New Delhi: Bharat Biotech will submit safety data of its Covid-19 vaccine, Covaxin, every 15 days to India’s drug regulator — reporting even non-serious side effects — for the first two months, and every month thereafter. This is among the conditions set by the Modi government for granting an emergency-use authorisation to the vaccine.
Covaxin is the first indigenous Covid-19 vaccine, a collaborative effort between the Bharat Biotech — known for its low-cost vaccines — and the Indian Council of Medical Research (ICMR).
The apex regulator, Drugs Controller General of India, Sunday granted permission to the Hyderabad-based company to manufacture the vaccine for sale and distribution in India after approving the product under restricted emergency-use provisions.
The approval to the vaccine has been given based on the incomplete phase 3 clinical trial data, raising concerns among health experts. According to the DCGI, the vaccine has received the nod for “restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode”.
Also read: Covaxin approved as it’s more likely to act against mutant Covid strain, says ICMR chief
What ‘permission form’ orders
According to the ‘permission form’ signed by DCGI V.G. Somani, accessed by ThePrint, the regulator has said “the firm should submit safety data including the data on adverse event following immunisation (AEFI) and adverse event of special interest (AESI), with due analysis, every 15 days for the first two months and monthly thereafter and also as per requirement of New Drugs & Clinical Trials (Rules), 2019”.
According to the World Health Organization, an AEFI means any untoward medical occurrence following immunisation, which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease.
AESI, the WHO says, is a relatively new AEFI classification that started with pandemic vaccine development. AESI refers to adverse events of significant scientific, medical, and public interest among pandemic vaccines. This may include serious or non-serious side-effects of a vaccine.
According to the New Drugs and Clinical Trials Rules, 2019, the firm has to report the “serious adverse events (SAE)” within 14 calendar days from the “awareness of SAE or death”.
Bharat Biotech has also been asked to submit the risk-management plan, which comprises a series of activities to identify, evaluate, monitor, control, and prevent any factor that can be harmful.
ThePrint had earlier reported that the subject expert panel that granted approval to the vaccine agreed to do so — despite it still being under trial — based on a condition that the manufacturer would closely follow up with the recipients of the vaccine and do rigorous reporting.
The government’s apex laboratory, Central Drug Laboratory (CDL), Kasauli, will evaluate Bharat Biotech’s vaccine before it gets ready for distribution. The lab, reportedly, has already cleared 2.5 crore doses of Serum Institute of India’s vaccine, Covishield, developed by Oxford University and AstraZeneca.
“The permission is subject to conditions of satisfactory evaluation and lot release by CDL, Kasauli. Further, each batch/lot of whole virion inactivated coronavirus vaccine shall be released from CDL, Kasauli,” the permission form said.
Other conditions to start manufacturing, sale
The DCGI has also asked Bharat Biotech to provide the protocol to be followed in using the vaccine in emergency situations.
The company will also provide the “updated prescribing information or package insert and summary of product characteristics for whole virion inactivated coronavirus vaccine and also disseminate the necessary information, instructions and educational materials through their website”.
Another condition states: “The firm should submit updated safety, efficacy and immunogenicity data from the ongoing Phase 1, 2 and 3 clinical trials till the completion of trials as per the requirement of New Drugs & Clinical Trials Rules, 2019.”
Bharat Biotech will also submit the “ongoing stability of commercial scale batches (real-time and accelerated) of drug substance and drug product”, which means data on the content of the vaccine and its shelf-life for storage and transportation.
Also read: Congress questions why Bharat Biotech’s Covaxin was cleared without completing phase-3 trials