Pfizer, BioNTech launch trial of omicron-specific COVID-19 vaccine
Pfizer and BioNTech said Tuesday that they have initiated a clinical study to assess the safety and efficacy of a COVID-19 vaccine for adults aged 18 to 55 years that specifically targets the omicron variant of SARS-CoV-2.
The study will consist of 1,420 participants in three cohorts, including separate cohorts of people who have received two or three doses of the current Pfizer-BioNTech vaccine, and a smaller cohort of unvaccinated people.
“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,” Kathrin U. Jansen, PhD, Pfizer’s senior vice president and head of vaccine research and development, said in a news release.
The first cohort will include 615 people who received two doses of the current vaccine 90 to 180 days before enrollment and who will receive one or two doses of the omicron-based vaccine.
In the second cohort, 600 participants who received three doses of the current vaccine 90 to 180 days before enrollment will receive either one more dose of the current vaccine or one dose of the omicron-based vaccine.
The third cohort will include 205 previously unvaccinated people who will receive three doses of the omicron-based vaccine.
“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 toward this goal,” Jansen said.
The omicron variant now accounts for almost all U.S. cases of COVID-19. Although omicron has caused less severe disease on average than previous variants, it has overloaded hospitals with sick patients, and officials have urged Americans to get boosted to improve their protection.