Approval To Covaxin Expands Availability Of Vaccines, Says WHO Official

The Emergency Use Listing nod to Bharat Biotech's Covaxin, which was found to have 78 per cent efficacy against COVID-19 of any severity, expands the availability of vaccines, the most effective medical tools to end the pandemic, a top World Health Organisation (WHO) official said today.
The WHO today issued an emergency use listing (EUL) for Covaxin, adding to a growing portfolio of vaccines validated by the UN health agency for the prevention of COVID-19 caused by SARS-CoV-2.
"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."
WHO's EUL procedure assesses the quality, safety and efficacy of COVID-19 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.
WHO Director-General Tedros Adhanom Ghebreyesus said that he is "glad" to see Covaxin get the Emergency Use Listing approval, as he underlined that the more products the world has to fight the coronavirus pandemic, the better it is.
"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," Mr Ghebreyesus said in a tweet.
Following the EUL approval for Covaxin, manufactured by Bharat Biotech, WHO Chief Scientist Soumya Swaminathan said in a tweet, "One more vaccine gets @WHO emergency use listing. Congratulations India @BharatBiotech @ICMRDELHI @MoHFW_INDIA for successful development of indigenous vaccine #Covaxin as well as for a massive vaccination program!."
"Congratulations India for Emergency Use Listing of its indigenously produced #COVID19 vaccine COVAXIN," WHO South East Asia Regional Director Poonam Khetrapal Singh said in a tweet.
Covaxin was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan and programmatic suitability. The Technical Advisory Group (TAG), convened by WHO and made up of regulatory experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs risks and the vaccine can be used globally, WHO said.
The Bharat Biotech's vaccine is formulated from an inactivated SARS-CoV-2 antigen and is presented in single dose vials and multidose vials of 5, 10 and 20 doses.
Covaxin was also reviewed on October 5 by WHO's Strategic Advisory Group of Experts on Immunization (SAGE), which formulates vaccine specific policies and recommendations for vaccines' use in populations (i.e. recommended age groups, intervals between doses, specific groups such as pregnant and lactating women).
The SAGE recommended use of the vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above. Covaxin was found to have 78 per cent efficacy 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.
Available data on vaccination of pregnant women with the 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, WHO said.
 

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