AstraZeneca seeks authorization of new treatment to prevent COVID-19 | CBC News

The latest:

WATCH | A ventilator, hallucinations and goodbyes:

A Ventilator, hallucinations, and good-byes

COVID-19 ravaged Paul Hemsing’s body and left him with deep physical and emotional scars. He hopes sharing his story saves someone else from having to go through the same thing. 5:27

AstraZeneca has requested emergency use authorization from U.S. regulators for its new treatment to prevent COVID-19 for people who respond poorly to vaccines because of a weakened immune system.

In a statement on Tuesday, the Anglo-Swedish drugmaker said it included data in its filing with the Food and Drug  Administration from a late-stage trial that showed the drug reduced the risk of people developing any COVID-19 symptoms by 77 per cent.

The antibody therapy called AZD7442 could protect people who do not have a strong enough immune response to COVID-19 vaccines or to supplement a vaccination course for those, such as military personnel, who need to boost their protection further, AstraZeneca has said.

While vaccines rely on an intact immune system to develop targeted antibodies and infection-fighting cells, AZD7442  contains lab-made antibodies designed to linger in the body for months to contain the virus in case of an infection.

A U.S. authorization for AZD7442 — based on two antibodies discovered by Vanderbilt University Medical Center in the United States — could be a major win for AstraZeneca, whose widely used COVID-19 vaccine has yet to be approved by U.S. authorities.

Talks regarding supply agreements for AZD7442 are ongoing with the United States and other governments, AstraZeneca said.

COVID-19 therapies based on the same class of monoclonal antibodies are being developed by rivals Regeneron, Eli  Lilly and GlaxoSmithKline with partner Vir, competing for a role in COVID-19 treatment and prevention. But Astra’s filing has cemented its lead in prevention.

Trial results on the AZD7442 therapy, first published in August, were taken three months after injection, but the company  hopes it can tout the shot as a year-long shield as trial investigators will follow up with participants as far out as 15  months. 

J&J seeks authorization for booster

Also on Tuesday, Johnson & Johnson said it had submitted data to the FDA for emergency use authorization of a booster shot of its single-dose COVID-19 vaccine in people aged 18 years and older.

J&J said its submission includes data from a late-stage study that found a booster of its vaccine given 56 days after the primary dose provided 94 per cent protection against symptomatic COVID-19 in the United States and 100 per cent protection against severe disease, at least 14 days after the booster shot.

The FDA has already authorized a booster dose of the vaccine developed by Pfizer Inc. and partner BioNTech for 65-year olds and older, people at high risk of severe disease and others who are regularly exposed to the virus. Moderna submitted its application seeking authorization for a booster shot of its two-dose vaccine last month.

J&J said it plans to submit the data to other regulators, the World Health Organization and National Immunization Technical Advisory Groups to inform decision-making on local vaccine administration strategies, as needed.

What’s happening across Canada

Stories from Alberta’s ICUs during the COVID-19 fourth wave

Alberta’s ICUs have 257 COVID-19 patients. That’s more than any other province. But the number alone doesn’t explain the impact. In a place where small details and moments matter, struggling ICUs mean struggling patients. This is the situation they see. 11:32

What’s happening around the world

As of early Tuesday, more than 235.4 million cases of COVID-19 had been reported worldwide, according to Johns Hopkins University’s coronavirus-tracking tool. The reported global death toll stood at more than 4.8 million.

In Asia, China reported no new local COVID-19 cases for the first time in more than three weeks.

In Europe, the Kremlin has implored people to get vaccinated, as Russian authorities mulled reintroducing health restrictions to cope with daily cases rising to their highest levels since January.

In the Americas, New York State’s largest health-care provider has fired 1,400 employees who refused to get vaccinations.

Source link

Leave a Reply

Your email address will not be published.