Pfizer in talks with government over ‘expedited approval’ for its COVID-19 vaccine in India

Amid the second wave of COVID-19 in India and the shortage of vaccine doses from the two domestic manufacturers, Covishield by Serum Institute of India and Covaxin by Bharat Biotech, the American pharmaceutical company Pfizer on Monday said that the company is in discussions with the Indian government to seek an “expedited approval pathway” to make Pfizer-BioNTech vaccine available in the country.

The company was also revealed that the application to register its COVID-19 vaccine “was submitted months ago”, but the government has yet not responded to the application. Pfizer in their earlier statement had even said that the company had decided to prioritise orders from the government, and will supply doses of its COVID-19 vaccine “only through government contracts” in India.

“Pfizer is aware that access to vaccines is critical to ending this pandemic. Unfortunately, our vaccine is not registered in India although our application was submitted months ago. We are currently discussing with the Indian government an expedited approval pathway to make our Pfizer-BioNTech vaccine available for use in the country,” the company’s chairman and CEO Albert Bourla wrote to Pfizer’s India employees in a letter.

Pfizer helping India:

Apart from being in discussions with the Indian government regarding the approval of the Pfizer-BioNTech vaccine, the company’s chairman Albert Bourla also said that the firm is donating medicines worth $70 million (over ₹510 crore) for the treatment of COVID-19 patients.

Also, Pfizer is helping India in its fight against the deadly coronavirus disease by working towards mobilising the largest humanitarian relief effort in the company’s history.

Emergency use approval by Indian government:

Last month, the Government of India allowed emergency use approval of the imported vaccines in the country which have been granted emergency approval for restricted use by the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (UK MHRA), Pharmaceuticals and Medical Device Agency (PMDA) Japan or which are listed in WHO (emergency use listing).

Leave a Reply

Related Posts
Total
0
Share