The Drugs Controller General of India (DCGI) has urged Pfizer twice in writing to apply for emergency use authorisation (EUA) for its COVID vaccine so that the application is processed well in time, but Pfizer has not applied for the licence yet, sources have told ANI.
The development comes in the backdrop of US vaccine maker Moderna's much anticipated India entry awaited this week. It was expected that Pfizer would soon be given a go-ahead to access the Indian market. About a fortnight ago, reports had quoted Pfizer CEO Albert Bourla saying the company is in the final stages to get approval for COVID-19 vaccine in India. "I hope very soon we will finalise an agreement with the government," Bourla had said.
It is to be noted that talks with Pfizer had hit roadblocks multiple times over the issue of the company's demand for indemnity. Indemnity provides protection to vaccine makers against legal proceedings and costs of compensation for severe side effects among those who receive the shots.
The vaccine, developed in partnership with the German firm BioNtech, is touted to be among the most efficient in preventing Covid globally. There has been a significant drop in COVID cases in the US and Israel that have vaccinated a majority with the Pfizer vaccine.
Recently, DCGI did away with specific trials of COVID-19 vaccines approved by other international regulatory bodies—a big move that is likely to clear the way for foreign vaccines like Pfizer's and Moderna's for the country's urgent requirement. Soon, Moderna's COVID vaccine was given emergency use approval in India.
So far, four vaccines—Moderna, Bharat Biotech's Covaxin, AstraZeneca's Covishield (manufactured by Serum Institute of India), and the Russian-made Sputnik V—are in use in India currently.
