India can immediately have a Messenger or MRNA vaccine, with phase 3 clinical trials which are almost complete by Gennova biopharmaceuticals, even when companies also begin to develop a variant or omicron vaccine using the same technology platform.
Pune company recently sent Phase 2 test data from more than 3,000 mRNA vaccine subjects they were developed in the Delta variant, and almost completed the phase 3 trial, said the source to TOI.
It has begun to make a “risky” vaccine and can launch a “sufficient” number after getting a rules.
Indian drug regulators are expected to review the data this week and make decisions regarding approval immediately, the official source said.
Gennova-based Pune has developed a MRNA vaccine for omicron variants in the laboratory, which will be tested for human use for efficacy and imunogenicity immediately, said the source to TOI.
Dr.
VK Paul, head of the National Covid-19 task force, told TI that the development of the MRNA platform was a significant scientific achievement for the country.
The thermo-stable vaccine (using existing cold chain infrastructure) and platforms can be useful for Covid after being deployed, and even outside, he said.
Omicron specific vaccines that are being developed are also exciting while the platform will quickly play as and when the mutant strain appears, he said.
“The drug regulator will study and make a decision whether the approval can be given (to Gennova),” Dr.
NK Arora, Chairman of the Indian technical advisory group about Covid vaccination, said.
Bharat Biotech recently claimed that the Booster’s shot from Covaxin would neutralize the omicron variant, but it was understood that the data had not been studied by the regulator.
Globally, also, modern, Janssen, Sinopharm, Gamaleya, Novavaks and Astrazeneca are being tested to check their efficacy of Omicron, while many others are in development.
Pfizer said the MRNA vaccine targeting the Omicron variant would be ready in March.
The safe and effective vaccine using the next generation MRNA platform can be an important choice for increasing the immunity of health workers and vulnerable populations, and expanding the vaccine basket for the country’s Covid immunization program.
Gennova, a subsidiary of Emcure Pharmaceuticals, also developed on a pediatric vaccine for the age group of 5 to 17 years, and has submitted a protocol determined to conduct trials.
MRNA vaccine technology is synthetic and has the potential to reduce the velocity of the vaccine development timeline, Biopharm Gennova CEO Dr.
Sanjay Singh to Ti.
The same technology platform, called ‘ready to pandemic’, can be used and enhanced quickly like a virus mutating.