ACIP expands Pfizer’s ABRYSVO vaccine guidance to include at-risk adults aged 50–59

Pfizer's RSV vaccine ABRYSVO now recommended for at-risk adults aged 50–59. Learn what it means for public health and Pfizer’s expanding vaccine portfolio.

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In a critical step towards strengthening adult immunisation strategies in the United States, the Centers for Disease Control and Prevention’s () Advisory Committee on Immunization Practices () has voted to extend its recommendation for the use of Pfizer Inc.’s respiratory syncytial virus () vaccine, ABRYSVO, to adults aged 50 to 59 who are at increased risk of developing severe RSV-related lower respiratory tract disease. The updated recommendation, which follows the U.S. Food and Drug Administration’s (FDA) approval of the vaccine for high-risk adults aged 18 to 59 in late 2024, is still pending final sign-off from the CDC Director and the Department of Health and Human Services.

This vote reflects growing awareness of the significant disease burden RSV poses not only to the elderly and infants but also to adults in midlife who are managing chronic health conditions such as cardiovascular disease, obesity, diabetes, chronic obstructive pulmonary disease (COPD), and asthma. According to CDC estimates, RSV causes between 15,000 and 20,000 hospitalisations annually in U.S. adults aged 50 to 59—figures that underscore the urgent need for targeted vaccination efforts in this demographic.

Why Is RSV Vaccination Now Recommended for Adults in Their 50s?

RSV is a highly contagious virus that affects the lungs and airways, potentially resulting in life-threatening complications, especially for individuals with pre-existing conditions. Traditionally viewed as a threat to the very young and elderly, RSV’s impact on middle-aged adults with comorbidities has received increasing scientific attention. A growing body of clinical and epidemiological evidence now shows that adults between the ages of 50 and 59 with underlying medical issues face risks of hospitalisation and death similar to those experienced by older adults.

The expansion of ACIP’s recommendation to this younger, high-risk cohort aligns with broader public health goals aimed at reducing preventable hospitalisations and healthcare system strain during peak respiratory virus seasons. By targeting vulnerable individuals earlier in life, public health officials aim to disrupt the trajectory of severe illness caused by RSV, particularly during the autumn and winter months when RSV circulation typically peaks.

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What Sets Pfizer’s ABRYSVO Apart in the Competitive RSV Vaccine Market?

Pfizer’s ABRYSVO holds a unique position in the RSV vaccine market as the only product approved for use across three major adult and maternal populations. Initially approved by the FDA in May 2023 for adults aged 60 and over, the vaccine later received expanded approval in October 2024 for high-risk individuals aged 18 to 59. In addition, in August 2023, ABRYSVO was greenlit for use in pregnant individuals to help protect infants through passive immunisation during their first six months of life—a vulnerable period during which RSV can lead to bronchiolitis, pneumonia, and even death.

Unlike some other RSV vaccines on the market, ABRYSVO is unadjuvanted and bivalent, meaning it targets both RSV-A and RSV-B subtypes. Its mechanism is based on the prefusion form of the RSV fusion (F) protein, a structure known to elicit potent neutralising antibody responses. This approach provides broader protection and potentially longer-lasting immunity across a wider range of RSV strains.

Pfizer has continued to reinforce ABRYSVO’s global footprint. In August 2023, the European Commission granted marketing authorisation for the vaccine across older adult and maternal immunisation categories. By March 2025, this authorisation was expanded to cover a broader adult population, reflecting harmonised policy changes across global regulatory bodies and increasing demand for midlife RSV prevention.

How Does the Expanded Guidance Fit into Pfizer’s Broader Strategy?

The ACIP recommendation represents more than a clinical milestone—it is also a strategic win for Pfizer as the company works to diversify its post-pandemic vaccine portfolio and strengthen its respiratory disease franchise. While Pfizer’s stock faced downward pressure throughout much of 2024 due to declining vaccine revenues, renewed confidence in products like ABRYSVO, along with pneumococcal vaccine PREVNAR 20 and antiviral PAXLOVID, has begun to stabilise investor sentiment.

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As of April 18, 2025, Pfizer Inc. (NYSE: PFE) shares were trading at approximately $31.20, reflecting a 2.4% gain over the past week. However, the stock remains down 9% year-to-date, with analysts citing a challenging transition period for the company’s commercial strategy. Despite this, ABRYSVO’s expanded use is expected to contribute meaningfully to revenue in the latter half of 2025 and beyond.

Investor consensus currently rates Pfizer as a Hold, with target prices ranging from $30 to $38. The company’s attractive 5.5% dividend yield and pipeline visibility continue to draw interest from income-focused investors, healthcare ETFs, and institutional funds. Institutional ownership remains strong, with more than 65% of shares held by large asset managers, including Vanguard and BlackRock. While there has been some rotation out of large-cap pharma in recent quarters, Pfizer’s growing RSV footprint could attract reinvestment as confidence in its non-COVID products grows.

What Are the Safety and Efficacy Considerations with ABRYSVO?

Clinical trials across adult and maternal populations have shown that ABRYSVO is generally well tolerated, though not without risks. Among adults aged 60 and older, the most common side effects included fatigue, injection site pain, muscle aches, and headaches. In adults aged 18 to 59, joint pain and nausea were also commonly reported.

More serious but rare side effects, such as Guillain-Barré syndrome, have been observed, prompting additional post-marketing surveillance. In pregnant individuals, ABRYSVO is recommended only between 32 and 36 weeks of gestation due to a potential risk of preterm birth. Trial data also indicated slightly elevated rates of low birth weight and jaundice among infants born to vaccinated mothers, although the clinical significance of these findings remains under review.

Importantly, the vaccine may not confer full protection for all recipients, particularly those with severely compromised immune systems. Nonetheless, the benefit-risk profile remains favourable, especially in high-risk populations where the cost of RSV-related hospitalisation and complications is substantial.

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What Does This Mean for Public Health and Vaccine Uptake?

If finalised, the ACIP recommendation will authorise a significant expansion in the eligible population for RSV vaccination, opening the door for millions more adults to receive protection during the 2025–26 RSV season. Public health officials are expected to roll out updated awareness campaigns and provider guidelines to ensure eligible adults understand their risk and the benefits of vaccination.

Pfizer, meanwhile, is anticipated to ramp up engagement with primary care physicians, pulmonologists, and cardiologists—clinicians who often serve patients with the very comorbidities that increase RSV susceptibility. By embedding ABRYSVO into chronic disease management protocols, the company can enhance uptake and integrate RSV vaccination into routine care pathways.

As RSV continues to pose a seasonal threat with cross-generational impacts—from infants to older adults—broadening access to effective vaccines like ABRYSVO is becoming an essential component of the U.S. respiratory virus strategy. Pfizer’s leadership in this space not only reinforces its scientific credibility but also positions it to play a central role in shaping future immunisation policy across emerging adult risk segments.


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