Pfizer and BioNTech announced Tuesday that enrolment for a clinical trial to evaluate the safety and immunological response of their Omicron-specific Covid-19 vaccine in individuals aged 55 and older has commenced.
Albert Bourla, the CEO of Pfizer, had stated that the pharmaceutical firm could be ready to file for regulatory approval of the injection by March.
Up to 1,420 healthy adults aged 18 to 55 will be included in the trial to assess the vaccine's safety, tolerability, and amount of immune response as a primary series and booster dose.
While recent data revealed that boosters against the original Covid strain continued to protect against severe outcomes with Omicron, the business was operating cautiously, according to Kathrin Jansen, the company's head of vaccine research.
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."
The original vaccine's protection against mild and moderate Covid appeared to fade more quickly against Omicron, according to Ugur Sahin, CEO of the German biotech business BioNTech.
"This study is part of our science-based approach to develope a variant-based vaccine that achieves a similar level of protection against Omicron as it did with earlier variants but longer duration of protection."
A total of 1,420 persons between the ages of 18 and 55 will participate in the study.
The study did not include anyone over the age of 55, according to a Pfizer spokesman, because the purpose of the study was to assess the immunological response of participants dosed rather than to estimate vaccination efficacy.
The trial is being conducted in the United States and South Africa, with the first dose being administered in North Carolina.
Three groups of volunteers have been formed.
A total of 1,420 persons between the ages of 18 and 55 will participate in the study.
The study did not include anyone over the age of 55, according to a Pfizer spokesman, because the purpose of the study was to assess the immunological response of participants dosed rather than to estimate vaccination efficacy.
Kathrin Jansen, Pfizer Senior Vice President and Head of Vaccine Research and Development, stated in a statement, “While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, 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.”
The first group of patients will receive one or two doses of the Omicron vaccination after receiving two doses of the current Pfizer-BioNTech vaccine 90-180 days prior to enrollment.
The second group will get either another dose of the existing vaccine or an Omicron-specific vaccine after receiving three doses of the current vaccine 90-180 days previous to the research.
The third and final group will receive three doses of the Omicron-specific vaccination if they have never had a Covid vaccine before.
In December 2020, the Pfizer-BioNTech vaccination became the first Covid injection to be approved in the West.
It is quite simple to update to reflect the genetic coding of new variants because it is based on messenger RNA technology.
“Additional real-world effectiveness data and laboratory investigations will further inform the duration of protection, potential need for an additional dose at a later time, and whether an Omicron modified vaccine is required,” Researchers from the University of Texas Medical Branch, Pfizer, and BioNTech collaborated on the study.
Even while global new cases are still climbing, several nations have begun to emerge from their most recent waves, which were fueled by Omicron, the most transmissible strain to date.
Since the outbreak in China in December 2019, the coronavirus has killed over 5.6 million people.
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