Should a potentially 'unsafe' vaccine be used to treat pneumonia?

WrittenBy

Written By: Editorial Team | Updated : October 18, 2012 1:07 PM IST

Despite being attributed with the highest child mortality rate from pneumonia by WHO, India has only partially introduced one of two available vaccines in the market for children against pneumonia under a national programme. This is due to litigation over the vaccines. Pakistan has become the first South Asian country to introduce a new vaccine.

With the support of WHO and UNICEF, the Global Alliance for Vaccines and Immunisation is supplying both available variants for a minimum of five years to India and Pakistan along with 16 other developing countries. Pneumococcal vaccine, the newly introduced variant, protects against at least 13 strains. The other variant, pentavalent haemophilus influenza type B (Hib) vaccine combines the existing DPT vaccine with those for hepatitis B and the Hib bacteria that cause meningitis and pneumonia. It has been rolled out in Kerala and Tamil Nadu so far.

'Most of the developed world and now even the developing world have introduced both vaccines. We must understand that most of the pneumonia deaths occur among the poorest of the poor who cannot afford the vaccine at market prices. If it is available in the market, why should it not be made available to these people through a national programme?' said Dr N K Ganguly, chairperson of ICMR's task force on pneumonia.

After health activists filed a PIL in the Delhi High Court in 2009, the National Technical Advisory Group on Immunisation advised a cautionary approach to the approval given to the vaccines. 'As the vaccine has not been introduced there is not enough data on vaccine safety; therefore the vaccine should be initially used in the states with better adverse effects following immunisation (AEFI) management and surveillance system to monitor the vaccine safety. Data may be reviewed after one year of introduction (in Tamil Nadu and Kerala) before expanding the vaccine to other states,' a 2010 NTAGI report said.

'In the last one year, not only has there been no monitoring of AEFI, but seven reported deaths are not being recorded. The government is also dismissing reports of deaths in Sri Lanka and Bhutan within 48 hours of the vaccine being administered,' said Dr Jacob Puliyel, one of the petitioners. He is also an NTAGI member and head of the paediatrics department at Delhi's St Stephen Hospital.

Denying these claims Dr Ajay Khera, Deputy Commissioner, Child Health & Immunisation in the health ministry said, 'The deaths are not due to the vaccine... It is a safe vaccine. Besides the two states where it has been introduced, we are in the process of finalising its launch in six other states.'

3,70,000 children die in India due to the disease every year which, according to WHO, accounts for half the world's global pneumonia deaths. According to a report, Pakistan recorded about 80,000 child deaths annually.

Critics maintain that there is no comprehensive data available on the prevalent serological strains of pneumonia in the country. So, India should not 'blindly' follow Pakistan. An evidence-based approach, a practice that was not followed for the Hib vaccine, should be followed before introducing the pneumococcal vaccine, doctors say.

'Without proper data on existing strains, how do we know if any of the existing vaccines will actually be helpful in protecting our children?" said Dr Puliyel.

Refuting the claim, Dr Ganguly of the ministry said, 'There is also evidence of hard immunity. Even if 30 per cent of the population is vaccinated, the immunity percolates to many others.' According to him studies have shown 80 per cent of the strains in India are covered by the pneumococcal vaccine.

'The Invasive Bacterial Infection Surveillance Group study published in The Lancet in 1997 had given us nationwide data on pneumococcal serotypes. It is true than only 50 per cent of the pneumonia strains respond to antibiotics, but considering the morbidity and mortality rates of pneumonia, I think there is sufficient evidence of the efficacy of the vaccines,' said Dr N K Arora, director of The INCLEN Trust International which has been promoting the vaccine.

'We have more data than Pakistan, so there is no question of blindly following them. But we should introduce a pilot project in some districts to evaluate the latest pneumonia vaccines in a focused manner to evaluate the morbidity and mortality rates, particularly now since many Indian companies have started manufacturing the product. Based on the evidence, a decision on the national programme can be taken,' Dr Arora added.

Add The Health Site as a Preferred Source Add The Health Site as a Preferred Source

Disclaimer: The content on TheHealthSite.com is only for informational purposes. It is not at all professional medical advice. Always consult your doctor or a healthcare specialist for any questions regarding your health or a medical condition.