A team of MoHFW, DCGI, ICMR and WHO is continuously monitoring the situation
There have been reports in a section of the print media mentioning that bivalent oral polio vaccine supplied by a particular manufacturer had some quality issues.
As a part of efforts to maintain high immunity against all polioviruses, India provides inactivated poliovirus vaccine (IPV) and bOPV to all infants across the country under routine immunisation. To ensure vaccination of all children, effective campaigns have been undertaken. Further, as per the advice of the India Expert Advisory Group, India continues to conduct mass vaccination campaigns against polio, using bOPV to maintain high immunity against polio. Two nationwide and one sub-national pulse polio campaign have already been conducted in 2018.
On investigation, it was found that in a few vials of bOPV supplied by one manufacturer, there were traces of P2 vaccine. The Ministry of Health and Family Welfare taking WHO on board took immediate and comprehensive action. Following the report, the use of all the vaccine supplied by this manufacturer was immediately stopped in the country till investigation was completed. Additional legal samples of bOPV were immediately sent for testing to the Central Drug Laboratory in Kasauli, which confirmed the previous report of presence of traces of P2 polio vaccine virus. The Drugs Controller General of India immediately filed an FIR and issued notice to the company asking it to stop manufacturing and supplying till further orders. The MD of the company was immediately arrested.
Type 2 polio vaccine virus traces which have been found in bOPV vials is the attenuated (weakened) poliovirus and does not cause paralysis and was also earlier used in tOPV till April 2016. The recipients of such vaccine will usually shed the vaccine virus through fecal route for about four to six weeks after which it will die down. In small areas where such vials were used, polio surveillance in environment and through stool collection has been significantly enhanced by MoHFW, with support from WHO and partners to keep constant vigil on the shedding of the polio vaccine virus. To enhance immunity against type 2 poliovirus further, special mop up rounds for administering IPV are being conducted in the specified areas to reach out to such children who may have missed IPV. This would provide immunity to all the children against all the three types of polio virus including Type 2.
In view of high routine immunisation coverage being achieved in India and administration of tOPV till 2016, our population level immunity against all three types of virus is very high. This fact was acknowledged and appreciated in a recently conducted India Expert Advisory Group on Polio which comprises of international and national experts.
In light of all the above facts and measures taken, the risk of any child getting vaccine derived polio disease is practically nil.
Sufficient polio vaccine from alternate sources is available in the programme to implement Routine Immunisation (RI) and Pulse Polio Immunisation (PPI) and maintain the immunity against polio-viruses.
No sample has tested positive for wild poliovirus in sewage or AFP cases since 2011. The country remains polio-free and this status has been maintained for more than seven years since the last wild poliovirus case in the country was reported in January 2011. No child has been infected with wild poliovirus as reported in some sections of the media.
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