Pfizer and BioNTech Initiate Clinical Trial of Omicron-Targeted mRNA Vaccine in Healthy Adults Aged 18–55

News on January 26, 2022 /BioValleyBIOON/ ---Pfizer(Pfizer) and BioNTech recently announced the launch of a clinical study to evaluate in healthy adults aged 18-55.Candidate mRNA Vaccine Based on OmicronSafety, tolerability, and immunogenicity.

The study will have three cohorts, testing different regimens of the current COVID-19 mRNA vaccine (Pfizer-BioNTech COVID-19 vaccine) and an Omicron-based vaccine. The study will utilize some participants from Pfizer and BioNTech's Phase 3 COVID-19 booster study, as part of their ongoing efforts to address Omicron, aiming to determine the potential need for a variant-based vaccine.

The first batch of subjects has been enrolled.Clinical Trial, and received a vaccine based on Omicron, as part of a two-dose primary immunization schedule along with one booster shot.

Specifically, the study will evaluate up to 1,420 subjects across 3 cohorts:

——Cohort 1 (n=615): Subjects have received two doses of the current COVID-19 mRNA vaccine (Pfizer-BioNTech COVID-19 vaccine) 90-180 days prior to enrollment. In this study, subjects will receive one or two doses of the Omicron-based vaccine.

——Cohort 2 (n=600): Subjects have received 3 doses of the current COVID-19 mRNA vaccine (Pfizer-BioNTech COVID-19 vaccine) 90-180 days prior to enrollment. In this study, subjects will receive one dose of either the current COVID-19 mRNA vaccine (Pfizer-BioNTech COVID-19 vaccine) or an Omicron-based vaccine.

——Cohort 3 (n=205): Subjects who have not been previously vaccinated will receive three doses of the Omicron-based vaccine.

Pfizer Senior Vice President and Head of Vaccine Research and Development, Kathrin U. Jansen, Ph.D., stated: "While current studies and real-world data indicate that booster shots continue to provide high levels of protection against severe disease and hospitalization due to Omicron, we recognize the need to be prepared in case this protection wanes over time and potentially helps address issues with Omicron and future new variants. Staying vigilant against the virus requires us to identify new ways to keep people highly protected. We believe that the development and study of variant-based vaccines, like this one, are crucial to our efforts in achieving this goal."

Prof. Ugur Sahin, CEO and co-founder of BioNTech, stated: "The vaccine continues to provide strong protection against severe disease caused by Omicron. However, new data indicates that the protection induced by the vaccine against infection and mild to moderate disease declines more rapidly compared to previous viral strains. This study is part of our scientific approach aimed at developing a variant-based vaccine that offers a level of protection against Omicron similar to earlier variants but with a longer duration of protection."

The COVID-19 vaccine from Pfizer/BioNTech is based on BioNTech's proprietary mRNA technology., co-developed by BioNTech and Pfizer. BioNTech is the marketing authorization holder in the United States, the European Union, and the United Kingdom, as well as the holder of Emergency Use Authorization (EUA) or equivalent authorization in the United States (together with Pfizer), Canada, and other countries. The two parties plan to submit applications in countries where EUA or equivalent authorization was initially granted to seek regulatory approval. (Bioon.com)

Source of the original text:Pfizer and BioNTech Initiate Study to Evaluate Omicron-Based COVID-19 Vaccine in Adults 18 to 55 Years of Age