Pfizer and BioNTech are beginning a new study testing out a vaccine specifically aimed at going after the Omicron variant of SARS-CoV-2, the virus that causes COVID-19.
On Tuesday, the companies reported that they have started taking in participants for the trial, noting that the clinical study is being done to “evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate in healthy adults 18 through 55 years of age.”
The trial will include three groups of up to 1,420 people, and will look at “different regimens of the current Pfizer-BioNTech COVID-19 vaccine or an Omicron-based vaccine.” It will also use some people who were involved in the Phase 3 COVID-19 booster study.
The cohorts in the study include:
- Cohort #1 (n = 615): Received two doses of the current Pfizer-BioNTech COVID-19 vaccine 90-180 days prior to enrollment; in the study, participants will receive one or two doses of the Omicron-based vaccine
- Cohort #2 (n = 600): Received three doses of the current Pfizer-BioNTech COVID-19 vaccine 90-180 days prior to enrollment; in the study, participants will receive one dose of the current Pfizer-BioNTech COVID-19 vaccine or the Omicron-based vaccine
- Cohort #3 (n=205): Vaccine-naïve participants will receive three doses of the Omicron-based vaccine
“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, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer. “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.”
“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. “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 longer duration of protection.”
The companies noted, “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.”
Pfizer CEO Albert Bourla tweeted about the move, noting, “My fellow Pfizer colleagues continue the important work of addressing [Omicron] & preparing for potential future variants. Today, with BioNTech we announced the initiation of a study evaluating an Omicron-based [COVID-19] vaccine in adults 18 through 55.”
My fellow Pfizer colleagues continue the important work of addressing #Omicron & preparing for potential future variants. Today, with BioNTech we announced the initiation of a study evaluating an Omicron-based #COVID19 vaccine in adults 18 through 55. https://t.co/VdQY8g1Hg8
— Albert Bourla (@AlbertBourla) January 25, 2022
According to Fox Business, Bourla has said in the past that a vaccine focused on Omicron would be ready by March.
“We already have begun work on a DNA template tailored to the sequence of omicron, a critical step in the process of advancing a variant version of our vaccine if in fact we find one is needed,” a Pfizer spokesperson reportedly told FOX Business earlier this month. “[We are] also manufacturing the variant vaccine at risk, as we did for beta and delta before.”
Bourla also recently said on CNBC that annual COVID vaccines could become normalized, similar to flu shots that come around every year.
“We will have perfectly normal lives, with just injection maybe once a year. And the pill in case we are sick will make it more flu like rather than life-threatening disease,” he said. However, Bourla added, “Two doses of the vaccine offers very limited protection, if any.”
The Wall Street Journal reported drug company Moderna, which also has an mRNA vaccine against COVID-19, is planning to initiate a clinical trial of its Omicron-focused vaccine within days, according to a Moderna spokeswoman.