MUMBAI (Reuters) – The World Health Organisation (WHO) said on Monday that there was minimal risk of children contracting the polio virus in India from a tainted batch of vaccines. The public health scare, which potentially affected thousands of children, put a renewed spotlight on lax pharmaceutical quality control procedures in India. The latest concerns emerged over the weekend after vaccines produced by privately-held Bio-Med Pvt Ltd and distributed as part of a free government drive to eradicate polio were found to have a strain of the virus that had been eradicated around the world and phased out of vaccines. However Shamila Sharma, a spokeswoman for the WHO, said any risk to children was “minimal” due to the high routine polio immunization coverage in India. The WHO funds and supports India’s polio-control program. Health officials in New Delhi said they were investigating why and how Bio-Med was still producing such vaccines, and that the affected lots were being recalled. The Indian government had ordered this type of vaccine to be discontinued in 2016. Local media reported on the weekend that police arrested the managing director of the northern India-based Bio-Med Pvt Ltd, after routine testing revealed it had made and shipped some 150,000 lots of oral polio vaccines that contained the type 2 polio vaccine virus. India, often dubbed the pharmacy of the world, is home to thousands of factories churning out drugs and vaccines for sale globally, but local regulation is lax. In recent years, U.S. and European regulators have slammed many Indian drug factories for faulty manufacturing practices, often issuing warnings or bans. For latest news and updates Email-id is invalid By signing up, you will receive emails about Physician's Weekly products and you agree to our Terms & Conditions and Privacy Policy. “We don’t have good quality control mechanisms,” said Oommen Kurian, a health researcher at New Delhi-based Observer Research Foundation, adding the country also doesn’t have the capacity to implement regulation. Bio-Med and India’s top drugs regulator, the Central Drug Standard Control Organisation, did not respond to requests for comment on Monday. Some batches of typhoid vaccines produced by Bio-Med were also found to be “not-of standard quality” by the CDSCO earlier this year, according to a public notice by the agency dated March 14, 2018. (Reporting by Zeba Siddiqui in Mumbai and Aditya Kalra and Blassy Boben in New Delhi; Editing by Toby Chopra)<doc-sep>MUMBAI: Putting to rest the fears of anxious parents, the union health ministry has said the chance of any child developing a serious illness due to polio vaccination is “practically nil”. Following reports that parents were afraid to immunize their children, doctors have said the use of oral polio vaccine (OPV) and inactivated polio vaccine (IPV) is safe and should be continued as per the immunization schedule.The trigger for the anxiety is discovery of traces of p2 vaccine-virus in environmental samples in Mumbai and stool samples of two children in UP. The centre discovered contamination of some vials of bivalent OPV, supposed to contain type 1 and type 3 strains, with the p2 strain.The use of the strain had been discontinued in vaccines world over since 2016.Speaking to TOI, a senior union health ministry official said, “People need to understand that the wild form of the p2 virus was eradicated in 1999. A weak form of the virus is used in vaccines so that it can replicate in the gut of children and give them immunity. The contamination that happened was with this weak vaccine-virus which, till 2016, was given to children as part of the national programme. So, something that was not harmful then wouldn’t cause grave issues now.” Maharashtra government has confirmed that none of the contaminated vials have come to the state. Doctors also rubbished messages doing the rounds on social media groups that the vaccine-virus can mutate. “The risk of any child getting vaccine-derived polio is practically nil,” a statement from the union health ministry said. “Surveillance has been heightened everywhere. We haven’t come across a single case where a child has developed weakness in the limb or paralysis following vaccination. In short, there is no stopping of polio vaccination,” said Dr Bela Verma, head of paediatrics at JJ and president Indian Academy of Paediatrics (IAP), Mumbai.Paediatrician Dr Samantha Castelino said parents of children born after 2016 are worried their children are not immunised against the p2 strain. “They should know that the injectable IPV vaccine protects them against all three strains,” she said. Over 90% children in the city are vaccinated with two to four shots of IPV<doc-sep>In April 2016, after due recommendations from Global Polio Eradication Initiative, India decided to switch from the trivalent to bivalent vaccine (Representative Photo) LUCKNOW: The Uttar Pradesh government ordered the recall of an entire batch of bivalent oral polio vaccine ( BoPV ) vials manufactured by a Ghaziabad-based firm after a health ministry team found that the vaccine had been contaminated. Confirming the order on Thursday, director general family welfare Dr neena gupta said: "the entire batch of vaccine -- B100318 -- has been recalled following instructions from the Union ministry of health and family welfare." She added that the polio vaccine being administered under the routine immunisation campaign and pulse polio immunisation campaign was safe. Explaining the matter, health officials said that polio is caused by three strains -- P1, P2 and P3. India reported the last P2 case in 1999 while the last wild polio case in India was detected on 13 January 2011. But India continued to administer polio vaccine (called trivalent oral polio vaccine) that targeted all the three strains. In April 2016, after due recommendations from Global Polio Eradication Initiative, India decided to switch from the trivalent to bivalent vaccine (oral vaccine that targets P1 and P3 strains). Though India was certified polio-free in March 2014, it continues to be vigilant against all three types of polio viruses by regularly collecting stool samples of children who show polio like symptoms including sudden onset of paralysis. Each year over 80,000 samples are evaluated across 45 sites that work under the leadership of the World Health Organisation National Polio Surveillance Project. "In the past few months, presence of P2 was noted in several stool samples which was unusual as neither the strain is prevalent in the country nor the vaccine being administered contains its vaccine," a health officer said. Acting on the matter, health ministry and WHO got the vaccine samples collected from the manufacture based in Ghaziabad to check if there was any problem with the vaccine or not. The samples were sent to the Central Drug Laboratory Kasauli which confirmed the presence of P2 vaccine in the bivalent vaccine. Following the report, an FIR was registered against the manufacturer while its owner was arrested in the last week of September. Besides, the use of all vaccine supplied by him was immediately stopped till further investigation. "Though the deviation is not going to harm the children, it is essential to be on the safe side. Thus, the entire batch has been recalled," said a senior health officer.<doc-sep>The contamination of oral polio vaccine has increased concerns among doctors because of the constant shortage of a safer injectable polio vaccine. The contamination of oral polio vaccine reported last week has increased concerns among doctors because of the constant shortage of a safer injectable polio vaccine in the country for the past two years. The injectable polio vaccine would have given children protection from any such contamination, say doctors. The Health Ministry found that a batch of oral polio vaccines was “contaminated” with a strain of virus — type 2 — that has been withdrawn from vaccines globally. The worry is that this batch leaking into the supply of vaccines could be dangerous for children in a community who had never been exposed to this strain before, and didn’t have immunity. India was declared free of wild polio virus in 2014. Oral polio vaccine contains a live, weakened version of the polio virus. The virus in the vaccine replicates in the intestine of a child and is then excreted for six to eight weeks. On the other hand, the inactivated polio vaccine, that is injected, does not have live virus. Both vaccines prompt the immune system of a person to respond as if it were infected by the virus. The Ministry of Health and Family Welfare in their statement said, “As a part of efforts to maintain high immunity against all polio viruses, India provides inactivated polio virus vaccine (IPV) and bOPV to all infants across the country under routine immunization.” However, there has been a major shortage of the IPV. “A majority of children have not received 2 doses of IPV to protect them from type 2 infection, transmission,” said T Jacob John, a retired professor from Christian Medical College, who has conducted extensive research on polio. “Type 2 (polio virus) is not a risk for the vaccinated child.” Recently, two children from a district in Uttar Pradesh were admitted to a hospital with acute flaccid paralysis or AFP, a sudden onset of paralysis or weakness in the limbs. One of the causes of AFP could be poliomyelitis, or polio. Traces of type 2 polio virus were found in the samples of their stools, a senior official told Hindu Business Line. After investigation, the government officials examined the OPV samples which were found to have the type 2 virus. These were traced to Biomed, a Ghaziabad-based pharmaceutical company. Up to 1.5 lakh vials were manufactured by the company, of which two-thirds were administered to children. One-third of the batch has been withdrawn. The batches of contaminated OPV had traveled to UP and Maharashtra, said government officials. In fact, in August, type 2 polio virus was found in sewage samples in Mumbai. The government planned a “mop-up” of administering inactivated polio vaccine in specific areas to children who may have missed these doses. Why was polio type 2 strain withdrawn? Before April 2016, the oral polio vaccine had three strains of polio virus — type 1, type 2, type 3 — to prevent acute flaccid paralysis caused by polio. In April 2016, the World Health Organisation called for a withdrawal of the type two polio virus in the oral polio vaccine globally. The WHO said it was to “eliminate the rare risk of vaccine-associated paralytic polio (VAPP) and circulating vaccine-derived polio virus (cVDPV).” The vaccine-derived polio virus circulates in a community when the virus is excreted from a vaccinated child for more than six weeks. If allowed to remain in the environment, it can genetically change into a form that can paralyse. Vaccine-acquired polio virus occurs when the oral polio vaccine virus mutates in a vaccinated child’s intestine, causing acute flaccid paralysis. This form of polio does not spread. Both these forms of polio cause paralysis. The type 2 polio virus in the oral polio vaccine is most likely to cause the spread and infection of vaccine-derived polio virus in a community, said Dr John. In India, the last such vaccine-derived polio type 2 case was reported in February 2016 in a five-and-half-year-old boy in Bihar’s Siwan district. While withdrawing the type 2 polio virus from the OPV, the WHO introduced the idea of starting the dosage of inactivated polio vaccine in the country. The idea of introducing IPV — which covers all three strains of polio — is to also protect all the children from type 2 polio (which was withdrawn from oral polio vaccine). The inactivated polio vaccine does not cause any sort of vaccine acquired or vaccine derived polio and is therefore safer. Since then, the global health community has been facing severe shortages of inactivated polio vaccine, despite reassurances from manufacturers over the past two years. It is only this year that the gap of stocks has been filled to some extent, but many children across India have missed out on inactivated polio vaccine doses. In India, pediatricians say that IPV is consistently available only in the private sector and is sold as a combination of five of six vaccines, said Dr Vipin Vashishtha, who used to advise the government on the vaccination programme. Concerns of possible vaccine derived polio outbreak Doctors are concerned about the possibility of vaccine-derived polio in the community. “We are at God’s mercy. So far, we have been protected by a large outbreak of vaccine derived polio virus,” said Dr Vashishtha. Between April 2016 and August 2017, five outbreaks of vaccine-derived polio virus type 2 cases were reported in Nigeria, Pakistan, Democratic Republic of Congo and Syria. The virus can spread via migration, Dr Vashishtha explained. The Health Ministry in its statement said that children who receive the contaminated vaccine will shed it through their faeces for about 4-6 weeks “after which it will die down.” However, the WHO said that on rare occasions, if the population is under-immunised, the excreted virus can continue to circulate longer, and in turn undergo mutations. These genetically changed vaccine-virus can paralyse children in the community who are exposed to it. In areas of inadequate sanitation, this excreted vaccine-virus can spread in the immediate community, the WHO said.<doc-sep>
India’s once again facing the spectre of a paralysing disease that had been eradicated, though the World Health Organisation (WHO) has downplayed the potential threat. The detection of contaminated vials of type-2 polio vaccine among batches administered to children in some parts of the country has sparked concern in medical and government circles, besides the public. A private pharmaceutical company reportedly reintroduced the virus in at least 150,000 vials of its oral vaccine, which were then administered to children in the states of Uttar Pradesh, Maharashtra, and Telangana. In September 2015, the WHO had declared type-2 polio fully eradicated. On the WHO’s advice, India phased out the type-2 virus from its oral vaccines in April 2016 to ensure that the threat of vaccine-derived polio was mitigated. “The reason why type-2 vaccine was systematically withdrawn was because the wild virus was eradicated, and only harm was being done by the vaccine virus,” said Oommen Kurian, public health fellow at the New Delhi-based think-tank Observer Research Foundation. “When the enemy is absent, there is no case for injuries by friendly fire.” However, the recent identification of the type-2 strain by government health inspectors in the stool samples of children in Uttar Pradesh has raised fears of a public health crisis. Virus and vaccine Polio, a permanently paralysing and sometimes fatal disease, can afflict children if they come into contact with any of the three distinct polio viruses—types 1, 2, and 3. So, from infancy up to six years of age, four doses of vaccination are administered, either orally or through an injection, to immunise them. The injective method, known as inactivated poliovirus vaccine (IPV), contains only dead strains of the three types of the virus. “IPV does not cause vaccine-derived infection or outbreaks,” Kurian said. The oral method, however, contains live, but less virulent, strains of the virus and can result in vaccine-induced polio. However, it is extremely rare—about one in 750,000 cases. “The vaccine virus is a problem because of all the oral vaccine strains, the strain of type-2 is most likely to cause vaccine-associated paralytic polio, which is why it was removed in the first place,” said public health researcher Sylvia Karpagam. Who’s at risk? The WHO has, however, downplayed the risk, crediting the high routine vaccination coverage in India. “The strains reintroduced were of the vaccine virus which is less virulent (compared to the wild virus). Its mutation would have required multiple exposures,” paediatrician and polio researcher Jacob T John agrees. “The risk is low, but it should have remained zero.” If the virus does turn virulent, the risk would be greater for kids who have received only the oral vaccines from which the type-2 strain was removed in 2016. “Children who have received three doses of trivalent oral vaccination (given before April 2016) are protected. After 2016, children who received IPV are protected,” said Karpagam. “The risk will be for kids who had only bivalent oral vaccination (given after April 2016) or no polio vaccine at all, as there is no herd immunity (the resistance of an entire population to a disease) to protect them anymore, because IPV protects only individuals,” Kurian said. The government has not fully replaced the oral vaccines with IPV because it is more expensive, in short supply, and protects only individuals instead of entire communities. IPV penetration is also lower among marginalised communities, Karpagam said. “Children residing in slums, conflict areas, orphan children, and children of migrant workers are more at risk.” Government response India’s health ministry has said it is ramping up IPV vaccination “in the specified areas to reach out to such children who may have missed IPV”. “If kids have IPV along with the bivalent oral vaccine, they will be free from any risk. Kids who skip IPV and kids who skip vaccines altogether are at risk,” Kurian said. Government teams in Telangana and Mumbai are also conducting door-to-door visits to monitor the children who may have received the contaminated vaccine. After the type-2 strain was found in Uttar Pradesh, the virus was traced to the Ghaziabad-based pharmaceutical firm Bio-Med. Its managing director was arrested and further production was halted. “Quality control in the pharmaceutical sector has been a matter of concern for India,” Kurian said. “The government should be making sure that trivalent vaccine is not being released by design or by accident. That is exactly what is being done, even if it is being done rather late.”