In the vein of the World Health Organization (WHO) and the US Food and Drug Administration (US FDA), the Comptroller General of Medicines of India (DGCI) has issued a new set of guidelines for Covid-19 vaccine candidates, focusing on safety, immunogenicity parameters and efficacy.
According to the guideline, a Covid-19 candidate vaccine must be at least 50 percent effective in the phase 3 clinical trial to be widely deployed. In addition, the pharmaceutical companies developing the vaccines must provide adequate data reporting the potential risk of improved respiratory disease (ERD) associated with the vaccine.
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The DGCI has also asked drug companies to take pregnant and childbearing-age women into account while developing vaccines. Safety assessments throughout clinical development and all pregnancies in study participants for whom the date of conception is prior to vaccination or within 30 days of vaccination should be followed for pregnancy outcomes, including pregnancy loss, stillbirth and birth defects, he said.
Fifty percent efficacy is a world standard, since the WHO, in its guidelines, mentioned 50 percent efficacy for a vaccine to be accepted and pharmaceutical giants such as Astrazeneca, also, in their test plan stated that the company is working toward a 50 percent vaccine. percent efficiency. “For respiratory viruses, we never get 100% efficacy. Our goal is to achieve 100% efficiency, but we could achieve 50-100%, ”said Dr. Balram Bhargava, Director General of ICMR.
The DGCI has also asked pharmaceutical companies to submit a final analysis plan before closing the route database. “This should include any planned interim analyzes, which should be adequately addressed in terms of purpose, timing, and any required statistical adjustments,” the guide said.
“If a trial does not meet predefined criteria of superiority and / or non-inferiority with respect to any of the antigenic components, the possible reasons for the result and the clinical implications of the same must be carefully considered before proceeding with clinical development or licensing. . ”Said DGCI.
(With ANI inputs)
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