Pfizer and Indian market: Company’s Indian subsidiary will have to approach regulator for vaccine approvals

After the approval for rolling out Coronavirus vaccines in the UK, Pfizer’s entry is Indian market is much more of an academic interest. It is known that the COVID-19 vaccine developed by Pfizer needs a temperature of minus 70 degrees Celsius for storage and Indian does not have cold supply change for it, but that does not mean India does not have any plans for this vaccine.

According to a report by The IE citing government officials, while this vaccine may not be able to meet the country’s demand, the talks are still going on. The official highlighted that the Indian subsidiary of Pfizer will have to approach the Indian regulator and share the data with them, which Pfizer had shared with the UK regulator. VK Paul, who is head of National Expert Group on Vaccine Administration said that vaccines by Pfizer and Moderna have not been tested in the Indian market but have shown quite good results in the US. He added that while India will not get large quantities of these vaccines, the country, if it requires it, is preparing itself. The government has parallel plans for this vaccine.

Paul believes that even if Pfizer vaccine will come to India, it will be after a few months, and the health department will chalk out a different strategy. Currently, India is relying on vaccines by five companies that will fulfill the country’s large scale immediate demand. The five vaccines produced in India will be by Oxford-AstraZeneca, Bharat Biotech-ICMR, Zydus Cadila, Dr Reddy’s and Biological E. According to Paul, all these vaccines will provide for Indian audience and will allow the country to arrange cold-chain supply much easier than the one needed for Pfizer and Moderna.

To be sure, Pfizer vaccine against the Coronavirus infection is mRNA based vaccine. Taking a cue from this, the Department of Biotechnology has granted seed funding to Gennova Biopharmaceuticals to focus on the country’s first mRNA based vaccine development. The report said that while mRNA based vaccines have never been used before, their synthetic nature will allow ramp up the capacity easily as their manufacturing is not that difficult.