October 4, 2023

An unusual experiment to prevent nursing home employees and residents from being infected with the coronavirus is successful, drug manufacturer Eli Lilly announced on Thursday.

A drug containing monoclonal antibodies – laboratory-bred virus fighters – prevented symptomatic infections in residents who have been exposed to the virus, even in the frail elderly, who are most vulnerable. This is based on preliminary results from a study conducted in collaboration with the National Institutes of Health.

The researchers found an 80 percent reduction in infections in residents who received the drug compared to those who received a placebo and a 60 percent reduction in staff, results that were very statistically meaningful, Eli Lilly said.

The data has not yet been reviewed or published by experts. The company expects to present the results at a future medical meeting and publish them in a peer-reviewed journal, but did not say when.

The study included 965 participants in nursing homes: 666 employees and 299 residents. (The company had hoped more residents would attend, but it proved difficult to enroll. Many had dementia and others were suspicious of intravenous medication.)

There were four deaths from Covid-19 among study participants. All of them were among those living in nursing homes who were given a placebo, not the drug.

The drug Bamlanivimab already has an emergency approval from the Food and Drug Administration, which enables Eli Lilly to make it available to symptomatic patients early in the course of their infection.

However, this study asked if the drug could stop infections before they started. It was an unusual experiment: medical staff rushed to nursing homes in trucks equipped with mobile laboratories as soon as a single infection was found there. Once the workers arrived, they set up temporary infusion centers to administer the drug.

The research ended that weekend with an emergency meeting of the Data Protection and Monitoring Committee, an independent group that oversees the incoming results. The data was strong and convincing enough to bring the placebos to a halt.

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Answers to your vaccine questions

If I live in the US, when can I get the vaccine?

While the exact order of vaccine recipients may vary from state to state, most doctors and residents of long-term care facilities will come first. If you want to understand how this decision is made, this article will help.

When can I get back to normal life after vaccination?

Life will only get back to normal once society as a whole receives adequate protection against the coronavirus. Once countries have approved a vaccine, they can only vaccinate a few percent of their citizens in the first few months. The unvaccinated majority remain susceptible to infection. A growing number of coronavirus vaccines show robust protection against disease. However, it is also possible that people spread the virus without knowing they are infected because they have mild symptoms or no symptoms at all. Scientists don’t yet know whether the vaccines will also block the transmission of the coronavirus. Even vaccinated people have to wear masks for the time being, avoid the crowds indoors and so on. Once enough people are vaccinated, it becomes very difficult for the coronavirus to find people at risk to become infected. Depending on how quickly we as a society achieve this goal, life could approach a normal state in autumn 2021.

Do I still have to wear a mask after the vaccination?

Yeah, but not forever. The two vaccines that may be approved this month clearly protect people from contracting Covid-19. However, the clinical trials that produced 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 with the coronavirus can spread it without experiencing a cough or other symptoms. Researchers will study this question intensively when the vaccines are introduced. In the meantime, self-vaccinated people need to think of themselves as potential spreaders.

Will it hurt What are the side effects?

The vaccine against Pfizer and BioNTech, like other typical vaccines, is delivered as a shot in the arm. The injection is no different from the ones you received before. Tens of thousands of people have already received the vaccines, and none of them have reported serious health problems. However, some of them have experienced short-lived symptoms, including pain and flu-like symptoms that usually last a day. It is possible that people will have to plan to take a day off or go to school after the second shot. While these experiences are not pleasant, they are a good sign: they are the result of your own immune system’s encounter with the vaccine and a strong response that ensures lasting immunity.

Will mRNA vaccines change my genes?

No. Moderna and Pfizer vaccines use a genetic molecule to boost the immune system. This molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse with a cell, allowing the molecule to slide inside. The cell uses the mRNA to make proteins from the coronavirus that can stimulate the immune system. At any given point in time, each of our cells can contain hundreds of thousands of mRNA molecules that they produce to make their own proteins. As soon as these proteins are made, our cells use special enzymes to break down the mRNA. The mRNA molecules that our cells make can only survive a few minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a little longer, so the cells can make extra viral proteins and trigger a stronger immune response. However, the mRNA can hold for a few days at most before it is destroyed.

“When I saw the results table, my jaw dropped,” said Dr. Myron Cohen, professor of medicine at the University of North Carolina at Chapel Hill and principal researcher who helped design and conduct the study.

Although the study has ended, Dr. Daniel Skovronsky, Eli Lilly’s chief scientist, said the company would continue to rush to nursing homes on its study network if an outbreak is detected. “Everyone will get the drug,” he said.

Experts who did not take part in the study were delighted, but emphasized that they had not yet seen complete data. “I only see positive results here,” said Dr. Ofer Levy, director of the Precision Vaccination Program at Boston Children’s Hospital. “That’s a win.”

Dr. Kathleen Neuzil, director of the Center for Vaccine Development and Global Health at the University of Maryland Medical School, was also encouraged.

“The mortality effect is remarkable,” she said, adding that the drug should be used more widely to prevent and treat Covid-19, “especially in populations such as nursing home residents who have high mortality rates and may not respond optimally to vaccines . ” ”

Vaccines also protect people from contracting the virus, of course, and nursing home staff and residents were among the first group to be prioritized for the shots. But supplies are inadequate, and many nursing home workers who fear the vaccines have refused to get them.

And after vaccination, it can take six weeks for the body to produce enough antibodies for maximum protection, said Dr. Srilatha Edupuganti, vaccine researcher at Emory University in Atlanta and study researcher.

Treatment with monoclonal antibodies could provide almost equivalent protection immediately, although it does not last as long as the protection offered by a vaccine.

Eli Lilly plans to reach out to the FDA for an emergency clearance to use the drug to help prevent infection in frail elderly populations, especially in nursing homes or long-term care facilities, said Dr. Skovronsky.