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RSV Vaccine Could Protect High-Risk Adults Under 60, Pfizer Says
ToplineA late-stage trial of Pfizer's RSV vaccine showed promising results in adults under 60 years old, suggesting the shot could help people as young as 18, the company announced Tuesday, amid an effort to expand the vaccine's availability to more people who are at a higher risk to the potentially lethal infection.
Pfizer said the shot—approved for adults age 60 and older—had similar effects in adults over age 18. ... [+]
Getty Images Key FactsPfizer's vaccine, marketed as Abrysvo, resulted in an immune response in adults aged 18 to 59 who are at a higher risk of RSV disease because of underlying medical conditions after a single dose, the company said.
The immune response was not worse than the response observed in adults aged 60 and above, whom the Food and Drug Administration approved the vaccine for last year, Pfizer said.
Participants in the late-stage trial had increased levels of antibodies that fight against the two main RSV subtypes compared with levels before vaccination, according to Pfizer, which noted its vaccine was "well-tolerated" and had safety findings similar to previous trials involving other groups.
Pfizer's trial involved 681 adults aged 18 to 59 who received a single dose of Abrysvo or a placebo, in addition to 200 immunocompromised adults—half of whom were age 60 or older—who received two doses of the vaccine one month apart.
What To Watch ForPfizer said it would send its data to regulatory groups for approval while requesting the vaccine become available to patients over 18 years old. The biotech company is also studying the vaccine's response in high-risk children ages 2 to 17.
Big Number9.5%. That's how many adults aged 18 to 49 have a chronic condition that puts them at a high risk of severe RSV disease, according to Pfizer. This increases to 24.3% among adults aged 50 to 64.
Key BackgroundThe FDA approved Pfizer's vaccine to protect adults ages 60 years and older from respiratory syncytial virus, or RSV, a common respiratory infection. A late-stage clinical trial of Abrysvo indicated the vaccine was nearly 86% effective against severe illness for the age group, according to Pfizer. RSV causes mild, cold-like illness in healthy adults, though it could trigger potentially fatal disease in older adults, infants and people with underlying medical issues like asthma, diabetes and chronic obstructive pulmonary disease.
TangentGlaxoSmithKline announced last fall it would seek regulatory approval for its RSV vaccine for adults aged 50 or older. The drugmaker said its Arexvy shot elicited an immune response in high-risk adults aged 50 to 59, which was not worse than the response observed in adults aged 60 and older. GSK said it was "on track" to become the first company to submit data to regulators covering this age group, adding it expected a "label expansion" in 2024.
Further Reading ForbesRSV Vaccine Shows Hopeful Early Results In 50 To 59-Year-Olds, GSK SaysBy Robert HartForbesFDA Approves Pfizer's RSV Vaccine For Older Adults-It Could Be Available This FallBy Robert Hart ForbesFDA Approves First RSV Vaccine For Kids-Given To Pregnant Moms-Here's What To KnowBy Robert HartCOVID, Flu And RSV Vaccines Are Lifesavers. Why Aren't More Older Adults Getting Them?
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For the first time, we have vaccines that can protect older adults against three leading—and sometimes fatal—respiratory viral diseases: influenza, COVID and respiratory syncytial virus (RSV). This is a breakthrough; studies show that these vaccines are effective at protecting older adults from severe disease outcomes, including hospitalization and death.
Yet some seniors—including many who live in nursing homes—aren't getting these vaccines. And the prevaccine days of the COVID pandemic showed us how deadly respiratory illness could be among older people in group settings. As scientists at the Centers for Disease Control and Prevention, we have been tracking vaccination rates among older people. Given how easily these diseases are spread, and the possibility of severe disease with long and complex hospitalizations, we must do more to help inoculate them.
As this winter respiratory virus season winds down, it's crucial we start planning for the next one. We can use the lessons we've learned from the vaccine rollouts for flu, COVID and RSV to give seniors the best shot at protection.
Older adults have a higher risk of severe disease and death from these respiratory virus infections compared to other age groups. Both their first-line innate immune responses and their slower, infection-specific adaptive immune responses decline. This decline, combined with higher rates of chronic diseases such as heart disease and diabetes and—for people who live in long-term care facilities—an increased chance of disease spread, leaves older folks at risk for severe disease and death.
Improving the use of these vaccines through the fall and winter respiratory illness seasons could mean healthier seniors and fewer visits to urgent care and the emergency department and fewer hospitalizations.
In 2022–2023, experts estimate that flu vaccination prevented nearly 31,000 hospitalizations and 2,500 deaths among people ages 65 and older. COVID vaccination greatly lowered rates of hospitalizations and deaths among adults ages 65 years and older too. And in clinical trials, the new RSV vaccines had an efficacy of 83 to 89 percent in preventing symptomatic RSV in the lower respiratory tract in adults ages 60 years and older.
The CDC's latest data show that as of late March, 74 percent of adults age 65 years and older had gotten the flu vaccine and just 42 percent had received the updated COVID vaccine. Although coverage for influenza vaccine is trending slightly higher than at this point last year, COVID vaccine coverage remains about as low as last year. Among those ages 60 years and older, 24 percent had gotten an RSV vaccine. As of late March, only 43 percent of nursing home residents had received an updated COVID vaccine; as of December 10, 72 percent had received an influenza vaccine and 10 percent had received an RSV vaccine.
The fact that nearly three quarters of older adults received a flu vaccine this season, as opposed to less than half for the COVID vaccine, shows us that we have a lot of work to do to help people get up-to-date on COVID vaccines. And there is more to be done to help people and their providers understand whether an RSV vaccine is right for them.
The CDC surveyed unvaccinated older folks to better understand their reasons for not getting vaccinated, and the results varied. People 65 and older who said they were probably or definitely not going to get the influenza vaccine were concerned primarily about vaccine effectiveness and side effects and said they were not worried about the flu. For the COVID vaccine, participants most often shared concerns about heart-related or unknown serious side effects, followed by concerns about effectiveness and having "vaccine fatigue," meaning they were likely burned out on vaccine information. The primary reasons for people age 60 and older not getting the RSV vaccine were not being worried about RSV, not knowing enough about RSV or the RSV vaccine, and the vaccine being "too new."
These reasons for not getting vaccinated and the differences across vaccines are perhaps understandable in the context of where we are in the vaccine rollouts. Influenza vaccines have been licensed in the U.S. Since the 1940s. In contrast, COVID vaccines were introduced little more than three years ago, and while these vaccines have undergone the most rigorous safety monitoring in U.S. History, some people still have misconceptions about the vaccines' safety.
In addition, the vaccine fatigue expressed by respondents to the CDC survey is a genuine challenge. In the early days of COVID vaccines, older adults enthusiastically accepted vaccination. But over time, fewer and fewer seniors have been willing to get additional recommended doses. Many people are also less concerned about COVID itself, despite the fact that many people are still dying from it each day in the U.S.
RSV vaccines were licensed in 2023—and from prior new vaccine rollouts we know that it can take years for vaccination coverage to increase. Moreover, instead of recommending that all adults 60 years and older get vaccinated, the CDC recommended that people and their health care providers have a conversation to determine if RSV vaccination is right for them. As a result, not all eligible adults are likely to get the vaccine.
Plus it is hard for some people to access vaccines. On one hand there is ample supply of all three vaccines, and they are covered by Medicare and many private insurance plans at no out-of-pocket cost. Still, there are around 400,000 people age 65 and older who are uninsured. Nonetheless, the health care provider or facility has to absorb the up-front costs of purchasing vaccines and then seek reimbursement for vaccination.
Furthermore, disparities in access to health care among ethnic and racial groups make getting respiratory vaccines challenging for some communities in the U.S. For example, during the 2022–2023 season, influenza vaccination coverage among adults ages 65 years and older ranged from 54 percent in American Indian/Alaska Native people to 71 percent in non-Hispanic white people.
There also are barriers to receiving these three vaccines within a relatively short period of time. Even though the CDC says that influenza, COVID and RSV vaccines can be given at the same time, not everyone is open to that. Furthermore, each of these vaccines became available at different points in time during this past season, which made it more difficult for people to receive these vaccines at once. For some, it may not have been a priority or a possibility to return for a follow-up visit for additional vaccines that they were unable to receive on prior visits.
Long-term care facilities face additional unique challenges to vaccinating residents, including the monumental task of strengthening vaccine confidence and demand not only among residents but also among staff at the facilities and family members involved in residents' medical decisions. In addition, long-term care facilities may not have the necessary infrastructure, staffing and financial resources to routinely offer vaccines to residents. Furthermore, the end of the Public Health Emergency and transition from a federal COVID vaccine distribution system to a commercialized market ended certain regulatory flexibilities and continued the shift to more sustainable channels for vaccinating residents, though with fewer dedicated resources.
The relatively high influenza vaccination coverage among older adults suggests that it is possible to get more older people vaccinated for all recommended vaccines. The CDC is working to improve access to adult vaccines through programs such as the Bridge Access Program, which provides COVID vaccines at no cost to uninsured or underinsured adults. The CDC is working to strengthen confidence in and demand for vaccines; to communicate the benefits of vaccination to the public, and to use data to target vaccination efforts. In addition, because a strong recommendation from a health care provider remains the leading reason why people choose to get vaccinated, the CDC has worked to equip providers with resources on vaccine recommendations and on having effective conversations with patients about vaccines.
It will take ground-up efforts across every community, vaccination provider location and household around the U.S. To ensure that older adults get not only the respiratory virus vaccines but all recommended vaccines.
The views expressed in this article do not necessarily represent those of the Centers for Disease Control and Prevention.
This is an opinion and analysis article, and the views expressed by the author or authors are not necessarily those of Scientific American.
World's First RSV Vaccine For Older Adults Now Registered For Use In NZ
Monday, 6 May 2024, 8:37 amPress Release: Impact PRThe registration of a new vaccine which took around 50 years to develop, is set to offer older Kiwis protection against RSV-associated lower respiratory tract disease for the first time.[1][2][3]
RSV is a common and highly contagious respiratory virus, often considered an illness that mainly impacts children and causes cold and flu-like symptoms. However, the disease can also cause serious illness and in some cases, even death, in older adults. Data shows the impact of RSV in adults aged 60 years and older is significant, resulting in over 470,000 hospitalisations and 33,000 deaths in high-income countries.[4][5][6][7][8][9][10][11][12]
Older adults with certain chronic medical conditions, including asthma, diabetes, chronic obstructive pulmonary disease (COPD) and congestive heart failure have an elevated risk of being hospitalised from RSV compared with those without these conditions.[13][14][15][16]
Maori, Pacific peoples and those living in lower socioeconomic areas also have a greater risk of hospitalisation from the disease.[17][18]
Symptoms of RSV in adults are often similar to other acute respiratory infections, like colds or influenza, including a blocked nose, cough, fatigue, fever, sore throat, runny nose, body aches and headache, and a test is needed to confirm a diagnosis.[19][20][21][22] 23
Arexvy is the world's first respiratory syncytial virus (RSV) vaccine for older adults and has been registered for use in Australia, the UK, the European Union, the US, Canada and Japan. Research shows an estimated 24% of US adults aged 60+ have reported receiving a RSV vaccine.[23][24][25]
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Trial data shows Arexvy has an overall efficacy of 82.6% against RSV-Lower Respiratory Tract Disease (LRTD).[26][27][28]
A 94.6% efficacy was observed against RSV-LRTD in adults aged 60 and over with underlying conditions such as heart disease or diabetes – the population that is associated with the majority of RSV hospitalisations.[29][30][31][32][33][34][35]
Nonetheless, as with other vaccines, the vaccine may not protect all recipients.[26]
The vaccine was granted priority assessment through its NZ registration process to ensure availability ahead of the winter season.[36] A funding application for Arexvy has also been submitted to Pharmac for their assessment.[37]
Brett Marett, GSK NZ medical director, says the NZ registration and consent to distribute is an important step closer to delivering New Zealand's first vaccine for RSV to help protect adults aged 60+.[38][39]
"Until now, RSV was one of the major respiratory infectious diseases with no vaccine.[40][41][42][43]
"We welcome the NZ registration which will mean that older adults in New Zealand, including those who are most at risk of developing severe disease from RSV due to underlying health conditions, have the opportunity to receive a vaccine to help protect them for the first time. This is a major step forward from a public health perspective.[44][45][46][47]
"Arexvy has demonstrated high efficacy in clinical trials and we look forward to working with healthcare stakeholders to ensure those at high risk of severe RSV infection can access it," he says.[48]
Older adults may consult with their healthcare professional for further information on RSV. The Arexvy vaccine will be available for private purchase from GP clinics from 1 May 2024. The most common side effects are injection site pain, fatigue, muscle pain, headache, and joint pain.[49][50]
Notes:[1] Anderson LJ, Dormitzer PR, Nokes DJ, Rappuoli R, Roca A, Graham BS. Strategic priorities for respiratory syncytial virus (RSV) vaccine development. Vaccine. 2013 Apr 18;31 Suppl 2(Suppl 2):B209-15. Doi: 10.1016/j.Vaccine.2012.11.106. PMID: 23598484; PMCID: PMC3919153.
[2] New Zealand. 2024. Arexvy Gazettal - Consent to the Distribution of a New Medicine
[3] GlaxoSmithKline New Zealand. AREXVY Data Sheet. GSK NZ; 2024. Available at https://www.Medsafe.Govt.Nz/Profs/Datasheet/a/Arexvyinj.Pdf (Last accessed 23 April 2024).
[4] Cleveland clinic;2023;1;RSV in children and adults
[5] Kaler J et al. Cureus 2023;15(3):e36342.
[6] Kodama F et al. Infect Dis Clin North Am 2017;31:767–90.
[7] Saravanos GL et al. Med J Aust 2019;210(10):447–53
[8] Branche AR et al. Clin Infect Dis 2022;74(6):1004–11.
[9] Tseng HF et al. J Infect Dis 2020;222(8):1298–1310.
[10] Savic M. Et al. Respiratory syncytial virus disease burden in adults aged 60 years and older in high-income countries: A systematic literature review and meta-analysis. Influenza Other Respi Viruses. 2023;17:e13031.
[11] Estimated based on 2019 population
[12] GSK;Press release;2024;1-6 Australia's first RSV vaccine
[13] Branche AR et al. Clin Infect Dis 2022;74(6):1004–11.
[14] Prasad N et al. Clin Infect Dis 2021;73(1):e158–63.
[15] Kujawski SA et al. PLoS One 2022;17(3):e0264890.
[16] GSK;Press release;2024;1-6 Australia's first RSV vaccine
[17] Farquharson, K. A., Anthony, D. D., Menzies, R., & Homaira, N. (2024). Burden of respiratory syncytial virus disease across the lifespan in Australia and New Zealand: a scoping review. Public Health, 226, 8–16. Https://doi.Org/10.1016/j.Puhe.2023.10.031
[18] Prasad N, Newbern EC, Trenholme AA, Thompson MG, McArthur C, Wong CA, Jelley L, Aminisani N, Huang QS, Grant CC. The health and economic burden of respiratory syncytial virus associated hospitalizations in adults. PLoS One. 2020 Jun 11;15(6):e0234235. Doi: 10.1371/journal.Pone.0234235. PMID: 32525898; PMCID: PMC7289360.
[19] Cleveland clinic;2023;1;RSV in children and adults
[20] Kaler J;Cureus;2023;15;1-17 10.1371/journal.Pone.0234235. PMID: 32525898; PMCID: PMC7289360.
[21] Kodama F et al. Infect Dis Clin North Am 2017;31:767–90.
[22] Tseng HF et al. J Infect Dis 2020;222(8):1298–1310.
[23] GSK;Press release;2024;1-6 Australia's first RSV vaccine (v1.0)
[24] Venkatesan P;The Lancet;2023;4;e577 https://www.Thelancet.Com/journals/lanmic/article/PIIS2666-5247(23)00195-7/fulltext Accessed 23 April 2024
[25] Vaccination Trends—Adults. (n.D.). Https://www.Cdc.Gov/respiratory-viruses/data-research/dashboard/vaccination-trends-adults.Html#:~:text=The%20percent%20of%20the%20population%20reporting%20receipt%20of%20a%20flu,%25%20(22.8%2D25.1). (Last accessed 23 April 2024).
[26] GlaxoSmithKline New Zealand. AREXVY Data Sheet. GSK NZ; 2024. Available at https://www.Medsafe.Govt.Nz/Profs/Datasheet/a/Arexvyinj.Pdf (Last accessed 23 April 2024).
[27] Papi A;N Engl J Med;2023;388;595-608
[28] For adults aged 60 and older (96.95% CI, 57.89, 94.08; n=12,466)
[29] Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrøm V; AReSVi-006 Study Group. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. N Engl J Med. 2023 Feb 16;388(7):595-608. Doi: 10.1056/NEJMoa2209604. PMID: 36791160.
[30] Falsey AR;The New England Journal of Medicine;2005;352;1749-1759
[31] 94.6% efficacy (95% CI, 65.88, 99.87; n=4937)
[32] Feldman RG, Antonelli-Incalzi R, Steenackers K, Lee DG, Papi A, Ison MG, Fissette L, David MP, Maréchal C, Van der Wielen M, Kostanyan L, Hulstrøm V; AReSVi-006 Study Group. Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions. Clin Infect Dis. 2024 Jan 25;78(1):202-209. Doi: 10.1093/cid/ciad471. PMID: 37698366; PMCID: PMC10810713.
[33] GlaxoSmithKline New Zealand. AREXVY Data Sheet. GSK NZ; 2024. Available at https://www.Medsafe.Govt.Nz/Profs/Datasheet/a/Arexvyinj.Pdf (Last accessed 23 April 2024).
[34] Branche AR et al. Clin Infect Dis 2022;74(6):1004–11.
[35] Prasad N et al. Clin Infect Dis 2021;73(1):e158–63.
[36] AREXVY Medsafe Product Detail;2024;1-1. Available from https://www.Medsafe.Govt.Nz/regulatory/ProductDetail.Asp?ID=24590 (Last accessed 23 April 2024).
[37] PHARMAC AREXVY Proposal - Application Tracker;2024;1-5
[38] New Zealand. 2024. Arexvy Gazettal - Consent to the Distribution of a New Medicine
[39] GlaxoSmithKline New Zealand. AREXVY Data Sheet. GSK NZ; 2024. Available at https://www.Medsafe.Govt.Nz/Profs/Datasheet/a/Arexvyinj.Pdf (Last accessed 23 April 2024).
[40] Mosscrop L. Et al. Respiratory syncytial virus after the SARS-CoV-2 pandemic — what next?.Nature Reviews Immunology. 22, 589–590 (2022)
[41] New Zealand. 2024. Arexvy Gazettal - Consent to the Distribution of a New Medicine
[42] Falsey A. Et al. Respiratory Syncytial Virus Infection in Elderly and High-Risk Adults. N Engl J Med 2005; 352:1749-1759
[43] Prasad N et al. Clin Infect Dis 2021;73(1):e158–63.
[44] New Zealand. 2024. Arexvy Gazettal - Consent to the Distribution of a New Medicine
[45] Branche AR et al. Clin Infect Dis 2022;74(6):1004–11.
[46] GlaxoSmithKline New Zealand. AREXVY Data Sheet. GSK NZ; 2024. Available at https://www.Medsafe.Govt.Nz/Profs/Datasheet/a/Arexvyinj.Pdf (Last accessed 23 April 2024).
[47] Prasad N et al. Clin Infect Dis 2021;73(1):e158–63.
[48] Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrøm V; AReSVi-006 Study Group. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. N Engl J Med. 2023 Feb 16;388(7):595-608. Doi: 10.1056/NEJMoa2209604. PMID: 36791160.
[49] Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrøm V; AReSVi-006 Study Group. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. N Engl J Med. 2023 Feb 16;388(7):595-608. Doi: 10.1056/NEJMoa2209604. PMID: 36791160.
[50] GlaxoSmithKline New Zealand. AREXVY Data Sheet. GSK NZ; 2024. Available at https://www.Medsafe.Govt.Nz/Profs/Datasheet/a/Arexvyinj.Pdf (Last accessed 23 April 2024)
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