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Coronavirus – US: FDA approval for Omicron vaccines

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Coronavirus – US: FDA approval for Omicron vaccines

News vaccine against COVID-19 that are made especially for her. Omicron variant received approval from the Food and Drug Administration (FDA) today at USAwhich paves the way for their release. The preparation is aimed at improving protection against serious illness and death due to a possible increase in the incidence of coronavirus in the autumn-winter period.

The booster doses, which have been modified to affect the Omicron BA.4 and BA.5 sub-options, will be evaluated Thursday by CDC consultants. If these vaccines are recommended by these experts, some may be available as early as next weekend.

The Emergency Use Authorization for Moderna and Pfizer/BioNTech boosters marks the beginning of the Biden administration’s intensified efforts to protect the public from a virus that has changed dramatically in the past 2.5 years and still causes an average of 400 deaths. up to 500 people in the US daily.

Expert Warnings

Scientists and doctors are wondering if US citizens who take booster doses slowly will be more willing to take this new batch of drugs.

Some experts, such as Paul A. Offit, one of the FDA’s top vaccine advisers, have criticized the agency, arguing that it acted too quickly and emphasizing that it’s unclear whether the new booster vaccine is better than existing ones. They even warn that the fact that the FDA relies so heavily on research in mice might invite skepticism.

“We already have a problem with taking booster doses,” says Eric Topol, a professor of molecular medicine at the Scripps Research Institute. If this phenomenon is exacerbated by the lack of evidence from human studies of new vaccines, “I think that would be unfortunate.”

What the FDA and Fauci say

Peter Marks, the FDA’s top vaccine official, defended the agency’s approach, saying that mRNA vaccines have a high safety record. And while cases are down this time around, he says, some experts fear there could be a big spike in infections by Thanksgiving as people congregate more indoors and immunity continues to wane. He added that waiting for more data could lead to a significant delay in the release of booster doses.

“We have always been one step behind the virus and we have had to think constructively about how we can prevent it in a safe way,” Marks said. “If we want to intervene, now is the time.”

Anthony Fauci, for his part, agreed with Marks, stating that the updated vaccines would be useful even if a new option other than BA.4 and BA.5 came along.

Source: Washington Post.

Author: newsroom

Source: Kathimerini

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