An immunization program supported by the World Health Organization has faced criticism after the deaths of 21 babies in the past 18 months thought to be linked to a controversial vaccine.
The Pentavalent vaccine, as it is popularly called, offers protection against diphtheria, tetanus, whooping cough, hepatitis B and Haemophilus Influenza B (Hib).
But public health experts in India are against the expensive vaccination after adverse effects, including deaths, were reported. The program began in the southern Indian states of Tamil Nadu and Kerala in December 2011, and was later extended to six other states.
Pediatric head doctor Jacob M Puliyel of New Delhi's St. Stephen’s Hospital says the unexplained deaths of infants who received the vaccine needs to be probed, given similar deaths in other countries where the vaccination program was launched.
On Monday the Supreme Court of India issued a notice to federal health departments to file their response within four weeks on a petition to ban the vaccine.
The petition, filed by Yogesh Jain, a former pediatrician and public health physician based in Madhya Pradesh, claims the vaccine is deadly. His lawyer Colin Gonsalves told court that the vaccine had already been banned in the US, Australia, the UK, Japan and some European nations.
Puliyel said that Vietnam had also suspended the vaccination program after 12 deaths. Eight deaths have been recorded in Bhutan, five in Sri Lanka and three in Pakistan.
The WHO declined to comment when contacted by ucanews.com. In a report in June, health officials from the organization said they were unable to establish a relationship between fatalities and the vaccine.
"As peak incidence of sudden infant death syndrome occurs in early infancy, a close temporal relationship between sudden deaths after receiving the vaccine is expected by simple chance," the WHO committee reported.
"Based on those reviews, none of the fatal cases could be classified as having a consistent causal association with immunization," said a statement on their website, referring to investigations of the deaths.
But Dr. Puliyel points out that death rate is too high. “The vaccine was given to 40,000 infants in Kerala in the first six months of the launch and five infants died. It means 3,125 infants may die when 25 million babies are vaccinated each year in India. It’s an indication of great risk in the public health module.”
According to Puliyel, the risk undermines the very concept of an immunization program designed to launch to reduce the infant mortality rate.
Parents have blamed the vaccination for putting the lives of their children at risk. Sophy Roy, mother of Hanna Theresa, of Athirampuzha village in Kerala, said she was lucky to save her baby daughter.
“Hanna was given the vaccination when she was 14 months old on August 1, 2012 and following a high fever on August 6 she was hospitalized. Soon she was moved to the intensive care unit as her condition deteriorated but doctors could not diagnose the cause of her fever.
"Being a medical nurse, I told doctors about her vaccination history. Later it was identified as the faulty vaccination that caused a fever,” Sophy told ucanews.com. “Now, Hanna is healthy. We saved her, but had to spend huge amount of money for her treatment.”
But parents of 47-day-old Ajilesh were not so lucky. The boy died within 24 hours of receiving the vaccination. According to records he was vaccinated at noon on December 29, 2012 and died on December 30.
Dr. P.S. Sanjay of Thrissur Medical College, who conducted the post mortem, stated that “death due to natural disease, injury and aspiration are ruled out."
The postmortem report should be enough to stop the vaccination, says Dr. P.G. Hari, a medical practitioner and public health campaigner in Kerala. “What more evidence you need to show that the vaccine is deadly? We have a clear pattern of death, 18 deaths in one state alone. But government officials tried to hush up the cases and claimed that the vaccine was safe,” Hari said.
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