BioNTech / Pfizer begins clinical trial of Omicron vaccine

Pfizer and BioNTech have enrolled the first participants in a clinical trial of a vaccine tailored to the Omicron coronavirus variant as companies weigh whether they need to replace the Covid-19 injector existing or not.

The drug makers said Tuesday the study will evaluate the safety, tolerability and effectiveness of an Omicron-based vaccine in 1,420 adults ages 18 to 55.

This is the first human trial of an Omicron-specific vaccine by a major Western drugmaker and will play a key role in determining whether Pfizer and BioNTech adjust their plans to produce 4 billion doses of the drug. their existing injections in 2022 or not.

The companies said they do not expect production capacity to change if they decide to switch to a new vaccine based on Omicron. Pfizer has begun production of several doses of the new aircraft, which it previously said could be ready by March.

Professor Ugur Sahin, CEO and co-founder of BioNTech, said: “Vaccines continue to offer strong protection against the serious disease caused by Omicron. However, emerging data suggest that protection against vaccine-induced infections and mild to moderate disease declines more rapidly than in previous strains.”

“This study is part of our science-based approach to developing a vaccine-based variant that achieves the same level of protection against Omicron as has been done with previous variants. there.”

Several studies have shown that currently available mRNA vaccines provide a high degree of protection against severe illness and hospitalization. But research published by the UK’s Health Security Agency last month found that effectiveness against symptomatic infections dropped to around 10 per cent around 20 weeks after a second dose.

Some epidemiologists have warned that the Omicron-specific vaccine may be in surplus by the time it is produced on a large scale given the rate at which this variant has spread. Others have urged vaccine manufacturers to invest in multivalent vaccines that can target a number of different variants.

Amesh Adalja, an infectious disease specialist at the Johns Hopkins Center for Health Security, said it would be better to have an Omicron-based version of the virus before this variant spikes. But he said it could still be beneficial if new variants sprout from Omicron and drift further away from the Wuhan strain the vaccine is currently targeting.

Adalja added: “What is really game-changing will be a common coronavirus targeting a conserved region of all human coronaviruses,” Adalja added.

Pfizer and BioNTech said they expect to launch an additional study in the first quarter of 2022 to evaluate their currently approved vaccine, the Omicron-based vaccine candidate, and the association combination of two vaccines at different doses.

Kathrin Jansen, Pfizer’s head of vaccine research and development, said: “Staying vigilant against the virus requires us to identify new approaches for people to maintain a level of protection. protection and we believe that developing and researching variant-based vaccines, like this one, is essential in our efforts towards this goal. ”

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