: Pfizer in talks with India for expedited approval of Covid vaccine #IndiaNEWS Pfizer’s Chief Executive Officer Albert Bourla said on Monday that the pharmaceutical company was in talks with the Indian

Pfizer in talks with India for expedited approval of Covid vaccine #IndiaNEWS
Pfizer’s Chief Executive Officer Albert Bourla said on Monday that the pharmaceutical company was in talks with the Indian government for an “expedited approval pathway??? for use of its coronavirus vaccine in the country.“Pfizer is aware that access to vaccines is critical to ending this pandemic,??? Bourla said on LinkedIn. “Unfortunately, our vaccine is not registered in India although our application was submitted months ago.???Russia’s Sputnik V is the third vaccine to receive emergency-use authorisation in India after the Serum Institute’s Covishield and Bharat Biotech’s Covaxin. Several states in India have run out of vaccines, exacerbating a dire second wave of infections.Although Pfizer had not conducted local trials in India, provisions under Clinical Trial Rules, 2019, allowed it to seek approval without conducting the tests. It was permitted as the vaccine had received approval from a foreign drug regulator recognised by the Central Drugs Standard Control Organization.Last month, the Centre had also allowed emergency use approval of the imported vaccines in India which got permission for restricted use by United States Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, among others.Bourla said the company was “deeply concerned??? by the coronavirus situation in India. “Our hearts go out to you, your loved ones and...Read more

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