Kozhikode: The Kerala government has procured anti-rabies vaccine which has not undergone the mandatory tests. The company which supplied the vaccine has warned that only the Kerala Medical Services Corporation Limited (KMSCL) will be responsible for any adverse effects caused by it.
The first batch of this order of the Equine Rabies Immune Globulin (ERIG) for anti-rabies vaccination (16,000 vials) reached the warehouses of the Kerala Medical Services Corporation Limited (KMSCL) in Thiruvananthapuram (6,000), Ernakulam (6,000) and Kozhikode (4,000) on Saturday morning.
They not only lacked the final test reports from the Central Drug Lab (CDL) but have also not completed the mandatory examination to be conducted by its manufacturers. The CDL is the national control laboratory for testing and quality control of immunobiologicals (vaccines and antisera) for human use.
According to the rules, the vaccine should be kept under observation of the company for 14 days. However, the units that reached Kerala on Saturday were observed only for seven days.
The rest of the first batch of consignments would reach on July 21.
KMSCL responsible for protocol: MO
State Health Minister's office said the KMSCL had been instructed to take immediate steps to procure the vaccine as there was a severe shortage of it. The corporation is supposed to decide and observe the protocols of procurement, the minister's office said. Neither Minister Veena George nor the KMSCL has responded yet.
State Drugs Controller P M Jayan said the rules stipulate that a vaccine should not be supplied without the final certification by the central lab. "We don't know under which circumstances permission was given to procure these vaccines. The State Drugs Control wing can test the vaccines only if there's an official request," the official said.
The vaccine supply to hospitals had commenced as soon as the early consignments landed in the warehouses. The KMSCL directed to start the supply of vaccines immediately, citing shortage in hospitals.
In all 60,500 vials will be supplied to hospitals in the first phase. The state has ordered 1.40 lakh vaccine vials in total.
Hurried despatch, CDL report awaited
Although there is a condition that the payment for the procured vaccine would be settled only after the CDL’s final report, there are no such terms for vaccine distribution. The relaxation of tender norms by the KMSCL is quite unusual.
As the efficacy and safety of the vaccine have not been tested and proven completely, there are fears of adverse effects if administered. However, the KMSCL has ordered the despatch of the vaccine stocks based on mere test reports from the manufacturers and without waiting for the final CDL report on efficacy and safety.
Recently a girl died of rabies infection in Palakkad despite getting anti-rabies vaccination. What exactly caused her death is yet to be ascertained convincingly.
Delay in placing order
While the process for the procurement of the anti-rabies vaccine drugs must have started in November and completed by March, the order was placed by the KMSCL on June 6. Had the order been placed in March, the quality checking and efficacy testing could have been done as mandated on time.
The usual process
It takes 27 days to manufacture one batch of anti-rabies vaccines. Then, the testing at the manufacturer’s end takes another 14 days. The sample of the packaged vaccine is sent to the CDL for further testing. It is stored at the CDL’s facility for 21 days before the test commences here.
This is done to give ample time for the activation of harmful viruses in the vaccine, if at all present.
On day 30, the testing would be completed and the sample would be approved by the CDL. The vaccine manufacturers begin the supply of the vaccine only with this final report approving the vaccine’s safety and efficacy. This is why the supply takes 90 days once the order is placed for the anti-rabies vaccine.
What happened in this case
In the first stage, the anti-rabies vaccine procured by the State has only completed the 14-day testing by the manufacturer. The entire first batch of vaccines is reaching Kerala this week 40 days after its production, instead of the required 90 days.
ERIG and HRIG
ERIG is produced in horses, whereas Human Rabies Immune Globulin (HRIG) is produced in humans. Both products contain antibodies specifically made against rabies virus. Both products are produced by vaccinating horses (ERIG) or humans (HRIG) and harvesting their plasma which contains antibodies against rabies virus.