The official tests of DPT vaccine samples, collected in the wake of reported deaths of children following vaccination under the universal immunisation programme, have found to be of 'standard quality' and none of the 83 cases during the year of 2009 and 2010 could be attributed to the substandard quality of vaccines.
According to sources in the health ministry, the district and state level Adverse Event Following Immunisation (AEFI) committees held detailed investigations and over 100 samples were collected and sent for laboratory tests. “All of the samples were cleared and declared as of standard quality by the concerned labs in the Government sector,” a senior official said.
A total of 83 AEFI deaths following administration of DPT vaccine have been reported during the year 2009 and 2010 from different parts of the country, forcing the government to launch investigations and testing of samples. Out of the total cases, 41 were reported from Maharashtra, followed by Andhra Pradesh with 15 cases.
All these cases were investigated and majority (55) were co-incidental, in 2 cases deaths were due to individual vaccine reaction, in 1 case death was due to toxic shock syndrome and in the remaining (23) cases cause could not be found out.
However, the government has taken several steps to avoid such cases. The officials have been asked to report early detection of adverse reactions and do rapid management to prevent and reduce amount of damage that could be caused.
To prevent programme error related AEFI, guidelines have been issued for each step related to immunization. Hands-on training and supportive supervision of the immunization session have been given. Training of all level of health care personnel (medical officers, ANM, cold chain handlers etc) was being held on issues related to prevention of AEFI and management and reporting in case of an AEFI.
After the suspension of licences to the three PSU vaccine manufacturing units in 2008, the Government has been depending fully on the private players like Serum Institute of India Ltd and Shantha Biotech Ltd for the supply of Diphtheria, Pertussis and Tetanus (DPT) vaccines for the national programme.