RSV Vaccine Approved by FDA for Adults 60 and Older

The U.S. Food and Drug Administration (FDA) has approved a license for the world’s first respiratory syncytial virus (RSV) vaccine to be given to people 60 years of age and older. Pharmaceutical and biotechnology company GSK (formerly GlaxoSmithKline) has already begun manufacturing doses of the vaccine, which will be sold as early as this fall under the brand name Arexvy. ^{1 2}

Although approved by the FDA, Arexvy will need to be recommended by the U.S. Centers for Disease Control and Prevention (CDC) before it can be distributed and used. This may happen in June 2023 following a scheduled meeting of the agency’s Advisory Committee on Immunization Practices (ACIP)

“The goal is to have shots available in the fall so that people can get them before the next RSV season coming up late fall and winter,” said Phil Dormitzer, MD, PhD, GSK’s senior vice president and global head of vaccines research and development.

RSV infection is a common, typically-mild lower respiratory infection that has been associated with early childhood illness. In cases with serious complications, RSV can lead to pneumonia, bronchiolitis and death. Lately, public health officials have been publicizing RSV risks for those over age 60. According to the CDC, RSV admissions have risen from 19 per 100,000 people last season to 51 per 100,000 people, and reportedly RSV infections claim the lives of 10,000 elderly and up to 300 children under five years old in the United States each year.³

Surge in RSV Cases Attributed to Relaxing COVID-19 Measures

While reported cases of RSV dropped significantly during the COVID-19 pandemic, along with reported cases of influenza, some researchers attribute the surge in RSV cases to lifting the strict COVID measures such as masking. NPR reported in 2022 that Vandana Madhavanm, MD, director of advanced pediatrics at Mass General Brigham in Boston, said, “When the pandemic hit the U.S. in March 2020, we saw the rates of all viruses plummet” largely due to people staying indoors, wearing masks and frequently washing or sanitizing their hands. She speculated that very young children born just before or during the pandemic did not benefit from regular or early exposure to common viruses, including RSV, which would have helped build up an immunity.

We’ve had this whole cohort of young children who haven’t had that usual constant exposure to viruses at day care or in preschool or out in the community. And so now they’re getting exposed and it’s hitting them really hard.⁴

An analysis of 78 global studies published on Jan. 30, 2023 by the Cochrane Institute found that masks only reduced the risk of infection and death by a mere five percent. Also among the key findings was that community mask-wearing made little to no difference in lab-confirmed infections, compared to not masking.^{5 6}

Earlier RSV Clinical Trials Resulted in Hospitalization and Death of Children

While Arexvy is the first RSV vaccine to be licensed by the FDA, it is not the first to be developed. In the 1960s, clinical trials for an earlier RSV vaccine were disastrous. Eighty percent of children who were given that vaccine ended up being hospitalized with severe respiratory disease, and two children died.⁷

While participants in clinical trials of many childhood vaccines were only monitored for a few days after each dose—the RECOMBIVAX HB for example which monitored participants a mere five days after administering each dose—participants in Arexvy’s main clinical study will remain through three RSV seasons to assess the safety and efficacy of the shot.⁸

Manufacturers of vaccines added to the CDC’s recommended vaccination schedule were effectively shielded from product liability under the 1986 National Childhood Vaccine Injury Act by a 2011 U.S. Supreme Court ruling.⁹ GSK is still studying whether the vaccine can be administered in conjunction with high-dose or adjuvanted influenza vaccines.

While COVID-19 shot manufacturers Pfizer and Moderna are expected to see plummeting sales of their Comirnaty and Spikevax products in 2023, the RSV vaccine hold significant financial promise for GSK. The British firm is expected earn $2.5 billion in profit from its pioneer RSV vaccine and analysts estimate the RSV vaccine market will exceed $10 billion by 2030.^{10 11}

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