Early Safety Findings Among Persons Aged ≥60 Years …

Methods

V-safe (https://vsafe.cdc.gov) is a voluntary, active U.S. surveillance system that sends web surveys to enrolled participants on days 0–7 after vaccination, based on the reported vaccination date.^§ V-safe surveys for adults aged ≥60 years who received an RSV vaccine were available starting October 20, 2023. Daily surveys include questions about local injection site and systemic reactions and health impacts experienced.^¶ Participants reporting medical care for symptoms are also prompted to complete a VAERS report.

VAERS (https://vaers.hhs.gov) accepts reports of adverse events from health care providers, vaccine manufacturers, and members of the public (5). Reports to VAERS generally cannot be used to determine causal associations between adverse events and vaccination. Medical Dictionary for Regulatory Activities Preferred Terms (MedDRA PTs) are assigned by VAERS staff members to signs, symptoms, and diagnostic findings in VAERS reports.** Reports of serious events (including death) to VAERS during May 3, 2023–April 14, 2024, and relevant available medical records were reviewed by CDC experts to form a clinical impression of each reported outcome^†† (6). Using selected MedDRA PTs, a search was performed to identify outcomes of interest, including GBS and immune thrombocytopenia (ITP), multiple cases of which were identified in clinical reviews of serious reports.^§§

Symptoms and health impacts reported during the week after RSV vaccination were described for V-safe participants aged ≥60 years who were vaccinated during May 3, 2023–April 14, 2024, and completed one or more daily surveys. Primary VAERS adverse event reports after RSV vaccination for persons aged ≥60 years were described by serious and nonserious classification and MedDRA PTs.^¶¶ All analyses were conducted using SAS software (version 9.4; SAS Institute). Reporting rates for GBS reports that met the Brighton Collaboration case definition (6) were estimated using available doses administered as the denominator. This activity was reviewed by CDC, deemed not research, and was conducted consistent with applicable federal law and CDC policy.***

Review of V-safe Data

During May 3, 2023–April 14, 2024, a total of 16,220 V-safe participants aged ≥60 years reported receiving an RSV vaccine and completed at least one daily survey (Table 1). The median age of these participants was 70 years (range = 60–94 years), 9,684 (59.7%) were women, 6,402 (39.5%) received GSK vaccine, 3,882 (23.9%) received Pfizer vaccine, and 5,936 (36.6%) did not know the manufacturer of the vaccine they received. Approximately one third (5,043; 31.1%) of participants reported receiving one or more other vaccines during the same visit; those most commonly reported were COVID-19 (3,370; 20.8%) and influenza (2,630; 16.2%) vaccines. During the week after vaccination, 6,328 (39.0%) participants reported symptoms they considered possibly related to RSV vaccination. Injection site symptoms were reported by 2,808 (43.9%) participants who received GSK vaccine and 787 (20.3%) who received Pfizer vaccine. Most injection site symptoms were mild (3,351; 20.7%) or moderate (1,889; 11.6%) (Table 2). Systemic symptoms were reported by 2,344 (36.6%) who received GSK and 839 (21.6%) who received Pfizer. Most systemic symptoms were mild (1,997; 12.3%) or moderate (2,184; 13.5%). The most frequently reported symptoms after RSV vaccination were pain at or near the injection site (5,026; 31.0%), fatigue or tiredness (3,327; 20.5%), and muscle or body aches (2,843; 17.5%). Among those who reported other symptoms, those most commonly reported were sore throat (54; 0.3%), dizziness (38; 0.2%), and runny nose (38; 0.2%).

During the week after vaccination, 1,264 (7.8%) participants reported that they were unable to complete their normal daily activities because of the reported symptoms; 68 (0.4%) reported receiving medical care for the reported symptoms. Among those who reported receiving medical care, five completed a report to VAERS; events reported were chalazion, lower than normal blood pressure, exacerbation of chronic obstructive pulmonary disease, injection site pain, and suspected lichen planus.

Review of VAERS Data

During May 3, 2023–April 14, 2024, VAERS received and processed 3,200 reports of adverse events among persons aged ≥60 years who reported receiving an RSV vaccine (Table 3),^††† including 2,191 (68.5%) for GSK vaccine, 921 (28.8%) for Pfizer, and 88 (2.8%) for which the vaccine manufacturer was unknown. The median age of persons for whom a VAERS report was received was 72 years (range = 60–112 years), and 2,237 (69.9%) reports were for women. At least one other vaccine was received at the same visit for approximately one third (1,050; 32.8%) of reports, with influenza vaccine administered most commonly (625; 19.5%). Among the 3,200 VAERS reports, 346 (10.8%) specified a vaccination error (e.g., product administered at an inappropriate site, extra dose administered, or incorrect route of product administration); 64 (2.0%) reports also indicated that an adverse health event had occurred. Overall, 2,919 (91.2%) reports were classified as nonserious, including 2,026 (92.5%) after receipt of GSK vaccine and 821 (89.1%) after receipt of Pfizer vaccine. Commonly reported events included pain in an extremity (384; 13.2%), headache (376; 12.9%), pain (373; 12.8%), injection site pain (370; 12.7%), and fatigue (355; 12.2%).

Among all VAERS reports, 281 (8.8%) were classified as serious, including 216 (6.8%) for hospitalization, 81 (2.5%) for a life-threatening illness, 66 (2.1%) for a permanent disability, and 34 (1.1%) for death. Clinical impressions of serious reports included stroke or transient ischemic attack (24), GBS (37; 28 met case definition),^§§§ atrial fibrillation (14), other thromboembolic event (13), encephalitis or aseptic meningitis (11), immune thrombocytopenia (11), sepsis, bacteremia, or both (11), and shoulder pain (11). Among the 28 reports of GBS after vaccination that met case definition, 11 (39.3%) were after GSK vaccine (1.5 reports per 1 million doses administered), and 17 (60.3%) were after Pfizer vaccine (5.0 reports per 1 million doses administered). For the 18 reports of death with sufficient information for review, reported causes of death were acute respiratory distress syndrome, bronchopneumonia, cardiac event, cardiopulmonary arrest, ehrlichiosis, GBS (two), hepatic encephalopathy, hypoxic respiratory failure, multifocal leukoencephalopathy, respiratory failure, rhabdomyolysis, RSV infection, sepsis, sepsis secondary to pneumonia, Pseudomonas bacteremia, varicella-zoster virus meningoencephalitis, and vascular dementia.