WHO Approves Indian Covid 19 vaccine, Bharat Biotech’s COVAXIN for Emergency Use

Coming on the heels of PM Modi’s aggressive vaccine diplomacy during the G20 summit and COP26 at Glasgow, 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 COVID19, that the benefit of the vaccine far outweighs risks & the vaccine can be used. #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.

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. 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.

Covaxin EUL expands the availability of , the most effective medical tools we have to end COVID19. It was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan & suitability in low- & middle-income  countries. WHO’s EUL procedure assesses the quality, safety and efficacy of COVID19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

The EUL procedure assesses the suitability of novel health products during public health emergencies. The aim is to make medicines, vaccines & diagnostics available as rapidly as possible while adhering to stringent criteria of safety, efficacy & quality. The Technical Advisory Group for Emergency Use Listing is an independent advisory group that provides a recommendation to WHO whether an unlicensed vaccine can be recommended for emergency use under the EUL procedure, and if so, under what conditions.

Many leaders hailed this as a true Atmanirbhar Bharat achievement giving an impetus to Make in India initiatives and confidence in Indian scientists R&D efforts.

(Compiled from tweets by @WHO)