Pfizer’s Covid-19 vaccine seeks expedited approval for use in India
International pharmaceutical giant Pfizer is under discussions with the government of India as it seeks expedited approval for its Covid-19 vaccine availability and use in the country. The development was shared by Chairman and CEO of Pfizer, Albert Bourla on Monday. In April, the company had offered a “not for profit” price quotation to Indian government’s national vaccination program as an extension of its commitment to make vaccine available to the maximum population across the globe. The company asserted that it is continuing with its commitment to engage with the government along the same path.
Bourla sent a mail to all Pfizer employees in India, a copy of which was also shared on his Linked.in profile. It read, “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.”
Pfizer has cleared that during pandemic it would be making the vaccine against Covid-19 available only through government contracts.
Last month, the government of India had announced of giving emergency use authorization (EUA) to all those imported Covid-19 vaccines that have been granted emergency approval for restricted use by 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 whichever are listed in WHO’s emergency use listings.
India is witnessing one of the most catastrophic and devastating second wave of Covid-19 infection with mounting new cases tally as well as death rate. The struggle has been aggravated by mounting pressure on country’s healthcare framework in form of shortage of medical oxygen and hospital beds, depleting stocks of Covid-19 vaccine. Many countries have extended support to India by dispatching oxygen, medicines and other aid.