WHO grants much-awaited emergency use listing to Bharat Biotech's Covaxin

Bharat Biotech’s Covaxin has obtained the much anticipated and much awaited Emergency Use Listing (EUL) from the World Health Organisation (WHO) in a development that comes as a relief for students, medical tourists, business travelers and people who have international travel plans.

The WHO granted an EUL to Covaxin on November 3, after a risk-benefit assessment for global use of the company's Covaxin vaccine. The WHO said in a tweet: “WHO has granted emergency use listing (EUL) to #COVAXIN® (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of #COVID19”

WHO’s approval is critical for citizens who wish to take up international travel in the near future. The delay has been a concern especially for students and business travelers.

So far, the WHO has recognised the Pfizer-BioNTech, AstraZeneca, Johnson & Johnson-Janssen, Moderna and Sinophram vaccines for emergency use. (See table: Vaccines with WHO EULs)

Covaxin demonstrated 77.8 per cent efficacy against symptomatic Covid-19 infection and a 93.4 per cent efficacy against severe symptomatic Covid19 infection.

WHO’s Technical Advisory Group (TAG), which met on October 26, sought additional clarifications from Bharat Biotech. Rolling data submission for Covaxin to the WHO began on July 6, and the company has been providing additional data as and when sought by the WHO.

TAG is an independent advisory group that provides recommendations to WHO on whether a Covid19 vaccine can be listed for emergency use under the EUL procedure.

On Monday Australia recognised Covaxin for the purpose of establishing a traveller's vaccination status. Apart from Australia several other countries including Oman, Philippines, Mexico, Botswana, Cameroon, Guatemala, Guyana, Honduras, Iran, Mauritius, Myanmar, Nepal, Nicaragua, Paraguay, Zimbabwe, Oman, Iran, Nepal, Sri Lanka, UAE have allowed travelers inoculated with Covaxin.

Last week, the US Centres for Disease Control and Prevention had also recently put Covaxin on the list of qualifying Covid-19 vaccine candidates, under the category of "Participants in certain Covid-19 vaccination.”

India had thrown its weight behind locally manufactured Covid19 vaccines getting global recognition. Prime Minister Narendra Modi at a G-20 summit session in Rome on Saturday said that it was necessary that the WHO approves Indian vaccines "at the earliest".

The EUL process is centred on determining if a manufactured product is quality-assured, safe and effective. The WHO Strategic Advisory Group of Experts on Immunization (SAGE) is centred on issuing evidence-based policy recommendations for the best use of vaccines against COVID-19.

Last month, in the SAGE review meeting, the Hyderabad-based vaccine maker made a 25-minute presentation before the SAGE working group on clinical data on Covaxin from phase-1, 2, 3 and post marketing studies on safety, immunogenicity, efficacy and effectiveness.

The presentation by Raches Ella, project lead, Covid19 vaccines, Bharat Biotech gave an outline of ongoing and planned studies on safety and effectiveness.

“Such product-specific recommendations are issued once a vaccine is authorized through a regulatory process, including the assessment of safety and efficacy from phase III clinical trials,” the spokesperson of WHO has said.

The EUL was long anticipated.

In May Bharat Biotech had said that it expects the EUL from WHO between July and September. The firm had submitted all the necessary documents for the EUL on July 9.

Later that month, Suchitra Ella, the company’s co-founder and joint managing director, had said that approval from WHO is not expected to be a “long-drawn process”.

“We are working closely with the World Health Organisation for the inclusion of Covaxin in its Emergency Use Listing. Approval from WHO is not expected to be a long-drawn process as the cell line and majority of our facilities have already been audited and approved by WHO for our other vaccines in the past,” Suchitra Ella had said in a tweet.

A source in India’s vaccine industry said, “Pfizer and Moderna got WHO EULs within six to nine weeks or so after they published their phase 3 clinical trial results. Bharat Biotech declared the results around July, and it’s been over 12 weeks or so. An inadequately drafted application can be a reason behind the back and forth between the company and the WHO.”

The person quoted above who is a senior executive at a vaccine maker also added that ‘back and forth’ with queries is part of the normal process of approval though. “In some cases it takes longer than usual. It is not a matter of concern,” he added.

Controversial highlights of Covaxin’s journey

• In July 2020, ICMR chief Balram Bhargava directed clinical trial sites of Covaxin to speed up the trials so that the vaccine could be ready around August 15, 2020. Public health experts and the media raised a hue and cry. ICMR later clarified that Bhargava’s letter was meant to cut ‘red tape’ and speed up recruitment of participants

• January 2021 India’s drug regulator gave an emergency use authorisation (EUA) to Covaxin in ‘clinical trial mode’. The approval in ‘clinical trial mode’ meant that beneficiaries will have to give consent and there will be regular follow up. Such persons will not receive the placebo. Media and health experts raised concerns around such an approval. Bharat Biotech said data from phase 3 clinical trials will be available around March. By Jan 7, the company completed recruiting 25,800 people for phase 3 trials. On March 3, it released interim data from the phase-3 trial.

• In March 2021, the Drugs Controller General of India granted EUA to Covaxin after phase-3 data came in.

• In June 2021 Bharat Biotech said that the Indian government’s procurement price of Rs 150 a dose for the Covid-19 vaccine was “non-competitive” and “not sustainable in the long run”. Hence, it said that a higher price in the private market was required to “offset part of the costs”.

• In June 2021, Brazilian lawmakers started working on a $324-million deal with Bharat Biotech to supply 20 million doses of Covaxin around the issue of pricing. Bharat Biotech said on June 30 that it has not received any payment from the Brazilian health ministry. On July 23 the company said it terminated the MoU it entered with Precisa Medicamentos and Envixia Pharmaceuticals LLC for its Covid-19 vaccine Covaxin for Brazilian market.