The drug regulatory authority of India is upset with Pune-based vaccine-maker Gennova Biopharmaceuticals over the alleged violation of clinical trial protocols for its mRNA vaccine against Covid-19, News18.com has learnt.
The vaccine, known as GEMCOVAC-19, is the country’s first homegrown mRNA Covid- 19 vaccine, which is a heat stable product and pegged as a game-changer for the future of the healthcare industry.
While Gennova had submitted interim data on its mRNA Covid vaccine to the drug regulator seeking the emergency use authorisation in March, the regulatory agency, Central Drugs Standard Control Organisation (CDSCO), has noticed at least five modifications in the trial protocol which were undertaken without seeking approval from the drug regulator, thus violating the protocols.
“The modifications went unnoticed even by the subject expert committee (SEC) and now deliberations are going on with the company to seek more clarity,” a top official at the Ministry of Health and Family Welfare told News18.com. “The violations of the protocol are taken very seriously.”
A text message sent to Gennova’s CEO, Dr Sanjay Singh, did not receive immediate response. The copy will be updated as and when he responds.
INTERNAL DOCUMENT
According to the internal document, titled ‘Legal Position With Respect to Amendment to Protocol’ accessed by News18.com: “It is observed that the firm has not informed in time either after Phase II trial or before submission of marketing authorization application, however, made major changes in approved protocol and not complied with the following requirements of NDCT Rules, 2019.”
The documents in the next three points establish that as per the rule of clinical trials, changes cannot be made without seeking prior approvals from the relevant authorities.
“No deviations from or changes to the protocol should be implemented without prior written approval of the ethics committee and Central Licensing Authority except when it is necessary to eliminate immediate hazards to the trial subject or when change involves only logistic or administrative or minor aspects of the trial.”
The document states: “The law clearly states that all such exceptions must be immediately notified to the ethics committee as well as to the Central Licensing Authority. Even if the changes are minor in nature, they should be notified to the Central Licensing Authority within thirty days.”
It also says that as per the Rule 25 (Conditions of permission for conduct of clinical trial), “clinical trial shall be conducted in accordance with the approved clinical trial protocol and other related documents and as per requirements of Good Clinical Practices Guidelines and the provisions of these rules”.
APPROVED AND MODIFIED PROTOCOLS
According to the study design, a total of 2,916 subjects were randomised in the study. Subjects were approved to be randomised in a ratio of 2:1 with 1,944 subjects randomised to mRNA vaccine arms and 972 subjects randomised to Covishield arm.
However, the document states: “As per the revised sample size calculation, immunogenicity assessment for testing non-inferiority will be evaluated in a total of 714 subjects [476 subjects in GEMCOVAC-19arm (378 evaluable subjects) and 238 randomised subjects in Covishield arm (189 evaluable subjects).”
As per the government document, some changes introduced while conducting the clinical trial protocol include changing the objectives and endpoints in phase 1 and phase 2 trials. For instance: In the Phase II and III subhead, the objective was to test neutralisation antibodies against SARS-CoV-2 using a surrogate assay at Day 29, Day 43, Day 57, Day 119 and Day 209.
Here, the test on day 57 was cancelled. In another instance, measuring another specific serum neutralising antibody levels using live virus was planned at Day 29, Day 43, Day 57, Day 119 and Day 209. Here modifications were made to remove Day 57, Day 119 and Day 209, as per the government document.
Now, the emergency use authorisation shall be granted to the vaccine only after seeking the clarification on the modifications. “The process is going on,” the official quoted above said.
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