Pfizer and BioNTech announced Tuesday that enrolment for a clinical study to assess the safety and immunological response of their Omicron-specific Covid-19 vaccination in individuals aged 55 and older has commenced.
Pfizer CEO Albert Bourla had stated at a conference that the company might be ready to submit a regulatory application for the injection by March.
While recent data revealed that boosters against the original Covid strain continued to protect against catastrophic outcomes with Omicron, the business was operating cautiously, according to Kathrin Jansen, the company’s head of vaccine research.
“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 said.
The initial 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 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.”
A total of 1,420 persons between the ages of 18 and 55 will participate in the study.
The study did not include anyone above 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 volunteers are separated into three groups.
The first group of patients will get one or two doses of the Omicron vaccination after receiving two doses of the existing Pfizer-BioNTech vaccine 90-180 days prior to enrolment.
The second group will get either another dose of the existing vaccination 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 vaccine if they have never received a Covid vaccine before. In December 2020, the Pfizer-BioNTech vaccine became the first Covid shot to be approved in the West.
It is quite simple to update to reflect the genetic coding of new variations because it is based on messenger RNA technology. Even while worldwide new cases are still climbing, some 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.