PIL was filed in the Supreme Court alleging that the vaccine had serious adverse effects on children

The National Technical Advisory Group on Immunisation (NTAGI) has recommended scale-up of the pentavalent vaccine across the country, along with activities to monitor potential adverse effects.

The recommendation comes within days of the Supreme Court issuing notice to the Centre on a PIL petition filed by Dr. Yogesh Jain alleging that the vaccine had serious adverse effects on children, and in the face of stiff resistance to the vaccine.

The pentavalent vaccine simultaneously provides protection against the five life threatening diseases — Diphtheria, Pertussis, Tetanus, Hepatitis B and Hib (Haemophilus influenza type b). DPT (Diphtheria, Pertussis, Tetanus) and Hepatitis B are already part of the national routine immunisation programme. Protection against Haemophilus influenza type B (Hib), which causes severe pneumonia, meningitis and other life-threatening conditions in children less than five years of age, is a new addition.

The NTAGI recommendation will now go to the Ministry of Health and Family Welfare.

The pentavalent vaccine, which was recommended by NTAGI in 2008 to be added to the universal immunisation programme, has been introduced in a phased manner since 2011 in Kerala, Tamil Nadu, Karnataka, Puducherry, Goa, Gujarat, Haryana, Jammu & Kashmir and Delhi.

“Safe and effective”

Separately, the National AEFI (Adverse Events Following Immunisation) Committee, which investigated the reported deaths in Kerala following pentavalent vaccine administration, has submitted a report to the Ministry that the deaths are not causally related to the vaccine. The recommendation of the committee to further strengthen the AEFI surveillance systems has been accepted by NTAGI.

“The NTAGI recommendation for a national scale-up and the report from the national AEFI Committee are consistent that the best experts in the country have judged the pentavalent vaccine to be safe and effective,” said Dr. Jacob John, infectious disease expert and former Professor at Christian Medical College, Vellore.

The pentavalent vaccine, which is being used in 188 countries, is an important tool to reduce under-five mortality in India. Its rollout in Sri Lanka, Bhutan and Vietnam was briefly suspended to investigate concerns over a few deaths, but has since been re-introduced in all of these countries. Private practitioners in India have vaccinated lakhs of infants of the rich with this vaccine without any report of adverse effects. With the proposed national scale-up, it is expected that the pentavalent vaccine will reach all children, more so those from the poor families who need it the most and are least able to afford it.