Vaccine Industry losing skill?
News reports since the last one month regarding the Polio vaccine are, least to say, disturbing. They actually raise very serious concerns as they pose a threat of a likely vaccine contamination.
Some batches of oral polio vaccine have been found to be contaminated with polio type-2 virus. Its presence appears to be a serious threat to public health because this strain has been eradicated worldwide. Hence its re-emergence is a serious problem. Some vaccine vials containing type-2 virus were administered to children in Maharashtra, Uttar Pradesh and Telangana. The incident came to light when surveillance reports from Uttar Pradesh showed signs of virus in stool samples of some children in Uttar Pradesh. So, on suspicion when vaccine samples were sent for testing the reports confirmed contamination of some batches.
Medical experts fear that the virus may mutate and could lead to vaccine related Polio cases. The government health machinery and the regulatory has swung into its usual action of precaution, inquiry and action. A case has been filed against Ghaziabad based Biomed, which manufactured the vaccine. It has also been asked to stop producing, distributing and selling the vaccine.
The states have been asked to trace the children who have been given the contaminated vaccines. As precautionary measures all the children in the areas from the three states where contaminated vaccines were supplied are being administered with Inactivated Polio Virus (IPV) injections. But, the problem is the country has witnessed shortage of IPV injections during the last two years. The government will have to ensure smooth supply and it is very crucial now. The Polio surveillance teams in the three state have also stepped up monitoring of all children in these areas and a close watch has been kept on them for any symptoms.
Still, a very crucial question is how this strain entered into the vaccine. The Global Commission for the certification of Poliomyelitis Eradication said on September 20, 2016 that type 2 has been eradicated from the world. Just prior to that the Indian government had ordered all manufacturers to completely destroy all traces of the strain by April 25, 2016. The question is that whether Biomed had retained the strain? If so, the subsequent questions are how it retained it and how it pass through the regulatory mechanism. An inquiry has been ordered for the same.
Even a possibility of the virus coming through the key starting material (KSM) is also being examined. A team from the drug regulatory visited Indonesia’s PT Bio Farma. It supplies KSM to Indian companies to produce vaccine. PT Bio Farma is one of the largest suppliers of polio and measles bulk vaccine in the world. The company, with WHO prequalification, produces at least 1.4 billion doses of oral polio vaccines to meet the global demand.
This incident takes us back to the recent episode where the Chinese vaccine maker Changsheng Biotech recalled batches of rabies vaccines from across the globe, including India. On account of that the Chinese authorities have slapped a fine and asset seizures totaling a whopping $1.3 billion on Changsheng.
India with its sustained campaign & efforts in the last few years has eradicated Polio. The last Polio cases detected in India were in 2011. After that when no single case was reported for consecutive three years, in 2014, WHO officially announced India Polio free. Even now, both WHO and UNICEF have provided relief by saying that the risk of children getting vaccine derived polio virus was minimal due to the routine immunisation coverage.
But, for people such words of comfort are no relief, particularly when their children’s health is at stake. Experts feel that there are several possible and unpredictable outcomes of the development and the authorities should prepare themselves to face the worst. That is most worrisome news and a very serious challenge before the health authorities.