Polio Vaccine scandal: CDSCO scanning Bio-Med premises

 NEW DELHI:  Drug regulators on Wednesday launched a probe into the premises of the Ghaziabad-based company, Bio-Med, to find out the source of type-2 poliovirus contamination in oral polio vaccine after failing to extract information from its managing director who was arrested last week.

The authorities have also ordered scrutiny of oral polio vaccine samples from all domestic suppliers amid investigations into how one company released an oral polio vaccine (OPV) containing type-2 poliovirus which was withdrawn globally in 2016 as it was considered more risky than beneficial.
“A four-member team is now on the company premises and trying to find out if there was something wrong in the manufacturing or packaging process that could have led to the contamination,” a senior official of the Central Drug Standards Control Organisation (CDSCO) informed Express.
“We will also test samples from other five domestic OPV suppliers to ensure that they don’t carry polio type 2 virus,” the official said.

India, as per the World Health Organisation (WHO) guidelines, had ordered withdrawal and destruction of all trivalent stocks by April 2016.

All oral polio vaccines since then are expected to be bivalent, containing only type-1 and type-2 viruses.
“We still have no confirmation on whether type-2 virus contamination in Bio-Med’s vaccines was deliberate or accidental. But we want to assure the public that there is no need to panic and our children everywhere are safe,” a senior official in the Union Health and Family Welfare Ministry said.
The company’s managing director, who is in custody, has claimed he cannot explain how type-2 virus got into the vaccines and four company directors who could provide crucial leads are absconding, the official also said.

Government sources said that polio eradication efforts had eliminated the type-2 wild poliovirus by 1999 but the the presence of type-2 virus in trivalent OPV continued to cause rare outbreaks of vaccine-derived polio, prompting the global switch to bivalent vaccines in 2016.
“The breach by Bio-Med is being taken very seriously because it reintroduces into the community a vaccine eradicated in 1999 and therefore we will carry out mop-up rounds of injectable polio vaccines in districts in Uttar Pradesh and Telangana where 1.5 lakh vials of OPV from Bio-Med had been administered,” another official said.

At present, the National Institute of Virology, Pune is the only lab in India authorised to maintain stocks of wild and vaccine strains of type-2 poliovirus. The Pune institute is among about 50 such designated “poliovirus essential facilities” in about 20 countries worldwide with type-2 poliovirus.
The CDSCO official said the government would also seek information from an Indonesian company that provides raw material -- seed stocks of vaccine virus -- to vaccine suppliers in India to make OPV.

Kids in TS are now given bOPV of another firm

Hyderabad: From second week of September, children in the Telangana were not administered bOPV after alerts were sent by Ministry of Health and Family Welfare officials to immediately stop using bOPV manufactured by Bio-Med. Only Inactivated Polio Vaccine (IPV) was given to children. After a gap of at least 19 days, the bOPV manufactured by another company, started to be given to children from Wednesday.

The alert on September 10 was followed by another from the Ministry’s officials who informed that B10048 batch was contaminated with Type-2 Polio virus. “All batches of Bio-Med were recalled form entire State  and surrendered to Vaccine Stores. After that children were not given bOPVs. It is only from Wednesday that bOPV manufactured by another company is reintroduced,” said officials from the State Health Department. Besides this, children below two years who missed taking IPV will be administered the Inactivated Polio Vaccine.

“At a meeting in Delhi, instructions were passed to further strengthen surveillance. This means the process of collecting sewage water and active surveillance where children below 15 years have sudden onset of paralysis, experience weakness in knees, stools samples will be collected for tests to know if Type-2 Polio virus is present,” officials said.