Bharat Biotech's Covaxin May Get WHO's Approval By End Of September, Says Dr V K Paul

Covaxin by Bharat Biotech, India's indigenously developed vaccine against Covid-19, may get Emergency Use Listing (EUL) by the World Health Organization (WHO) by the end of this month. The Hyderabad-based company had applied for the EUL earlier this year.

The approval would be an international recognition of safety and efficiency of the vaccine.

The EUL by WHO to vaccines, therapeutics and in-vitro diagnostics is meant to expedite their availability and usage in urgent fight against a public health emergency. It is a risk-based procedure that is considerably shorter than the time required to get a regular license.

The listing is done after a panel of the world body assesses the vaccine's immunogenicity, safety and effectiveness, and programmatic suitability such as cold chain requirements, said industry experts.

On 12 August, Union Health Minister Mansukh Mandaviya had met WHO chief scientist Soumya Swaminathan to discuss the matter. Swaminathan, in July, had said that the WHO may take a decision on EUL to Covaxin in four-six weeks.

Bharat Biotech had reportedly submitted all documents required for the listing to the WHO by 9 July, and the WHO review process, which takes close to six weeks, had commenced by July-end. So far, the WHO has given EUL to six vaccines.

Covaxin, developed by Bharat Biotech in partnership with the National Institute of Virology and ICMR, displayed an efficacy of nearly 78 per cent in clinical trials. It was approved by the Indian government for emergency use in January this year.

International Travellers

The approval "would bring in ease of international travel to Indians," Dr N K Arora, member, COVID-19 Task Force, was quoted as saying by The Hindu on Tuesday (14 September). He added that WHO may take a decision on the issue this week.

Dr V K Paul, member of Niti Aayog and head of the Covid-19 task force, said that Covaxin's data looked promising, and the approval may come by September-end.

After Covaxin gains WHO EUL, Indians travelling internationally can be at ease in terms of the host country not insisting on revaccination by a 'WHO recognised COVID-19 vaccine' or wanting an RT-PCR test or even quarantine period.

Indian travellers have been facing visa-related issues as many countries delayed the normalisation of visa procedures with India based on the notion that the Delta variant of the novel coronavirus was India-specific.

For example, while individual countries of Europe recognised the Serum Institute of India's (SII) Covishield, the European Union (EU), which introduced EU Digital Covid Certificate, has not eased the visa procedures for India till now. The European Medicines Agency maintains that it has not received any application from the SII requesting recognition for Covishield. Reportedly, the student visas for Australia also remain closed, despite promising a phased opening.

Apart from international travel, the WHO EUL will also allow countries to expedite their own regulatory approval to import and administer Covaxin, as the EUL is a prerequisite for COVAX facility vaccine supply.

"The EUL will also assist interested UN procurement agencies and Member States in determining the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data," the WHO states.

Covaxin has already received EUAs from 14 countries and another 50 in the process. In June, Bharat Biotech had said that its US partner, Ocugen, has received a recommendation from the US Food and Drug Administration to pursue Biologics License Applications (BLA) path for Covaxin, which is a full approval.

The company is exploring manufacturing partnerships with its partners in other countries.