By Shalini BhardwajNew Delhi [India], May 14 (ANI): Even as Central Drugs Laboratory (CDL) Kasauli has already cleared more than 21 lakh doses of m-RNA Covid-19 vaccine doses for stockpiling, the Pune-based pharma company Gennova is facing allegations of violations of the clinical trial protocol.

The vaccine - GEMCOVAC-19 - is the country's first homegrown mRNA COVID- 19 vaccine and is seen as a game-changer for the healthcare industry.

A Gennova Biopharmaceuticals spokesperson told ANI that the company hasn't violated the protocol related to the clinical trial and will be submitting all necessary data for product approval.

"Product development using innovative technologies like mRNA, a fourth-generation vaccine platform stable at 2-8C, is a challenging journey during pandemic times. Regulators continuously review the data during various stages starting from pre-clinical studies to Phase III trials and seeking clarifications is a standard process. Gennova is in communications with the regulatory agency and submitting all necessary data and information required for the product approval," the spokesperson said.

A Health Ministry document accessed by the ANI titled 'Legal Position With Respect to Amendment to protocol' said it is observed that firm has not informed in time either after Phase II trial or before submission of the Marketing Authorisation application...however made major changes in approved protocol and not complied with the following requirements of NDCT Rules, 2019."The document has three points that show that according to the rule under clinical trials, changes cannot be made without any approval from the relevant authorities.

"No deviations from or changes to the protocol should be implemented without the prior written approval of the ethics committee and Central Licencing 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," it said.

"All such exceptions must be immediately notified to the ethics committee as well as to the Central Licencing Authority. Administrative or logistic changes or minor amendments in the protocol should be notified to the Central Licencing Authority within thirty days," the document noted.

The document has also mentioned the conditions of permission for the conduct of clinical trials as per rule 25.

"As per condition VI of 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".

As per approved and modified documents, according to the study design, a total of 2,916 subjects randomized in the study who give consent for immunogenicity assessment will be part of the cohort. Subjects are randomized in the ratio of 2:1 with 1944 subjects randomized to the HGCO19 arm and 972 subjects randomized to the Covishield arm.

The documents states that "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, some changes were done to the protocol. For instance, m-RNA vaccine amendments under phase 2 and 3 trials some changes were introduced - like day 29 day 43 day 57, day 119 and day 209 was supposed to include neutralisation antibodies against SARS-CoV-2 using surrogate assay but it was modified and day 57 was "cancelled" during the clinical trial protocol. (ANI)