After decades of research into respiratory syncytial virus, a particularly dangerous disease for newborns and the elderly, scientists this week announced a major development in plans for a possible vaccine that could be available as soon as the year next.
“Among very young children, especially those [younger] less than 6 months, we now have a high probability of protecting against serious illness and hospitalization,” Dr. William Gruber of Pfizer told ABC News.
Gruber is responsible for the company’s vaccine development programs and has personally worked on the RSV vaccine for more than 40 years.
Pfizer announced Tuesday that, given promising preliminary data on its maternal RSV vaccine for newborns, the Food and Drug Administration has given the green light to stop enrolling new patients in the study. The company said it would continue with the vaccine approval process.
Pfizer’s traditional protein-based RSV vaccine works by vaccinating a pregnant person, who then transmits certain protective antibodies to the infant. The company also said the same vaccine also showed promising data in adults 65 and older.
According to data collected from preliminary studies, Pfizer said, the vaccine was 82% effective in protecting newborns, in the first three months of life, against severe RSV disease. Within six months of an infant’s life, vaccine effectiveness dropped to 69%.
“To be able to be in a position where we have the potential to provide 80% or more protection against critical illness is a dream come true,” Gruber said.
Pfizer expects to submit the vaccine for formal FDA approval by the end of the year and, if approved by the FDA and recommended by the Centers for Disease Control and Prevention, the maternal RSV vaccine could be available as early as next year.
Currently, there is no approved RSV vaccine. If Pfizer’s vaccine is approved, it would be the first RSV vaccine given to pregnant women to protect infants. The company said there were “no safety concerns” for vaccinated pregnant participants and their newborns during the trial.
The news comes as children’s hospitals across the country are experiencing an increase in the number of patients admitted with RSV. RSV infections have increased 69% in the past four weeks and are emerging earlier than usual this year, according to the CDC.
U.S. pediatric bed occupancy is reported to have hit its highest level in two years, with 75% of the estimated 40,000 beds occupied, according to an ABC News analysis.
RSV usually causes mild cold-like symptoms and is the most common cause of bronchitis and pneumonia in children under 1 in the United States, according to the CDC.
The CDC also indicates that premature infants and young children with weakened immune systems, congenital heart disease or chronic lung disease are most vulnerable to RSV complications.
Dr. William Linam, a pediatric infectious disease physician at Children’s Healthcare in Atlanta, told ABC News last year that parents can help protect their children from RSV by following the three Ws of the coronavirus pandemic: wear a mask, wash your hands and watch your distance.
“Almost all children have had RSV at least once by the time they turn 2 years old, but it’s really the younger ones, especially those under 6 months old, who can really have trouble with RSV. RSV and sometimes end up in the hospital,” Linam said. at the time.
“If you have a child who has significant underlying health conditions, you probably need to maintain some of those precautions that you were following during the worst of the pandemic, such as continuing to wear more masks when in enclosed spaces, being diligent to keep hand sanitizer with you, use it a lot and avoid crowds,” he added.