The Center today said it respects the US decision to deny emergency use authorization for Covaxin, however, it will have no impact on India’s vaccine plan.
“Every country’s regulatory system may have some things in common with others and some things may be different. We respect that. The scientific framework is the same but its specifics depend on the context. These are all scientific considerations and should be taken into account. Keeping this in mind, the specifics may be different, especially in countries where the science is strong. Our manufacturing is strong. They have decided that. We respect that,” said Dr VK Paul, Member-Health, NITI Aayog.
Dr VK Paul also expressed hope that the vaccine maker will follow what the FDA wants.
“We are hopeful that our manufacturers will be able to comply. It has no impact on our own schedule. Our regulator has approved it,” he said.
Dr Paul also mentioned that a phase 3 trial of Covaxin will be published sometime in 7-8 days.
Citing the example of rotavirus for children, Dr Paul said, “A vaccine manufactured in India may not be equally effective in Argentina.”
“Nutrition levels, the gut flora of a population make a difference in the impact of rotavirus. This can lead to some differences, especially in countries where the science is strong, and our build is strong,” said Dr. Paul.