacity is not expected to change if an adapted vaccine is required.
Pfizer-BioNTech vaccine against COVID-19
The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech’s patented mRNA technology, was developed by both BioNTech and Pfizer. BioNTech holds the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada, and other countries, and the Holder of Emergency Use Licenses or equivalent in the United States (in conjunction with Pfizer). and other countries. Submissions are expected for regulatory approval in those countries where emergency use permits or equivalent were initially granted.
“While current research and real-world data show that reinforcements continue to offer a high level of protection against serious illness and hospitalization with Omicron, we recognize the need to be prepared in case this protection decreases over time and potentially help address Omicron and new variants in the future, “said Kathrin U. Jansen, Ph.D., senior vice president and head of vaccine research and development at Pfizer. “Staying vigilant against the virus requires us to identify new approaches for people to maintain a high level of protection, and we believe that developing and researching variant-based vaccines like this is essential to our efforts to achieve this goal.”