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The GSK monoclonal antibody therapy sotrovimab is no longer authorized for use in northeastern states –

The Food and Drug Administration (FDA) has withdrawn authorization for sotrovimab monoclonal antibody therapy for use in the Northeast, in a move that shows the agency fears an impending wave of COVID-19 latent variants.

The agency announced Friday that it will no longer approve the drug produced by pharmaceutical giant GlaxoSmithKline (GSK) and Vir Biotechnology for use in Covid patients in Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, New Jersey and New York. .

These states make up Zone 1 and Zone 2 classified by the U.S. Health and Human Services and also have the highest prevalence of the latent variant of BA, according to the most recent data from the Centers for Disease Control and Prevention (CDC).

Some experts fear that the “hidden” variant of Covid, the most contagious variant to date, could soon cause an outbreak in the United States.

Sotrovimab, a monoclonal antibody against the Covid treatment developed by GSK and Vir, has received FDA clearances for use in the northeastern United States, fearing it is ineffective against the “hidden” variant BA.

The FDA has a fact sheet for the drug stating that it may not be effective against BA.2.

Sotrovimab was one of the survivors of the last time the institution removed monoclonal antibody treatments from shelves.

In January, approval of treatments manufactured by Eli Lilly and Regeneron was withdrawn as they were ineffective against the Omicron variant.

As the virus continues to mutate, further treatments will gradually become ineffective.

The agency notes that along with remdesivir, oral treatments such as Pfizer’s Paxlovid and Merck’s molnupiravir continue to be used in these regions.

According to their Market Overview reports, GSK responded to the FDA’s decision by saying that the drug would be packaged in higher doses.

The two regions where the drug license has been revoked are the only two regions in the United States where the stealth variant has become dominant.

In zone 1, which includes Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont, the species accounts for 55% of cases.

Zone 2 includes New York and New Jersey, along with the territories of Puerto Rico and the U.S. Virgin Islands, where the drug has also been revoked.

BA.2 accounts for 52 percent of cases in the region, the CDC reported this week.

The region also includes Cornell University in Ithaca, New York, and has this week faced a massive wave of Covid, driven by stealth variants, increasing the number of cases by more than 400%.

Cornell also experienced an increase in cases last year leading to the devastating wave of Omicrons that hit the country over the winter.

As BA.2 continues to slowly roll out in America, authorities seem to be preparing for a similar outcome this spring.

The CDC reported that the latent variant accounts for 35% of Covid cases in the United States, compared to 23% of cases the previous week.

The CDC reported that the latent variant accounts for 35% of Covid cases in the United States, compared to 23% of cases the previous week.

BA.2 represents more than half of consecutive Covid cases in both northeastern regions where authorization was revoked

BA.2 represents more than half of the listed Covid cases in both northeastern regions where authorization was revoked

The “hidden” variant, named for its ability to evade detection by some sequencing methods, is believed to be the most contagious version of Covid, but as mild as Omciron’s all-year-round version of BA.1.

According to the latest data released last week by the Centers for Disease Control and Prevention (CDC), BA.2 represents 35% of active Covid cases in the United States, where BA.1 is still dominant.

However, the share of BA.2 Covid infections in America is increasing, with the variant accounting for only 23% of cases in the previous week.

However, not everyone makes gloomy predictions for the future. Dr. Anthony Fauci, the country’s leading infectious disease expert and one of the generally more cautious voices during the pandemic, said that while he expects the number of cases to increase this week, a full increase is unlikely.

“I wouldn’t be surprised if we see a slight increase,” he said in a Washington Post event this week.

“Unless something changes drastically, I don’t really see a big wave coming.”

Source: Daily Mail

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