A​​straZeneca Seeks US Authorization for COVID-19 Preventive Treatment

The logo for AstraZeneca is seen outside its North America headquarters in Wilmington, Del., on March 22, 2021. Rachel Wisniewski/Reuters

A European biotechnology firm on Tuesday announced it’s seeking emergency authorization of a treatment it says can prevent symptomatic COVID-19.

AstraZeneca said it submitted an emergency use authorization (EUA) request for an antibody combination drug dubbed AZD7442.

“Vulnerable populations such as the immunocompromised often aren’t able to mount a protective response following vaccination and continue to be at risk of developing COVID-19. With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines,” Mene Pangalos, executive vice president for biopharmaceuticals for AstraZeneca, said in a statement.

AZD7442 combines tixagevimab and cilgavimab, two long-acting antibodies. The antibodies are derived from B-cells donated by convalescent patients who contracted COVID-19.

The drug is administered as a shot through intramuscular injection and meant to prevent symptomatic COVID-19, the disease caused by the CCP (Chinese Communist Party) virus. It has had mixed results in clinical trials. In June, the British-Swedish biotech company said it failed to provide evidence it protected people exposed to a confirmed COVID-19 case. Two months later, though, it said a trial showed it was 77 percent effective.

The trial showing positive effects has not yet been peer-reviewed and the side effects weren’t detailed.

The primary medicines used prophylactically in the United States for COVID-19 are monoclonal antibodies, which are expensive and in short supply after the Biden administration recently started rationing courses. The antibodies are also used to treat confirmed non-hospitalized patients.

Medicines developed for another use, such as the HIV treatment ivermectin, have also shown promise as a prophylaxis. It’s used widely in India and studies show it helped reduce COVID-19 infections among healthcare workers. U.S. government authorities have recommended against its use but some outside experts have said the drug can be used to prevent the CCP virus.

AstraZeneca also makes a COVID-19 vaccine, but it has not yet asked U.S. regulators for authorization for the shot. There was a flap in the spring where AstraZeneca said an interim analysis of a trial showed strong results but U.S. officials said the company used outdated information, prompting an update. The vaccine has also been linked to thrombosis with thrombocytopenia syndrome, a disorder that includes severe blood clots.

Results from a phase 3 trial involving more than 32,000 participants were published in the New England Journal of Medicine last week. The trial showed the vaccine was overall 74 percent effective.

A spokesperson for AstraZeneca told The Epoch Times via email that the company plans to seek authorization from the U.S. Food and Drug Administration for the jab before the end of the year.

Meiling Lee contributed to this report.