Pfizer and BioNTech Start Studies of an Omicron-Specific Vaccine

Pfizer and BioNTech announced today that they have started testing an Omicron-specific COVID-19 vaccine in healthy adults.

While data show that the current vaccine made by the companies and approved by the U.S. Food and Drug Administration continues to protect against severe disease, the vaccine is less effective at preventing infection with the virus. Studies also show that the level of immune cells generated by the vaccine wanes over time, which led the FDA to authorize a booster dose.

The quick dominance of the Omicron variant made clear the need to increase the protection provided by the existing vaccine, and the shot’s mRNA technology allowed scientists to modify the genetic base of the vaccine to reflect the Omicron variant in only about six weeks.

The new study will include more than 1,400 people divided into three groups. One group includes people who have been vaccinated with two doses of the current vaccine and will receive one or two doses of the new Omicron vaccine; another group includes those who have been vaccinated and boosted with the Pfizer-BioNTech vaccine and will receive a fourth dose of the existing vaccine or a dose of the Omicron shot; the final group includes unvaccinated people who will get three doses of the Omicron vaccine.

The data will allow researchers to compare infections and symptoms among people who are currently vaccinated and who get one dose or two doses of the Omicron shot to those who have been boosted with the current vaccine and receive a dose of the Omicron vaccine. The data will help scientists and public health experts to learn more about how beneficial variant-specific vaccines might be, and whether they will be necessary going forward.