London, United Kingdom (CU)_ According to the statement from Pfizer and BioNTech, clinical trial enrollment has begun to evaluate the safety and immune response of their Omicron-specific Covid-19 vaccine in adults aged up to 55. Albert Bourla, CEO of Pfizer, stated earlier that the pharmaceutical giant could be ready to submit a regulatory application for the vaccine by March.
According to Kathrin Jansen, the firm’s head of vaccine research, while current data indicated that boosters against the original Covid strain continued to protect against severe outcomes with Omicron, the company was exercising caution. She said, “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”. She added, “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 longer duration of protection.”
According to Ugur Sahin, CEO of the German biotechnology company BioNTech, the original vaccine’s protection against mild and moderate Covid appeared to wane faster against Omicron. Nearly 1,420 individuals aged 18 to 55 years are expected to participate in the trial. According to a Pfizer spokesperson, the study excluded participants over the age of 55 as the study’s objective was to examine the immune response of dosed participants rather than to estimate vaccine efficacy.
The trial is being conducted throughout the United States and South Africa, with the first dose administered in North Carolina. Three groups of volunteers were formed. The first cohort comprises individuals who were earlier administered with two doses of the current Pfizer-BioNTech vaccine 90-180 days before the enrollment and will get one or two doses of the Omicron vaccine.
The second group will consist of individuals who received three doses of the current vaccine 90-180 days before the study and will get either another dose of the current vaccine or an Omicron-specific vaccine. The third and final group consists of individuals who had never got a Covid vaccine earlier and will be administered with three doses of the Omicron-specific vaccine. In December 2020, the Pfizer-BioNTech vaccine became the first Covid dose to be approved in the Western world. Due to the fact that it is based on messenger RNA technology, it is quite simple to update to reflect new strains’ genetic coding.
