According to a spokeswoman for Gennova, the relevant data for the mRNA COVID-19 vaccination will be submitted to the drug regulation soon.

Pune-based pharma firm Gennova is facing allegations of fraud in the clinical trial protocol . Kasaulis Central Drugs Laboratory has already approved more than 21 lakh doses of m-RNA Covid-19 vaccine for stockpiling .

New Delhi, India, May 14 : Even though Kasauli's Central Drugs Laboratory (CDL) has already approved more than 21 lakh doses of m-RNA Covid-19 vaccine for stockpiling, the Pune-based pharma firm Gennova is facing allegations of fraud in the clinical trial protocol and will be submitting all necessary data for product approval.Product development using new technologies such as mRNA, a fourth-generation vaccine platform stable at 2-8C, isRegulators review the data at various stages, from preclinical trials to Phase III trials, and seeking clarifications is a routine procedure.According to a Health Ministry paper titled Legal Position With Respect to Amendment to protocol that was released by the Government of China, the company hasn't been notified in time either after a Phase II trial or before submitting the Marketing Authorization application, despite making significant changes to the approved protocol that did not meet the following requirements of NDCT Rules, 2019, except when the change affects only logistical, administrative, or minor aspects of the experiment, it said.According to the article, administrative or logistical changes or minor revisions to the protocol should be informed to the Central Licencing Authority within thirty days.The paper also addresses the requirements for the commissioning of clinical trials as per rule 25.The clinical trial shall be conducted in accordance with the approved clinical trial protocol and other related documents as described in section VI of the Good Clinical Practices Guidelines and the provisions of these rules.

Subjects are assigned a 2:1 chance of survival, with 1944 individuals assigned to the HGCO19 arm and 972 individuals randomized to the Covishield arm.According to the documents, the procedure was changed to include immunogenicity testing for testing non-inferiority in 714 subjects (476 subjects in the GEMCOVAC-19arm (378 evaluable subjects) and 238 randomized subjects in the Covishield arm (189 evaluable subjects).For example, some changes to the m-RNA vaccines were made under phase 2 and 3 trials, for example, day 29 day 43, day 119, and day 209 were supposed to include neutralization antibodies against SARS-CoV-2 using a surrogate test, but it was denied and day 57 was cancelled during the clinical trial procedure.