Headlines December 7, 2020
Pfizer India seeks emergency approval for Covid vaccine
American pharma company Pfizer has sought approval from India’s drug regulator – Drugs Controller General of India for emergency use authorisation of its coronavirus vaccine. The vaccine is ready to be rolled out in the United Kingdom and Bahrain. This is the first such request received by the DCGI amid the race to find a vaccine for the deadly virus, which has affected over 96 lakh people in India.
In its application Pfizer India has sought approval to “import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019.
United Kingdom is the first western country to clear the Covid-19 shot developed jointly by Pfizer and German biotechnology partner BioNTech, which has reported an efficiency of 95% in the third stage of trials.
For a vaccine to be allowed in India it must clear clinical trials here. However, the DGCI has the power to wwaive localised clinical trials for a vaccine.
Pfizer vaccine is said to have efficacy of over 90%.
Prime Minister Narendra Modi on Friday said “three indigenous vaccines are already in the final stages of trial. “Vaccines for COVID are likely to be ready within few weeks. Indian health agencies and manufacturers are working in tandem with global agencies. We are fully prepared for the roll out,” he said after an all-party meeting.
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