Polio vaccine shortage looms over India with Sanofi plants’ shutdown – The Economic Times

An unprecedented crisis looms over supplies of injectable poliomyelitis vaccine, or IPV - a crucial tool in India's efforts to eradicate polio - as French drugmaker Sanofi has shut down its manufacturing plants in the country, documents reviewed by ET showed. Sanofi - a leading supplier of the vaccine - ceased production of its IPV brand ShanIPV in December 2023, triggering concerns among health experts regarding an imminent supply disruption that may hobble the country's most ambitious immunisation campaign.

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IPV is manufactured by only two companies - Sanofi Pasteur and Serum Institute of India (SII). Pune-based SII started its supplies of the vaccine only in 2021. Sanofi is believed to cater to over 80% of India's IPV dose requirements.

"Having been a long-standing contributor to India's journey to become polio-free, we stay dedicated to supporting India's public health programme for polio eradication in alignment with the authorities." In September 2023, however, Sanofi had announced in a public notice that due to the discontinuation of the manufacturing and marketing, the product may not be available in the market. IPV is an integral part of India's Universal Immunization Programme (UIP) that provides free immunisation to children against 12 preventable diseases including measles, diphtheria, hepatitis B, and tuberculosis. IPV was introduced into UIP in 2015 as part of a global polio endgame strategy.

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"Time is running out to find alternate supply arrangements," a public health expert told ET on the condition of anonymity. "By now, the government should have floated tenders or placed additional orders to Serum. This shows the callousness as it will affect polio surveillance and polio control measures."

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Pune-based SII may need to ramp up its capacity to bridge the demand shortage, experts said. The IPV shots are administered to children at six weeks, 14 weeks and nine months. While oral polio drops are administered at birth and then at 6,10,14 months and 1.5 years. India was the first country to introduce fractional doses in 2016 to dissipate a shortage of IPV.

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Sanofi has made multiple submissions to the union health ministry, cautioning against the impending supply challenges and had sought relaxation of a condition for continuation of such supplies, the documents showed.

However, Sanofi at that time had maintained that supplies of the polio vaccines will remain unimpacted.

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Sanofi has made multiple submissions to the union health ministry, cautioning against the impending supply challenges and had sought relaxation of a condition for continuation of such supplies, the documents showed.

The company had noted that while its product (IPV vaccine) is fully compliant during the term of the tender with a residual shelf-life of less than 18 months, a second condition requires that the manufacturing date of the product does not exceed six months at the time of the supply.

Since ShanIPVs shelf life is 36 months, thus meeting the primary requirement of the tender, we would humbly request you to kindly consider relaxation of the second criteria, that is the product should not be older than six months at the time of supply, the company said in a letter sent in June last year.

It clearly stated that the company would not be able to adhere to the six-month shelf-life clause from May 2024 onwards. Such a relaxation would not in any way impact the clinical profile of the vaccine, it pointed out.

The deadline mentioned in the letter implies that the last date for production of the vaccine was in December 2023.

People aware of the matter said Sanofis vaccine supplies may not be impacted till the end of this month, but any further delay in making an alternate plan could hinder the shelf-life condition of its existing tender agreement.

Sanofi had also volunteered to make a one-time exception of extending half of the total volume of product that exceed six months from the manufacturing date at no extra cost.

As an alternative to ShanIPV, Sanofi is understood to have accelerated the process to seek regulatory approval for Imovax polio, a 10-dose IPV that it sells across the world.

Meanwhile, it is learned that Sanofi may sell its Medchal and Muppireddypally facilities to Gland Pharma, one of the largest generic injectables manufacturers. Gland was picked among two other shortlisted entities Bharat Biotech and SII. This, however, could not be confirmed from Gland Pharma.

Meanwhile, the health ministry is planning to hand over procurement of IPV to its central procurement agency CMSS, which may further delay the procurement of the polio vaccines.

Questions from ET sent to the health ministry remained unanswered.

A senior government official, though, said things are under control. If need be, we will use option clause, which gives the government the right to increase the quantity to be ordered up to 20-30% from the current supplier. In this case it will be Serum Institute of India, he said.

UIP is one of the largest public health drives of the government targeting over 27 million new-borns and 29 million pregnant women annually.

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Polio vaccine shortage looms over India with Sanofi plants' shutdown - The Economic Times