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No Buyers For Covaxin: Embarrassment For India As Bharat Biotech’s Vaccine Still Awaits WHO Nod

Covaxin Vaccine has been widely used in India and has been developed by Bharat Biotech, In what is seen as a global embarrassment for India, the world’s largest vaccine maker is yet to receive the mandatory “emergency use” approval to its homegrown Covaxin jab.

Indian pharmaceutical firm Bharat Biotech will have to furnish more information to the World Health Organization (WHO) to get the approval for its anti-Covid-19 vaccine, Covaxin, according to reports.

India is facing an acute shortage of vaccines amid a devastating second wave of the pandemic. Covaxin was granted restricted emergency use approval in ‘clinical trial mode’ on January 2, 2021. Along with Covishield manufactured by Pune-based Serum Institute of India, Covaxin is being administered as part of India’s nationwide inoculation drive.

Recently, India has allowed the use of Russin-made Sputnik in the face of the vaccine shortage.

On April 19, 2021, Bharat Biotech submitted an EOI (Expression of Interest) to seek Emergency Use Listing (EUL) for Covaxin. The Hyderabad-headquartered company has already submitted 90 percent of the documents to WHO for obtaining the Emergency Use Listing (EUL).

Bharat Biotech, in a statement, said regulatory approvals for Covaxin are in process in “more than 60 countries” including the US, Brazil and Hungary.

“Emergency use authorizations have been obtained in 13 countries with more to follow. Application for Emergency Use List has been submitted to WHO-Geneva and regulatory approvals are expected in July-September,” said the company.

Responding to an email query from The EurAsian Times, Bharat Biotech’s PR team said, “If there is any official update we will share with you.”  

Submissions for prequalification or listing under emergency use are confidential. If the product submitted for assessment is found to meet the criteria, WHO publishes it widely. The duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on those data meeting WHO criteria.

The EUL is assessed on the parameters of quality, safety, and efficacy of the vaccine. Other programmatic suitability such as cold chain requirements are also taken into account.

EU Travel Ban On Covaxin Users

Last week, 27 European Union (EU) member countries approved a proposal to allow ‘fully vaccinated’ tourists from nations outside Europe under certain criteria.

While AstraZeneca vaccine Covishield will be included on the WHO and EU listings, the same is not the case with Bharat Biotech’s Covaxin. This means that Indians, who receive a dose of the Covaxin may find it difficult to travel abroad till the vaccine obtains the required approval.

According to a report by The Hindu, India was assessing if anything can be done to expedite the process. However, the fact remains that WHO processes are beyond political or diplomatic influence. Such processes are solely based on the ability of the vaccine manufacturer to provide the required documentation to validate its claim.

The US, Canada, Australia, Ireland and the EU are among those do not have Covaxin on their approved list of vaccines for now. The WHO has Pfizer, Moderna and Covishield on its approved list but for Covaxin, it says “more information required”.

Indian Vaccine Maker’s Dilemma  

It seems that Bharat Biotech has been trying to get approval from countries around the world for Covaxin. In February 2021, it was reported that the company is pursuing approval for Covaxin in 40 countries.

In the same month, Bharat Biotech signed a pact with Ocugen Inc., allowing the US-based biopharmaceutical firm to develop, supply, and commercialize the Covaxin in the US market.

The website of Bharat Biotech also shows that Emergency Use Listing (EUL) was expected to be approved by a number of countries, in the months of March and April. However, no such updates on those approvals are available on the company’s website. Neither have such updates been provided on email queries.

Apart from India, Covaxin has received the EUL from only a handful of countries, such as Iran, the Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay, and Zimbabwe.

Search For More International Buyers? 

The company maintains that many countries have shown interest in buying its Covid-19 vaccine. However, it seems that most of these dealings have been unsuccessful.

Bharat Biotech was approached by the Government of Hungary for 1 million doses of Covaxin. It is believed that this may lead to the granting of EU Good Manufacturing Practice (GMP) certification to the Bharat Biotech facilities.

Such a move can amplify the vaccine export to the wider EU markets. The Covaxin samples received were approved by the National Institute of Pharmacy and Nutrition and the Hungarian National Drug Authority.

They were ready to grant emergency-use authorization to the Covaxin. But certain issues were flagged during the visit of the team to the Bharat Biotech facilities.

In a similar case, in March, the Brazilian health regulator Anvisa denied permission to import Covaxin, when its officials found that the plant in which the vaccine is being made did not meet the current Good Manufacturing Practice (CGMP) requirements.

India’s Vaccine Diplomacy

India’s much-publicized Vaccine Diplomacy (Vaccine Maitri), launched in January this year, has taken a hit in the face of a much larger second wave of the COVID-19 pandemic back home.

While the international media has blamed what is seen as the Modi government’s missteps and complacency for the unprecedented health crisis, New Delhi has hit back saying, these are “completely baseless, malicious and slanderous” allegations.

When the South Asian nation rolled out its domestic inoculation campaign and global vaccine outreach earlier this year, many were congratulating New Delhi for somehow getting through the COVID-19 crisis with low infection and death rates.

It’s true that India became the largest producer of generic medicines, contributing about 20% of the total global production, and then 62% of the global demand for vaccines.

However, the second wave of the pandemic caught the country unawares, exposing India’s ill-equipped healthcare system. This put a damper on India’s ‘Vaccine Maitri’ initiative as the “world’s pharmacy” has turned into the “world’s ICU” in the past few months.

OPED By: Anupama Ghosh, Ph.D.

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