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A government laboratory has confirmed the presence of polio type 2 virus in oral vaccine samples made by Bio-Med during its retest, raising concerns about children's health due to contaminated samples, according to a report by Mint.
The finding, submitted to the Ghaziabad district court on March 15, puts India's polio-free-country status at risk as it was believed to have been eradicated polio from India in 2016.
"The samples that were sent for testing following the court order were found to be positive again, which means that the batches had type 2 virus in it," sources told the newspaper.
After 1.5 lakh contaminated vials of a polio virus strain were suspected to have entered the government's immunisation programme in September 2018, the government had set-up a committee to probe the contamination of some batches of the vaccine.
Read: Contaminated polio vaccines given to children in Maharashtra, Telangana, UP
Initial tests conducted by the state-run Central Drugs Laboratory (CDL) Kasauli confirmed the presence of polio type-2 virus in oral vaccine samples produced by Bio-Med. However, the company challenged the results.
Sylvia Karpagam, a public health expert in Karnataka, told the newspaper that this contaminated vaccine has put in danger the health of those who have not been vaccinated for the polio type-2 virus strain. The latter was withdrawn from vaccines worldwide as it was eradicated a long time ago.
"The bigger problem is that the virus can mutate and no one knows into what form: mild or virulent," Karpagam said. "The contamination endangers many who have not received inactivated polio vaccine (IPV) and are exposed to type-2 strain."
A mystery polio virus strain threatens India — all you need to know
It is interesting to note that the current polio vaccines do not protect against type-2 strain. Vaccine producers were asked to remove its traces from the vaccines and destroy their stock by April 2016. Bio-Med may have violated the said instruction.
In October 2018, drug inspectors visited Indonesia's PT Bio Farma, the company that supplies the bulk vaccine to Bio-Med. However, the company denied any contamination of oral polio bulk vaccine supplied to Bio-Med, bringing the spotlight back on the company that supplied vaccines to government programmes.
Read: Exclusive: As polio threat looms, Indonesia's Bio Farma denies contamination of oral vaccine
"Bio Farma has proactively investigated the matter internally comprising batch review, facility assessment and testing of retain samples of all bulks shipped to Bio-Med using the validated test method," the company told Moneycontrol in an email earlier.
"Results have shown that there have not been any discrepancies in the manufacture of these bulks. Test results of retain samples do not indicate presence of type-2 polio virus," the company added.
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