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 on Monday. The drug, if authorized, could offer another line
of defense against the disease for people who are not protected by vaccination.
اضافة اعلان
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 authorization — for
high-risk people who already have COVID-19 but are not hospitalized — 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 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 percent less
likely to get sick with COVID compared to volunteers who got a placebo.
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 enroll 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 authorization 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.
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