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Now, Bharat Biotech seeks emergency use approval for COVAXIN

Now, Bharat Biotech seeks emergency use approval for COVAXIN

Dec 08, 2020
12:14 pm

What's the story

After US-based Pfizer and Pune's Serum Institute of India, Bharat Biotech has sought an emergency use approval for its coronavirus vaccine, named COVAXIN. The vaccine is being developed indigenously by the Hyderabad-based company and the Indian Council of Medical Research (ICMR), the top government body leading the fight against coronavirus. The vaccine is currently in phase three trials. Here's more.

Details

Countries are giving approvals considering the unprecedented situation

As per reports, an application regarding the same has been sent to the Drugs Controller General of India (DCGI). If granted permission, doses of the vaccine will be given to a select group of people. Such approvals are rare in nature, but countries have been going ahead with it considering the intensity of the pandemic. Till now, 1,550,263 have died worldwide.

Quote

Bharat Biotech submitted its application on Monday

"This (Bharat Biotech's) is an application (under the category of) issue of permission to either import, manufacture a drug or for grant of clinical trial NOC (no-objection certificate)," a person privy to developments told Indian Express.

Process

Expert panel will review the submissions of three companies tomorrow

As three companies have sought emergency use authorization, the government has also framed the next steps. As per reports, an expert panel will review their submissions tomorrow. After thoroughly assessing the requests, the panel will share its findings with DCGI, which will then take a call. The approval will only be granted once authorities are confident that the vaccine is safe and effective.

Looking back

Earlier, minister, who was given COVAXIN, tested positive for coronavirus

Notably, last week, Haryana's minister Anil Vij, who was administered a dose of COVAXIN in November, tested positive for COVID-19. Later, officials conducting trials refused to link Vij's infection with the vaccine, saying he was only given the first of the two doses needed. They argued that antibodies to protect someone from the disease are generated after the second dose, reports Indian Express.

India's tally

Meanwhile, India's coronavirus tally is nearing the one crore mark

Disturbingly, India is the second worst-hit nation and is inching close to the one crore mark, as far as infections are concerned. At 9,703,908 total cases, the country has lost 140,994 to the contagious disease. This means citizens are desperately waiting for a vaccine. Last week, Prime Minister Narendra Modi assured India won't have to wait for long.