Highlights:
- Central Govt submits all data to WHO for Covaxin’s approval as COVID-19 vaccine
- AIIMS director Randeep Guleria hopeful World Health Organisation will provide the authorisation soon
Director of the All India Institute of Medical Sciences (AIIMS) Delhi, Randeep Guleria, is hopeful that the World Health Organisation (WHO) will provide the authorisation for emergency use listing to Indian COVID-19 vaccine, Covaxin, soon.
News agency ANI quoted Guleria as saying, “We are hopeful that now with all the data in and studies having been done it should happen soon rather than happening late”.
He added, “It will make travel easy; it will encourage people, especially those who have taken both the shots of the vaccine to be able to travel abroad.
“Also as we start moving out from the pandemic it is very important to have the approval so that one does not have to quarantine or isolate at any place”.
The Indian government said that it had recently submitted all the data which is required for the clearance of Covaxin to WHO and now the global health body has to make a decision.
While speaking at a press conference regarding the COVID-19 situation in the country, Director General (DG) at Indian Council of Medical Research (ICMR) Dr Balram Bhargava said, “All the data has been given on which clearance is given by WHO. The data is being looked at, WHO to take a decision.”
Earlier, the World Health organisation had said that the final decision on Bharat Biotech’s submission on the EUL for Covaxin will be made in October.
As of now, the status of assessment for Covaxin is “ongoing”, the WHO informed in a document citing the status of COVID vaccines.
WHO observes four steps when it processes the approval procedure for a COVID-19 vaccine which includes:
- Acceptance of the manufacturer’s Expression of Interest (EoI)
- A pre-submission meeting between WHO and the manufacturer
- Acceptance of the dossier for evaluation by WHO
- The decision on the status of assessment.
The Union Health Minister Mansukh Mandaviya had recently met the WHO Chief Scientist to hold discussions over the approval of Covaxin.
WHO has so far approved Covid vaccines developed by Pfizer-BioNTech, US pharma giants Johnson & Johnson, Moderna along with China’s Sinopharm and Oxford-AstraZeneca for emergency use.
