COVID-19: WHO Approves India’s Covaxin for Emergency Use

On Wednesday, the World Health Organization(WHO) approved Bharat Biotech’s Covaxin for emergency use against COVID-19, making it India’s first homegrown vaccine to be approved by the regulatory body. The decision paves the way for the shot to be made available in poorer countries through COVAX, a global vaccine sharing scheme.

Prior to its approval, Covaxin was assessed under WHO’s Emergency Use Listing (EUL) procedure. Through the review of data on efficacy, safety, and risk management, the Technology Advisory Group (TAG), made up of regulatory experts, determined the shot meets WHO standards for protection against COVID-19. In a nutshell, the benefit of the vaccine far outweighs the risk of getting COVID-19.

“This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Dr. Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. “But we must keep up the pressure to meet the needs of all populations, giving priority to the at-risk groups who are still waiting for their first dose before we can start declaring victory.”

Another review by the WHO’s Strategic Advisory Group of Experts (SAGE) conducted on October 5 recommended the vaccine be used in two doses, given up to four weeks apart, in all age groups 18 and above.

The vaccine is not recommended for pregnant women as the existing data was deemed insufficient. However, studies have been planned, which would assess the safety and efficacy of Covaxin in pregnant women.

Covaxin had been approved for emergency use in India since January. Late-stage trials completed later on revealed the shot to be 78% effective against severe COVID-19.

Bharat has said that it will be able to manufacture 1 billion Covaxin shots annually by the end of 2021. In a tweet, Bharat said: “The Emergency Use Listing approval by WHO validates the international safety and quality standards of Covaxin. Bharat Biotech is motivated to mitigate the worldwide pandemic.”

The news has been welcomed by Sugathan R.R., who has been stranded in Southern India for nine months and unable to return to his job in Saudi Arabia.

Speaking to Reuters, Sugathan said he was “greatly relieved with the development since the WHO approval preludes the need for taking a local vaccine in Saudi Arabia.” He added his intent to leave for Dubai on Sunday on the way to Saudi.

Eighth WHO-Approved COVID-19 Vaccine

Covaxin is the eighth COVID-19 vaccine to be backed by the WHO. Of the other seven, Covaxin shares its trait as an inactivated vaccine with China’s Sinopharm and Sinovac’s shots.

Three approved vaccines made separately by AstraZeneca, Johnson & Johnson, and the Serum Institute of India (using AstraZeneca’s formulation) use non-replicating viral vectors to prevent infection.

Finally, the WHO has approved two mRNA vaccines, made independently by Moderna and Pfizer/BioNTech.

Author

Joy Lin

Without knowledge, there is no imagination. Without imagination, knowledge is meaningless