Pentavalent vaccine safe, say health officials

A high-level team consisting of experts from the Union Ministry of Health and the World Health Organisation (WHO) has started investigating into the sudden death of a 58-day-old baby at Vithura near here on Thursday.

The death of the infant, which occurred a day after she was given the first dose of pentavalent vaccine, is being treated as the first case of Adverse Events Following Immunisation (AEFI) following the introduction of the vaccine under the Universal Immunisation Programme in the country on December 14.

Kerala was the first State to have introduced the pentavalent vaccine, which combines the antigens against five diseases in a single shot (diphtheria, pertussis, tetanus, hepatitis B and Hib or meningitis) under the national immunisation schedule.

To allay any fears about any possible risks of the vaccine, Health Secretary Rajeev Sadanandan had made it clear earlier that every case of AEFI would be thoroughly investigated and that every child who had been given the vaccination would be followed up over a period.

The infant, Ansi, daughter of Shabeer and Shajila, had been administered the vaccine on December 14 at the Vithura Community Health Centre (CHC). She was brought dead around 9 a.m. to the Vithura CHC. The body was sent for post-mortem to the Medical College Hospital for a full pathological analysis.

On Saturday, a team of experts, including N.K. Arora, former Professor of Paediatrics at the All-India Institute of Medical Sciences and the chairperson of the national AEFI committee; Jayant Liyanang, from the office of the WHO's South East Asian Region Office (SEARO); National Polio Surveillance Project regional coordinator Pavana Murthy; and senior State Health Department officials visited the infant's house at Vithura and held detailed interviews with the infant's mother and rest of the family.

They visited the Vithura CHC and also spoke to all the hospital staff.

A total of 18 infants had been administered the pentavalent vaccine at the CHC on December 14, using two 10 dose-vials. The same vial from which Ansi had received the vaccine, had been used to administer vaccine to seven other infants also, all of whose houses were visited by the team.

The remaining two doses from the vial used to vaccinate the infant had been taken as sample by the team, which will now be sent to the Central Research Institute at Kasauli for detailed analysis.

“We are awaiting the final report from the experts, also the post-mortem report. However, the initial observation of the team is that the death could not be due to the vaccine. The cause of death is probably asphyxia, we have been told,” a senior Health official told The Hindu.

The cause could also be Sudden Infant Death syndrome, which is not rare, he added.

Senior Health officials said about 10,000 doses of pentavalent vaccine had already been administered to infants since Wednesday across the State and that apart from mild fever, no deaths or other AEFIs had been reported from anywhere.

Process to continue

The State government had, made it clear that vaccinations using pentavalent vaccine will continue as the Centre had given no instructions to stop the vaccination process and also because the health officials were fully convinced about the safety of the vaccine.

“It could take months before we get down to the bottom of this because there are so many investigations being carried out, apart from meetings of the national AEFI committee. We cannot stop the vaccination programme in the middle because not only would many infants be losing out but also because of several logistics issues. We are doing a close follow-up of all vaccinated children and the pentavalent vaccinations will continue,” a high-level Health official said.

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