Pfizer and BioNTech have begun enrollment for their clinical trial assessing an Omicron-specific COVID-19 vaccine.
Although Omicron causes a milder disease presentation, the variant carries a higher re-infection risk than other strains. Moreover, the heavily mutated strain continues to affect everyone, irrespective of their vaccine status. The reduction in vaccine efficacy has led vaccine manufacturers to work on a variant-based vaccine. On Tuesday, Pfizer and BioNTech announced their plans for an Omicron-specific COVID-19 vaccine. The vaccine makers are currently enrolling participants for the clinical trial.
According to the press release, the clinical trial will evaluate the current Pfizer vaccine and an Omicron-specific candidate among 1,420 participants from across three cohorts. The first cohort will involve 615 people who have received two doses of the current Pfizer vaccine 90-180 days prior to enrollment. They will receive one or two doses of the Omicron-based vaccine. In the second cohort, 600 individuals who have already received all three doses of the Pfizer vaccine will receive a fourth dose of either the new Omicron-specific vaccine or the current Pfizer shot. Finally, the last cohort will include 205 unvaccinated individuals who will receive three doses of the new vaccine. Moreover, researchers also plan to recruit participants from Pfizer’s Phase 3 COVID-19 booster study.
The clinical trial aims to evaluate the new vaccine’s safety and efficacy in healthy adults aged 18 to 55 years. It will further compare the modified vaccine’s immunogenicity to Pfizer’s current shot.