Pfizer and BioNTech have launched a clinical trial to study the effectiveness of an Omicron-specific COVID-19 vaccine, the companies announced Tuesday.
The drugmakers said the study will evaluate the safety and immune response of the new inoculation in up to 1,420 healthy adults ages 18 through 55.
The first group of participants, some 615 people, have received two doses of the current Pfizer-BioNTech vaccine between 90 and 180 days of enrolling in the study. They’ll then receive one or two doses of the Omicron-targeted shot.
A second group, another 600 people, who have received three doses of the current Pfizer-BioNTech vaccine prior to the study, will receive a dose of either the current treatment or the Omicron-based vaccine.
A third group of unvaccinated people will receive three doses of the Omicron-specific shot, the drugmakers said.
“Vaccines continue to offer strong protection against severe disease caused by Omicron,” BioNTech CEO and cofounder Ugur Sahin said in a statement. “Yet, emerging data indicate vaccine-induced protection against infection and mild to moderate disease wanes more rapidly than was observed with prior strains.”
The study aims to develop a “variant-based vaccine” that provides a similar level of protection against the raging Omicron variant as it did with earlier strains while providing an extended period of protection, Sahin said.
The companies previously announced they expect to produce some 4 billion doses of its COVID-19 vaccine in 2022.
“And this capacity is not expected to change if an adapted vaccine is required,” the drugmakers said.
Pfizer said one subject has already received the Omicron-specific shot, the Wall Street Journal reported. The study’s early results are expected in the first half of the year, according to the newspaper.
If the Omicron-specific shot proves safe and effective, Pfizer could ask regulators for authorization and start distribution as early as March, the Journal reported, citing past statements by Pfizer CEO Albert Bourla.
The announcement comes one day after a World Health Organization official said the Omicron variant could portend a new phase of “stabilization and normalcy” amid the ongoing pandemic with continued vaccination and natural immunity.
Dr. Hans Kluge, who heads WHO’s European region, said the Omicron variant appears to cause “much less severe disease” than its Delta counterpart.
“The pandemic is far from over, but I am hopeful we can end the emergency phase in 2022 and address other health threats that urgently require our attention,” Kluge said in a statement.
Research and data show that boosters still provide a high level of protection against severe illness and hospitalization with Omicron, but Pfizer and BioNTech officials said they want to be prepared if that wanes over time.
“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 to towards this goal,” said Kathrin Jansen, Pfizer’s senior vice president and head of vaccine research.
The virus, meanwhile, has killed in excess of 868,000 Americans and more than 5.6 million people worldwide as of Tuesday, according to data from Johns Hopkins University.