Pfizer and BioNTech reported in a statement on the initiation of a clinical study to evaluate the safety, tolerability and immunogenicity of a vaccine based on the Ómicron variant.
1,420 volunteers without comorbidities between 18 and 55 years old will participate in the trial, who will receive this vaccine in three different schedules or cohorts.
According to what was announced by the companies, one of the groups, with 615 volunteers who received two doses of the current Pfizer-BioNTech COVID-19 vaccine between 90 and 180 days before registration, will be completed with one or two dose of the Ómicron-based vaccine.
Another set of 600 participants who have received all three doses of the current Pfizer-BioNTech vaccine between 90 and 180 days before enrollment will receive one dose of the current vaccine or the Omicron-based vaccine during the study.
And a third group of 215 participants who do not have any vaccine will receive three doses of the Ómicron-based vaccine.
"While current research and real-world data show that boosters continue to provide a high level of protection against serious illness and hospitalization with Omicron, we recognize the need to be prepared should this protection wane over time and potentially help to address Omicron and new variants in the future," said Kathrin Jansen, senior vice president and director of vaccine research and development at Pfizer, in the statement released by both companies.
"Staying vigilant against the virus requires us to identify new approaches for people to maintain a high level of protection, and we believe that developing and researching vaccines based on variants like this one are essential in our efforts to achieve this goal," he continued.
Repercussions
Dr. Antony Fauci, a member of the White House COVID-19 Response Team and chief medical advisor to US President Joe Biden, said a coronavirus vaccine specifically targeting the omicron variant would be "prudent," although it could There is a possibility that it was not necessary.
"It makes sense to think about having at least one specific booster ready for Omicron. We may not need it (...) but I think it is prudent to at least prepare for the possibility that this is a persistent variant that we have to deal with, even if it is at a very low level," added the main US infectious disease representative.
