- Advertisement -
- Advertisement -
- Advertisement -
- Advertisement -

Find a job

Subscribe for free

All things Pharma

Pfizer and BioNTech initiate clinical study of Omicron vaccine

Pfizer and BioNTech have announced the initiation of a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate in healthy adults 18-55 years of age.

The study will have three cohorts examining different regimens of the current Pfizer-BioNTech COVID-19 vaccine or an Omicron-based vaccine. The study will draw upon some participants from 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.

The study will evaluate up to 1,420 participants across the three cohorts:

  • Cohort #1: 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: Received three doses of the current Pfizer-BioNTech COVID-19 vaccine 90-180 days prior to enrollment; in the study, participants will receive one dose of the current Pfizer-BioNTech COVID-19 vaccine or the Omicron-based vaccine
  • Cohort #3: Vaccine-naïve participants will receive three doses of the Omicron-based vaccine.

The companies have previously announced that they expect to produce four billion doses of the Pfizer-BioNTech COVID-19 Vaccine in 2022, and this capacity is not expected to change if an adapted vaccine is required.

Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer said: “While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, we recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future. Staying vigilant against the virus requires us to identify new approaches for people to maintain a high level of protection, and we believe developing and investigating variant-based vaccines, like this one, are essential in our efforts towards this goal.”

Prof. Ugur Sahin, CEO and Co-founder of BioNTech said: “Vaccines continue to offer strong protection against severe disease caused by Omicron. Yet, emerging data indicate vaccine-induced protection against infection and mild to moderate disease wanes more rapidly than was observed with prior strains. This study is part of our science-based approach to develop a variant-based vaccine that achieves a similar level of protection against Omicron as it did with earlier variants but with longer duration of protection.”

- Advertisement -
Emma Cooper
Emma is Digital Editor at Pf.

MORE FROM AUTHOR

- Advertisement -

LATEST POSTS

Subscribe

Sign up to receive your free UK subscription to Pf Magazine and our digital newsletters, for all the essential headlines, Jobs of the Week, and thought-provoking features.

Claim my free subscription