Good News for Covaxin-Users, WHO Grants Recognition

Manas Dasgupta

NEW DELHI, Nov 3: In a major relief to the Covaxin users in India wanting to go abroad, the World Health Organisation (WHO) on Wednesday finally granted emergency use listing (EUL) for the Bharat Biotech-developed COVID-19 vaccine paving way for easing entry in various countries for the Covaxin-administered passengers.

“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. The Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that the Covaxin vaccine meets WHO standards for protection against Covid-19, that the benefit of the vaccine far outweighs risks & the vaccine can be used,” the organisation tweeted.

The WHO granting EUL to Covaxin means the ‘made-in-India’ vaccine will finally be recognised by other countries and Indians who received the shot need not self-quarantine or face restrictions when travelling abroad.

A large number of Indian consumers who have been administered Covaxin have been anxiously waiting for the day when the WHO would grant its recognition paving way for their foreign visit as many countries had refused entry to the Covaxin users treating them as “unvaccinated” needing to follow stringent protocols framed for the purpose. Even a case is pending before the Supreme Court where litigants had demanded the apex court to issue directives to the government to administer two more doses of “Covishield” which has already received WHO recognition, to the Covaxin users to facilitate their foreign travel.

Covaxin has been cleared by the WHO for use in all age groups (18+) over two doses spaced four weeks apart. No recommendation has been made for use on children, and available data on use of Covaxin on pregnant women is insufficient to assess safety or efficacy. “Available data on vaccination of pregnant women with Covaxin vaccine are insufficient to assess vaccine safety or efficacy in pregnancy; studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry,” the organisation tweeted.

The TAG-EUL is an independent advisory group that provides recommendations to WHO on whether a COVID-19 vaccine can be listed for emergency use under the EUL procedure.

Covaxin has demonstrated 77.8% effectiveness against symptomatic COVID-19 and 65.2% protection against the new Delta variant. In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.

The emergency listing, or EUL, comes after a lengthy and rigorous review period – manufacturers Bharat Biotech applied in April and provided the first batch of data on July 6 – that involves assurances about the vaccine’s safety, efficacy and stability, as well as checks of production facilities.

The extended delay left millions of Indians – students, working professionals, families divided by the pandemic and others – waiting anxiously for news that Covaxin will be accepted by other countries.

So long as Covaxin was not a WHO-approved vaccine, Indians who had been given the shot and had to travel abroad were either asked to quarantine on arrival, take (at their own expense) and return negative Covid tests, or receive a fresh dose of vaccines approved in the destination country.

Last week the Technical Advisory Group (an independent panel that provides the WHO with recommendations) asked for “additional clarifications” to conduct a “final risk-benefit assessment.” The WHO spokesperson Dr Margaret Harris had then said “… if the committee is satisfied, we expect a recommendation within the next 24 hours or so.”

The WHO had said it “understand 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.” The global health body, which said EULs depended on how quickly manufacturers provided extra information, has also said Bharat Biotech had “regularly and quickly” responded to data requests.

Faced with growing concerns over the delay, the WHO also underlined its trust of the Indian vaccine industry, which has emerged as a key supply point in the world’s fight against the coronavirus. In its defense the WHO referred to grant of the EUL for Serum Institute’s Covishield (the name under which the AstraZeneca-Oxford University shot is made here), which it said took 30 days.”… this is not about moving quicker with one or another vaccine. We really trust the Indian industry,” it said.

Covaxin is one of a few ‘made-in-India’ vaccines and, with Covishield, is the mainstay of the country’s vaccination drive; as of till Wednesday evening over 12.14 crore people have been vaccinated with Covaxin. However, Bharat Biotech has yet to release peer-reviewed data on efficacy and safety; data from a pre-print study indicates it is 77.8 per cent effective against symptomatic COVID-19. It also offers 65.2 per cent protection against the new ‘delta’ variant of the virus.

Apart from Covishield and Covaxin, the WHO has so far approved vaccines produced by Pfizer, Johnson & Johnson-Janssen, Moderna, and China’s Sinopharm for emergency use.

In another positive development for the Hyderabad-based vaccine manufacturer Bharat Biotech, the Central Drugs Standard Control Organisation (CDSCO) has also approved the shelf life extension of Coaxin to 12 months from the date of manufacture. This came just hours before the WHO granted it EUL paving way for its recognition by other countries.

In a tweet, the company stated, “This approval of shelf life extension is based on the availability of additional stability data, which was submitted to CDSCO. The shelf life extension has been communicated to our stakeholders.” Earlier, Australia, Greece, Oman, Mauritius, Philippines and some other countries had granted recognition to Covaxin for the purpose of entry of its users in their respective countries.  Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India.

Meanwhile, the prime minister Narendra Modi, who returned on Wednesday after a five-day trip to Italy and Scotland, held a review meeting with district magistrates of over 40 districts having low COVID-19 vaccination coverage.

The meeting held via video conferencing, included districts with less than 50 per cent coverage of the first dose and low coverage of the second dose of vaccine. The 40 districts are spread across Jharkhand, Manipur, Nagaland, Arunachal Pradesh, Maharashtra and Meghalaya, among other states, according to the Prime Minister’s Office. The PM exhorted the officials that any slackness in continuing vaccination on war-footing would ruin all the advantages the country gained by administering more than 100 crore vaccine doses expeditiously.