Why India can't drop the ball on polio-free status

3 | Pfizer says COVID-19 vaccine still possible in 2020 despite data lag: Pfizer executives expressed measured optimism Tuesday over the prospect of providing a coronavirus vaccine in 2020 even as they signaled key data on the vaccine would not be released before the US election. Pfizer Chief Executive Albert Bourla said the drug giant could supply some 40 million doses in the United States in 2020 if clinical testing proceeds as expected and regulators approve a vaccine.

The recent discovery of type 2 polio virus in some sewage and stool samples from Uttar Pradesh, as part of the joint surveillance by the World Health Organisation and Health Ministry, has jolted India's status as a polio-free country and left millions of parents worried about their child's health.

The polio virus causes paralysis, but it is easily preventable by the polio vaccine.

After years of massive efforts and immunisation drives, India was finally certified by WHO as polio-free in March 2014. The last polio case due to the wild polio virus in the country was detected on January 13, 2011.

Polio eradication is one of very few success stories that India can boast off after small pox elimination.

However, the latest detection of  type 2 polio virus is startling, as it was linked to certain batches of bivalent oral polio vaccine (bOPV) manufactured by the Ghaziabad-based Bio-Med, clearly indicating that it's a man-made blunder.

India as part of the polio end game strategy switched to inactivated polio virus vaccine (IPV) and bivalent Oral Polio Vaccine (bOPV) from trivalent Oral Polio Vaccine (tOPV) in all polio campaigns and routine immunisation.

tOPV that contained the type 2 polio virus had been phased out globally, and in India, in April 2016, following certification of global eradication of type 2 wild polio virus.

Government action The Drugs Controller General of India (DCGI) immediately filed an FIR and issued notice to the company asking it to stop manufacture and supply till further orders. The Managing Director of the company was immediately arrested. The investigation is still underway.

No risk The government after much dilly-dallying issued a statement stating that the risk of any child getting vaccine derived polio disease is practically nil.

"Type 2 polio vaccine virus traces, which have been found in bOPV vials, is the attenuated (weakened) polio virus and does not cause paralysis. It was also earlier used in tOPV till April 2016," a release by the Ministry of Health and Family Welfare said.

"The recipients of such vaccine will usually shed the vaccine virus through the fecal route for about 4-6 weeks after which it will die down," it added.

The government is looking to enhance immunity against type 2 polio virus 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.

"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 recently conducted India Expert Advisory Group on Polio, which comprises of international and national experts. India has also made remarkable progress under Swachh Bharat Abhiyaan," the government said.

Lessons to be learnt Experts who track the vaccine industry said it is a case of criminal negligence by the manufacturer.

"How did the Type 2 polio virus strains that were supposed to be destroyed, were still available with Bio-Med, it's baffling," said a former executive of a PSU vaccine company.

The Wire reported that Bio-Med doesn’t have a WHO pre-qualification certification for OPV vaccine.

WHO pre-qualification is the necessary condition for vaccine companies to participate in tenders to supply vaccines for global immunisation programmes. But in India, this standard is not necessary for domestic sale.

The executive said the government procurement of vaccines in India is a faulty one. "It only cares whether you are L1 (lowest bidder) or not. It doesn't matter what quality standards you maintain. One can even import vaccines from China and sell them here," the above executive said.

"Thankfully, we have a robust polio surveillance, otherwise this would never could have come to light. Unfortunately, this is not the case for other drugs and vaccines. It's time the Indian drug regulator woke-up," the executive added.