According to News18.com, India’s drug regulatory body is concerned with Pune-based vaccine producer Gennova Biopharmaceuticals for allegedly violating clinical trial standards for their mRNA vaccine against Covid-19. The vaccine, known as GEMCOVAC-19, is the country’s first indigenous mRNA Covid-19 vaccine, which is a heat-stable product and has been dubbed a game-changer for the future of the healthcare business.
While Gennova submitted interim data on its mRNA Covid vaccine to the drug regulator in March, seeking emergency use authorization, the regulatory agency, Central Drugs Standard Control Organisation (CDSCO), discovered at least five changes in the trial protocol that were made without seeking approval from the drug regulator, thus violating the protocols.
‘The changes went unreported even by the subject expert committee (SEC), and now discussions with the corporation are underway to obtain further clarification,’ a top official at the Ministry of Health and Family Welfare told News18.com. ‘Protocol infractions are regarded extremely seriously’, Dr. Sanjay Singh, the CEO of Gennova, did not respond immediately to a text message. When he answers, the copy will be updated.
DOCUMENT INTERNAL
‘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,’ according to an internal document obtained by News18.com.
The papers in the following three points prove that, according to clinical study protocol, modifications cannot be done without prior clearance from the appropriate authorities. ‘No modifications or changes to the protocol shall be executed without the previous written consent of the ethics committee and the Central Licensing Authority, except where essential to avoid urgent dangers to the trial subject or the trial environment.’
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 states that ‘clinical trials shall be conducted in accordance with the approved clinical trial protocol and other related documents, as well as the requirements of Good Clinical Practices Guidelines and the provisions of these rules,’ according to Rule 25 (Conditions of permission for conduct of clinical trial).
PROTOCOLS APPROVED AND MODIFIED
The study’s design called for a total of 2,916 volunteers to be randomly assigned. Subjects were randomly assigned in a 2:1 ratio, with 1,944 assigned to the mRNA vaccination arms and 972 assigned to the Covishield arm. ‘According to the updated sample size calculation, immunogenicity assessment for evaluating non-inferiority will be tested in a total of 714 participants [476 subjects in GEMCOVAC-19arm (378 evaluable)],’ the paper adds.
According to the government document, some of the alterations made throughout the clinical study procedure included modifying the objectives and outcomes in phase 1 and phase 2 studies. As an example: The goal of the Phase II and III subhead was to evaluate neutralisation antibodies against SARS-CoV-2 using a surrogate assay on Days 29, 43, 57, 119, and 209. The test on day 57 was cancelled here. Another particular serum neutralising antibody level measurement using live virus was scheduled for Day 29, Day 43, Day 57, Day 119, and Day 209. According to the official document, Day 57, Day 119, and Day 209 were removed. The vaccine will now be awarded an emergency use authorization.
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