WHO Gives India’s Covaxin Approval, Opening the Door to COVAX distribution



The World Health Organization (WHO) has issued an emergency use listing (EUL) for India’s Covaxin, making it the eighth COVID-19 vaccine to be approved by the global body. 

“The emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Dr Mariangela Simao, WHO Assistant-Director for Access to Medicines and Health Products on Wednesday.

“But we must keep up the pressure to meet the needs of all populations, giving priority to at-risk groups who are still waiting for their first dose, before we can start declaring victory,” she added.

Covaxin has been developed by the Indian pharmaceutical company, Bharat Biotech, and is formulated from an inactivated SARS-CoV-2 antigen.

It was found to be 78% effective against COVID-19 of any severity, 14 or more days after the second dose. 

The vaccine was assessed by the WHO’s Technical Advisory Group (TAG), which determined that the vaccine meets WHO standards for protection against COVID-19, and its benefits far outweigh the risks.

The WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), also reviewed the vaccine, and recommended it be used in two doses, with a dose interval of four weeks for people 18 and above.  However, data on vaccination of pregnant women remains insufficient, and studies in pregnant women are being planned in the future. 

Listing enables supply to COVAX 

Following EUL approval, the pharma company said in a tweet, “Bharat Biotech is motivated to mitigate the worldwide pandemic.” 

Days prior, the company celebrated its approval for use in Australia and for travel to Oman without quarantine, with Prime Minister of India Narendra Modi commenting on the “post-COVID partnership of India and Australia.”  

The Indian government has already approved the use of the vaccine for children from the age of two in October. 

Covaxin was approved by India back in January while its third phase clinical trials were still underway. Data in March showed the indigenous COVID vaccine showed an efficacy trend of 81% during an interim analysis of Phase 3 trials. 

Covaxin is already being used in 21 Indian states, according to Suchitra Ella, co-founder of Bharat. More than 105 million Covaxin doses have been administered so far in the country.  

The vaccine is suitable for low- and middle-income countries as it can be stored in a normal fridge at 2 to 8 degrees C. India’s regulatory body for pharmaceuticals and medical devices,  the Central Drugs Standard Control Organization recently been approved an extension of its shelf life for up to 12 months from the date of manufacture. 

WHO EUL also means that Covaxin can be distributed by COVAX. In addition, it means that Indians who have been vaccinated with Covaxin are likely to be able to travel internationally as most countries have agreed to recognise WHO-approved vaccines.

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