While many Indian health expert and ministers have lauded World Health Organisation's EUL for Covaxi, the global health body's Director-General Tedros Adhanom Ghebreyesus on Wednesday said that 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," 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!."
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.
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% 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.
