 "A young Indian girl receiving a dose of oral polio vaccine by a trained healthcare worker")
As the country focuses on ensuring a secure supply of oral polio vaccines (OPV), the Union health secretary visited the manufacturing unit of Bilthoven Biologicals at Utrecht, Netherlands, an arm of the Pune-based Serum Institute of India that manufactures OPV, on Wednesday.
Amid concerns about supplies of injectable inactivated poliomyelitis vaccines (IPV), Union Health Secretary Apurva Chandra told Business Standard that they envisage no shortage this year. "We have enough supplies. We do not envisage any shortage of IPV," he clarified.
On Wednesday, Chandra had a meeting with Bilthoven CEO Juergen Kwik and CEO of Poonawalla Science Park (PSP) Jef De Clercq on European Union pandemic preparedness partnership and collaboration on production of vaccines.
The health secretary's visit assumes significance after concerns rose about supplies for injectable IPV for India's public health programme, as one of the key suppliers, Sanofi, had discontinued its IPV product ShanIPV in December.
Bilthoven Biologicals B.V. Company makes vaccines for polio, diphtheria-tetanus-polio, and tetanus along with bacillus calmette-guerin (BCG). Chandra met the senior management at the facility and was briefed about their future manufacturing plans.
Senior government officials told Business Standard that the Bilthoven plant also makes IPV, and if needed, these could be procured at a later date. "No decision on this has been taken yet. Having another potential supplier for IPV de-risks the supplies," the official said.
The bioengineering and vaccine production firm Bilthoven Biologicals was purchased by SII in 2012. This has strengthened its capacity to produce vaccines and also provided it with a valuable manufacturing base in Europe.
Recently, Serum and Bharat Biotech announced a collaboration for enhanced production of OPV. Under the agreement, Bharat Biotech will procure drug substances for making OPV from Bilthoven, which will be supplied within India as well as globally.
The Health Ministry said: “This will contribute to the supply security of oral polio vaccines. With this partnership, the capacity of Bharat Biotech to manufacture Oral Polio Vaccine has increased to 500 million doses every year.”
The Universal Immunisation Programme of the Union Health Ministry is one of the key interventions for the protection of children from life-threatening conditions by providing vaccination, including vaccines against polio. India was certified free of polio in March 2014.
“However, to maintain the polio-free status, polio vaccine is given to children as part of the high-quality national and sub-national polio rounds across the country. A sustained supply of OPV is essential for keeping India polio-free. The partnership between Bharat Biotech and SII will contribute to providing a sustained supply of OPV in the country,” the Ministry added.
As concerns loom about a potential supply of IPV for India's Universal Immunisation Programme, SII had said earlier this month that it can ramp up supplies to meet India's full annual requirement within three to four months if the need arises.
Adar Poonawalla, CEO of SII, had told Business Standard: “At the Serum Institute of India, we currently have a production capacity of around 60-70 million doses of IPV per year from our Dutch facility. While there is no current shortage, we can ramp up supplies to meet India's full annual requirement within three to four months if the need arises.”
He added that SII is committed to prioritising India's needs as the only domestic supplier presently. “Following this, we are ready to provide additional doses as this is vital for maintaining India's polio-free status,” he said. India was declared polio-free in March 2014 and continues to hold that status.
IPV has been introduced in the Universal Immunisation Programme as part of the Global Polio End-Game Strategy since November 2015, initially in six states, and was expanded across the country by April 2016.
French drugmaker Sanofi has discontinued its IPV named ShanIPV (by December 2023), which was only filled and packaged at our factory in Hyderabad, India. The antigens for the polio vaccine have been manufactured in France. A Sanofi India spokesperson had told Business Standard earlier this month that they remain committed to supporting India's public health programme for polio eradication.
“To ensure that there is no interruption to the availability of IPV vaccines, we have already obtained approvals for our product IMOVAX-Polio, an alternative IPV vaccine that has been in use in more than 100 countries for over 40 years. It also has the same composition or formulation as ShanIPV,” the spokesperson highlighted.
