On Wednesday, the World Health Organization(WHO) granted Covaxin an emergency use listing, or EUL, which 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.
“The Technical Advisory Group (an independent panel that provides the WHO with vaccine recommendations) has determined Covaxin meets standards for protection against COVID-19… the benefit of the vaccine far outweighs risks (and) the vaccine can be used,” the global health body said.
WHO said that 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. “Covaxin was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended use of this vaccine (is) in two doses, with an interval of four weeks, in all age groups 18+. Available data on vaccination of pregnant women with Covaxin 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 WHO tweeted.
The WHO confirmed Covaxin had been found to be 78 per cent effective against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements.
WHO Director Dr Tedros Adhanom Ghebreyesus tweeted, “Glad to see one more vaccine, #Covaxin, being granted @WHO emergency use listing. The more products we have to fight #COVID19, the better, but we must keep up the pressure to deliver #VaccinEquity & prioritize access to vulnerable groups who are still waiting for their 1st dose.”
Bharat Biotech said that the grant of the EUL was a very significant step towards ensuring global access to India’s widely administered, safe and efficacious (vaccine). “As an organisation we have focused on maintaining stringent quality and safety standards that meet rigorous assessment and scientific standards established by WHO. EUL authorisation for Covaxin will enable us to contribute to accelerating the equitable access of COVID-19 vaccines, and the access to our vaccine globally thereby addressing the current public health emergency, ” Dr Krishna Ella, Bharat Biotech Chairman and Managing Director, said.
Bharat Biotech Joint Managing Director Suchitra Ella quoted that the WHO nod for Covaxin is a validation of the tremendous effort made by everyone at Bharat Biotech and the partners. “The WHO nod for Covaxin is a validation of the tremendous effort made by everyone at Bharat Biotech and our partners. It is also an opportunity for us to create meaningful impact at a global level. Such an impact can only be orchestrated when multiple stakeholders come together to work towards a common goal. Covaxin is a great example of a successful public-private partnership in developing a world-class COVID-19 vaccine,” she stated.
The EUL comes after a lengthy and rigorous review period. Bharat Biotech provided the first batch of data in July that involves assurances about the vaccine’s safety, efficacy and stability as well as checks of production facilities. It was a huge problem for Indian students studying abroad in countries like Canada, the US, the UK, and Australia.
The WHO had said that it understands many people are waiting for Covaxin to be included in the COVID-19 Emergency Use Listing but had also stressed that they cannot cut corners before recommending a product for emergency use and must evaluate thoroughly to make sure it is safe and effective.
The WHO also underlined its trust of the Indian vaccine industry, and in its defense, referred to the 30 days it took for an EUL for Serum Institute’s Covishield (the AstraZeneca-Oxford University shot).
The approval is also likely to clear the way for India to commit vaccine supplies to COVAX – the global vaccine-sharing effort co-led by the WHO which aims to provide vaccines to poorer countries.
Last month news agency Reuters reported the government was delaying a deal on that point while the World Health Organization deliberated on approval for Covaxin.
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.
Bharat Biotech said that 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.
