“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 Kathrin U. Jansen, PhD, senior vice president and head of vaccine research and development at Pfizer, in a statement. “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 towards this goal.” Currently, the U.S. Food and Drug Administration has approved the current two-dose vaccine (called Comirnaty) for anyone 16 and over and granted an emergency use authorization for ages 5 and up. Initial research has shown, however, that the current vaccine is less effective against preventing infection from the omicron strain. RELATED: Get Up-to-Date COVID-19 News in the Daily Coronavirus Alert A recent investigation out of the University of Oxford, for example, found the current Pfizer shot induced lower levels of neutralizing antibodies against the omicron variant. In December 2021, the South African insurance company Discovery Health released data showing that people who were fully immunized with the Pfizer vaccine but not yet boosted had just 33 percent protection against COVID-19 infection during the omicron wave, although protection against hospitalization with the current vaccine was still very high, at 70 percent. “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 Professor Ugur Sahin, CEO and cofounder of BioNTech, in a statement. “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.” Trials will be divided into three groups involving up to 1,420 participants. The first group of 615, made up of those who have already received two doses of the current vaccine three to six months prior, will receive one or two doses of the omicron-based vaccine. A second group of 600, which will include those who have received three doses of the current Pfizer vaccine three to six months prior to enrollment, will receive either one dose of the omicron-specific shot or an additional dose of the current vaccine. The third cohort of 205 will be given three doses of the new omicron-based inoculation. While an omicron-specific shot may improve defenses against the virus, William Schaffner, MD, an infectious disease specialist and professor of preventive medicine and health policy at the Vanderbilt University School of Medicine in Nashville, Tennessee, is not certain one will be required. “If the reduction in omicron cases across the United States continues, there may not be a need for an omicron booster, but it would be good to have it on the shelf, ready for use, if necessary,” says Dr. Schaffner.
