Pfizer seeks emergency approval for COVID-19 vaccine in India
United States-based pharmaceutical giant Pfizer has sought emergency approval for its COVID-19 vaccine from India's drug regulator. The vaccine, developed by Pfizer and the German firm BioNTech, has already received emergency approval in the United Kingdom and Bahrain. It has been found 95% effective. Notably, this is the first such request received by the Drugs Controller General of India (DCGI).
Pfizer seeks permission to import doses, waiver clinical trials
In its application, submitted to the DCGI on December 4, Pfizer India sought emergency use authorization for its COVID-19 vaccine, sources told PTI. The firm sought permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials on the Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, sources added.
Pfizer's two-dose vaccine found 95% effective
Pfizer-BioNTech's vaccine, called BNT162b2, uses messenger RNA (mRNA) technology, which has never been used for an approved vaccine. Late-stage trial data found the two-dose vaccine to be 95% effective. The efficacy was consistent across age, race, and ethnicity demographics, the companies said. The UK had granted emergency approval to the vaccine on Wednesday, followed by Bahrain shortly after on Friday.
India has indicated disinterest in Pfizer's vaccine
Since the vaccine's doses require low temperatures of -70°C, India does not seem too keen on procuring Pfizer's product. Top government officials have said that maintaining such cold chain facilities would be very difficult, especially in its smaller towns and rural areas. Pfizer told PTI that it remains committed to engaging with India and explore opportunities to make the vaccine available in the country.
How bad is the outbreak in India?
According to the Union Health Ministry, as of 8 am on Sunday, India reported 96,44,222 COVID-19 cases with 36,011 fresh infections in the past 24 hours. The total cases include 4,03,248 active cases, while the number of recovered patients reached 91,00,792 with 41,970 new discharges. The death toll has climbed to 1,40,182 with 482 new deaths.
