Pfizer has decided to prioritize government orders, and supply doses of its Covid-19 vaccine “only through government contracts” in India.
This may mean that the American drug giant’s vaccine, developed with BioNTech, may not be available through private hospitals in the country – unless the Center or state governments decide to sell doses to these facilities.
Pfizer’s decision comes at a time when India has opened up its immunization strategy, and allowed companies to choose to charge states and private hospitals for possibly a higher rate for their vaccines.
Expressing the company’s commitment to making its vaccine available in India, a spokesman for Pfizer reiterated its decision to prioritize governments in their immunization programs “during this pandemic”.
The company would supply its vaccine “only through government contracts based on agreements with appropriate government authorities and following regulatory authorization or approval”, the spokesman said.
The statement from Pfizer came in response to queries from The Indian Express about whether the government’s decision to allow the sale of a 50 per cent supply of the Covid-19 company “in the open market” vaccine had affected its plans for India.
The company was asked how many doses of its vaccine it could supply, and what prices it would charge central government and the open market.
The company was also asked if it had applied for an Emergency Use Authorization (EUA) in India, and when it expected to start supplying this vaccine.
“Pfizer remains committed to continuing our engagement with Government towards making the Pfizer and BioNTech vaccine available for use in the Government’s immunization program in the country,” the spokesman said.
The New York-based multinational pharma company was the first to approach the Central Drug Standard Control Institute (CDSCO), India’s leading drug regulatory body, for a limited use permit of its Covid-19 vaccine. When it submitted its application on December 4, the company had already received EUA in the United Kingdom. Although Pfizer had not conducted local trials or bridging studies of its vaccine in India, provisions under the Indian Clinical Trials Rules, 2019, allowed the company to seek approval with waivers on local tests, as it had already received approval by a foreign regulator recognized by the CDSCO.
However, on February 5, the company said it was withdrawing its application after an expert body under the CDSCO raised safety concerns, and asked it to conduct local trials in the country to test vaccine safety in the Indian population.
But with the second surge furious, the government vacated its position earlier this month. It allowed vaccines with EUAs in the US, UK, EU and Japan, as well as those with WHO’s Emergency Use Listing, to receive limited use approval in India before conducting transition studies. The announcement was made in hopes of attracting more foreign vaccines to the country.
Subsequently, the government changed its stance on opening vaccinations, and making everyone over the age of 18 eligible for the shot. In doing so, he said 50 percent of the stock provided by a vaccine manufacturer to the country could be sold to states and in the “open market” to private hospitals.
Following this announcement, the Indian Serum Institute, which had been supplying Covishield to the Center at Rs 150 per dose, decided to charge state governments Rs 400 per dose, and private hospitals Rs 600 per dose of the vaccine.
Earlier, when the central government was responsible for procuring the vaccines from SII and Bharat Biotech, which makes Covaxin, it had capped the price that private hospitals could charge at Rs 250 a dose.