‘Clinical trial mode’ condition of Covaxin manufactured by Bharat Biotech International taken off; Covaxin granted licence similar to Covishield
The Union government March 11, 2021 said the resurgence of the novel coronavirus disease (COVID-19) cases in a few states of India, especially Maharashtra, was a matter of serious concern.
The daily new cases, that had decreased to less than 9,000 per day in mid-February, have now increased to more than 20,000 cases per day. The graph of active cases of the disease that was consistently declining, has also increased now for the first time in the last couple of months. Currently, the number of active cases in India is 189,226.
Maharashtra is the biggest contributor to the tally. The active cases in the state February 11, 2021 were 36,917, officials from the Union Ministry of Health and Family Welfare said in a press conference. This number increased to 100,240 March 11.
There has been a more than four-fold increase in the number of active cases in Punjab. “The other states that are showing rise that is not consistent include Haryana, Gujarat and Madhya Pradesh. They are at the tipping point,” Union Health Secretary Rajesh Bhushan said.
“Be careful. Be watchful. The virus has not gone away,” Niti Ayog Member (Health), VK Paul said.
The top 10 districts of India in terms of active cases are Pune, Nagpur, Thane, Bengaluru urban, Ernakulam, Amravati, Jalgaon, Nashik and Aurangabad.
“The strategy to beat the virus is the same but with more efficiency, including testing, tracking and treating,” Bhushan said.
A specific query posed at the press meet was whether newer variants of the virus were responsible for the surge. Indian Council of Medical Research Director General Balrama Bhargava said a categorical “no”. However, a ministry team that went to Maharashtra to study the causes, did say that some “internal mutation” in the virus was reported from Amravati but did not attribute the surge to it.
“Reduced testing, suburban trains, congregations and improper following of COVID-appropriate behaviour seem to have contributed to the surge,” Bhargava said.
Ramping up vaccination
Paul said the states that were witnessing a surge should ramp up vaccination. He also informed that Bharat Biotech International’s Covaxin has been granted an emergency use authorisation licence similar to Covishield made by the Serum Institute of India and the ‘clinical trial mode’ condition of the former had been taken off. The subject expert committee had made such a recommendation to the Drug Controller General of India March 9 and the licence was to be changed based on his decision.
A revision in the licence would be mean the beneficiaries of this vaccine will not have to sign a consent form. Also, the recipients were supposed to get four-follow up calls from the centre from where they would have taken the vaccine. That would also stop now.
“We look forward to scaling up production of this vaccine now. Some 1.9 million have been administered till now and a minimal of 311 adverse events were observed,” Paul said.
The government officials, however, refused to answer how many doses of the two vaccines would be procured in the near future. “That is something we would not want to address because procurement and manufacturing is under consideration of the Delhi High Court and Supreme Court of India,” Bhushan said.
The ministry also refuted claims of Rajasthan’s Chief Minister Ashok Gehlot that the state was facing a shortage of vaccines. The ministry also claimed that India was only behind the United States in terms of the cumulative doses administered, according to data collected till March 9.
The ministry did not share any numbers about deaths following immunisation. “The national committee to investigate this has met only once and considered only two such deaths. No causal link was found between them and vaccination. It will be meeting again soon,” Manohar Agnani, joint secretary, said.
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