India is considering full approval for two covid-19 vaccines

Seal of approval.
Seal of approval.
Image: REUTERS/Adnan Abidi
We may earn a commission from links on this page.

The Indian government’s vaccine panel has made way for two of its main covid-19 shots to receive full market approval.

The committee under the Central Drugs Standard Control Organisation (CDSCO) of the Indian health ministry has recommended that the Serum Institute of India (SII) and Bharat Biotech be granted “new drug permission.”

A final nod from the main drug authority is still pending, though.

SII manufactures the AstraZeneca vaccine in India under the Covishield brand and Bharat Biotech makes the homegrown Covaxin.

In January 2021, when India launched its nationwide covid inoculation drive starting with healthcare and frontline workers and the elderly, Covishield was granted restricted emergency authorisation while Covaxin was approved in “clinical trial mode.”

A full market approval, as in the case of Covishield and Covaxin, would now mean that, on paper, these vaccines can be sold in the open market. This is only meant for adults and will not benefit children awaiting vaccination—doses in India are only targeted at those aged above 15.

So far, the whole process is handled only through the government’s Cowin portal. This is unlikely to change anytime soon, given that vaccine certificates are issued via Cowin.

An upgraded approval, however, could have other benefits.

How will a full approval help Covishield and Covaxin?

Should India’s drug authority give a final nod to SII and Bharat Biotech, it could help boost public confidence in their vaccines.

This was observed when the US Food and Drug Administration granted Pfizer’s Comirnaty full approval on Aug. 23, 2021, after months of analysing its risks and benefits.

“Full FDA approval takes place when enough data demonstrate that the vaccines are safe and effective for most people who receive them, and when the FDA has had an opportunity to review and approve the whole vaccine manufacturing process and facilities,” according to the the Hopkins Medicine website.

In the US, such approval was crucial in countering vaccine hesitancy. “It’s the next and probably the last big opportunity to sharpen and drive home a clear message that the COVID vaccines are safe and effective,” Drew Altman, CEO of the Kaiser Family Foundation (KFF), wrote in an op-ed.

US president Joe Biden, while announcing the FDA approval for Pfizer, drove home the point about the importance of vaccine mandates.

Full approval for Covaxin and Covishield will likely have similar benefits in India. At the moment, vaccine mandates are not universal and only some cities like Mumbai, Chennai, and Gurugram ask for certificates to access public spaces. This will likely change once India achieves reasonable vaccine coverage, especially in densely populated cities.