Wednesday, November 30, 2022

Vaccines for Respiratory Syncytial Virus, Which Causes Thousands of Infants and Children Hospitalization Expected to Roll Out Next Year

Young children are flooding pediatric hospital rooms across the nation as they battle a virus that few adults are familiar with. RSV, also known as respiratory syncytial virus, is a common cold-causing virus that infects nearly everyone by age 2. RSV is a primary cause of hospitalization in newborns and young children, accounting for 58,000 hospitalizations annually.

“A lot of parents who come into the hospital and their babies are sick with it tell me, ‘I had no idea this even existed. I had no idea my baby could get so sick from this,'” said Dr. Elizabeth Schlaudecker, medical head of Cincinnati Children’s division of Infectious Diseases.

RSV also affects the elderly, resulting in more than 177,000 hospitalizations and 14,000 fatalities per year. Despite decades of work, the RSV arsenal has only contained one monoclonal antibody, which is given monthly to children at high risk of severe disease. There has never been a cure for RSV.

But six drug companies are actively developing RSV vaccines or antibodies, suggesting this year could be the last one. However, six pharmaceutical companies are actively developing RSV vaccines or antibodies, implying that this year may be the previous without effective instruments to combat the virus.

“We’re experiencing a new hope that the RSV landscape will change dramatically, especially in the very young infant, in the next year or so,” said Dr. Octavio Ramilo, chief of infectious diseases at Nationwide Children’s Hospital in Columbus, Ohio.

Pfizer released the results of Phase 3 clinical trial on Tuesday, indicating that its experimental RSVpreF vaccine protected newborns when given to pregnant volunteers between 24 and 36 weeks of gestation. The vaccine was more than 80% efficient at avoiding severe disease in the first 90 days of a baby’s life. According to the study, it was still roughly 70% effective after six months. The trial raised no severe safety issues for either the parent or the youngster.

Pfizer intends to submit an application to the FDA by the end of the year, perhaps allowing its vaccine to reach the public before next year’s RSV season, which generally begins in late October.

Earlier this year, Sanofi Pasteur and AstraZeneca demonstrated protection against severe sickness with their antibody nirsevimab; the trial, hampered by COVID-19 lockdowns, failed to show a statistically significant reduction in the probability of RSV hospitalization. When an infant’s immune system is too immature to benefit from a vaccine, antibodies can provide protection, according to Jon Heinrichs, Sanofi’s worldwide head of Innovation and Emerging Sciences.

“The majority of hospitalization and severe disease caused by RSV happen in that first year of life,” said Heinrichs. “It’s critical to protect these infants.”

RSV is contracted by about 70% of kids before their first birthday and 90% by their second. It’s hard to predict in advance which kids will experience a straightforward, mild case and which handful will get a severe illness that needs hospitalization to assist them in breathing.

According to doctors, RSV has been particularly problematic this fall because of the precautions taken during the earlier stages of the pandemic, which protected babies against COVID-19 and RSV. The illness is typically less severe in children older than six months. Currently, RSV is being introduced to youngsters for the first time in three years, with some experiencing severe repercussions.

For older adults, Johnson & Johnson, GlaxoSmithKline, Moderna, and Vir Biotechnology are each developing their RSV vaccinations, while Johnson & Johnson and GlaxoSmithKline are also developing RSV vaccines for children and adults aged 60 and older.

According to a 25,000-person phase 3 trial, GSK’s vaccine, AReSVi 006, reduced severe RSV in older individuals by 94% this summer. The business claimed that the shot could be given with a flu shot and had a good safety profile. The FDA’s clearance might occur as early as this year.

According to CEO Stéphane Bancel in a September interview, Moderna is six months behind other businesses but anticipates having safety information this month for the first 6,000 trial participants six months after their injection. He said the company would conduct an interim analysis at some point in the winter or spring, depending on infection rates.

The protection against RSV that adults over 60 may have developed as children may be waning. Diseases like lung illness make people more vulnerable, and as people get older, their immune systems gradually deteriorate.
It’s unknown if older individuals would require RSV vaccinations annually. If so, Heinrichs of Sanofi, whose business is also researching an RSV vaccine in addition to its antibody, said that the shot might be paired with the flu and COVID-19 vaccination.

According to a Pfizer announcement from August, a single dosage of RSVpreF proved beneficial in preventing severe illness in persons 60 and older. More than 37,000 participants in the research provided conclusive evidence that the vaccine was safe and well-tolerated.

Both Sanofi and AstraZeneca request regulatory approval to administer the antibody to all newborns beginning their first RSV season and to all kids who continue to be at risk in their second year due to chronic illness. The Committee for Medicinal Products for Human Use of the European Medicines Agency supported the initiative in September. Later this year, the manufacturers want to send the FDA a licensing request.