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Pfizer and BioNTech begin study of omicron vaccine

By Benjamin Mueller


Pfizer and BioNTech have launched a study of an omicron-specific coronavirus vaccine, the companies announced earlier this week, another step on the uncertain path toward a shot designed to target the highly contagious variant sweeping the United States.


The study, which is expected to include up to 1,420 volunteers, will evaluate the safety and tolerability of the updated vaccine and the extent to which it raises antibody levels, the companies said. This first trial is not expected to be large enough to evaluate how well the vaccine works to prevent infections.


Pfizer said that it expected results from the study in the first half of this year. But American regulators have not outlined exactly how much data they will require before authorizing an omicron-based shot.


Pfizer’s CEO has said that the updated vaccine will be ready in March. Pfizer and BioNTech said Tuesday they expected to be able to make 4 billion doses of coronavirus vaccine this year, as they had previously projected, whether or not the new shot was needed.


Those vaccine-makers, along with Moderna, started working on an omicron-specific shot as evidence emerged that the variant would cause a global surge of cases.


The existing Pfizer-BioNTech and Moderna vaccines offer protection from severe disease and hospitalization in cases of omicron infections — even more so when people are given booster doses. But they are less effective at preventing COVID cases caused by omicron than those caused by earlier variants.


Pfizer and BioNTech said Tuesday that vaccine protection from mild and moderate illness waned more quickly than with earlier variants, and that the companies wanted to be prepared in case the current vaccine’s effectiveness against severe illness dropped, too.


“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,” said Kathrin U. Jansen, Pfizer’s head of vaccine research and development, “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.”


The new study will look at three groups of volunteers, some of whom also participated in evaluations of the companies’ booster shot, they said.


One group of up to 615 volunteers will have received two doses of the current Pfizer-BioNTech vaccine, and will either be given one or two doses of the omicron-specific shot.


For another group of 600 participants, the companies will select people who received three doses of the original Pfizer-BioNTech vaccine, and give them either an additional dose of either that same vaccine or the omicron-based shot.


The companies will also recruit a smaller group of up to 205 volunteers who have not been vaccinated but will now receive three doses of the new omicron-specific vaccine.

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