Health Desk – 13 Apr, 2021: A monoclonal antibody cocktail developed by the drugmaker Regeneron offered strong protection against COVID-19 when given to people living with someone infected with the coronavirus, according to clinical trial results announced Monday. The drug, if authorised, could offer another line of defence against the disease for people who are not protected by vaccination.
The findings are the latest evidence that such lab-made drugs not only prevent the worst outcomes of the disease when given early enough, but also help prevent people from getting sick in the first place.
Using the cumbersome drugs preventively on a large scale won’t be necessary as vaccines are sufficient for the vast majority of people and are increasingly available.
Still, antibody drugs like Regeneron’s could give doctors a new way to protect high-risk people who haven’t been inoculated or who may not respond well to vaccination, such as those taking drugs that weaken their immune system. That could be an important tool as rising coronavirus cases and dangerous virus variants threaten to outpace vaccinations.
Regeneron said in a news release that it would ask the Food and Drug Administration to expand the drug’s emergency authorisation — for high-risk people who already have COVID but are not hospitalised — to allow it to be given for preventive purposes in “appropriate populations.”
There’s “a very substantial number of people” in the United States and globally who could be a good fit to receive these drugs for preventive purposes, said Dr Myron Cohen, a University of North Carolina researcher who leads monoclonal antibody efforts for the COVID Prevention Network, a National Institutes of Health-sponsored initiative that helped to oversee the trial.
“Not everyone’s going to take a vaccine, no matter what we do, and not everyone’s going to respond to a vaccine,” Cohen said.
Regeneron’s new data come from a clinical trial that enrolled more than 1,500 people who lived in the same household as someone who had tested positive for the virus within four days. Participants, who were recruited after their household contact sought treatment at a health care facility, had to test negative for the virus to enroll in that section of the study. Those who got an injection of Regeneron’s drug were 81% less likely to get sick with COVID compared to volunteers who got a placebo.
Dr Rajesh Gandhi, an infectious diseases physician at Massachusetts General Hospital who was not involved in the study, said the data were “promising” for people who have not yet been vaccinated. But he said that the study did not enrol the type of patients that would be needed to assess whether the drug should be used preventively for immunocompromised patients. “I would say we don’t yet know that,” Gandhi said.
Scientists do not yet understand how well immunocompromised people are responding to COVID-19 vaccines, though there are reasons for concern: Researchers at Johns Hopkins University reported last month that most transplant patients in a small study did not produce detectable antibodies against the virus after being inoculated with a first dose of the Pfizer and Moderna vaccines.
Regeneron’s cocktail, a combination of two drugs designed to mimic the antibodies generated naturally when the immune system fends off the virus, got a publicity boost last fall when it was given to President Donald Trump when he got sick with COVID.
The treatment received emergency authorisation in November. Doctors are using it, as well as another antibody cocktail from Eli Lilly, for high-risk COVID patients.
Jeff Zients, the White House COVID-19 response coordinator, said last week that the Biden administration would send more therapeutics, along with more vaccinators and coronavirus testing, to hard-hit regions. But use of the antibody drugs has been slowed not by a shortage of doses, but by other challenges, though access has improved in recent months. Many patients don’t know to ask for the drugs or where to find them.
Many hospitals and clinics have not made the treatments a priority because they have been time-consuming and difficult to administer, in large part because they must be given via intravenous infusion. Regeneron plans to ask the FDA to allow its drug to be given via an injection, as it was administered in the results of the study announced Monday, which would allow it to be given more quickly and easily.