There has been rather little research or innovation in improving the efficacy of the KFD vaccine, a rather old product. Decided to understand vaccine safety using this product as a proxy and here is a compilation of ongoing work to understand this.
Given that CDSCO seems to have completely left vaccine safety moniotoring to the state drug licensing authority, I asked them for information on how they do this.
Regarding the vaccine that is labelled as "Viral vaccine for human use: Kyasanoor forest disease vaccine (Killed)" manufactured by "M/S Institute of Animal Health & Veterinary Biologicals, Bellary Road, Bangalore", please provide information on the following questions with respect to the aforementioned vaccine: 1) When was the manufacturing license provided for this vaccine? Provide date of latest license issued and by whom? 2) Has this vaccine been approved by Government of India CDSCO? If yes, please provide copy of the approval and the date of approval. 3) How frequently does the State Drugs Control Dept. receive information on the potency of the vaccine? If yes, when was the last information on its potency received and pls provide a copy of the report? 4) Have any adverse effects been reported for this vaccine? If yes, mention number of instances across the state in the years 2018, 2019, 2020 & 2021. 5) If no monitoring of the potency is being conducted by the department, please outline steps that department has taken since 2018 to ensure that the vaccine is safe and effective?
As this was incomplete, I filed an appeal and was asked to appear for a hearing which I appeared leading to the following order. The order gives 7 days for the rest of the information to be supplied
Few unanswered questions:
1. Is there no need for any oversight from CDSCO for vaccine products once they give a license to a manufacturer (in this instance CDSCO oversight on vaccine has not happened since granting licence in 2000)
2. How competent are state DCDs in conducting efficacy and potency studies? Do they do this?
3. How good is our adverse effects monitoring system?
4. Whose responsibility is vaccine safety? The manufacturers or the State’s (DCDs)?
What is of course deeply puzzling is the complete washing off of hands of adverse events tracking by the regulator in their response that the manufacturer has no adverse events recording.