Lisa Leon, a patient service coordinator, draws up a syringe full of the Pfizer COVID-19 vaccine at the Esperanza Health Centers vaccination clinic on Tuesday, Dec. 21, 2021, in Chicago. (Stacey Wescott, Chicago Tribune/TNS)
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(Tribune News Service) — Vaccine makers Pfizer and BioNTech announced plans early Tuesday to test an omicron-specific COVID-19 vaccine in people.
The companies will run three simultaneous trials in adults ages 18-55 to determine if an omicron-specific vaccine is more effective than current shots.
The existing vaccine was developed to target the original or "ancestral" strain of COVID-19. While three shots appear to provide some protection against omicron, the vaccine, called Comirnaty, is not as effective as it was against earlier strains.
"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 (with a) longer duration of protection," BioNTech CEO and co-founder Uğur Şahin said in a statement.
In the first trial, 615 people who received two doses of Comirnaty at least three to six months ago will receive one or two shots of the omicron-specific vaccine.
In the second trial, which will include 600 volunteers, those who received three doses at least three to six months ago will receive one dose of the current vaccine or one dose of the omicron-specific version.
And in a third trial, 200 participants who have never been vaccinated will receive three doses of the omicron-specific vaccine.
Initial vaccine trials included about 40,000 people to prove that the shots were safe and effective at protecting against symptomatic and severe infections. Now, trials only have to show that altered vaccines are safe and trigger roughly the same immune response
"Staying vigilant against the virus requires us to identify new approaches for people to maintain a high level of protection, and we believe developing and investigating variant-based vaccines, like this one, are essential in our efforts towards this goal," Kathrin Jansen, Pfizer senior vice president and head of Vaccine Research & Development, said in a prepared statement.
The two-dose Pfizer-BioNTech vaccine has been fully approved for anyone 16 and over and is allowed under an emergency use authorization for ages 5 and up. A third, booster dose is allowed for anyone over 12 who already received two doses of Comirnaty or younger children with weakened immune systems.
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