An unusual experiment to prevent nursing home staff members and residents from infection with the coronavirus has succeeded, the drug maker Eli Lilly announced on Thursday.
A drug containing monoclonal antibodies — laboratory-grown virus-fighters — prevented symptomatic infections in residents who were exposed to the virus, even the frail older people who are most vulnerable, according to preliminary results of a study conducted in partnership with the National Institutes of Health.
The researchers found an 80 percent reduction in infections among residents who got the drug, compared with those who got a placebo, and a 60 percent reduction among the staff, results that were highly statistically powerful, Eli Lilly said.
The data have not yet been peer-reviewed or published. The company expects to present the findings at a future medical meeting and to publish them in a peer-reviewed journal, but did not say when.
The study included 965 participants at nursing homes: 666 staff members and 299 residents. (The company had hoped more residents would participate, but it proved difficult to enroll them; many had dementia, and others were leery of getting an intravenous drug.)
There were four deaths from Covid-19 among study participants. All were among nursing home residents who got a placebo, not the drug.
The drug, bamlanivimab, already has an emergency use authorization from the Food and Drug Administration that allows Eli Lilly to provide it to symptomatic patients early in the course of their infection.
But this study asked if the drug could stop infections before they started. It was an unusual experiment: In trucks equipped with mobile labs, medical staff sped to nursing homes the moment a single infection was detected there. As soon as the workers arrived, they set up temporary infusion centers to administer the drug.
The research ended this weekend with an emergency meeting of the data safety and monitoring board, an independent group monitoring the incoming results. The data were strong and convincing enough to call a halt to the placebos.
While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.
Life will return to normal only when society as a whole gains enough protection against the coronavirus. Once countries authorize a vaccine, they’ll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But it’s also possible for people to spread the virus without even knowing they’re infected because they experience only mild symptoms or none at all. Scientists don’t yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.
Yes, but not forever. The two vaccines that will potentially get authorized this month clearly protect people from getting sick with Covid-19. But the clinical trials that delivered these results were not designed to determine whether vaccinated people could still spread the coronavirus without developing symptoms. That remains a possibility. We know that people who are naturally infected by the coronavirus can spread it while they’re not experiencing any cough or other symptoms. Researchers will be intensely studying this question as the vaccines roll out. In the meantime, even vaccinated people will need to think of themselves as possible spreaders.
The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection won’t be any different from ones you’ve gotten before. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. But some of them have felt short-lived discomfort, including aches and flu-like symptoms that typically last a day. It’s possible that people may need to plan to take a day off work or school after the second shot. While these experiences aren’t pleasant, they are a good sign: they are the result of your own immune system encountering the vaccine and mounting a potent response that will provide long-lasting immunity.
No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.
“My jaw dropped when I saw the table of outcomes,” said Dr. Myron Cohen, a professor of medicine at the University of North Carolina at Chapel Hill, and a principal investigator who helped design and implement the study.
Although the study has ended, Dr. Daniel Skovronsky, Eli Lilly’s chief scientific officer, said the company would continue to rush to nursing homes in its study network when an outbreak is detected. “Everyone will get the drug,” he said.
Experts who were not part of the study were enthusiastic, but emphasized that they had not yet seen complete data. “I see only positives here,” said Dr. Ofer Levy, director of the precision vaccine program at Boston Children’s Hospital. “This is a win.”
Dr. Kathleen Neuzil, director of the Center for Vaccine Development and Global Health at the University of Maryland, also was encouraged.
“The mortality effect is remarkable,” she said, adding that the drug should be used more widely to prevent and treat Covid-19, “particularly in populations such as nursing home residents, who have high mortality and may have suboptimal responses to vaccines.”
Vaccines, of course, also protect people from infection with the virus, and nursing home staff and residents were among the first group prioritized for the shots. But supplies are inadequate, and many nursing home workers, afraid of the vaccines, have declined to get them.
And following vaccination, it can take six weeks for the body to produce enough antibodies for maximum protection, said Dr. Srilatha Edupuganti, a vaccine researcher at Emory University in Atlanta and a study investigator.
The monoclonal antibody treatment, she said, can give nearly equivalent protection immediately, although it will not last as long as the protection offered by a vaccine.
Eli Lilly plans to approach the F.D.A. about an emergency use authorization for use of the drug to prevent infections in frail older populations, especially those in nursing homes or long-term care facilities, Dr. Skovronsky said.