The World Health Organization (WHO) has issued emergency use listing (EUL) for India’s indigenous vaccine Covaxin, adding to a growing portfolio of vaccines validated by WHO for prevention of Covid-19. The WHO said in a tweet that the Technical Advisory Group, convened by World Health Organisation (WHO), has determined that the Hyderabad-based Bharat Biotech’s Covid-19 vaccine meets WHO standards for protection against Covid-19. “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,” WHO said in a tweet.
“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 and the vaccine can be used,” it added.
The global health body said that the Covaxin vaccine was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended the 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,” WHO said.
The WHO has said that Covaxin is extremely suitable for low and middle-income countries due to easy storage requirements. The UN health body said that Covaxin was found to have 78% efficacy against Covid-19 of any severity, 14 or more days after the second dose. “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,” WHO said in a tweet on Wednesday.
The UN health body’s emergency use listing procedure assess the vaccine under the procedure based on the review of data on quality, safety, efficacy, a risk management plan and suitability in low- and middle-income countries. The 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.
In a press note released on Wednesday, Bharat Biotech said: “The WHO’s Emergency Use Listing (EUL) for COVAXIN facilitates countries to expedite their regulatory approval processes to introduce and administer India’s indigenously made Covid-19 vaccine developed and manufactured by Bharat Biotech. The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies, with the objective of providing rapid access to medicines, vaccines and diagnostics, while adhering to stringent criteria of safety, efficacy and quality.”
Further, Dr Krishna Ella, Chairman and MD of Bharat Biotech, said: “The validation by WHO is a very significant step towards ensuring global access to India’s widely administered, safe, and efficacious COVAXIN. As an organization, we have focused on maintaining stringent quality and safety standards that meet rigorous assessment, and scientific standards established by WHO, as a result, many of our vaccines have received WHO prequalification. The EUL authorisation for COVAXIN will enable us to contribute to accelerating the equitable access of the Covid-19 vaccine, and the access to our vaccine globally thereby addressing the current public health emergency.”
Also on Wednesday, Covaxin received an extension of shelf life for up to 12 months from the date of manufacturing by India’s pharmaceuticals and medical regulatory body. “The Central Drugs Standard Control Organisation (CDSCO) has approved the extension of shelf life of COVAXIN up to 12 months, from the date of manufacture,” said Bharat Biotech in a statement posted by the biotechnology company on its official Twitter handle. The company said, “Extension is based on the availability of additional stability data, which was submitted to CDSCO. The extension has been communicated to our stakeholders.” Earlier, Covaxin had a shelf life of six months, which was later extended to nine months.
WHO Director-General Tedros Adhanom Ghebreyesus on Wednesday said that he was glad to see Covaxin get WHO approval for Emergency Use Listing (EUL). “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 tweeted.
In a congratulatory tweet on Covaxin getting Emergency Use Listing by WHO, Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia, said: “Congratulations India for Emergency Use Listing of its indigenously produced COVID-19 vaccine COVAXIN”
WHO Chief Scientist Soumya Swaminathan on Wednesday congratulated India after WHO granted approval for Emergency Use Listing (EUL) for Covaxin. “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,” the WHO Chief Scientist tweeted.
External Affairs Minister Dr S. Jaishankar on Wednesday welcomed the WHO’s decision to grant approval for Emergency Use Listing for Covaxin. “Welcome @WHO’s decision to grant Emergency Use Listing to #COVAXIN. It facilitates travel for many Indian citizens and contributes to vaccine equity. Also a global recognition to PM @narendramodi’s vision of an #AtmanirbharBharat. A Happier Diwali,” Jaishankar tweeted.
Union Health Minister Mansukh Mandaviya congratulated scientists of the Indian Council of Medical Research (ICMR) and Bharat Biotech after Covaxin was approved by WHO. Mandaviya said, “Covaxin, which is regulated and modified in India, has been approved by WHO today. I congratulate scientists of the Indian Council of Medical Research (ICMR) and Bharat Biotech and WHO.”
Earlier, the WHO panel had sought additional clarifications from the manufacturer of Covaxin, in order to conduct a final EUL risk-benefit assessment for global use of the vaccine.
Bharat Biotech’s Covaxin and AstraZeneca and Serum Institute’s Covishield are two widely used vaccines in India against Covid-19. WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson 7 Johnson-Janssen, Moderna, and Sinopharm for emergency use.