The WHO clearance for Covaxin is significant because it means that the ‘made-in-India’ vaccine will finally be recognised by foreign governments and Indians travelling abroad won’t need to self-quarantine or face other travel restrictions
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Bharat Biotech’s Covaxin, India’s first indigenous COVID-19 vaccine, received approval for emergency use listing (EUL) from the technical committee of World Health Organisation on Wednesday.
“Covaxin has been cleared for use in all age groups (18+) over two doses spaced four weeks apart. However, no recommendation has been made for use on children, and available data for use on pregnant women is insufficient to assess safety or efficacy,” WHO said.
Why WHO is authorisation important
The WHO clearance for Covaxin is significant because it means that the ‘made-in-India’ vaccine will finally be recognised by foreign governments and Indians travelling abroad won’t need to self-quarantine or face other travel restrictions. The delay left millions in limbo, in particular it was a huge problem for Indian students studying abroad in countries like Canada, the US, the UK, and Australia.
EUL is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies. Moreover, EUL is also a prerequisite for a vaccine to be supplied through COVAX, the global Covid vaccine equity scheme.
Covaxin’s journey to WHO approval
Bharat Biotech had been stuck in a regulatory limbo, with independent technical experts of the UN health body taking longer to analyse the data seeking more clarification from the vaccine maker.
November: WHO chief scientist Soumya Swaminathan had said the Technical Advisory Group (TAG) would meet on 26 October to consider the Emergency Use Listing for Covaxin. But the approval did not come. The WHO said that once “the information provided addresses all questions raised”, the organisation and its Technical Advisory Group would “complete the assessment and come to a final recommendation whether to grant Emergency Use Listing to the vaccine”.
October: The TAG of WHO on sought additional clarifications from Bharat Biotech on the grant of EUL. “The committee expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, 3 November,” WHO said.
The WHO had said it “understands many people are waiting for Covaxin to be included in the COVID-19 Emergency Use Listing” but had also stressed “we cannot cut corners before recommending a product for emergency use… we must evaluate thoroughly to make it is safe and effective”.
September: On 29 September, WHO had updated the decision date for Covaxin EUL to October 2021 in its latest EUL guidance document for COVID-19 vaccines from the “yet to be confirmed” status.
July: Bharat Biotech had announced the safety and efficacy analysis data from Phase III clinical trials of its vaccine and stated that Covaxin demonstrated 77.8 percent effectiveness against symptomatic COVID-19 and 65.2 percent protection against the new Delta variant.
In the same month, the government told the Rajya Sabha that all documents required for the WHO’s EUL had been submitted by Bharat Biotech, and the global health body had commenced the review process.
June: The company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials
April: The company applied for Emergency Use Listing on 19 April, submitting an Expression of Interest (EoI).
Emergency Use Authorisation
The grant of emergency use authorisation to Covaxin by India’s drugs regulator on 3 January, 2021, was severely criticised as the company was yet to make public even interim efficacy results at the time. But the regulator cited the need for protection against the Alpha variant, which was then spreading fast and outcompeting previous variants.
The Alpha variant was later overtaken by the more dangerous Delta variant. Covaxin manufacturer Bharat Biotech has repeatedly insisted that the vaccine is safe and provided a robust immune response.
Besides Covaxin, the WHO has approved vaccines developed by Pfizer-BioNTech, US pharma majors Johnson & Johnson, Moderna, China’s Sinopharm and Oxford-AstraZeneca for emergency use.
In another development, Bharat Biotech, earlier Wednesday said the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of shelf life of Covaxin up to 12 months from the date of manufacture.
With inputs from agencies