FDA approves first RSV vaccine

CNN
—

After 60 years of scientific research, the world has the first vaccine to protect against respiratory syncytial virus (RSV).

on Wednesday, U.S. Food and Drug Administration Made by Arexvy Approved GSKMoreis designed to be administered as a single injection to adults over the age of 60.

Pending a recommendation for use from the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, it may soon be available to older adults this fall.

“Older people, especially those with underlying medical conditions such as heart or lung disease or a weakened immune system, are at increased risk of severe illness from RSV,” the study said in a statement. “Today’s first approval of his RSV vaccine is a significant public health achievement in preventing a potentially life-threatening disease and the development of a safe and effective vaccine for use in the United States. It reflects the FDA’s continued commitment to promoting

RSV is common in babies and young children, but it can also be dangerous for older people. In the United States, an estimated 159,000 adults aged 65 and older are hospitalized with RSV each year, and an estimated 10,000 to 13,000 die as a result of infection.

“RSV is certainly an important disease for older people. In some years, the burden of RSV disease approaches that of influenza in older people. And this is truly a wonderful development,” said Johns Hopkins University Bloomberg. said Ruth Caron, Ph.D., professor of global health at the Graduate School of Public Health.

In a clinical trial involving approximately 25,000 elderly people, It was published The New England Journal of Medicine found that the GSK vaccine was 83% effective in preventing lower respiratory tract disease caused by the virus.

In this study, lower respiratory tract disease was defined as having two symptoms for at least one day with a positive test, including cough, wheezing, shortness of breath, rapid respiratory rate, low blood oxygen, and lung crackling. I was. The doctor picks up with a stethoscope.

The vaccine was 94% effective in preventing severe disease in the elderly. You were considered critically ill if you needed supplemental oxygen or if you needed mechanical respiratory assistance, such as a ventilator.

GSK’s RSV vaccine works by using a small fragment of the virus. This protein is a protruding protein on its surface called a fusion protein or F protein that helps the virus enter and infect cells of the upper respiratory tract. The protein pieces of the vaccine are made in the lab using cells specially programmed to manufacture them.

This vaccine is based on a pivotal discovery made by researchers at the National Institutes of Health ten years ago. The discovery also includes the scientists who helped produce the Covid-19 vaccine.

Normally, the F protein is wavy, flips back and forth, and changes shape after fusing with the cell.

NIH researchers have figured out a way to freeze the protein in its shape before it fuses with the cell. In this form, the body can develop strong antibodies against it.

The GSK vaccine uses this powerful prefusion. A form of protein, along with ingredients called adjuvants that enhance immune activity.

When researchers specifically examined how effective vaccines are in the most vulnerable older adults (those with underlying conditions such as COPD, heart failure, and heart disease), they found that 94 It turns out that % has an effect.

“This is really exceptional information because it’s the type of disease that we want to prevent. We want to prevent people from being hospitalized with RSV,” said GSK’s Science Dr. Len Friedland, Director of Problems and Public Health, said.

The most common side effects reported by people in clinical trials included injection site pain and fatigue.

A small number of serious adverse events occurred in this study. Friedland said there was a balance between the vaccinated and placebo groups. Friedland said researchers will continue to monitor safety signals as the vaccine is rolled out to a wider population.

He said it was unclear exactly how long the protection from the vaccine would last. Researchers will follow study participants for three years and continue to evaluate vaccine efficacy over time. So far the protection seems to have worked well for about a year.

Three other RSV vaccines for the elderly are also in the final stages of trials.

The FDA expects to make a decision on Pfizer’s RSV vaccine for the elderly by the end of May. The agency is also considering a Pfizer maternal vaccine to protect the infant and expects to make a call about it by the end of August.

Moderna has completed a Phase 3 trial of an RSV mRNA vaccine in the elderly and plans to submit results to the FDA for approval in the coming months.

Bavarian Nordic, maker of the Jynneos mpox vaccine, said it will report results from a phase 3 trial of an RSV vaccine for the elderly later this year.

According to Paul Chaplin, President and CEO of Bavarian Nordic, there is a saying in the UK that if you wait too long for a bus, four buses will show up at once. The race to the goal of an RSV vaccine is like that, he says.

“We have been waiting for decades for a safe and effective RSV vaccine, but there have been many failed attempts.

“And while we know GSK is likely to get the first approval, there will be other approvals, including ours. It is a huge unmet medical need and I hope there are many effective vaccines that can help protect people.”

The quest for an effective vaccine against RSV is a story of scientific triumph over tragedy.

Two children died in the 1960s and many others were hospitalized with severe RSV. That’s when it turns out that the vaccine given to them strengthens the infection instead of protecting it.

The study tested a vaccine made by chemically inactivating the RSV virus and mixing it with an ingredient called alum to wake up the immune system and help it respond.

Tested in US clinical testing facilities from 1966 to 1968.

At first, everything looked good. After the vaccine was tested on animals and well tolerated, it was administered to children, who also appeared to respond well.

Unfortunately, when the RSV epidemic began that fall, many of the vaccinated children required hospitalization and had more serious RSV infections than usual.

In a study on this trial, 80% of vaccinated children who later became infected with RSV required hospitalization, compared with only 5% of placebo-treated children. two of them died.

The result was a sea change for vaccine science. Efforts to develop a vaccine and treatment against RSV were halted as researchers tried to figure out what went wrong.

Many of the guardrails currently in place for clinical trials of vaccines arose from the failure of the RSV vaccine.

A scientific breakthrough that allowed scientists to freeze the virus’ F protein in place, NIH scientists Dr. Jason McClellan and Bernie Graham said could stabilize the spike protein of the coronavirus and fight Covid-19. -19 accelerated vaccine development.

“RSV has taken time to unlock its mysteries and secrets,” said Dr. Stephen Varga, dean of the St. Jude Children’s Research Hospital School of Biomedical Sciences, who has spent his career studying viruses. . And designed a nanoparticle vaccine against it.

“It’s a really exciting time. It’s been a long time coming,” he said.

Minnesota resident Tania Richter wishes the vaccine had been made available to her grandfather, Adam Kaesman, a retired school bus driver who died of a severe respiratory syncytial virus infection last summer. I’m here. He was 95 but otherwise healthy and on welfare in Jamestown, North Dakota, when RSV ripped the facility apart.

He was hospitalized and later recovered enough to be discharged to a nursing home, but Richter said it was the beginning of the end for him.

“He was a great grandpa. I didn’t get to see him much in the last few years, but because of Covid, I was trying to keep everyone safe and not let that happen,” she said. Told.

“Vaccines give us a chance to fight, so I really hope there was one before this happened,” she said. I have.”