Hepatits A Vaccines

There are currently two vaccines licensed for Hepatitis A:  Havrix which is manufactured by GlaxoSmithKline and VAQTA which is manufactured by Merck.

HAVRIX

HAVRIX – GlaxoSmithKline – Package Insert
http://us.gsk.com/products/assets/us_havrix.pdf

HAVRIX is a suspension of inactivated virus which is propagated in MRC-5 human diploid cells (from aborted fetal tissue). (Page 7)

“The presence of antibodies to HAV confers protection against hepatitis A infection. However, the lowest titer needed to confer protection has not been determined. “(Page 8)

"Syncope (fainting can occur in association with administration of injectable vaccines, including HAVRIX.  Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements.  Procedures  should be in place to avoid falling injury and to restore cerebral perfusion following syncope." (Page 3)

"Hepatitis A has a relatively long incubation period (15 to 50 days).  HAVRIX may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination.  Additionally, vaccination with HAVRIX may not protect all individuals. (Page 3)

“Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice.” (Page 3)

Post-marketing Adverse Reactions: Rhinitis, thrombocytopenia, anaphylactic reaction, anaphylactoid reaction, serum sickness-like syndrome, convulsion, dizziness, encephalopathy, Guillain-Barre syndrome, hypoesthesia, multiple sclerosis, myelitis, neuropathy, paresthesia, somnolence, syncope, vasculitis, dyspnea, hepatitis, jaundice, angioedema, erythema multiforme, hyperhidrosis, congenital anomaly, musculoskeletal stiffness, chills, injection site reaction, local swelling. (Page 6)

“Animal reproduction studies have not been conducted with HAVRIX. It is also not known whether HAVRIX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HAVRIX should be given to a pregnant woman only if clearly needed. “(Page 7)

“It is not known whether HAVRIX is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HAVRIX is administered to a nursing woman.” (Page 7)

“The duration of immunity following a complete schedule of immunization with HAVRIX has not been established.” (Page 12)

HARVIX Ingredients: aluminum hydroxide, amino acid supplement, polysorbate 20, formalin, neomycin sulfate, MRC-5 cellular proteins

http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf

VAQTA

VAQTA – Merck – Package Insert
http://www.merck.com/product/usa/pi_circulars/v/vaqta/vaqta_pi.pdf

VAQTA is an inactivated whole virus vaccine derived from hepatitis A (HAV) grown in cell culture in human MRC-5 diploid fibroblasts. (from aborted fetal tissue)

“Animal reproduction studies have not been conducted with VAQTA. It is also not known whether VAQTA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VAQTA should be given to a pregnant woman only if clearly needed.” (Page 10)

“It is not known whether VAQTA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VAQTA is administered to a nursing woman.” (Page 10)

Adverse Reactions:  See pages 7-9

Adverse reactions in the clinical studies affecting between1-10% of subjects included constipation, vomiting, injection-site bruising, injection site ecchymosis, otitis media, nasopharyngitis, rhinitis, viral infection, croup, pharyngitis streptococcal, laryngotracheobronchitis, viral exanthema, viral gastroenteritis, roseola, anorexia, insomnia, crying, cough, nasal congestion, respiratory congestion, vesicular rash, measles-like/rubella-like rash, varicella-like rash, rash morbilliform.  (Page 6)

Serious adverse events included febrile seizure, dehydration, gastroenteritis, and cellulitis. (Page 6)

“Animal reproduction studies have not been conducted with VAQTA. It is also not known whether VAQTA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VAQTA should be given to a pregnant woman only if clearly needed.” (Page 10)

“It is not known whether VAQTA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VAQTA is administered to a woman who is breastfeeding.” (Page 10)

VAQTA Ingredients: amorphous aluminum hydroxyphosphate sulfate, bovine albumin, formaldehyde, neomycin, sodium borate, MRC-5 (human diploid) cells 
http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf
 

 
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