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Johnson & Johnson Withdraws Speedy Approval Request- Indian Drug Regulator

Following statements from the Drugs Controller General of India (DCGI) over Johnson and Johnson pulling its speedy approval proposal for local trials, the company has responded saying it is still discussing possibilities with the Indian government.  

Though the reason was cited neither by the drug regulator nor the pharmaceutical company, the latter in an emailed statement said, “We are in ongoing discussions with the Government of India and are exploring how best to accelerate our ability to deliver our COVID-19 vaccine to India.” 

In May this year, India had removed the compulsion for “well established” foreign vaccines to undergo local trials as part of its process for introducing the vaccine in the market. The move was made in an attempt to expedite the availability of covid shots to protect citizens against the wrath of the virus during the second wave.  

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While J&J was approved by the US FDA for emergency use in February this year, the vaccine candidate is yet to receive full approval. Controversies have surrounded the drugmaker since it started getting administered with a rare but serious blood-clotting disorder being linked to it.  

Europe joined the list recently as the country said it found Guillain-Barre syndrome, a rare nerve-degenerating disorder the vaccine’s side-effect. The finding was made following 108 global cases assessment. 

Speaking about foreign vaccines, the junior health minister said the government has formed a panel to discuss with the drug makers. “This team is in continuous dialogue with Pfizer, Moderna, and Johnson & Johnson to discuss and address various issues including the issue of indemnity,” Bharati Pravin Pawar had said last week during a press conference.  

Johnson and Johnson’s vaccine is told to be 66.3 per cent effective for mild to moderately affected cases of covid-19 and 76.3 per cent effective for critical to severe infection. Apart from this, the shot gives 100 per cent protection from getting hospitalized due to covid, 28 days after inoculation, as per the World Health Organization (WHO). 

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According to the data collected till July 28th, only 10 per cent of Indian adults had been vaccinated with both doses amongst the 944 million people who live here. 47 per cent people have been administered with at least one dose of a vaccine.