India is going to have its first indigenous mRNA vaccine which is stable at 2-8 degrees Celsius as the expert panel advising the Central Drugs Standards Control Organization (CDSCO) has green-signaled Gennova Biopharma’s mRNA vaccine candidate for Covid19. The Subject Expert Committee (SEC) has recommended granting the Emergency Use Authorisation (EUA) to the country’s first mRNA-based Covid-19 vaccine in a meeting.
Now, the Drugs Controller General of India (DCGI) will take a final call on granting the final approval.
The SEC has reviewed data from the trials done on 4000 volunteers. The CDSCO had raised some queries after Gennova had submitted interim data from the trials in April. The company submitted the additional data eventually. In June, the company further approached CDSCO seeking approval.
Gennova’s vaccine has an edge over its international peers as it does not require sub-zero temperatures like Pfizer-BioNTech and Gennova’s vaccine has an edge over its international peers as it does not require sub-zero temperatures like Pfizer-BioNTech and Moderna’s vaccines.
NK Arora, head of Covid-19 working group, NTAGI, had earlier told Business Standard that they would consider the indigenous mRNA vaccine for inclusion in India’s ongoing national program for Covid19 vaccination.
The vaccine, however, is embroiled in controversies. US firm HDT Bio Corp has filed a lawsuit in a Seattle federal court against Gennova’s parent company Emcure Pharmaceuticals. HDT has accused Emcure of ‘stealing’ and misappropriation of HDT’s billion-dollar trade secrets and sought $950 million in damages. The US firm has alleged that Emcure’ willfully and maliciously violated the Defend Trade Secrets Act and Washington’s laws against trade secret theft.
Legal experts feel that the reliefs requested by HDT are primarily monetary in nature and not aimed at inducing any form of injunctions.
The lawsuit in a Seattle court by a US-based start-up may not immediately impact the launch of Pune-based Gennova Biopharmaceuticals’ mRNA vaccine HGCO19; once the vaccine receives the Indian regulator’s nod, feel legal experts. The long-term prospects of the vaccine may depend on how the case progresses.
