Wave of protests demanding its withdrawal from government’s immunisation programme

Even as the Centre is set to scale up use of pentavalent vaccine across the nation, there has been a fresh wave of protests, this time with Leader of the Opposition V.S. Achuthanandan demanding that the “vaccine, which has led to the mass death of infants”, be dropped from the government’s immunisation programme.

Health Department officials say they see no reason why there should be more protests against the vaccine, now that the National Technical Advisory Group on Immunisation (NTAGI), which conducted a study on vaccine-related infant deaths, has recommended to the Union Health Ministry that the vaccine is safe and effective.

In October, the NTAGI recommended that the pentavalent vaccine, which was rolled out in Kerala for the first time in the country in 2011 and subsequently in seven other States, be introduced across the nation. The recommendation came after the national Adverse Events Following Immunisation (AEFI) committee, which studied all infant deaths in various States (supposedly due to the vaccine), gave a clean chit to the vaccine.

Conjugate vaccine

Pentavalent vaccine is a conjugate vaccine which combines antigens against five infections – diphtheria, pertussis and tetanus (DPT), hepatitis B and Hib - in a shot. The vaccine was rolled out as part of introducing a vaccination against Haemophilus influenzae type B (Hib) infection - a major cause of meningitis and pneumonia deaths in children - in the national immunisation schedule for infants.

“It was just two months ago that AEFI committee chairperson N.K. Arora, who is also a Professor of Paediatrics at the All India Institute for Medical Sciences, visited the State to conduct a safety and efficacy study on the vaccine following reports about 18 infant deaths after vaccination. Dr. Arora, after doing causality analysis of each case, has conclusively said in his report that the vaccine is not implicated in any of the infant death. He suggested tightening AEFI surveillance, which we are doing,” says N. Sreedhar, Additional Director of Health Services (H&FW).

All AEFI cases related to pentavalent vaccination in Kerala have been well analysed by several experts in State and Central agencies and there is no reason to believe that the vaccine is unsafe, he said.

18 cases of death

Since introduction, over 20 lakh doses of the vaccine have been administered to children. Of the reported 18 deaths following immunisation, two infants were not been given pentavalent vaccine.

Of the rest, in 12 cases, there were several co-morbid and congenital conditions.

“The post-mortem examination of infants in the remaining cases does not find anything to link the death to the vaccine. We tested all vaccine samples implicated in the said AEFIs at the Central laboratory at Kasauli and the vaccine came out clean. Early this year, we sent internal samples of two of the infants to AIIMS, as there was a suggestion that the deaths could be due to hypersensitivity reaction to the vaccine in their post-mortem reports. AIIMS reported back that no allergen or vaccine-related allergen had been detected in both samples,” Dr. Sreedhar points out.

The State has an infant mortality rate of 12 per 1,000, which roughly translates to 65 deaths per month, regardless of whether they have been administered pentavalent vaccine or not, a senior paediatrician and a member on the State AEFI committee said.

Doctors divided

Ever since the NTAGI began contemplating introduction of Hib component in the national immunisation schedule as pentavalent vaccine, doctors have been divided over the need as well as the safety profile of the vaccine.

“The deaths associated with this vaccine have been sporadic… and follows the pattern of anaphylaxis reactions… if a drug is known to have caused this form of fatal reaction, it is not permissible to give it without doing sensitivity testing… which is not carried out in the case of pentavalent…. Trivialising all these deaths as coincidental amounts to obscuring the real picture,” Jacob Puliyel, paediatrician and NTAGI member who has consistently been opposing pentavalent, says in a recent article in the Indian Journal of Medical Ethics.

T. Jacob John, public health professional and former professor of Clinical Virology, CMC Vellore, counters: “The pentavalent formulation in India had been tested in more than 23 clinical trials, monitoring over 12,000 infants, … and the safety profile has been excellent…. When we don’t scrutinise every death in the age group involved but only deaths after vaccination, the sequence can be mistaken for consequence….”