New Delhi: After months of dilly-dallying, the World Health Organization (WHO) on Wednesday gave a green signal for the inclusion of Covaxin — Bharat Biotech’s COVID-19 vaccine — in the Emergency Use Listing (EUL).
The Technical Advisory Group (TAG) of the WHO recommended EUL status for the India’s indigenously-developed vaccine.
Covaxin was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended its use 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 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.
As per sources, Prime Minister Narendra Modi had pushed for Covaxin’s EUL approval at G20 Summit in Rome with WHO;s director-general Tedros Adhanom Ghebreyesus.
Covaxin is one of the three COVID-19 jabs currently being used in India for the massive nationwide inoculation drive. The other two are Serum Institute of India’s Covishield and Russia’s Sputnik V.
Meanwhile, Union Health Minister Mansukh Mandaviya congratulated scientists of ICMR and Bharat Biotech. “This is a sign of capable leadership. This is the story of Modi Ji’s resolve,” he said in a tweet.
The WHO chief said, “Glad to see one more vaccine, Covaxin, being granted WHO emergency use listing. The more products we have to fight COVID-19, the better,” he said.
The global health body has, till now, approved COVID-19 vaccines manufactured by Pfizer-BioNTech, US pharma majors Johnson & Johnson, Moderna, China’s Sinopharm and Oxford-AstraZeneca for emergency use.
Last month, the TAG, an independent advisory committee of the WHO, had sought “additional clarifications” from Hyderabad-based Bharat Biotech for Covaxin to conduct a final “risk-benefit assessment” for Emergency Use Listing of the vaccine.
Covaxin has shown efficacy of 77.8 per cent against symptomatic COVID-19 and 65.2 per cent effectiveness against the new Delta variant.
In June, the manufacturer of the vaccine said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.
Source: TNN
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