The FDA approves the third COVID-19 antibody treatment for emergency use

0
17


(HealthDay): On Wednesday, the U.S. Food and Drug Administration approved a third antibody treatment designed to prevent high-risk COVID-19 patients from ending up in the hospital for emergency use.

It is important to note that in laboratory tests, the newly authorized drug, called sotrovimab, neutralized the highly infectious virus variant that is paralyzing India, as well as the variants first detected in Britain, South Africa, Brazil. , California and New York.

“With the authorization of this treatment with monoclonal antibodies, we offer another option to help keep high-risk patients with COVID-19 out of the hospital,” said Dr. Patrizia Cavazzoni, director of the Center for FDA Drug Evaluation and Research. an agency press release. “It is important to expand the arsenal of monoclonal antibody therapies that are expected to maintain activity against circulating variants of COVID-19 in the United States.”

Developed by GlaxoSmithKline (GSK), in consultation with the American company Vir Biotechnology Inc., the drug should be available to Americans “in the coming weeks,” company officials said in a statement.

“Sotrovimab is a new critical treatment option in the fight against the current pandemic and potentially also for future coronavirus outbreaks,” said George Scangos, chief executive of Vir.

Recently, the file stopped Eli Lilly’s antibody cocktail shipments to eight states due to the high prevalence there of the variants seen in South Africa and Brazil, The New York Times reported. Laboratory experiments have suggested that these variants may withstand Lilly’s treatment. (Regeneron’s antibody cocktail appears to neutralize the variants, based on lab tests).

GSK and Vir treatment is a unique drug, designed to mimic the antibodies generated when the immune system fights the coronavirus. Their emergency use authorization was based on a study of 583 volunteers who had begun to experience symptoms over the previous five days. The study found that those who received treatment with GSK-Vir showed an 85% reduction in the risk of hospitalization or death, compared with those who received a placebo.

Although vaccination figures are rising and infection rates are falling in the United States, antibody treatments are likely to be an important tool in preventing poor outcomes in high-risk patients. Time dit.

Last week, the FDA expanded the criteria doctors can use to determine eligibility for antibody treatments, the Time reported. This opens the door as well with certain medical conditions and members of high-risk racial or ethnic groups to receive treatments.

“Ultimately, it gives prescribers a lot of latitude in which they can give this,” he told Dr. Walid F. Gellad, who heads the University of Pittsburgh’s Center for Pharmaceutical Policy and Prescription. Time.

But Lilly and Regeneron’s antibody cocktails have not been used as widely as expected for a variety of reasons, according to public health experts.

They are cumbersome to administer because they require intravenous infusion and often patients do not know how to ask for them or where to find them. And many doctors were initially skeptical about the evidence supporting the treatments, although there have been more clinical trials since then that reported impressive results. Time reported.

“There’s still a role for these,” Gellad said. “The problem is that people can’t get them to benefit from it, and having another one on the market doesn’t necessarily solve it.”

Fully vaccinated in the US

Half of American adults are completely vaccinated against the new coronavirus, U.S. officials announced Tuesday.

“This is an important milestone in our country’s vaccination efforts,” Andy Slavitt, senior adviser to the White House’s COVID-19, said during a briefing in the White House media, noting that only 1 % of Americans were vaccinated when President Joe Biden took office in January.

Slavitt urged Americans who still doubt vaccination to receive their shots.

“Look for any reason you want to get vaccinated. For those who are still unsure, do your homework, talk to your doctor or pharmacist. All concerns are reasonable, but do yourself a favor: don’t let anyone Facebook ‘s answer to your question. When good answers are available, “said Slavitt.

Biden has said there will be enough vaccines for all American adults by the end of this month and that everyone 12 years of age or older can already get a vaccine. At least 25 states, plus Washington, DC, have completely vaccinated at least half of their adult residents, CNN reported.

At least 70% to 85% of the U.S. population will need to be immune to COVID-19 to reach the threshold of protection needed to limit the spread of the virus, health experts have reported. Vaccination of children, adolescents and young adults could help officials reach this percentage, while leaving young people unvaccinated could give the virus a chance to spread, mutate and develop a strain resistant to existing vaccines, CNN reported. Vaccination of children and adolescents will also help open schools more safely in the fall.

When the promising vaccination numbers were released, CDC director Dr. Rochelle Walensky offered a mixture of hope and caution as Americans prepare to celebrate Memorial Day weekend, the traditional start of summer with friends and family.

“If you’re vaccinated, you’re protected and you can enjoy your Memorial Day,” Walensky said during the White House briefing. “If you are not vaccinated, our guide has not changed for you, although you are at risk of infection. You still have to mask yourself and take other precautions.”

Holidays come amid a national decline in coronavirus cases, hospitalizations and deaths. Across the country, mask mandates are shrinking, restrictions are being lifted, and many states have returned to work as usual, the Time reported.

After numerous Memorial Day events last year due to the pandemic, vaccinated Americans may have been craving full beaches and barbecues in the garden, Walensky acknowledged.

But he also urged those who are not vaccinated to add a new activity to their Memorial Day rituals. “I want to encourage you to take this holiday weekend to give yourself and your family the gift of protection by vaccinating yourself,” he said. “We’re on a good downhill path, but we’re not quite out of the woods yet.”

Tough travel warnings for Japan

U.S. officials on Monday warned all Americans not to visit Japan due to an increase in coronavirus cases there just two months before the start of the Tokyo Olympics.

Travel warnings, issued by the U.S. Centers for Disease Control and Prevention and sourced from the U.S. Department of State, do not prohibit Americans from visiting Japan, but they can lead to higher travel insurance rates and can be discouraging. some Olympic athletes and spectators. to compete or attend games, the Associated press reported.

“Travelers should avoid all trips to Japan,” the CDC said in its alert. “Due to the current situation in Japan, even fully vaccinated travelers may be at risk of obtaining and disseminating variants of COVID-19 and should avoid all travel to Japan.”

The State Department’s warning was even more forceful.

“Don’t travel to Japan because of COVID-19,” he said in his ad, which raised the department’s travel alert from level 3 (reconsider travel) to level 4 (don’t travel).

However, the U.S. Olympic and Paralympic Committee said it still predicts that American athletes can compete safely at the Tokyo Games.

“We are confident that current mitigation practices applied to athletes and staff … along with pre-trip, on-arrival testing in Japan and during the Games, will allow for the safe participation of American team athletes. this summer, “the committee said in a statement to Reuters Monday.

Japanese Prime Minister Yoshihide Suga says he is determined to hold the Olympic Games in Tokyo from July 23, after a year of delay, and has vowed to end the vaccination of the country’s 36 million seniors in end of July. There is fear of the spread of new variants because such a small percentage of the Japanese population (estimated at 2% to 4%) is vaccinated, AP dit.

In the United States, the picture of vaccination is improving every day. As of Thursday, nearly 132 million Americans were fully vaccinated and 62% of adults had received at least one dose, according to the CDC. The U.S. Food and Drug Administration also recently approved the Pfizer vaccine for teens ages 12 to 15.

As of Thursday, the U.S. coronavirus case was approaching 33.2 million, while the death toll was approaching 592,000, according to a Johns Hopkins University account. More than 168.4 million cases were reported worldwide on Thursday, with nearly 3.5 million people killed by COVID-19.


The United States issues harsh travel warnings for Japan before the Olympics


More information:
The U.S. Centers for Disease Control and Prevention has more information on recent coronavirus.

Copyright © 2021 HealthDay. All rights reserved.

Citation: FDA Approves Third COVID-19 Antibody Treatment for Emergency Use (2021, May 27) Retrieved May 27, 2021 at https://medicalxpress.com/news/2021-05-fda- covid-antibody-treatment-emergency.html

This document is subject to copyright. Apart from any fair treatment for private study or research purposes, no part may be reproduced without written permission. Content is provided for informational purposes only.





Source link

LEAVE A REPLY

Please enter your comment!
Please enter your name here