The drugmakers explained that 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 615 participants has received two doses of the current Pfizer-BioNTech vaccine between 90 and 180 days after enrolling in the study. They’ll then receive one or two doses of the Omicron-targeted shot.
A second group, an additional 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. The drugmakers noted that the third group of unvaccinated people would receive three doses of the Omicron-specific shot.
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“Vaccines continue to offer strong protection against severe disease caused by Omicron,” BioNTech CEO and co-founder 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.”
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The study aspires 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 stated. The companies previously announced they expect to produce 4 billion doses of its COVID-19 vaccine in 2022.
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“And this capacity is not expected to change if an adapted vaccine is required,” the drugmaker confirmed. Pfizer noted one subject has already received the Omicron-specific shot, the Wall Street Journal reported. According to the newspaper, the study’s early results are expected in the first half of the year.
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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 suggested the Omicron variant could portend a new phase of “stabilization and normalcy” amid the ongoing pandemic with continued vaccination and natural immunity.
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Dr. Hans Kluge, who heads WHO’s European region, asserted 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.
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“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,” said Kathrin Jansen, Pfizer’s senior vice president and head of vaccine research.