Opinion
Video
Additional Clinical Considerations for RSV Vaccination
Panelists discuss recent safety updates on RSV vaccines, including a rare potential risk of Guillain-Barré syndrome (GBS) in older adults receiving recombinant vaccines, emphasizing that benefits outweigh risks and highlighting the pharmacist’s role in educating patients about common adverse effects, recognizing early signs of rare adverse events, and navigating regulatory guidance to support safe, informed vaccination decisions.
Recent safety updates regarding RSV vaccines highlight a rare but important concern: Guillain-Barré Syndrome (GBS). In early 2025, regulatory agencies updated the prescribing information for recombinant RSV vaccines after post-marketing studies suggested a slight increase in GBS cases within 42 days following vaccination in adults aged 65 and older. While this association was noted, the overall evidence was insufficient to confirm a direct cause-and-effect relationship. For the newer mRNA RSV vaccine, data are still under review, with no reported cases during clinical trials. Despite these findings, the benefits of vaccination continue to outweigh the risks, making it essential for health care providers to be aware of these concerns and communicate them clearly to patients without causing undue alarm.
Common adverse effects of RSV vaccines are similar to those seen with many other vaccines, typically including injection site pain, fatigue, headache, muscle aches, and fever. These vaccines are generally well tolerated, and patients should be informed about what to expect after vaccination. Pharmacists play a key role in educating patients on potential adverse effects and the importance of early recognition of rare adverse events like GBS, whose early symptoms can include tingling or weakness in the limbs. Prompt reporting of such symptoms is critical for timely intervention. Pharmacists are also responsible for monitoring and reporting adverse events to national vaccine safety systems, while patients themselves can report adverse effects directly, a practice that has become more common since the COVID-19 vaccine rollout.
The distinction between regulatory approvals and clinical recommendations influences how vaccines are administered and recommended. Regulatory agencies approve vaccines broadly based on age, while advisory committees provide more detailed guidance on which populations should be prioritized based on risk factors. Pharmacists must understand local regulations and standing orders, as these can vary by state and affect their ability to administer vaccines. Even when unable to administer, pharmacists remain vital in educating patients, discussing benefits and risks, and encouraging vaccination. Their involvement helps increase vaccine uptake and supports informed decision-making, ultimately enhancing patient care.
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