The Ministry of Health and Family Welfare has in a recent press release dated 3rd October, 2018, expressed concern over certain reports doing rounds that bivalent oral polio vaccine supplied by a particular manufacturer having some quality issues. The Drugs Controller General of India has filed an FIR and issued notice to the company from which this rumor had started asking it to stop manufacturing and supplying polio vaccines till further orders. The Managing Director of the company was also immediately arrested.
Background:
India along with World Health Organisation (“WHO”) has always tried to maintain international quality surveillance for poliovirus detection in the country. As a part of intensive surveillance, sewage samples are collected from 45 sites and tested for poliovirus in accredited polio laboratories in the country. Stool samples are also collected from all individuals that report sudden paralysis or other polio like symptoms every year. In April 2016, a decision to switch to inactivated poliovirus vaccine (IPV) and bivalent Oral Polio Vaccine (bOPV) from trivalent Oral Polio Vaccine (tOPV) was taken after it was certified globally that type 2 wild poliovirus was eradicated totally. The tOPV that was used till April 2016 contained three types of poliovirus vaccines (P1, P2 and P3) which protected against all three types of wild polioviruses – type 1, type 2 and type 3, while bOPV contains two types of poliovirus vaccines (P1 and P3) and it protects against type 1 and type 3 wild polioviruses. Type 2 component from oral polio vaccine was completely discontinued.
Recently, a form of type 2 polio vaccine virus was found in some sewage and stool samples indicating the use of a type 2 poliovirus containing vaccine, despite tOPV containing type 2 poliovirus vaccine had been phased out globally in April 2016. 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 along with WHO took immediate action and restricted the use of all the vaccine supplied by this manufacturer till investigation was completed. Additional legal samples of bOPV were also sent for testing to the Central Drug Laboratory in Kasauli, which too confirmed the previous report of presence of traces of P2 polio vaccine virus.
Source: Ministry of Health and Family Welfare
