Until March the company Moderna Inc could be ready for approval by the US authorities a booster dose of the vaccine her for him coronavirus, which will specifically target the Omicron mutation, its president said on Wednesday.
THE Steven Hogg believes that booster vaccines that carry genes specifically targeting Omicron mutations are the fastest way to address a possible reduction in the effectiveness of existing vaccines. “We have already started this program,” he told Reuters.
The company is also working on making one multivalent vaccine that will target up to four variants of SARS-CoV-2, including Omicron. However, it will take many more months to prepare this preparation, Hogg noted.
The conditions for the FDA “green light” are crucial
Given that the Food and Drug Administration (FDA) previous guidelines for the approval of medicinal products state that mid-stage clinical trials, Hong said the process of developing the vaccine could take three to four months.
“Realistically, boosts for Omicron are not expected before March, or even later, in the second quarter of the year,” Hogg said, unless the FDA change the instructions for the data needed to give its approval.
Moderna could make the vaccine while testing it, Hogg said, so that it would be ready for distribution. soon possible.
According to Hogg, the FDA could speed up the timetable if it follows the way it approves Influenza vaccines, which do not require large, randomized clinical trials.
Partial impact on the efficacy of existing vaccines is possible
“Based on the pattern of mutations observed in Omicron, which includes mutations that have already been shown to reduce the effectiveness of the Moderna vaccine in laboratory studies, Hogg said:”we expect that there will be some impact».
It is recalled that health authorities around the world are still studying whether this variant is more contagious, causes more serious illness or is not covered by existing vaccines.
It is not yet clear how much the reduction in efficiency due to Omicron will be, but it could be significant, he added. “Mutations that had previously led to a decrease in efficiency were observed in (variants) Delta and Beta. “And all these mutations exist in Omicron,” he concluded.
Hong also said that the American biotechnology company is conducting studies to find out if those who have been fully vaccinated with its formulation are protected from this variant, as well as what happens to those who have received their booster doses 50 and 100 micrograms.
“I still believe that the existing vaccines will be in place to slow down“if not to stop completely, the Omicron variant”, he concluded.
It is worth mentioning that just a few hours ago, it was located first case of the Omicron variant in the USA.