Sanofi gets approval for alternative inactivated polio vaccine

There is no shortage of polio vaccine from its side, company says

April 05, 2024 12:53 am | Updated 06:21 am IST - NEW DELHI

Image used for representational purpose.

Image used for representational purpose. | Photo Credit: AP

After the French drugmaker Sanofi India Limited recently discontinued ShanIPV, its inactivated polio vaccine (IPV), in India, the company has confirmed that it will ensure there is no interruption in the availability its IPV vaccine.

“We have already obtained the approvals for our product, IMOVAX-Polio, an alternative IPV that has been in use in more than 100 countries for 40-plus years. It also has the same composition/formulation as ShanIPV,” the company’s spokesperson said, following widespread concern that a pull out could lead to shortage of the vaccine in India.

Only recently, activists, public health experts, tuberculosis (TB) survivors, and people living with HIV had sought Prime Minister Narendra Modi’s intervention to halt what they said were frequent shortages in the availability of anti-TB drugs.

“There will be no shortage of IPV vaccines in India on our account, and towards safeguarding the nation’s status of remaining polio-free. We remain fully committed to fulfilling our public health mission in India,” the company said.

Sanofi India caters to a significant part of India’s injectable poliomyelitis vaccine needs. While the Union Health Ministry was unavailable for comment on the matter, Sanofi India had in 2023 issued a public notice to announce its decision to initiate the closure of ShanIPV, and apply for regulatory approval for a product with a similar composition.

Explaining its withdrawal of ShanIPV, Sanofi India said that the COVID-19 pandemic had accelerated the speed at which the healthcare sector had evolved both in India and globally, resulting in the emergence of new pharmaceutical manufacturers, and increased supply capacities in both vaccines and medicines.

As a result, Sanofi has had to adapt its strategy and portfolio to these trends. Accordingly, Sanofi Healthcare India Private Limited announced that, by the end of 2023, it would discontinue ShanIPV, which was only filled and packaged at their factory in Hyderabad. The antigens for the polio vaccine were manufactured in France.

“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,” the company added.

India was certified polio free by the Regional Certification Commission on March 27, 2014. The country reported its last polio case from district Howrah, West Bengal on January 13, 2011.

In order to maintain the polio-free status and keep the population protected, countries must ensure that population immunity remains high through routine immunisation coverage of >90% with vaccines. High quality surveillance is required to be on guard, and outbreak response plans must be in place, should polio return.

ShanIPV, launched in India in 2015 is a trivalent inactivated injectable vaccine. Under the Central government’s Universal Immunisation Programme, IPV is to be injected in two stages — at six weeks and 14 weeks of age.

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