Pfizer Seeks Emergency Authorization Of Its COVID Vaccine From India
The American Coronavirus vaccine manufacturer sought approval from India’s drugs regulatory body to approve its import and sale in the country
After its approval in the United Kingdom, American pharmaceutical giant Pfizer has approached India for an emergency approval of its newly launched Coronavirus vaccine. The company has applied to the Drugs Controller General of India (DGCI) to bring the COVID19 vaccine to the country for sale and distribution. It has also sought a waiver for clinical trials on the Indian population under the New Drugs and Clinical Trials Rules, 2019.
However, sources reveal that it will not be that easy for the pharma organization to penetrate the Indian market for technical reasons. First, no clinical trials have been conducted on the nation’s people yet and second, the storage requirements of the injection at -70 degrees Celsius makes it a more challenging endeavour.
The inoculation, developed in the United States in a joint effort with the Germany-based BioNTEch is touted to be the best currently, with an estimated efficacy rate of 95%. Last week, the United Kingdom became the first country to authorize a legal approval for the COVID dose. Britain is expected to start its mass vaccination program this week, with an initial 8 lakh doses imported for the health drive.
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