Pfizer and BioNTech start clinical trials for Omicron vaccine

Pfizer and BioNTech start clinical trials for Omicron vaccine
A production line at Pfizer Puurs in Antwerp. Credit: Pfizer

Pharmaceutical companies Pfizer and BioNTech have initiated a first clinical study of a vaccine targeting the Omicron coronavirus variant, they announced on Tuesday.

The safety, tolerability and efficacy of the vaccine candidate will be investigated. The study will involve 1,420 people divided into three groups.

“The study is part of our scientific approach to develop a variant-based vaccine that provides similar protection against Omicron as we observed with the previous variants, which also lasts longer,” said Ugur Sahin, CEO of BioNTech in a press release.

The first cohort consists of 605 participants who had already received two doses of the current vaccine between 90 and 180 days before the start of the study and will now receive one or two doses of the Omicron vaccine.

The second cohort consists of 600 people who have already received a booster. They will receive a further dose of the current Pfizer vaccine or a dose of the candidate vaccine against Omicron.

The third cohort, with 205 people, consists of non-vaccinated people and people who did not get sick with Covid-19. They will receive three doses of the Omicron vaccine.

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“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 recognise 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,” said Kathrin U. Jansen, Senior Vice President and Head of Vaccine Research & Development at Pfizer.

Pfizer and BioNTech expect to be able to deliver to the market by March, once they have permission from the relevant authorities.

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