Covaxin WHO approval: what is the latest Covid-19 vaccine and why is it so significant?

India's first homemade vaccine was approved for use in the country in January but is not yet recognised by the World Health Organisation

India administered its billionth Covid-19 vaccine dose on October 21, according to the health ministry, half a year after a devastating surge in cases brought the health system close to collapse. Prakash Singh / AFP

A health worker prepares to administer a Covishield vaccine in Chennai. Arun Sankar / AFP

A health worker inoculates a woman with a dose of the Covaxin vaccine in New Delhi. Prakash Singh / AFP

A health worker, left, registers a man for a dose of the Covaxin vaccine in New Delhi. Prakash Singh / AFP

A health worker inoculates a man with a dose of the Covaxin vaccine in New Delhi. Prakash Singh/ AFP

Volunteers decorate a vaccination centre to celebrate India administering its billionth Covid-19 vaccine. Prakash Singh / AFP

The World Health Organisation (WHO) will meet on Tuesday to discuss the long-awaited fate of India’s first homemade vaccine.

Covaxin has been used in India since its approval for emergency use in January. It accounts for about 11 per cent of total shots administered in the country.

Its manufacturer, Bharat Biotech, first submitted an expression of interest in applying to the WHO for emergency use in April.

So why has it taken so long for the organisation to consider the application?

The National explains.

Why the delay?

The WHO defended the long wait recently, saying it cannot cut corners when considering applications.

It said it was seeking one additional piece of information from Bharat Biotech, which it expected to receive imminently.

“We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the #COVID19 Emergency Use Listing, but we cannot cut corners — before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective,” the WHO said in a series of tweets last week.

“Bharat Biotech — the manufacturer of Covaxin — has been submitting data to WHO on a rolling basis and WHO experts have reviewed these data.

“WHO is expecting one additional piece of information from the company today.

"When the information provided addresses all questions raised, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation whether to grant EUL to the vaccine,” it added.

It is not known what data was missing.

Where else has the vaccine been approved, aside from India?

The vaccine has been approved in eight other countries: Guyana, Iran, Mauritius, Mexico, Nepal, Paraguay, Philippines and Zimbabwe.

An application for emergency use was rejected by the US Food and Drug Administration for Covaxin in June due to the submission of incomplete trial data.

What will change with WHO approval for emergency use?

Travel will become a lot easier for those who have had the shot.

Because most countries require travellers to be vaccinated, and they generally only recognise vaccines approved by themselves or the WHO, options for those inoculated with the Covaxin jab are extremely limited.

WHO approval will mean the vaccine will be recognised in more countries.

Approval would also greatly expand the number of vaccines available to Covax, which aims to provide equitable access to vaccines for poor nations.

The UN and the WHO recently launched a plan to fully vaccinate 40 per cent of the world’s population against Covid-19 by the end of the year and 70 per cent by the middle of 2022.

Last week, it emerged India had delayed committing supplies to Covax after WHO said it would not cut corners in approving the vaccine.

The manufacturer halted exports of the vaccine in April as the delta variant took hold but resumed them this month.

How effective is it?

It was found to be 81 per cent effective in phase 3 trials but is slightly less against delta, at 65 per cent.