RSV vaccine recap: what to know about vaccinations and safety- Bio.News

RSV recap: what to know about immunizations and safety in 2024

RSV vaccine

Recently, it’s seemed like everyone has been sick this winter—an observation that is not too far off. 

This year’s COVID surge is the second-highest after the Omicron surge of 2021-22. And flu contractions this year between Oct. 1, 2023 through Jan. 6, 2024 are estimated to be between 14–26 million, with 6.2–12 million flu medical visits, 150,000–320,000 flu hospitalizations, and 9,400–28,000 flu deaths, according to the Centers for Diseases Control and Prevention (CDC)

Respiratory Syncytial Virus Infection (RSV) trends this year, though harder to pin down, also indicate that we are midway through a building January 2024 surge, coming on the heels of a mid-November surge last year, according to the CDC. And for some portions of the population, staying on top of their RSV vaccination is equally as important as staying up to date on their COVID and flu vaccines. 

So, to keep you and your loved ones safe this year, here are a few things you need to keep in mind when it comes to RSV for the rest of the year.

Vaccines for elderly populations

If COVID and the flu are the power players of the winter respiratory disease season, then RSV is here to round out their ranks. The symptoms of the disease can vary from mild to severe. Oftentimes, RSV is responsible for that aggravating cold you catch that doesn’t seem to want to go away.

Luckily, for younger patients, RSV is often nothing more than a nuisance, but for elderly patients, an RSV contraction can be deadly. According to the CDC, “Respiratory syncytial virus (RSV) causes substantial morbidity and mortality in older adults, resulting in approximately 60,000–160,000 hospitalizations and 6,000–10,000 deaths annually among adults aged ≥65 years.”

Luckily, there are two RSV vaccination options for elderly patients: GSK’s Arexvy and Pfizer’s Abrysvo. The CDC requires that “all Health Insurance Marketplace plans and most other private insurance plans” must cover RSV vaccinations “without charging a copayment or coinsurance when provided by an in-network provider.” 

Additionally, Medicare Part D covers the RSV vaccine, and “beginning October 1, 2023, most adults with coverage from Medicaid and CHIP will be guaranteed coverage of all vaccines recommended by the Advisory Committee on Immunization Practice (ACIP) at no cost to them.” The RSV vaccine is listed in the ACIP recommended list of vaccinations.

Pediatric immunization

Pediatric patients are also more susceptible to the RSV virus. A 2022 paper published by the National Library of Medicine explains that, in the United States, “the CDC has estimated that approximately 40,000 infants are hospitalized due to RSV annually.”

The paper continued, “RSV hospitalizations in the United States were 2.9 per 1,000 children aged <5 years and 14.7 per 1,000 infants aged <6 months, with the highest rate observed among 1-month-old infants,” based on a 2015–2016 surveillance period. Another 2011–2019 study referenced by the paper observed, the “infant RSV hospitalization rate in 2019 was 17.2 per 1,000 live births.” However, the paper also notes the historically low reporting for RSV, positing that the numbers may very well be higher. 

All these numbers aside, a serious RSV contraction in the pediatric space is terrifying for parents and providers alike. 

“As a pediatrician,” Michael Greenberg, Vice President and Medical Head of Vaccines in North America at Sanofi, told Bio.News in Feb. 2023, “I can tell you, every single parent wants to protect their kids. There’s nothing like the terrified look on the parent’s face when they’re worried that their child might die. That feeling, as a pediatrician, doesn’t go away.”

Luckily, there are two RSV immunization options for the pediatric space as well, with another RSV vaccine option for the maternity space, which benefits infants. Both Sanofi’s Beyfortus and Sobi’s Synagis are monoclonal antibodies available for pediatrics, though with differing age schedules. 

Per CDC recommendations, “Nirsevimab (Beyfortus) is recommended for all infants younger than 8 months of age born during RSV season or entering their first RSV season. Except in rare circumstances, most infants younger than 8 months of age do not need nirsevimab if they were born 14 or more days after their mother got the RSV vaccine (more on maternity options later).” Beyfortus is also recommended for “some children aged 8 through 19 months who are at increased risk for severe RSV disease and entering their second RSV season.”

Sobi’s Synagis has more restricted use, only being recommended for “some children younger than age 24 months of age with certain conditions that place them at increased risk for severe RSV disease. It must be given once a month during RSV season.”

But another innovative option for parents when it comes to protecting their newborns is for pregnant mothers to get the Abrysvo vaccine during weeks 32 through 36 of pregnancy. As Bio.News reported in Nov. 2022, Pfizer’s Phase 3 study showed, “The RSVpreF investigational vaccine demonstrated 81.8% efficacy ‘for severe medically attended lower respiratory tract illness (severe MA-LRTI) through the first 90 days of life’ and maintained a substantial efficacy of 69.4% ‘for infants over the six-month follow-up period.’” 

RSV vaccination rates are still low

RSV vaccination rates are still low, but the willingness patients have voiced when it comes to getting vaccinated can be seen in an optimistic light. 

Self-reported data based on the  CDC’s National Immunization Survey’s Adults 60+ Coverage Module found that, “As of January 6, 2024, an estimated 20.1% of adults 60 years and older reported having received an RSV vaccine.” Additionally, “15.8% reported that they definitely plan to get vaccinated.”

And vaccination rates also differ from state to state and are informed and impacted by factors like race, economic status, and urban versus rural living. The CDC observes that “across states and DC, receipt of an RSV vaccine was lowest in Georgia and highest in Washington.” 

When it comes to maternity RSV vaccination rates, the CDC studied pregnant persons 18 to 49 years finding, “As of January 6, 2024, among persons who were pregnant and ≥32 weeks gestation since September 22, 2023, overall coverage with the RSV vaccine was 13.1%.” Additionally, “Vaccination coverage was highest among non-Hispanic Asian (18.4%) pregnant persons and lowest among non-Hispanic Black (7.7%) pregnant persons.”

Innovation decades in the making

At the end of the day, the rapid development of RSV vaccines and monoclonal antibodies, as was seen through the 2023 “Year of RSV” is a result of massive jumps in medical innovation and is something to be celebrated.

Prior to the last handful of years, RSV was a thorn in the side of those trying to develop vaccines to combat it. 

As we discussed in Feb. 2023, as the “Year of RSV” was kicking off, “‘Since RSV was first identified, there’s been a lot of work that’s been done to try and develop vaccines,’ explained Jon Heinrichs, Associate Vice President and Head of Innovation and Emerging Sciences at Sanofi, to Bio.News. ‘But the one holdback that the industry has had is that there was a series of clinical studies that were done in the 60s, in which a formalin-inactivated virus was given to infants, and when those infants then went on to have RSV infections, it actually led to more severe disease and death in a couple of kids that were vaccinated.’”

The industry was unequivocal in its step back from RSV vaccine development, not wanting to move forward until the understanding of the virus, technology, and development pipeline was safer. Eventually, over decades, key understandings about the crystalline and protein structure of the virus, coupled with the evolution of monoclonal antibody technology, allowed researchers to key into exactly how to attack and neutralize the virus.”

The medical advancements that developed during the COVID era paved the way for scientists to crack the code on RSV. Additionally, the incorporation of mRNA and monoclonal antibodies technology are diversifying the options patients have for treatment. 

Moderna’s mRNA RSV vaccine option has seen “83.7% effective at preventing infection in a Phase 3 trial,” while monoclonal antibody options for RSV immunization, like Beyfortus, helped expand the options for pediatric protection.

Bio.News reported in Aug. 2023, “‘It really does give promise to maybe one day making RSV in infants a disease for the medical history books,’ said Dr. Jose Romero, Director of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), at the conclusion of August 3 ACIP meeting. 

‘This news represents a milestone for innovation in prevention and will be an important addition to our growing set of preventive solutions for RSV,’ said Phyllis Arthur, the Biotechnology Innovation Organization (BIO) SVP of Infectious Disease and Emerging Science Policy, in an interview with Good Day BIO following the news.”

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