As children's hospitals grapple with intense capacity issues and an increase in patients with respiratory syncytial virus, treatment options are limited. Multiple RSV vaccine candidates are in the works, but the earliest timeline places the first approval next year.
Nearly all children contract RSV before their second birthday, according to the CDC. The generic palivizumab is an approved preventive therapy for preterm babies who are 6 months and younger, and children 2 years and younger who are born with a chronic lung condition and some heart diseases, but for most pediatric cases, supportive care is the only option.
"There's like a three to five day [period] of worsening symptoms, a three to five day period of kind of plateau phase, where they're at their sickest and they stay at their sickest and then three to five days where they improve," Aaron Harthan, PharmD, a pediatric critical care pharmacist at OSF HealthCare's Children's Hospital of Illinois in Peoria, told Becker's in late October. "It's all trying to just support them as their body goes through that process."
Here are the latest updates from six drugmakers that are developing RSV vaccines:
1. Pfizer: In a phase 3 trial, its pediatric RSV vaccine candidate was 81.8 percent effective at preventing severe RSV in hospitalized babies within the 90 days after birth, according to a Nov. 1 news release. The drugmaker's candidate is intended for pregnant people to take, meaning the hope is for the vaccine's antibodies to pass onto the child before birth. Pfizer said it plans to submit the data to the FDA and gain regulatory approval next year.
2. AstraZeneca and Sanofi: The two drugmakers' pediatric RSV vaccine candidate was 74.5 percent effective at preventing infants from requiring medical attention, according to a phase 3 trial published March 3 in The New England Journal of Medicine.
Vaccine-makers are also investigating vaccine options for older populations, which are also at high risk for RSV infections:
1. GSK: The FDA granted the drugmaker priority review for its RSV vaccine candidate's application Nov. 2, meaning the regulatory agency will make its decision by mid-2023. In mid-October, the global pharmaceutical company said its RSV vaccine candidate intended for adults 60 and older was 82.6 percent effective among phase 3 study participants.
2. Moderna: The Cambridge, Mass.-based company is recruiting volunteers for its phase 3 clinical trial to test an RSV vaccine candidate intended for adults 60 and older, according to a February news release.
3. Johnson & Johnson: Similar to GSK, J&J is investigating a RSV vaccine candidate for older adults, but the company has not announced any updates since October 2021 when its phase 2 trial found 80 percent efficacy in preventing any symptomatic RSV-associated acute respiratory infection. The company began a phase 3 trial late last year.
4. Bavarian Nordic: The Danish vaccine-maker reported positive results in 2021 from its RSV vaccine option's phase 2 trial. In April, Bavarian Nordic began enrolling participants for a global phase 3 trial.