Pfizer and BioNTech are launching a new clinical trial to test a potential omicron-busting COVID-19 vaccine.
The new vaccine will be included in a three-cohort study that will also examine different regimens of the companies’ existing COVID-19 shot, Comirnaty, according to a Tuesday press release.
This new trial is part of Pfizer and BioNTech’s efforts to find a solution for omicron, which has caused the efficacy of existing shots and some antiviral antibody medications to dip. The companies announced in December that lab-based studies suggested three Comirnaty doses were able to neutralize omicron, but, with only two doses, there was a 25-fold decrease in neutralizing antibody levels against the new variant compared to the original variant that the vaccine was designed against.
“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,” said BioNTech CEO and co-founder Ugur Sahin, M.D.
The goal is to create a vaccine that protects against omicron just as the earlier vaccines did with other strains but with a longer duration of protection, according to Sahin.
Pfizer has promised to roll out variant-based vaccines quickly, but some experts say it’s too late to bother with this current wave that’s sweeping the world.
Instead, the next generation of vaccines need to be pan-variant and go after parts of the virus that do not mutate as easily—like the spike protein, which is a hallmark of the SARS-CoV-2 virus and the main target for many vaccines but also sees a number of mutations with each variant.
For now, Pfizer and BioNTech will test the omicron-based vaccine in 1,420 healthy adults from 18 to 55 years old. Some participants will come from the companies’ ongoing phase 3 booster study.
“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,” said Pfizer’s Kathrin Jansen, Ph.D., senior vice president and head of vaccine research and development, in a statement.