First participants enrolled in clinical trial received Omicron-based vaccine candidate as a two-dose primary series and as a booster dose.
Drugs and pharma giants Pfizer and BioNTech have announced initiation of a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate in healthy adults aged between 18 and 55 years.
The study will compare the original shot of the vaccine with a version tweaked to recognize the highly contagious Omicron strain.
Participants of the study will come from the companies’ Phase 3 COVID-19 booster study. This study is part of the two companies’ ongoing efforts to address Omicron and determine the potential need for variant-based vaccines.
“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,” said Kathrin U. Jansen, Pfizer’s senior vice president and head of vaccine research and development.
“Vaccines continue to offer strong protection against severe disease caused by Omicron. Yet, emerging data indicate vaccine-induced protection against infection and mild to moderate disease wanes more rapidly than was observed with prior strains,” said Prof. Ugur Sahin, CEO and Co-founder of BioNTech.
The study will evaluate up to 1,420 participants across the three cohorts and the trial will involve 1,420 people in the 18 to 55 year age group across the United States and South Africa. First participants enrolled in clinical trial received Omicron-based vaccine candidate as a two-dose primary series and as a booster dose.
Vaccine manufacturers said new versions of their vaccines to target the highly infectious Omicron variant could be ready within 100 days, in the immediate days after the new strain of COVID-19 was detected. But there were doubts.
Omicron has spread at neck-break speed. Andrew Pollard, who led the development of the Oxford-AZ vaccine said that it was “quite difficult to make and deploy an updated vaccine quickly enough” to make a difference.
Clinical and real-world data continue to find people who are vaccinated, particularly those that have received a booster, maintain a high level of protection against Omicron, particularly against severe disease and hospitalization.
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