No approval yet for Bharat Biotech’s COVID-19 vaccine Covaxin: Expert panel seeks more data

The meeting of the Expert Committee says that the data provided by Bharat Biotech for its COVID-19 vaccine 'Covaxin' is not sufficient for grant of emergency use approval.

By: Jahnavi Sarma | | Published: January 1, 2021 10:42 pm

Covid Vaccine: 'कोविशिल्ड' के बाद 'कोवैक्सीन' को भी मिली आपात उपयोग की मंजूरी

Millions of Indians have been waiting with bated breath for the outcome of the meeting today on vaccine approval for the country. The decisions taken at the meeting are out now. The Subject Expert Committee of the Central Drug Standard Control Organisation has held that the data provided by Bharat Biotech for its COVID-19 vaccine ‘Covaxin’ is not sufficient for grant of emergency use approval and has asked for more information, top sources said. Meanwhile, the DCGI, on Thursday, had hinted at the approval of a vaccine and said that the country will have a “Happy New Year with something in hand”. Also Read - Covid-19 variant detected in UK may be ‘more deadly than the older virus strain’

Covishield becomes first vaccine to get approval in India

Earlier today, the expert committee, which is tasked with vetting COVID-19 vaccine proposals, recommended emergency licensure for the Serum Institute of India-manufactured ‘Covishield‘. It has now become the first vaccine to secure recommendation for emergency use in India. The Pune-based Serum Institute has partnered with Oxford-AstraZeneca for conducting clinical trials and manufacturing ‘Covishield’ while Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) for ‘Covaxin’. Also Read - ‘Enhanced immunity, no serious adverse events’: Lancet releases Covaxin’s Phase 1 trial data

Official sources said that the panel’s recommendation has been sent to DCGI V.G. Somani for approval. Once the approval comes, it will clear the way for the rollout of the vaccine in India, which incidentally has the highest number of infections in the world, after the US. Ministry sources said that the rollout will begin from January 6. The UK and Argentina have already approved Covishield. More than five crore doses of the vaccine have already been stockpiled by its manufacturer, the Pune-based Serum Institute of India. Also Read - Is reinfection of coronavirus a reality? Know if you are at risk

Three vaccine candidates in the fray

The committee had convened a meeting to take a call on the emergency use authorisation sought by the Serum Institute, Bharat Biotech and America’s Pfizer for their coronavirus vaccines candidates. Pfizer was the first one to apply for the accelerated approval on December 4, followed by the Serum Institute and Bharat Biotech on December 6 and 7, respectively.

Decision comes a day before dry run of vaccines in India

The meeting comes a day before dry run of the vaccine is slated to commence in all the states and Union Territories to equip the administration in management of vaccine supply, storage and logistics including cold chain management. The Central government plans to vaccinate nearly 30 crore people in the first phase of drive. It will be offered to one crore healthcare workers, along with 2 crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities.

(With inputs from IANS)

Published : January 1, 2021 10:42 pm

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