WHO decision on Covaxin likely by August end

The World Health Organization is likely to decide on emergency use listing (EUL) of Bharat Biotech's Covaxin by the end of August, WHO chief Scientist Soumya Swaminathan told ET. So far, the world body has approved Covid-19 vaccines developed by Pfizer-BioNTech, Oxford-AstraZeneca (Covishield in India), Johnson & Johnson, Moderna and Sinopharm for emergency use. In May, Bharat Biotech said an EUL application had been submitted to the WHO. The world health body had held a “pre-submission” meeting with Bharat Biotech on June 23. The pre-submission meeting provides an opportunity to the company to receive advice and guidance before the submission of the final dossier, as well as an opportunity to meet WHO assessors who will be involved in examining the product.Swaminathan said the whole process takes about six weeks after the submission of documents. She expects the decision to come “by the end of August, probably”.The EUL pathway involves a rigorous assessment of clinical trial data as well as additional data on safety, efficacy, quality and a risk management plan.A WHO pre-qualification, or EUL, is necessary for a vaccine company to supply its products for global facilities such as Covax or international procurement. If the organisation adds Covaxin to the list, it will enable easy international travel for Indian citizens who have been administered with the vaccine. Last month, the company presented its phase-3 data to the subject expert committee of India’s Central Drugs Standard Control Organisation, demonstrating 77.8% efficacy.

from Economic Times https://ift.tt/3kGwK2t