b'RSV in Older Adults Riskier Than Realized; Newly-Approved Vaccine Could HelpA new model suggests that as many as 4.8 million symptomatic cases of respiratory syncytial virus (RSV) could be occuring in the United States among patients 65 and older. That burden is greater than previously recognized, according to another study, which looked at the U.S. and other high-income countries. Recently approved vaccines are likely to be game-changers.By Brenda L. MooneyPALOALTO,CARespiratorysyncytialvirus 0.15% (95% CI: 0.09-0.22) for hospitalization (RSV) disease burden in older adults is greater thanattack rate, and previously thought in the United States and other 7.13% (95% CI: 5.40-9.36) for hCFR.high-income countries, according to industry-fund- In 2019, this would translate into approximately ed studies. 5.2millioncases,470,000hospitalizations,and At the VA, a 2020 review looking at cases from33,000 in-hospital deaths in 60-year-old adults in 2010-2018 found that RSV is an increasingly rec- high-income countries, the authors wrote.ognized cause of acute respiratory illness in olderRSV disease burden in adults aged 60 years in adults, which led to an estimated 177,000 hospital- high-income countries is higher than previously esti-izations and 14,000 deaths each year of the studymated, highlighting the need for RSV prophylaxis in period. 1 this age group, the researchers concluded.Currentstudiessuggested,however,thatcasesInearlyMay,theU.S.FoodandDrug might be undercounted. Administration approved Arexvy, the first respira-NotingthatRSV-associatedacuterespiratorytory syncytial virus (RSV) vaccine approved for use infection (ARI) is an underrecognized cause of ill- in the United States. Arexvy is approved for the pre-ness in older adults, authors of a more-recent reportvention of lower respiratory tract disease caused by published in the ISIRV conducted a systematic liter- RSV in adults 60 or older.ature review and meta-analysis to better understandOlder adults, in particular those with underly-the effects. 2 ing health conditions, such as heart or lung dis-TheresearchersgathereddataonRSV-ARIandeaseorweakenedimmunesystems,areathigh relatedhospitalizationattackratesandin-hospitalrisk for severe disease caused by RSV, said Peter case fatality rates (hCFR) in adults 60 or older fromMarks,MD,PhD,directoroftheFDAsCenter theUnitedStates,Canada,Europeancountries,for Biologics Evaluation and Research. Todays Japan and South Korea. To do so, they conducted aapprovalofthefirstRSVvaccineisanimpor-systematic literature from Jan. 1, 2000-Nov. 3, 2021,tant public health achievement to prevent a dis-or via other methods (citation search, unpublishedease which can be life-threatening and reflects the studies cited by a previous meta-analysis, gray lit- FDAscontinuedcommitmenttofacilitatingthe erature and an RSV-specific abstract booklet). Thedevelopment of safe and effective vaccines for use study team then performed a random effects meta- in the United States.analysis on estimates from the included studies. Today marks a turning point in our effort to reduce Ultimately, 21 studies were included in the meta- thesignificantburdenofRSV.Arexvyisthefirst analysis.Theresearchersdetermined,basedonapproved RSV vaccine for older adults, expanding pooled estimates, the following risks: GSKsindustry-leadingvaccineportfolio,which1.62% (95% confidence interval [CI]: 0.84-3.08)protects millions of people from infectious diseases for RSV-ARI attack rate, each year. Our focus now is to ensure eligible older 112'