Contaminated vaccines jeopardize India's "polio-free country" status | India News

NEW DELHI: At least three batches of polio vaccines containing 1.5 lakh flasks have been found contaminated with polio virus type 2, jeopardizing India's "polio-free" status as children born after April 2016 – when type 2 virus has been withdrawn from around the world, including India – are not immune to this virus, sources said.

The Ministry of Health and the World Health Organization (WHO) have intensified their surveillance, particularly in Uttar Pradesh, Maharashtra and Telangana, where contaminated vaccines have been administered to children. The vaccines were manufactured by the Biomed company based in Ghaziabad, as reported by TOI in its September 29 issue.

"Contamination can have very serious consequences for public health, because it amounts to reintroducing into the community a virus that has been eradicated. WHO and health authorities are closely monitoring any active strain of the virus in stool samples or in wastewater, "said a senior official.

The ministry has set up a three-member committee to study how the eradicated virus has been reintroduced, even after destruction orders from the manufacturing and supply chain. The group was invited to submit its report in one week.

While the chief executive of Biomed was arrested on Thursday, four of his directors are on the run, said the official. India's Comptroller General of Medicines filed a FIR and sent a notice of formal notice to the company to stop manufacturing until new orders were placed.

According to the experts, all oral polio vaccines (OPV) contain live polio viruses that are excreted by vaccinated children in their feces. At present, the government, regulators and practitioners are concerned that if type 2 virus passes into the sewer or water supply system, it may overwrite neurovirulence and spread polio.

"Another major risk is the mutation of the virus, which is a common phenomenon in 3 to 6 months," said the official.

Previously, trivalent polio vaccines containing types 1, 2 and 3 were used, but once the type 2 polio virus was eradicated worldwide, governments adopted bivalent vaccines containing only types of poliovirus. 1 and 3. In 2016, in accordance with WHO guidelines, India had ordered the removal and destruction of all trivalent OPV stocks by April 2016.

Biomed has provided polio vaccines for the government's universal immunization program. Contamination was suspected for the first time when UP surveillance reports showed signs of virus in some children's stool samples. As a result of these reports, drug inspectors collected OPV vaccine samples and sent them to the Kasauli Central Drug Testing Laboratory, which confirmed the contamination.

Although the government has ordered the vaccination of children with additional doses in all three states, it is difficult to identify these children quickly, the official said.

In March 2014, India was officially declared "polio-free" by WHO. The last case of wild polio type 2 in the country dates back to 1999. However, India continues to maintain a highly sensitive surveillance system for polio. The polio surveillance network detects all cases of sudden onset paralysis in children under 15 years of age (called acute flaccid paralysis or AFP). Each case is followed and stool samples are tested for polio virus in laboratories accredited by the WHO. In addition, wastewater samples are taken from more than 30 sites across the country to detect the polio virus at regular intervals.