DCGI issues new guidelines for pharmaceutical companies working on COVID-19 vaccine

Fresh guidelines have been issued for the pharmaceutical companies developing COVID-19 vaccine by DCGI (Drugs Controller General of India). These new guidelines focus on immunogenicity, safety and efficacy parameters of the vaccine.

Under the new DCGI rules a COVID-19 vaccine trial candidate should have a minimum of 50% efficacy in the Phase 3 trials and enough data to understand the potential risk associated with ERD (Enhanced Respiratory Disease) to be utilised. DCGI also requires the COVID-19 vaccine to be 'well-characterized and manufactured consistently' and to 'remain stable at the recommended storage conditions for the duration of the clinical trial during clinical development stage and throughout its shelf life post-approval'.

Pharma giants have also been instructed to study and ensure the safety of the vaccine in pregnant women as well as its impact on the reproductive system.

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New DCGI guidelines for COVID-19 vaccine

Under the draft regulatory guidelines issued by DCGI, companies should 'include any planned interim analyses, which should be adequately addressed in terms of purpose, timing, and any statistical adjustments required'. It also clearly states that if the COVID-19 vaccine trial fails to meet the adequate safety criteria, it's clinical impact should be analysed before the commencement of the clinical development. During the clinical trials and development, the impact of the vaccine on pregnant candidates as well as the pregnancy outcomes should be studied carefully. 

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The draft also suggests that once the COVID-19 vaccine candidate is developed, the routes of administration of the vaccine should be studied like the intranasal, intradermal, rectal, oral and intravaginal methods. This will aid in understanding its potency in terms of immunogenicity, tolerability, toxicity and safety depending on different administration methods. In another recommendation, the pharma companies have been told to utilise an independent data safety monitoring board (DSMB) for vaccine-associated ERD along with other safety signal monitoring.

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Speaking about the efficacy of the COVID vaccine, the ICMR Director-General, Dr Balram Bhargav said, "There are three things for a vaccine--(i) the safety, (ii) immunogenicity, and (iii) the efficacy. Even, WHO says that if we can get more than 50 per cent efficacy that is an accepted vaccine. For respiratory viruses, we never get 100 per cent efficacy. We are aiming for 100 per cent efficacy but may get 50-100 per cent."

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(With inputs from ANI)