Pfizer has decided to prioritize government orders and deliver doses of its Covid-19 vaccine “through government contracts only” in India.
This could potentially mean that the US 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 charge states and private hospitals a potentially higher rate for their vaccines.
Speaking of the company’s commitment to make its vaccine available in India, a Pfizer spokesman reiterated its decision to prioritize governments in their immunization programs “during this pandemic phase.”
The company would supply its vaccine “only through government contracts based on agreements with the respective government agencies and after approval or approval from regulatory agencies,” the spokesman said.
Pfizer’s statement came in response to questions from The Indian Express about whether the government’s decision to allow the sale of 50 percent of a company’s Covid-19 vaccine “on the open market” had an impact. on his plans for India.
The company was asked how many doses of its vaccine it could deliver and what prices it would charge central government and the open market.
The company was also asked whether it had filed for an Emergency Use Authorization (EUA) in India and when it expected to deliver the vaccine here.
“Pfizer remains committed to continuing our commitment to the government to make the Pfizer and BioNTech vaccines available for use in the government’s immunization program in the country,” said the spokesman.
The multinational pharmaceutical company headquartered in New York was the first to approach the Central Drugs Standard Control Organization (CDSCO), the leading drug regulatory agency in India, for limited use approval of its Covid-19 vaccine. When it filed its application on December 4, the company had already received EUA in the UK. Although Pfizer had not conducted local trials or bridging studies of its vaccine in India, the provisions of the Indian Clinical Trial Rules, 2019 allowed the company to seek approval with waivers for local testing, as it had already received approval from a foreign CDSCO.
However, on Feb. 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 prove the vaccine’s safety in the Indian population. .
But with the second wave raging, the government reversed its position earlier this month. This allowed vaccines with EUAs in the US, UK, EU and Japan, as well as those with the WHO emergency list, to receive limited use approvals in India before bridging studies were conducted. The announcement was made in hopes of drawing more foreign vaccines into the country.
Subsequently, the government also changed its stance on opening up vaccinations to make anyone over 18 eligible for the injection. In addition, it said that 50 percent of the stock supplied to the country by a vaccine manufacturer could be sold to states and in the “open market” to private hospitals.
Following this announcement, the Serum Institute of India, which had supplied Covishield to the center at Rs 150 per dose, decided on Wednesday to charge state governments Rs 400 per dose and private hospitals Rs 600 per dose of the vaccine.
Previously, when the central government was in charge of purchasing the vaccines from SII and Bharat Biotech, which makes Covaxin, it had capped the price that private hospitals could charge at Rs 250 per dose.