Bharat Biotech’s COVID-19 vaccine is likely to get approval this week by the World Health Organization (WHO). The homegrown vaccine Covaxin has not yet received a nod from WHO.
Back on September 1, a report claimed that a WHO team would order in the week to assess Covaxin’s application for emergency use listing. By this step, it will help persons immunized with Covaxin to travel freely.
Reportedly, the WHO team will review, study, and evaluate Covaxin’s ‘immunogenicity, vaccine safety, and vaccine effectiveness’. In addition, it will issue a certification that will permit Bharat Biotech to export Covaxin, making it easier for patients who have received the vaccine to travel internationally.
According to the Phase 3 clinical trials data, Covaxin showed 77.8 percent efficacy to the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO). The reports have been submitted to WHO. A pre-submission meeting for EUL was held in June, providing guidance and assistance prior to the submission of the final dossier.
Meanwhile, WHO’s Assistant Director-General for Vaccines, Mariangela Simao commented that the UN health agency’s evaluation of the Bharat Biotech vaccine was very advanced.
Covaxin is one of the three vaccines that is being administered in the country. The drug regulator in the country has given Emergency Use Authorisation (EUA) to Moderna and Johnson and Johnson.