As COVID-19 cases continue to mount in the world’s largest democracy, India is reportedly grappling emergency authorization of a developing COVID-19 vaccine, typically cutting short the phase III trial upon approval of the emergency use.
Health Minister Harsh Vardhan said on Sunday, that the nation may allow jabbing the high-risk people, especially the elderly and frontline COVID-19 workers with a developing vaccine if consensus is passed, Reuters reported.
If India happens to pass the authorization, it joins the likes of other nations like the US, which too is grappling with a potential mandate to use a currently under development vaccine on an emergency case-to-case basis.
Health Minister Vardhan, however, made it clear that the administration will leave no stones unturned when it comes to assessing the safety and efficacy of the vaccine in the clinical trials and the final rollout will be made only when the standard procedures are met.
“A vaccine expert group has been established recently by the government to look into various issues related to the delivery of vaccines to vulnerable populations,” Vardhan said.
Vardhan’s comments come as India records a skyrocketing number of daily cases. The fatality count has not downed 1k per day for nearly a month now. On Sunday alone, India recorded 94,372 new COVID-19 cases and 1,114 deaths.
The national total of India as of now stands at 4,754,356 cases as the nation pushes to re-open the fallen economy. Experts are interlinking the recent spurt in cases with the relaxed restrictions and reopening activities earlier prohibited to curb the spread.
Robust data required
In the US, the Trump administration is pushing vaccine makers to come up with an effective vaccine as soon as possible. Under Operation Wrap Speed, Trump said the US will come up with a potential vaccine for COVID-19 in record time, apparently pointing to the Nov. 3 election deadline.
However, experts have raised concerns over the usage of an underdeveloped vaccine which is not approved by the standard USDA protocol.
Emergency Usage Authorization or EUA typically means mandating the use of a potential vaccine on humans “in need when there are no adequate, FDA-approved, and available alternatives.”
However, it must be used only when enough data about the safety, efficacy and risks are there as per FDA’s website.
Just recently, the USDA has said it will require more robust evidence and detailed data on the efficacy of a vaccine before getting approved for emergency authorization.
In India, there’re almost 5 million confirmed cases, with over 78k deaths as of Monday, Johns Hopkins data shows.