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CDC Issues New COVID-19 Guidance After FDA Makes Change

John Symank by John Symank
January 29, 2023
0
CDC Issues New COVID-19 Guidance After FDA Makes Change

Raed Mansour, flickr.com/photos/raedmansour/29431936805

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The Centers for Disease Control and Prevention issued new guidance to people with weak immune systems after one COVID-19 antibody treatment had its emergency use authorization revoked by another federal agency, saying they should take extra precautions.

Last week, the U.S. Food and Drug Administration pulled its authorization of Evusheld, a combination antibody treatment, which is primarily utilized by people with weak immune systems. The agency said that it is not effective against most of the COVID-19 omicron subvariants including the XBB subvariant and BQ strain that is currently circulating around the United States.

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The CDC responded by once again calling for immunocompromised individuals to wear masks and engage in social distancing, despite CDC-cited studies and data providing evidence suggesting that masks provide minimal effectiveness in blocking the transmission of COVID-19.

Other former federal officials have previously said that the six-foot social distancing rule adopted throughout the United States in early 2020 was arbitrary.

“Among persons with immunocompromise and their household members and close contacts, prevention measures including wearing a high-quality and well-fitting mask, maintaining physical distance from others (at least six feet), improving indoor ventilation, practicing frequent handwashing, and developing a care plan, should be considered in addition to receipt of a bivalent booster dose,” said the CDC on Jan. 27.

The agency added that “it is important to wear a mask and maintain physical distance from others if it is not possible to avoid crowded indoor spaces … simple interventions should be used to improve ventilation in buildings and decrease SARS-CoV-2 transmission by improving air flow.” 

The agency reiterated their stance that immunocompromised people should get up-to-date COVID-19 vaccines.

The CDC advises that people with weakened immune systems who develop COVID-19-like symptoms get tested for the virus and, upon a positive test, receive an antiviral drug within five to seven days. 

“Early outpatient treatment of mild to moderate COVID-19 with a recommended first-line therapy, ritonavir-boosted nirmatrelvir (Paxlovid), or remdesivir (Veklury), or the second-line therapy, molnupiravir (Lagevrio), have been shown to reduce the risk for severe COVID-19, including hospitalization and death,” it says.

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Remdesivir has been claimed to possess potentially fatal side effects, such as kidney failure, by some doctors. 

CDC figures show that approximately seven million Americans have some condition which severely compromises their immune system, such as cancer.

Evusheld was pulled by the FDA on Jan. 26 and is manufactured by AstraZeneca. It was first authorized in December 2021 as a pre-exposure prophylaxis against COVID for individuals with weakened immune systems, who would struggle to produce antibodies via vaccination.

The agency said that as of now, the drug cannot neutralize a number of omicron subvariants like BQ.1, BQ.1.1, BF.7, BF.11, BA.5.2.6, BA.4.6, BA.2.75.2, XBB, and XBB.1.5.

“This means that Evusheld is not expected to provide protection against developing COVID-19 if exposed to those variants,” the FDA said in a press release explaining why the drug is being pulled.

“Today’s action to limit the use of Evusheld prevents exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when fewer than 10 percent of circulating variants in the U.S. causing infection are susceptible to the product,” the press release stated.

AstraZeneca plans to continue to share relevant data with the FDA and other health authorities regarding Evusheld and SARS-CoV-2 variants.

“AstraZeneca will continue to work with the FDA and other health authorities to collect, assess and share relevant data regarding Evusheld and SARS-CoV-2 variants,” the company said in a statement. “Evusheld currently remains authorized in other countries where it is approved for COVID-19 pre-exposure prophylaxis and treatment, including the EU and Japan.”

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