Intense scrutiny has accompanied the introduction of pentavalent vaccines throughout Asia. Sri Lanka, Bhutan and Vietnam temporarily suspended their use following adverse events. Now India is running a study to assess the safety of the vaccine.
India has administered pentavalent vaccines to protect against diphtheria, pertussis, tetanus, hepatitis B and haemophilus influenza type B since 2011, but criticisms of the jab have intensified in recent weeks. Last month The Indian Journal of Medical Ethics criticized the World Health Organization (WHO) for continuing to promote the vaccine despite reports of serious adverse events occurring following immunization. The WHO maintains the vaccine is safe, effective and provides tremendous public health benefits.
However, with 21 infant deaths occurring following immunization, India is to run its own tests with support from the WHO. "A major study is to be launched soon on the safety and effectiveness of pentavalent vaccine and to go into background of these deaths," chairman of the Committee of the Ministry of Health and Family Welfare N.K. Arora told the Economic Times. Pentavalent jabs from Indian manufacturers Biological E and Serum Institute of India are prequalified by WHO. Johnson & Johnson ($JNJ) subsidiary Crucell, GlaxoSmithKline ($GSK) and LG Life Sciences also have pentavalent vaccines prequalified by the WHO.
A WHO committee reviewed the use of the vaccine in four Asian countries--including India--at a meeting in June. Each country reported serious adverse events following immunization, but health officials were unable to establish a causal relationship between fatalities and the vaccine. "As peak incidence of [sudden infant death syndrome] occurs in early infancy, a close temporal relationship between SIDS and receipt of pentavalent vaccine is expected by simple chance," the committee concluded.