The first RSV vaccine could be approved in August, pending FDA review

After decades of research, a first-of-its-kind vaccine designed to protect newborns against RSV, or respiratory syncytial virus, could be approved by August.

Pfizer, the maker of the vaccine, announced on Tuesday that the US Food and Drug Administration has accepted its application for review and will make a decision on whether to approve the vaccine by August 2023.

“If approved, RSVpreF will help protect infants with their first breath from the devastating effects of this infectious disease, which, while well-known, has been particularly evident during this RSV season,” said Annalisa Anderson, Ph.D., senior vice president, Pfizer. and Chief Scientist of the Vaccine Research and Development Division, according to the statement. “We look forward to further review of Pfizer’s maternal RSV vaccine candidate with the FDA and other regulatory authorities, given its significant potential to make a positive contribution to global health in the prevention of RSV in infants.”

Pfizer’s protein-based RSV vaccine works by vaccinating pregnant women, who then pass on some protective antibodies to the infant.

The company also said the vaccine showed promising data in adults age 65 and older.

RSV usually causes mild, cold-like symptoms, but can become serious, especially in infants and the elderly. According to the Centers for Disease Control and Prevention, premature newborns and young children with weakened immune systems, congenital heart disease or chronic lung disease, and adults with chronic conditions such as heart or lung disease are among the most vulnerable to complications. RSV.

Babies aged 12 weeks or less at the start of RSV season are also at greater risk of serious illness.

According to the CDC, this virus is the most common cause of bronchiolitis and pneumonia in children under 1 year of age in the United States.

According to data collected in previous studies, the Pfizer vaccine was 82% effective in protecting newborns during the first three months of life against severe RSV. Within six months of the babies’ lives, the vaccine’s effectiveness dropped to 69%, according to Pfizer.

In November, the company announced that, given promising preliminary data on the maternal RSV newborn vaccine, the FDA had given the go-ahead to stop enrolling new patients in vaccine trials.

“Among very young children, especially those [younger] over 6 months of age, we now have a high probability of protection against serious illness and hospitalization,” Pfizer’s Dr. William Gruber, who has personally worked on the RSV vaccine for more than 40 years, told ABC News in November. “There will be an opportunity to be to be in a position where we have the potential to provide 80% or more protection against serious disease is a dream come true.”

RSV in children: symptoms, treatment and what parents should know

There is currently no approved vaccine against RSV.

The Pfizer vaccine will be the first RSV vaccine given to pregnant people to protect their babies. The company said there were “no safety concerns” for vaccinated pregnant participants and their newborns during the trial.

If the FDA approves the vaccine in August, it will go to the CDC for final approval and, if approved, could be available next year.

The news comes amid an increase in the number of patients admitted to pediatric hospitals across the country with RSV. Infections caused by RSV increased 69% last fall and occurred earlier than usual, according to the CDC.

Late last year, U.S. pediatric bed occupancy reached its highest level in two years, with 75% of the roughly 40,000 beds filled, according to an ABC News analysis.

Babies and toddlers can usually recover from RSV at home unless they start to have trouble breathing, are irritable, aren’t eating or drinking, or seem more tired than usual. In this case, parents should contact their pediatrician and/or take the child to an emergency room.

Home care for children with RSV may include Tylenol and Motrin for fever and making sure the child is hydrated and eating.

Doctors tell ABC News that parents can help protect their children from RSV by continuing to follow the three rules of the coronavirus pandemic as much as possible: wear a mask, wash your hands and keep your distance.

Babies born prematurely (less than 35 weeks) or born with chronic lung disease may benefit from medication to prevent RSV complications because they are at increased risk of severe disease. Parents should discuss this with their pediatrician.