why hasn’t the world health organization(WHO) authorized Covaxin yet?

Traveling the world is valuable and who doesn’t want such worthwhile experience. Even In this trying times, everyone has an urge to travel the globe to experience the beauty of the world and have incredible experiences to add up in their brain’s memory bank.

But are you the one who is vaccinated by covaxin but can’t be treated as vaccinated and be permitted to travel across international borders?

Well, here are the reasons why covaxin is not approved by world health organization yet. 

First of all, we need to understand the process of getting a vaccine approved By WHO. It consists of four parts, Namely,

1. acceptance of the manufacturer’s expression of interest, 

2.A pre submission meeting between WHO and the manufacturer, 

3. Acceptance of the dossier for review by WHO, 

4.Decision on status of assessment and the final decision on approval.

Now If we talk about  the approval of covaxine which was manufactured by Bharat Biotech. The first step itself is not completed yet. That is the acceptance of the manufacturer’s expression of interests is not accepted by the WHO and more information is needed as reported by Who in order to clear the first stage. Bharat Biotech, located in Hyderabad, submitted 90 percent of the documents required for the WHO’s Emergency Use Listing in April month. The rest of the paperwork would be presented this month, according to the statement provided by the manufacturing company.

The second step which consists of a pre submission meeting between WHO and the bharat biotech will also be held in this month Meanwhile, the WHO authorized the Pune-based Serum Institute of India (SII), which manufactures Astrazeneca’s Covishield vaccine, on February 15 after passing the same four phases. The approval procedure is classified, and it is unclear what papers are needed at this time to approve covaxine. Therefore, the Indian people who got fully vaccinated by covaxine are sceptical of it’s authorization by WHO because recently, US food and drug administration also rejected Bharat Biotech’s proposal for an emergency use authorization (EUA) of Covaxin, delaying the company’s vaccine launch in that country. 

The government of india’s take on US FDA disapproval is that it respects the FDA’s decision not to grant Covaxin an EUL, but claims it will have no influence on India’s immunisation programme. Union minister of information and broadcasting prakash javedekar said in the press briefing that “The World Health Organization (WHO) has not made a judgement on whether or not persons who have been vaccinated with Covaxin should be prohibited from travelling. Covaxin is a vaccination that has shown to be one of the most successful to date.”

So, when can we expect the authorization of covaxin by world health organization is a question we all needs answer for. On June 9 bharat biotech said that the company will reveal all of Covaxin’s phase 3 trial results in July 2021, after which it will commence the phase 4 trial while concurrently applying for a complete license in India. The submission of trial results are important because it is a prerequisite for Obtaining the WHO Emergency Use Listing.

A good news for the people who got inoculated by covaxine is that so far, few countries like Iran, Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay and Zimbabwe have approved the Covaxin. But, The European Union and the United States are unwilling to let Indians who have been vaccinated with Covaxin to enter their countries since WHO authorisation is still pending.