Pfizer-BioNTech commences clinical trials for omicron-specific vaccine

 

Washington: Pfizer and BioNTech have commenced enrollment for a clinical trial to test the safety and immune response of their Omicron-specific Covid-19 vaccine in adults aged up to 55. Pfizer’s CEO Albert Bourla had previously informed in a conference that the pharmaceutical giant could be ready to file for regulatory approval of the shot by March.

 

The company’s head of vaccine research Kathrin Jansen said in a statement on Tuesday that while current data showed that boosters against the original Covid strain continued to protect against severe outcomes with Omicron, the company was acting out of caution. ‘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’, she said.

 

Ugur Sahin, CEO of the German biotech company BioNTech added that the protection of the original vaccine against mild and moderate Covid appeared to wane more rapidly against Omicron. ‘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 longer duration of protection’, Sahin said.

 

According to the statement, the trial will involve 1,420 people aged 18-55. A spokesperson for Pfizer told AFP that it did not include people older than 55 because the goal of the study was to examine the immune response of participants dosed, rather than estimate vaccine efficacy.

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The volunteers are split into three groups. The first involves people who previously received two doses of the current Pfizer-BioNTech vaccine 90-180 days prior to enrollment, and will receive one or two doses of the Omicron vaccine. The second will be people who got three doses of the current vaccine 90-180 days prior to the study and will receive either another dose of the original shot or an Omicron-specific vaccine. The third and final group are people who have never previously received a Covid vaccine, and will receive three doses of the Omicron-specific vaccine. Notably, Pfizer-BioNTech vaccine was the first Covid shot to be authorized in the West, in December 2020.