Health
The RSV vaccine is ‘long overdue’, but here’s why that could change soon
of each place, The pediatric ward is full Few adults know about young children fighting the virus.
Respiratory syncytial virus infects almost everyone by age 2, but it usually goes unnoticed because it causes most common colds.
However, RSV is the leading cause of hospitalization in neonates and young children. 58,000 in a typical year.
“Many parents who come to the hospital and their babies are really sick have said, ‘I didn’t even know this existed. I never thought my baby would be sick with this.'” Cincinnati Children’s Medical Director of the Infectious Diseases Division.
RSV also affects other endings in life. 177,000 hospitalizations and 14,000 deaths among the elderly every year.
Despite decades of efforts, the arsenal to combat RSV has so far included only one monoclonal antibody given monthly to children at high risk of severe disease. Is not … There has never been a way to prevent RSV.
But six pharmaceutical companies are actively working to develop an RSV vaccine or antibody, suggesting that this year may be the last year we don’t have the right tools to fight the virus.
Octavio Ramilo, Ph.D., director of infectious diseases at Nationwide Children’s Hospital in Columbus, said: Ohio.
on tuesday, drug giant Pfizer Announces Phase 3 Clinical Trial Results We show that the RSVpreF vaccine protected infants when administered to pregnant participants between 24 and 36 weeks of gestation.
In the baby’s first 90 days, the vaccine was more than 80% effective in preventing serious illness. At six months, it remained nearly 70% effective, the study showed.
Pfizer plans to file an application with the Food and Drug Administration by the end of the year, and the vaccine could reach the public before next year’s RSV season, which usually begins in late October.
Earlier this year, Sanofi Pasteur and AstraZeneca also showed protection against severe disease with the antibody nirsevimab, but the trial, which was interrupted by the COVID-19 lockdown, showed a statistically significant reduction in the risk of hospitalization due to RSV. could not show.
John Hinrichs, global head of innovation and emerging sciences at Sanofi, says antibodies can provide protection when an infant’s immune system is too immature to benefit from a vaccine.
“The majority of hospitalizations and serious illness from respiratory syncytial virus occur within the first year of life,” he said. “It’s very important to protect these babies.”
Approximately 70% of children acquire RSV before their first birthday and 90% by age two. It is impossible to know in advance which children will have simple, mild cases and which will be severe enough to require hospitalization to help them breathe.
The disease is usually less severe in children under 6 months of age, but RSV is particularly prevalent this fall because precautions taken early in the pandemic have protected babies from RSV in addition to COVID-19. Experts say it has gotten worse.
Three years’ worth of children have now been exposed to RSV for the first time, and some suffer serious consequences.
Why New Approaches Are Coming Now
It took a long time for tools to combat RSV.
“Pediatricians and pediatric infectious disease doctors have been battling RSV for decades, and frankly, not much progress has been made.” It seems that.”
Research into an RSV vaccine was then put on hold for decades. A trial in 1967 killed two children and resulted in The vaccine actually made the disease worse.
In 2013, researchers at the National Institutes of Health discovered a way to stabilize proteins targeted by vaccines. (The same idea was used in his COVID-19 vaccine, which proved highly effective.)
Since then, companies have worked to develop RSV prevention tools, many of which have been successful at the same time.
“Instead of prophylaxis[for RSV]in a very small group, you can suddenly give it to all the children,” Ramiro said. This is important because there are no significant risk factors. Worldwide, RSV is her second leading cause of death in the first year of life, after malaria.
Ramiro said an inexpensive, easy-to-administer vaccine and monoclonal antibodies would be useful. Monoclonals may provide protection until children are old enough to vaccinate themselves.
“Both strategies have their roles and advantages,” he said. “It’s always good to have more than one.”
Alejandra Gurtman, Ph.D., vice president of vaccine research and development at Pfizer, said preventing the first serious respiratory infection could pay off later in life.
“If you can avoid the damage from the initial infection, you may have healthier lungs,” he says, potentially avoiding problems such as asthma later on.
Other approaches to RSV
Johnson & Johnson and GlaxoSmithKline are developing their own RSV vaccines for the elderly, Moderna is developing vaccines for children and adults over 60, and Vir Biotechnology is developing a vaccine to treat people at high risk for severe RSV. We are developing monoclonal antibodies for
GSK’s vaccine, AReSVi 006, Released this summer To A 94% reduction in severe RSV in older adults, according to a Phase 3 study of 25,000 people. The shot also had a good safety profile, according to the company, and could be given alongside a flu shot. FDA approval could come as early as later this year.
Moderna is six months behind other companies, CEO Stéphane Bancel said in an interview in September, but this month safety data from the first 6,000 trial participants are on track. The company expects to have an interim analysis in the winter or spring, depending on infection rates, he said.
Adults over the age of 60 may have weakened immunity to RSV acquired during childhood. Diseases such as lung disease increase vulnerability, and the immune system naturally weakens with age.
It is not known whether RSV vaccination in older adults is required annually. If so, the injection could potentially be combined with flu and COVID-19 vaccines, said Heinrichs of Sanofi, which is developing an RSV vaccine in addition to antibodies.
In August, Pfizer announced A single dose of RSVpreF was effective in preventing severe disease in adults aged 60 years and older. A study of more than 37,000 people showed that the vaccine was well tolerated and had no safety concerns.
Sanofi and AstraZeneca are seeking regulatory approval to give antibodies to all infants entering their first RSV season and all children who remain vulnerable in their second year due to chronic conditions. In September, the initiative won the support of the European Medicines Agency’s Committee for Medicinal Products for Human Use. The companies plan to submit a license application to the FDA later this year.
save young lives
Dr. Melissa Squires works in a pediatric intensive care unit, so she knows what it’s like for an infant who has trouble breathing.
So when she became pregnant with her second daughter last year, she was thrilled to sign up for a clinical trial of Pfizer’s RSV vaccine at Cincinnati Children, where she works.
Squires, a neurocritical care specialist who treats children with stroke, stroke and traumatic brain injury, said:
Squires had the injection at 34 weeks pregnant and her daughter Natalie was born a few days before Christmas. As part of her trial, she had to donate extra cord blood so the pediatrician could share the data and answer questions over the phone.
Despite having an older child at home, mother and baby survived last winter without catching a respiratory virus.
According to Squires, being pregnant during the pandemic has made her more aware of the virus and more committed to protecting vulnerable people.
“This was just one more thing I could do to protect this new life I was responsible for,” she told Spring. Having the reassurance of being protected from one person takes a little weight off my shoulders.
Prevention is the only solution to the scourge of RSV, says Schlaudecker.
“If we can save lives and prevent hospitalization of the most vulnerable infants, we need to do it as soon as possible.”
In newborns and infants, the bronchi entering the lungs are very small. Children can have trouble breathing and eating if fluids get filled during RSV infection. “Vaccination during pregnancy is a very good and creative way to protect pregnancy.”
The range of positive trial results is “really exciting from an RSV physician standpoint,” she said. “I can see the light at the end of the tunnel.”
Please contact Karen Weintraub at [email protected].
Health and patient safety coverage on USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial opinion.
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