Safety Data Confirm Viability of Flu, RSV Vaccines For Patients at Risk of Heart Failure

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Investigators reported a low incidence of adverse events after simultaneous vaccination against seasonal influenza and respiratory syncytial virus.

Simultaneous vaccination against seasonal influenza and respiratory syncytial virus (RSV) in individuals at high risk for heart failure (HF) was shown to be safe with a low incidence of adverse events, according to results of a study published in Vaccine. Investigators conducted a single-center randomized trial to investigate the simultaneous vaccination against influenza and RSV compared with the influenza vaccination alone.

Infectious viruses such as respiratory syncytial virus (RSV) causing respiratory infections | Image Credit: Artur - stock.adobe.com

Image Credit: Artur - stock.adobe.com

Investigators aimed to determine the early safety profile of vaccination for the active study arm, according to the study authors. Individuals included in the study had advanced HF with left ventricle assist device implantation, were hospitalized for acute HF within 18 months, had severe aortic stenosis awaiting transcatheter aortic valve implantation procedure, or had left ventricle ejection fraction of 35% or less and a daily diuretic dose of 80 mg of furosemide or the equivalent.

The endpoints were vaccine-related reactions, which included erythema, swelling and pain at injection site, fever, fatigue, myalgia, arthralgia and headache, flu-like symptoms, general well-being deterioration, allergic or systemic reactions, and additional medication usage. Further, data on HF-specific events were recorded and included increased dosage of diuretics, exacerbation of HF signs or symptoms, weight increase, hospitalization for acute HF, and death, according to the study authors.

In the active arm of the study, investigators included 105 individuals, 78 of whom were male and with a mean age of 66 years. According to the study authors, all individuals were White and 11 were smokers. Approximately 89% were on beta blockers, 89% were on angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors, 75% were on mineralocorticoid receptor antagonists, 71% were on SGLT-2 inhibitors, and 68% were on loop diuretics.

During the first 4 days post-vaccination, approximately 65% of individuals reported no symptoms and 21% reported mild impact on general comfort. Only 17% reported any sort of deterioration in well-being on day 1, but by day 4 only 4% mentioned physical and mental exhaustion, according to the study authors. The most common vaccine-related reactions included injection site reaction at 75%, fatigue at 22%, and swelling at the injection site at 13%. Investigators also noted that swelling and erythema are specific to RSV vaccination. Erythema at injection side was approximately 10% at day 1 and 11% at day 2.

Key Takeaways

  1. The combination vaccination was well-tolerated with a low rate of side effects.
  2. Injection site reactions, fatigue, and fever were the most frequent side effects, but none were severe enough to require hospitalization.
  3. The vaccination did not worsen heart failure symptoms and no patients experienced heart failure-related events.

Fever occurred in 4% of individuals, fatigue in 22%, headache in 9%, myalgia in 11%, and arthralgia in 6% at day 1, according to the results. According to the investigators, grade 3 reactions occurred in 6% and were defined as reactions severe enough to prevent normal daily activities. Further, 6 individuals had at least 1-day episodes of temperature at 38ºC (100.4ºF) or higher. Two individuals had flu-like symptoms and 5 individuals took antipyretic medications, according to the results.

However, investigators noted that none of the vaccinated individuals experienced significant exacerbations of signs or symptoms related to HF, with 2 individuals needing to escalate their diuretic on day 1 post-vaccination. Additionally, these individuals did not report worsening HF symptoms. No patients were hospitalized or died 1 week following vaccination. Furthermore, there were no implantable cardioverter defibrillator shocks reported or any other adverse events, according to the study authors.

Reference

Biegus J, Szenborn L, Zymliński R, et al. The early safety profile of simultaneous vaccination against influenza and Respiratory Syncytial Virus (RSV) in patients with high-risk heart failure. Vaccine. 2024. doi:10.1016/j.vaccine.2024.03.060

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