Muscat: Indian nationals who are unable to fly to Oman because they’ve been administered the Covaxin COVID-19 jab could soon do so, with the World Health Organization all set to approve the vaccine this week.
The vaccine’s developer, Bharat Biotech, has submitted its Phase 3 clinical trials data that demonstrated 77.8 per cent efficacy to the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), reported the ANI news agency.
Earlier in June, a pre-submission meeting for Emergency Use Listing Procedure (EUL), which provides advice before the submission of the final dossier, was also held.
Indian Union Health Minister Mansukh Mandaviya had also earlier met Chief Scientist Dr Soumya Swaminathan and held discussions over the approval of the vaccine.
Marianne Simao, a WHO assistant director general for vaccines, also said that the UN health agency’s assessment of this vaccine was quite advanced and officials hoped for a decision by mid-September.
Covaxin was developed by Hyderabad-based Bharat Biotech, in association with the Indian Council of Medical Research and the National Institute of Virology.
The vaccine, which has been developed in collaboration with the Indian Council of Medical Research (ICMR), contains a whole virion inactivated SARS-CoV-2 vaccine, which is produced in Vero cells. The vaccine is stable at 2 degrees Celsius to 8 degrees Celsius (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.
The WHO has so far approved vaccines from Pfizer-BioNTech, AstraZeneca, Johnson and Johnson, Moderna, and Sinopharm.
