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DCGI removes Covaxin out of ‘clinical trial mode’

Covaxin is a two-dose vaccine administered to an individual 28 days apart (Reuters)Premium
Covaxin is a two-dose vaccine administered to an individual 28 days apart (Reuters)

  • Covaxin is now in ‘regular’ emergency use authorisation, and our terminology for this is that it is now allowed for restricted use in emergency situations, an official said
  • The omission of the clinical trial mode followed the company’s announcement of its interim phase 3 trial data, which showed the vaccine had an 80.6% efficacy

The Drugs Controller General of India V.G. Somani has accepted a subject expert committee’s (SEC) recommendation to remove the condition of ‘clinical trial mode’ for use of Bharat Biotech International’s covid-19 vaccine Covaxin, NITI Aayog member (health) Vinod K. Paul said on Thursday.

“Covaxin is now in ‘regular’ emergency use authorisation, and our terminology for this is that it is now allowed for restricted use in emergency situations in public interest and this has taken the authorisation for Covaxin to the next level, the same level at which another great vaccine Covishield has been operating," Paul said at a press conference.

On the sidelines, Paul said that the government has already started increasing procurement of Covaxin but declined to give details on how many doses of Covishield and Covaxin are being procured.

“They are also increasing production of the vaccine very soon," Paul said, adding that they will be increasing their capacity by about 50 million doses per month.

In January, Mint had reported that Bharat Biotech was setting up three facilities at Hyderabad as well as another in Bengaluru, which would together raise their capacity by about 40-50 million doses a month. The company is aiming to have a total annual capacity of around 700 million doses.

Covaxin, developed by Bharat Biotech International, is one of two covid-19 vaccines authorised by the regulator in January but, controversially, this licensure for Covaxin was granted despite the developers’ inability to submit data from phase-3 trials. The other vaccine is Covishield, Serum Institute of India’s version of the jab developed by the University of Oxford and AstraZeneca plc.

The SEC on Wednesday had recommended the removal of the condition after it reviewed the company’s interim phase 3 trial data released on 3 March, which showed an efficacy of 80.6%. The data, which is yet to be peer-reviewed, was based on detection of 43 cases among the 25,800 participants, of which 36 were in the placebo arm and seven were in the vaccine arm of the trial.

“After detailed deliberation, the committee recommended for omission of the condition of the use of the vaccine in clinical trial mode. However, the vaccine should be continued to be used under restricted use in emergency situation condition," the SEC said in its recommendation.

The omission of the clinical trial mode followed the company’s announcement on 3 March of its interim phase 3 trial data to the regulator, which showed the vaccine had an 80.6% efficacy. This data is yet to be peer reviewed.

When the regulator had given its authorisation to the vaccine under ‘clinical trial mode’ in January it had placed an initial order of 5.5 million, and later that month also given the company a letter of comfort—a preliminary order—for another 45 million doses. It is not clear how many doses of the vaccine have so far been procured.

Health secretary Rajesh Bhushan on Thursday said that the government will not disclose the number of doses that have been procured as the matter is in courts.

As per the government’s Cowin platform, over 1.75 million people have received Covaxin while over 18 million people have received Covishield.

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