New Delhi | Jagran News Desk: Bharat Biotech COVID-19 vaccine Covaxin has shown the efficacy of 77.8 per cent in phase three human clinical trials, news agency ANI quoted sources as saying. The data was submitted to the Subject Expert Committee (SEC) today, which released the efficiency of the vaccine against the deadly virus in phase 3 trials. 

The Hyderabad-based COVID vaccine manufacturing company had submitted data from the Phase III clinical trials of Covaxin to the Drugs Controller General of India (DCGI) over the weekend. Bharat Biotech's 'pre-submission meeting with the World Health Organization (WHO) will take on Wednesday for the approval for Covaxin.

Covaxin is one of the three vaccines which are currently being used in India. The phase III data of its vaccine has been questioned various times and this is what makes the data that ascertains the efficacy of the vaccine crucial. The company has developed the vaccine in association with the Indian Council of Medical Research (ICMR).

In a press briefing a few days ago by the Union Health Ministry, Dr V K Paul, who is a member (Health) Niti Aayog and also the head of the COVID task force of the country, said that the company would be submitting the data within seven to eight days.

In May, Bharat Biotech had said that an emergency use listing (EUL) application had been submitted to WHO, with regulatory approvals expected between July and September.

The trial data for Phase-III is crucial as it will provide details of the efficacy of the vaccine, which was developed in association with the Indian Council of Medical Research (ICMR). Phase-III trial data is also required for getting emergency use listing (EUL) from the World Health Organisation (WHO).

Earlier, the company had said it will submit the data to the drug regulator, followed by peer-reviewed journals, with a timeline of three months for publication. Complete results of Covaxin's Phase-III trial data will be made public in July.

The pharmaceutical company has been facing hurdles in getting the made-in-India vaccine approved in some foreign countries since it lacks Phase-3 trial data, which is essential for approval by the WHO in order to export the vaccine.

Posted By: Talibuddin Khan