Explained: Why Covaxin is not approved by WHO? Why USFDA rejected its emergency use? Will it affect international travel?

Students, working professionals and people planning to travel abroad to meet their families are expected to wait longer if they have been vaccinated by Bharat Biotech’s Covaxin. What is the controversy about? Read on to know more.

Gaon Connection
| Updated: Last updated on July 30th, 2021,

Due to its pending approval from WHO, the European Union and the US are not willing to allow Indians who have been vaccinated by Covaxin to enter their countries.

When it comes to the approval of countries and regulatory bodies, people vaccinated with some of the COVID19 vaccines are finding it difficult to be treated as vaccinated and be allowed to cross international borders. 

Bharat Biotech’s Covaxin, India’s first indigenous COVID19 vaccine, is facing similar challenges.

The vaccine has not yet been approved by the World Health Organization for emergency use listing. Yesterday, June 10, the US Food and Drug Administration (US FDA) also rejected Bharat Biotech’s proposal for an emergency use authorization (EUA) of Covaxin, delaying the company’s vaccine launch in that country. 

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The FDA has cited insufficient information on Covaxin to grant approval to its emergency use authorisation request for this vaccine.

This has affected the travel plans of a large chunk of Indian population that has received Covaxin as part of the government’s COVID19 vaccination drive. Whether it is the Indian students who need to join the fall academic session in European countries, or job aspirants who need to travel to the US, all travel plans are in limbo.

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Why is Covaxin not approved by WHO?

The process for approval of a vaccine by WHO consists of four steps: an acceptance of the manufacturer’s expression of interest (EOI), a pre-submission meeting between WHO and the manufacturer, acceptance of the dossier for review by WHO, decision on status of assessment, and the final decision on approval.

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In case of Bharat Biotech’s Covaxin, the first step itself i.e. it’s EOI has not been accepted yet and in its status report, WHO remarks that ‘more information is required’.

The image on Bharat Biotech’s official website.

The Hyderabad-based biotech company had submitted its EOI on April 19. The second step, the pre-submission meeting is scheduled for this month (June 2021).

Meanwhile, Pune-based Serum Institute of India (SII), which manufactures Astrazeneca’s Covishield vaccine, was approved by WHO on February 15 after clearing the same four steps.

So far, only Brazil, Iran, Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay and Zimbabwe have approved the Covaxin.

Due to its pending approval from WHO, the European Union and the US are not willing to allow Indians who have been vaccinated by Covaxin to enter their countries.

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So far, only Iran, Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay and Zimbabwe have approved the Covaxin.

Source: Bharat Biotech

US FDA declines approval as well 

The US FDA has also declined to give its nod to Covaxin. The FDA has cited insufficient information on Covaxin to grant approval to its emergency use authorisation request for this vaccine.

Ocugen, the US partner of Bharat Biotech has said the company will now be seeking a full approval of Covaxin. The US FDA has asked the company to launch an additional trial so that the latter can file for a Biologics Licence Application (BLA), which is a full approval.

What is Indian government’s stand on Covaxin?

The Union government stated today that it respects the decision by FDA to not allow EUL for Covaxin but asserted it will have no impact whatsoever on India’s vaccination programme.

“Each country has its own regulatory system. Some parameters might be common while some might be different which we respect. Our country’s regulatory system also takes decisions in a similar manner,” VK Paul, Member (Health) NITI Aayog said.

“The scientific framework is the same but nuancing is on context… These are scientific considerations specially in those countries where science is strong and for us manufacturing is strong,” he added.

On May 22,  Union Minister of Information and Broadcasting Prakash Javadekar had rebuffed doubts about the travel ban on passengers who have been vaccinated using Covaxin as ‘baseless’. 

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“The World Health Organisation (WHO) has not taken any decision on banning people from travelling who have been vaccinated with Covaxin. Covaxin is one of the most effective vaccines to date,” Javadekar had said in a press briefing.

Students have been advised by professionals from foreign study programmes to prefer Covishield vaccine as it is recognised by the destination countries.

When can we expect Covaxin to get WHO’s clearances?

Bharat Biotech stated on June 9 that it will release the entire phase 3 trial data of Covaxin in July 2021, following which it would begin to conduct the phase 4 trial and simultaneously apply for a full licence within India.

The Hyderabad-based company will submit its trial data to Central Drugs Standard Control Organisation (CDSCO), which is the national regulatory body for pharmaceutical drugs and medical devices.

Bharat Biotech’s release of its phase-3 trial data holds significance as it is a compulsory requirement to get the WHO Emergency Use Listing (EUL).

Meanwhile, as per the guidelines issued by the health ministry on June 7,  people seeking to travel abroad for educational purposes, for employment or who are on India’s official contingent to the Tokyo Olympic Games, can now get their second dose of Covishield vaccine after  a shortened gap of 28 days. For others, the gap between two jabs continues to be at least 84 days.

Also, students have been advised by professionals from foreign study programmes to prefer Covishield vaccine as it is recognised by the destination countries.