A group of scientists has issued a warning after linking hepatitis B vaccines to disturbing musculoskeletal adverse events.
The warning was issued in response to a large-scale pharmacovigilance study led by Dr. Weiguo Bian of the First Affiliated Hospital of Xi’an Jiaotong University in China.
The study was in collaboration with researchers from Shanghai and Fujian.
The researchers investigated links between hepatitis B vaccination and musculoskeletal adverse events (AEs).
The team used the U.S. Centers for Disease Control and Prevention’s (CDC) Vaccine Adverse Event Reporting System (VAERS).
The results were published in the journal Frontiers in Public Health.
The study analyzed 76,887 VAERS reports from between 1990 and 2024.
The researchers sought to identify signals of tendon fibrosis, fasciitis, myofascitis, and osteoarthritis—adverse events potentially linked to aluminum adjuvants in hepatitis B vaccines.
The authors aimed to provide a scientific basis for vaccine safety evaluations amid persistent concerns regarding rare but serious post-vaccination complications.
This retrospective signal detection study employed disproportionality analysis using four methodologies:
- Reporting Odds Ratio (ROR)
- Proportional Reporting Ratio (PRR)
- Bayesian Confidence Propagation Neural Network (BCPNN)
- Multi-item Gamma Poisson Shrinker (MGPS)
The authors filtered all reports in which the hepatitis B vaccine was the primary suspect drug and classified symptoms using MedDRA terminology.
Multivariable logistic regression analysis was also performed to assess associations between recipient characteristics (age, sex, co-administration of other vaccines) and death as an outcome.
The final dataset included 16,921 musculoskeletal AEs, representing a significant subset of all hepatitis B vaccine-related events reported to VAERS.
The analysis revealed strong AE signal strengths for several musculoskeletal conditions.
Tendon fibrosis (ROR = 251.82), myofascitis (ROR = 107.51), and fasciitis (ROR = 71.52) ranked highest, with osteoarthritis (ROR = 7.56) and systemic lupus erythematosus (ROR = 5.82) also flagged.
Most AEs occurred within 30 days of vaccination.
However, some, such as myofascitis, presented years later (mean onset: 1,671 days).
The scientists note that the delayed onset implicates the slow-release behavior of aluminum-based adjuvants.
Regression analysis identified male sex and concurrent vaccine exposure as independent risk factors for fatal outcomes, while ages 18–64 were protective.
This study presents one of the most comprehensive analyses of musculoskeletal adverse events associated with hepatitis B vaccines, calling attention to a potential long-term safety signal.
The consistently strong associations between aluminum-adjuvanted hepatitis B vaccines and chronic musculoskeletal conditions, particularly in younger recipients and those receiving combination immunizations, warrant further investigation.
The finding is alarming considering that most hepatitis B vaccinations are deemed by health authorities as “safe and effective.”
Clinicians are advised to monitor patients with autoimmune or connective tissue disorders closely after vaccination and report suspected AEs to regulatory authorities.
The findings may also fuel ongoing debates about adjuvant safety and reinforce public skepticism if not accompanied by transparent scientific and regulatory follow-up.
Regulators, including the CDC and the Food and Drug Administration (FDA), should consider formal pharmacoepidemiological studies to evaluate causality and investigate mechanistic pathways.
This is especially vital in light of recent controversies over vaccine adjuvants’ role in persistent immune or inflammatory syndromes.
Vaccine developers, for their part, should accelerate innovation around non-aluminum-based adjuvants for populations at higher risk of long-term AEs.
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