Initial U.S. Approval: 1996
VAQTA is a vaccine indicated for the prevention of disease caused by hepatitis A virus…
≥55.7% of subjects experienced systemic adverse events.
[U]nsolicited local adverse reactions and systemic adverse events [which were] observed at a common frequency of ≥1% to <10%…
– Conjunctivitis
– Constipation; vomiting
– Injection-site bruising; injection-site ecchymosis
– Otitis media [ear infection]; nasopharyngitis; rhinitis; viral infection; croup; pharyngitis streptococcal; laryngotracheobronchitis; viral exanthema; gastroenteritis viral; roseola
– Anorexia
– Insomnia; crying
– Cough; nasal congestion; respiratory congestion
– Rash vesicular; measles-like/rubella-like rash; varicella-like rash; rash morbilliform
Serious Adverse Events
[F]ebrile seizure (0.05%), dehydration (0.02%), gastroenteritis (0.02%), and cellulitis (0.02%).
[U]nsolicited systemic adverse events [occurring] within 14 days at a common frequency of ≥1% to <10%…
– Back pain; stiffness
– Menstruation disorders
Post-Marketing Experience
– Thrombocytopenia.
– Guillain-Barré syndrome; cerebellar ataxia; encephalitis.
VAQTA is an inactivated whole virus vaccine derived from hepatitis A virus grown in cell culture in human MRC-5 diploid fibroblasts.
Each 0.5-mL pediatric dose contains… approximately 0.225 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate…
Each 1-mL adult dose contains… approximately 0.45 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate…
VAQTA has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.