On Tuesday, the U.S.-based pharmaceutical giant Pfizer and its German partner BioNTech SE announced they had started a clinical trial of a new version of their coronavirus jab specifically considered to protect against the more transmissible Omicron variant of the SARS-CoV-2. According to the joint statement by drug firms, it will test the new jab as both a primary and booster shot in over 1400 healthy adult participants ages 18 to 55.
Researchers will separate the participants into 3 groups. The first group of volunteers, which has gotten the primary two shots of the present COVID-19 vaccine, will get one or two shots of the new Omicron-specific jab into their arms. The 2nd group, who have gotten the first two doses and a booster dose of the original vaccine, will get one shot of either the current or the revised version. In contrast, the 3rd group of participants will be constituted of unimmunized adults who will be vaccinated with three shots of the vaccine manufactured specifically to fight Omicron.
The clinical trial of Omicron-based vaccine produced by Pfizer-BioNTech comes due to the release of new research that proposes antibodies produced by a 3rd shot of the current jab still provide strong protection 4-months after the final dose. Moreover, the results, part of a lab study conducted by researchers at the “University of Texas Medical Branch” in collaboration with scientists at BioNTech SE and Pfizer, was published online on Jan. 22 and haven’t been reviewed or published in a formal scientific journal.
Omicron Infection Causes Less Severe Illness
The highly contagious Omicron is more expected than previous strains to cause infection even in people who have been inoculated, but it isn’t yet apparent that a modification to the coronavirus vaccine recipe will be ordered.
Among the issues drug regulators are weighing, some of the first places to experience a surge in Omicron cases already are observing the mutant wane – and there is no way to realize if the next COVID-19 variant that emerges will resemble Omicron or be absolutely different. The current vaccines still provide better protection against serious sickness and unfortunate death. Research in America and elsewhere have made transparent that adding a booster shot strengthens that protection and enhances the chances of avoiding even a milder virus infection.
Furthermore, the latest American report on Jan. 25 echoes data from South Africa and the U.K. that infections from Omicron cause less severe sickness – at least in part because numerous people have some defense from immunization or previous infection. According to the U.S. CDC, during the more virulent Omicron surge, 13 percent of hospital admissions from COVID ended up in critical ICU, compared with nearly eighteen percent during previous earlier waves.
Still, Pfizer’s vaccine research chief Kathrin U. Jansen said that they recognize the need to be ready in the event this protection declines over time and to potentially help address contagious Omicron and new strains in the future.
Pfizer plans to manufacture 4 billion vaccine doses this year, and said the amount is not anticipated to change if an Omicron-adapted version is needed.
FDA Stops Antibody Drugs’ Use Ineffective vs. Omicron
In a related matter, on Monday, the U.S. FDA (Food and Drug Administration) proclaimed that it’s halting the use of two COVID-19 antibody medications because of their ineffectiveness against more virulent Omicron. In addition, the drug regulatory agency said that it’s limiting the EUA granted in connection with the cures developed by pharmaceutical firms Eli Lilly and Regeneron.
Regeneron + Eli Lilly monoclonal antibody treatments don’t work against Omicron. They shouldn’t be used because the science, the FDA, AMA, NIH and the manufacturers themselves tell us they are NOT effective.
— Rep. Carlos G Smith (@CarlosGSmith) January 26, 2022
Moreover, the decision to pull both treatments leaves hospitals and doctors in America with just a single antibody medication produced by American pharmaceutical company GSK and its partner Vir Biotechnology, along with Pfizer and Merck’s COVID-19 antiviral tablets – all of which are limited supply countrywide and tougher to find.