Pfizer and BioNTech to Start Omicron Trials

27.01.2022 - Pfizer and BioNTech are poised to begin their first clinical trial with a new vaccine candidate adapted to offer protection against the Omicron variant of the coronavirus. The study with 1,420 healthy adults aged 18 through 55 that will include some of the participants from the companies’ Phase 3 booster study is aimed at determining the potential need for variant-based vaccines.

Three distinct cohorts will examine different regimens of the current formulation of the Comirnaty vaccine or an Omicron-based vaccine. The first group, which received two doses of the current vaccine 90 to 180 days prior to enrollment, will receive one or two doses of the Omicron-based vaccine.

The second cohort, which also received three doses of the current vaccine 90 to 180 days prior to enrollment, will receive one dose of the current vaccine or the Omicron-based vaccine. The third, group, who have never been vaccinated, will be given 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, the American and German partners said they recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants.

Acknowledging that “emerging data indicate that vaccine-induced protection against infection and mild to moderate disease wanes more rapidly than was observed with prior strains,” the companies said they want 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.

Recent reports have indicated that even a booster dose of Comirnaty offers reduced protection after four months.

Pfizer licenses Acuitas’ LNP Technology

Separately, Pfizer has inked a deal with Acuitas to license that company’s lipid nanoparticle (LNP) formulation technology in up to 10 targets for vaccine or therapeutic development. The US drugmaker and Germany’s BioNTech currently use Acuitas’ LNP in their Comirnaty vaccine.

The companies did not reveal additional details of the plans that are aimed at finding new applications for mRNA therapies. Pfizer and BioNTech are also jointly working on mRNA-based vaccines for influenza and shingles.

Mikael Dolsten, chief scientific officer at Pfizer, said the agreement expands the New York drugs giant’s LNP capabilities and allows it to explore more projects within its existing vaccines area and new therapeutic areas where mRNA-LNP technology holds potential for success.

Author: Dede Williams, Freelance Journalist