AstraZeneca seeks approval for its cocktail vaccine in major step against virus

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AstraZeneca has requested emergency approval from U.S. regulators for its antibody cocktail, the first protective shot other than vaccines against COVID-19, another potential major step in the global fight to combat the virus.

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

COVID-19 therapies based on the same class of monoclonal antibodies are sold by rivals Regeneron, Eli Lilly and GlaxoSmithKline and its partner Vir to stop the disease from worsening during early, milder stages of the infection.

The AstraZeneca therapy, designed to last several months to a year, could protect people who do not have a strong enough immune response to COVID-19 vaccines due to, for instance, chemotherapy or anti-rejection drugs after organ transplants.

The drug, given in two sequential injections, could also supplement a vaccination course for those, such as military personnel, who need to booster their protection further, AstraZeneca has said.

The U.S. Food and Drug Administration authorized Regeneron’s drug in September for use in preventing COVID-19 after exposure to infected people. AstraZeneca’s application is however for prevention before any exposure.

Astra’s AZD7442 fell through in the post-exposure setting in a trial in June. Another trial is ongoing to test the drug as a treatment of the infected.

In a statement on Tuesday, the Anglo-Swedish drugmaker said it included data in its filing with the FDA from a late-stage trial that showed the drug reduced the risk of people developing any COVID-19 symptoms by 77%. The positive trial data was published in August.

REUTERS