Pfizer Begins Clinical Trials for Omicron-Specific COVID-19 Vaccine
Pfizer and its partner BioNTech have begun clinical trials for a new COVID-19 vaccine specifically targeting the Omicron variant, which they say could be available as early as the end of March.
The New York City-based pharmaceutical company announced Tuesday that it is recruiting 1,420 participants for a three-cohort trial that will determine the safety and effectiveness of the company’s injection.
Albert Bourla, the company’s CEO, indicated earlier this month that his company expects to submit data to the Food and Drug Administration (FDA) for authorization in March.
Some of the participants are the same as those who took part in trials for the company’s booster injection, and all are between the ages of 18 and 55 — meaning the shot will initially only be available to adults.
An Omicron-specific vaccine has been searched for since the variant was first discovered by South African health officials in late November, and early indicators were discovered that it could evade vaccine protection.
Since then, scientists have confirmed that the variant can evade vaccine immunity, and while boosters may boost protection, an injection tailored to the new strain could be most effective at preventing its spread.
Pfizer has begun trials for its Omicron-specific COVID-19 vaccine. The shot is tested in series of one, two and three doses. The company hopes to make the recording available as early as March (file photo)
Some experts believe that the release of the shots in March may be too late, as by then the Omicron Covid wave that is already showing signs of retreat may have completely disappeared. Pictured: A man in Nevada gets an injection of a COVID-19 vaccine on December 21
“While current research and real-world data show that boosters continue to provide a high level of protection against serious illness and hospitalization with Omicron, we recognize the need to be prepared in the event that this protection wanes over time and to potentially to help address Omicron and new variants in the future,” said Kathrin Jansen, head of Vaccine Research and Development at Pfizer, in a statement.
Staying vigilant against the virus requires us to identify novel approaches for humans to maintain a high level of protection, and we believe developing and researching variant-based vaccines, such as these, are essential in our efforts to achieve this goal.’
The trial will test three different regimens for the new vaccine. A one-time jab will be given to 615 participants, two shots to 600 participants and a three-shot version to 200.
Each of the participants received the Pfizer vaccine for their additional vaccine regimen. Those in the one-shot group did not get a boost, while those in the two- and three-shot groups had previously received the Pfizer booster shot.
“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 previous variants, but with a longer duration of protection.” Ugur Sahin, the CEO and co-founder of Germany-based BioNTech, said in a statement.
The vaccine is similar to that of the existing Pfizer-BioNTech Covid vaccine, the most widely used injection in America and much of the rest of the world.
Pfizer said in a statement that production of this new injection, if it proves effective, will not lead to a reduced capacity for the company to produce its base Covid shots.
Vaccines continue to provide strong protection against serious diseases caused by Omicron. Still, emerging data indicate vaccine-induced protection against infection and mild to moderate disease is declining faster than observed with previous strains,” Sahin said.
BioNTech initially developed the mRNA used to make the vaccine and partnered with Pfizer to create a flu vaccine in 2018. The company’s central focus when Covid arrived, developing what is considered the gold standard vaccine against the virus.
While Pfizer — and their competitor Moderna — may have Omicron-specific shots ready soon, not everyone is convinced the shots are necessary.
Booster shots have shown the ability to restore the immunity people have against Covid infection, and even people who don’t get a boost are still significantly less likely to have severe symptoms if they are vaccinated.
The Technical Advisory Group on COVID-19 Vaccine Composition at the World Health Organization earlier this month asked major pharmaceutical companies such as Pfizer to move away from making vaccines that require frequent updates and instead developing shots that last. be effective in the long run.
The Omicron wave is also coming to an end in some major countries – such as the UK – and showing signs of retreat in the US
By the time March rolls around and the injection becomes available, it may not be necessary — wasting time and resources that could have gone into research and development of other treatments.
“By the time we produce an Omicron-specific vaccine, this wave will be over,” Peter Marks, Center for Biologics Evaluation and Research at the FDA, told the FDA. Wall Street Journal earlier this month.