Study boosts case antibody drugs can prevent virus
BOSTON — U.S. colleges hoping for a return to normalcy next fall are weighing how far they should go in urging students to get the COVID-19 vaccine, including whether they should — or legally can — require it.
Universities including Rutgers, Brown, Cornell and Northeastern recently told students they must get vaccinated before returning to campus next fall. They hope to achieve herd immunity on campus, which they say would allow them to loosen spacing restrictions in classrooms and dorms.
But some colleges are leav- ing the decision to students, and others believe they can’t legally require vaccinations. At Virginia Tech, officials determined that they can’t because the U.S. Food and Drug Administration has only allowed the emergency use of the vaccines and hasn’t given them its full approval.
The question looms large as more colleges plan to shift back from remote to in-per- son instruction. Many schools have launched vaccination blitzes to get students immunized before they leave for the summer. At some schools, the added requirement is meant to encourage holdouts and to build confidence that students and faculty will be safe on campus.
“It takes away any ambiguity about whether individu- als should be vaccinated,” said Kenneth Henderson, the chancellor of Northeast- ern University in Boston. “It also provides a level of con- fidence for the entire community that we are taking all appropriate measures.”
Northeastern and other col- leges requiring shots believe they’re on solid legal ground.
It’s not unusual for colleges to require students to be vaccinated for other types of diseases, and a California court last year upheld a flu shot requirement at the University of California system.
But legal scholars say the COVID-19 vaccines’ emer- gency use status moves the issue to a legal gray area that’s likely to be challenged in court, and some colleges may take a more cautious approach to avoid litigation.
Harvard Law professor Glenn Cohen, who teaches health law and bioethics, said there’s no legal reason colleges wouldn’t be allowed to require COVID-19 vaccinations. It makes no differ- ence that the shots haven’t been given full approval, he said, noting that many col- leges already require students to take coronavirus tests that are approved under the same FDA emergency authorization. But there’s also no federal guidance explicitly permitting vaccination mandates.
The biggest clashes could come in states taking a stance against vaccination requirements, he said.
In Florida, Gov. Ron Desantis this month banned all busi- nesses from requiring customers to show proof of vaccination. The order raises questions about Nova Southeastern University’s plan to require students and staff to get vaccinated. The college’s president said he’s still confi- dent in the plan, but he also promised to “respect the laws of our state and all federal directives.”
The governor of Texas, the country’s second-largest state, issued a similar order.
There’s a parallel debate about whether to require vaccination for faculty and staff, an issue that employers across the nation are grap- pling with. At the University of Notre Dame, one of the latest schools to require student vaccinations, shots are still optional for workers. Northeastern is considering whether to extend its man- date to employees.
Even at schools making shots mandatory, there are exemptions. Federal law requires colleges to provide accommodations to students who refuse a vaccine for med- ical reasons, and most schools
should are also offering exemptions for religious reasons.
At Brown, students who forgo shots and have no valid exemption must file a petition to study remotely or take a leave of absence next fall, the school’s president, Chris- tina Paxson, told students in a letter last week.
But enforcing vaccine mandates will bring its own challenges. Cornell and North- eastern say students will be asked to show proof of vaccination, but there is no widely accepted vaccine credential. Cornell told students they can provide the card given out at their vaccination site, but card formats vary and generally seem like they would be easy to forge.
At Northeastern, officials are still deciding whether stu- dents will have to provide a medical record proving they were vaccinated or whether they will be allowed to attest to having been immunized— essentially taking their word for it.
“We would expect students to be honest and forthright about any attestation they make to the university,” Henderson said.
A monoclonal antibody cocktail developed by the drugmaker Regeneron offered strong protection against COVID-19 when given to people living with some- one infected with the coronavirus, according to clinical trial results announced Monday. The drug, if authorized, could offer another line of defense 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.
Regeneron said in a news release it would ask the Food and Drug Administration to expand the drug’s emergency authorization — for high-risk people who already have COVID 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 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 came 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 enroll the type of patients that would be needed to assess whether the drug should be used preventively for immunocompromised patients.
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.