Pfizer and BioNTech announced on Tuesday that they have begun a study comparing their Omicron-based Covid-19 vaccine against the original vaccine.
If regulators decide to wait for the results of such a study, it might be months before an Omicron-specific vaccination becomes accessible.
Initial data from the research, which will enrol 1,420 volunteers, is expected in the first half of 2022, according to Pfizer.
It is unclear, however, what information authorities, such as the Food and Drug Administration, would require before approving an Omicron-specific vaccination, or what criteria the Centers for Disease Control and Prevention will use to prescribe one.
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.
“We recognise 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.
According to Ugur Sahin, CEO of the German biotech business BioNTech, the original vaccine’s protection against mild and moderate COVID appeared to fade more quickly against Omicron.
A total of 1,420 people 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.
Three groups of volunteers have been formed.
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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 prior 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.
(With inputs from agencies)
