Covaxin Gets WHO Approval, Finally

New Delhi:

The World Health Organization on Wednesday 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.

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 on use of Covaxin on pregnant women is insufficient to assess safety or efficacy, WHO said.

“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.

“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 a dose interval of four weeks, in all age groups 18 and above,” the WHO tweeted.

#Covaxin vaccine was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended use of this vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above. #COVID19

— World Health Organization (WHO) (@WHO) November 3, 2021

“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,” it said.

Available data on vaccination of pregnant women with the #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. #COVID19

— World Health Organization (WHO) (@WHO) November 3, 2021

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”.

#Covaxin was found to have 78% efficacy against #COVID19 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.

— World Health Organization (WHO) (@WHO) November 3, 2021

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 – working professionals and families divided by the pandemic – waiting anxiously. This also posed a huge problem for Indian students studying abroad in countries such as Canada, the United States, the United Kingdom, and Australia. 

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 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 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).

“… this is not about moving quicker with one or another vaccine. We really trust the Indian industry.”

Covaxin is one of a few ‘made-in-India’ vaccines and, with Covishield, is the mainstay of the country’s vaccination drive; as of this evening over 12.14 crore people have been vaccinated with Covaxin.

Apart from Covishield and Covaxin, the WHO has so far approved vaccines produced by American pharma giants Pfizer, Johnson & Johnson and Moderna, and China’s Sinopharm.