AstraZeneca has requested US authorisation for emergency use of its new treatment to prevent COVID-19 in people who have a lessened response to vaccines because of a weakened immune system.
The drugmaker included data in its filing with the Food and Drug Administration from a late-stage trial showing the jab reduced the risk of people developing any coronavirus symptoms by 77%.
The antibody therapy, called AZD7442, could be used to protect people who do not have a strong enough immune response to COVID vaccines, or as a booster for those such as military personnel, AstraZeneca said.
AZD7442 differs from vaccines, which rely on the immune system to develop targeted antibodies and infection-fighting cells, by containing lab-made antibodies which are designed to stay in the body for months to contain the virus if a person becomes infected.
According to the ZOE COVID Symptom Study, which is funded by the UK government, the top five symptoms of coronavirus in those who are fully vaccinated are: headache, runny nose, sneezing, sore throat and loss of smell.
Symptoms in those who are unvaccinated are: headache, sore throat, runny nose, fever and persistent cough.
Trial results for the therapy, which were first published in August, were taken three months after it was injected.
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The company hopes it can promote the jab as providing year-long protection, as trial investigators will follow up with participants as far out as 15 months.
Mene Pangalos, executive vice president at AstraZeneca’s BioPharmaceuticals R&D, said: “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.
“We look forward to sharing AZD7442 data for the treatment of COVID-19 later this year.”
AZD7442 is based on two antibodies discovered by the Vanderbilt University Medical Center in the US.
AstraZeneca’s COVID-19 vaccine – which is used in the UK – is yet to be approved by US authorities. In July, the company said it expected to seek US approval for the vaccine in the second half of this year.