Pfizer and BioNTech start clinical trial for Omicron-based COVID-19 vaccine

Pfizer and BioNTech have announced a new clinical study examining different regimens of the currently available Pfizer/BioNTech COVID-19 vaccine or an Omicron-based vaccine.

The study will involve participants involved in the companies’ collaborative phase 3 COVID-19 booster trial and bolsters the companies’ goals of addressing the latest variant, while gaining further insight into the potential need for variant-based vaccines.

The trial will assess the safety, effectiveness, tolerability and immunogenicity of an Omicron-based vaccine candidate in healthy adults aged 18 to 55 and will include up to 1,420 candidates in the three groups.

The first group received two doses of the current Pfizer/BioNTech COVID-19 vaccine 90 to 180 days prior to enrolment – in the study, participants will receive one or two doses of the Omicron-based vaccine.

The second group received three doses of the current Pfizer/BioNTech COVID-19 vaccine 90 to 180 days prior to enrolment – in the study, participants will receive one dose of the current Pfizer/BioNTech COVID-19 vaccine or the Omicron-based vaccine.

The third group was made up of those who had not had any COVID-19 vaccines – they will receive three doses of the Omicron-based vaccine.

“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 Jansen, senior vice president and head of vaccine research & Development at Pfizer.

Speaking about the latest collaboration developments, Professor 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.”

Sahin added: “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.”

In terms of real-world data, reports continue to show that individuals who are vaccinated – especially those who have received a booster shot – maintain a high level of protection against the Omicron variant, specifically for protection against severe disease and hospitalisation.

Pfizer and BioNTech have announced in joint statements that their expectation to produce four billion doses of their COVID-19 vaccine in 2022 is not anticipated to change, even if an adapted vaccine is necessary.

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