The test result of the vaccine which was considered to be the cause for the hospitalisation of around 35 students after it was administered on around 321 students at National Higher Secondary School in Vattoli, Kozhikode, has been proved to be of standard quality. The cause of the illness in children was not on account of the defect in the drug.
The Tetanus Vaccine (adsorbed) IP 5 ml batch no TT 5095 23 A, manufactured by Mumbai based Haffkine Biopharmaceutical Ltd was sent to Central Research Institute, Kasauli, Himachal Pradesh after it was collected by the Drug Control Department. But the result of the test conducted by the institute states that there was no deficiency in the vaccine.
According to the report, "The T T Vaccine is found to be of standard quality and it passed the sterility test, abnormal toxicity test, biochemical test, label review and physical aspect." Even the syringe that was used for administering the vaccine was sent to Trivandrum Drugs testing Laboratory and the result has confirmed that the instrument was in accordance with the Indian Pharmacopoeia standards.
Sources in the Drug Control Department stated that even though there was no fault in the vaccine, the authorities would continue their investigations into other aspects. "Now that we know there is no fault in the vaccine as such, we will probe into the areas of cold storage, distribution, etc," said an informed source. He said that the test result of a similar incident that happened in Nilambur, Kerala is still awaited.
Even earlier, the issue of whether the vaccines were properly stored was under scrutiny and even the experts stated that the cause behind the tragic incident would have been a break in the cold chain. The tetanus vaccines have to be stored under a temperature of minimum 2 to maximum 8 degree centigrade. If the cold chain is not maintained, the potency of the vaccine reduces and the toxicity increases.
Meanwhile, the reason for the death of child who too was administered with the vaccine has been ascertained as "viral encephalitis" in the postmortem report. Earlier there was a rumour that the child's death was due to the vaccine and this caused a flutter in the district.
The three member high level team, which was appointed by the Kerala Government to investigate into reason behind the children falling sick, are in their final stages of probe and the reports are expected soon.
As Pharmabiz had reported earlier, the team comprises Sanjeev, neurology professor at Thiruvananthapuram based Sri Chitra Hospital, V Jayakumar, Professor of medicine department, Trivandrum Medical College and K Venugopal, HOD of cardiology department, Calicut Medical College, will be investigating into the issue.