Pfizer starts testing Omicron matched Covid-19 shots in adults
Key Takeaways:
- On Tuesday, Pfizer Inc and BioNTech SE announced the start of a clinical trial to test a new version of their COVID-19 Omicron variant vaccine.
- The trial will enroll over 1,400 people, and the industries intend to investigate the shots' safety and tolerability.
Pfizer Inc and BioNTech SE declared on Tuesday that they had begun a clinical trial to evaluate a new version of their COVID-19 Omicron variant vaccine, which has eluded a few of the protections offered by the original two-dose vaccine routine.
The companies intend to test the immune response created by the Omicron-based vaccine as a three-shot regimen in unimmunized people and as a booster shot for people who have already received 2 doses of their original vaccine, relying on volunteer groups in the United States.
They're also comparing a fourth dose of the current vaccine to a fourth dose of the Omicron-based vaccine in people who had previously received a third dose of the Pfizer/BioNTech vaccine three to six months ago.
More than 1,400 people will be enrolled in the trial, as well as the industries plan to study the shots' safety as well as tolerability.
"While current research and real-world statistics indicate that boosters continue to provide high levels of protection against serious disease and hospitalization with Omicron, we recognize the need to be ready if this safeguarding wanes over time and to potentially help address Omicron as well as unique variants in the future," stated Kathrin Jansen, Pfizer's head of vaccine research and development.
According to BioNTech, a present plan to initiate an Omicron-targeting vaccine by the end of March may not be possible due to the number of clinical trial data required by regulators.
According to Pfizer, two doses of the original vaccine may not be enough to protect against Omicron infection, and protection against hospitalizations and deaths may be waning.
Despite this, the US Centers for Disease Control and Prevention claims that the third dose of an mRNA vaccine, such as the Pfizer/BioNTech vaccine, provides 90% protection against COVID-19 hospitalization.
Some countries have already begun to offer additional booster doses. Still, a recent Israeli study found that while the fourth dose of an mRNA vaccine increased antibody levels, the level was insufficient to prevent Omicron infection.
DATA
Before approving a new vaccine, the European Medicines Agency (EMA) stated on Friday that international regulators want results of clinical studies like the ones being conducted by Pfizer and BioNTech.
According to the EMA, these studies should show that the fresh vaccines elicit more neutralizing antibodies in the blood than existing vaccines and may also protect against the latest variants of concern.
BioNTech refused to say what kind of data it was asked to submit to regulators. It stated analysis of antibodies elicited by its Omicron-targeted booster must help determine whether shots addressing multiple variants will be required.
It hopes to demonstrate that the antibodies can neutralize a wide range of variants. Nonetheless, some scientists question whether any changes are required at this time.
Dr. Paul Offit, an infectious disease expert at the University of Pennsylvania, said, "The goal of this vaccine is to protect against serious illness." "To date, these vaccines have provided that protection, including against Omicron."