The United States Centres for Disease Control and Prevention (CDC) has paved the way for Bharat Biotech manufactured-Covaxin-vaccinated individuals to travel to the US. This comes when the World Health Organisation (WHO) is dithering on granting emergency use listing (EUL) to Covid-19 vaccine Covaxin.
A Times of India (TOI) report stated that this clearance comes with a rider as the CDC has put Covaxin on the list of qualifying Covid-19 vaccine candidates. It meets its criteria for an exception under the category of “Participants in certain Covid-19 vaccine trials”, as per the CDC website.
Also Read: No Nod for Covaxin Yet as WHO Seeks More Data, Final Assessment Likely on November 3
However, it is unclear whether all those who have received both doses of Covaxin can avail of this exemption from quarantine or if it is only for those who participated in the Phase-3 trials. Along with this, it is also unclear if the eligibility extends to those who received Covaxin after it was granted restricted EUA under the ‘clinical trial mode’ while its Phase-3 trials were underway. In March this year, the ‘clinical trial mode’ tag was removed and regular EUA was granted by the Indian government.
The other vaccines (not approved by WHO or the US government) on this list of exceptions include the Chinese CanSinoBIO’s Ad5-nCoV, Clover Biopharmaceuticals’ SCB-2019, Novavax and Serum Institute of India’s NVX-CoV2373, or Covovax.
Meanwhile, the WHO has put off its decision on granting EUL to Covaxin till November 3 after its technical advisory group (TAG) met in Geneva. The body has asked for ‘additional clarifications’ from Bharat Biotech before announcing a decision for granting EUL. The TAG expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment.
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