The Drugs Controller General of India has issued a new set of guidelines for coronavirus vaccine facilities, on the lines of the World Health Organization and the United States Food and Drug Administration, the Hindustan Times reported on Wednesday.

According to the guidelines, a Covid-19 vaccine candidate should have at least 50% efficacy in the Phase-3 clinical trial for it to be widely used. The pharmaceutical companies developing the vaccines must provide data informing the users about the potential risk of vaccine-associated Enhanced Respiratory Disease.

The drug controller has also asked pharmaceutical companies to consider the situation of pregnant women and women of childbearing potential while developing vaccines. “For respiratory viruses, we never get 100% efficacy,” Indian Council of Medical Research Director General Balram Bhargava had said earlier this month. “We are aiming for 100% efficacy but may get 50-100%.”

The drugs controller also asked pharmaceutical firms to present a final analysis plan before closing the trail database. “This should include any planned interim analyses, which should be adequately addressed in terms of purpose, timing, and any statistical adjustments required,” it said. “If a trial fails to meet the predefined criteria for superiority and/or non-inferiority with respect to any of the antigenic components, the possible reasons for the result and the clinical implications of it should be carefully considered before proceeding with clinical development or licensure.”

On September 21, Union Minister of Health and Family Welfare Harsh Vardhan had told the Lok Sabha that four coronavirus vaccines in India were in advanced stages of pre-clinical trials. The same day, Phase-3 clinical trials of the “Oxford vaccine” began in Pune.

The Union health minister had told the Rajya Sabha last week that the government expected a vaccine against the coronavirus to be available in India by the beginning of the next year.

India’s coronavirus count rose to 56.46 lakh after the health ministry reported a rise of 83,347 new cases in 24 hours. The toll breached the 90,000-mark, with 1,085 more deaths. More than 45 lakh people have recovered from the virus in India. The country’s mortality rate is 1.59%.

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