Coronavirus Vaccination: Pfizer withdraws application for emergency use authorisation of its COVID vaccine in India
New Delhi | Jagran News Desk: Pharmaceuticals major Pfizer on Friday withdraws its application for the emergency use authorisation (EUA) of its vaccine candidate in India, news agency Reuters reported. Pfizer has developed its COVID-19 vaccine in association with Germany's BioNTech.
The decision to withdraw its application for EUA in India was taken after Pfizer officials met India’s drugs regulator on Wednesday regarding the approval of its vaccine candidate. Pfizer was the first pharma company to apply for the emergency use authorisation of its COVID-19 vaccine candidate in India.
"In pursuance of the Emergency Use Authorisation of its COVID-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3. Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time,” Pfizer said in a statement.
"Pfizer remains committed to making its vaccine available for use by the Government in India and to pursuing the requisite pathway for emergency use authorisation that enables the availability of this vaccine for any future deployment," the statement added.
Pfizer in its application submitted to the drug regulator in December 2020, had sought permission to import the vaccine for sale and distribution in India, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019.
However, the Indian drug controller rejected its application and stated that local clinical trials are a must for gaining emergency use authorisation in India. "As of now, the pre-condition for any vaccine to be implemented in India is that you have to do a bridging trial", NITI Aayog member VK Paul had said at that time.
Indian health officials said that they generally ask for so-called bridging trials to determine if a vaccine is safe and generates an immune response in its citizens whose genetic makeup can be different from people in Western nations.
India started its inoculation drive on January 16, during which, Covishield developed by Oxford and AstraZeneca and manufactured by Serum Institute of India and Bharat Biotech's Covaxin, are being administered to nearly 3 crore health care workers across the country.
Posted By: Talibuddin Khan