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HYDERABAD: At a time when the World Health Organisation (WHO) is dithering on granting emergency use listing (EUL) to Bharat Biotech’s Covid-19 vaccine Covaxin, the US Centres for Disease Control and Prevention (CDC) has paved the way for Covaxin-vaccinated individuals to travel to the US.
However, this clearance comes with a rider. CDC has put Covaxin on the list of qualifying Covid-19 vaccine candidates that meet its criteria for exception under the category of “Participants in certain Covid-19 vaccine trials”, as stated on the CDC website.
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.
It is also unclear if the eligibility extends to those who received Covaxin after it was granted restricted EUA under “clinical trial mode” by the Indian drug regulator in January this year while its Phase-3 trials were underway. The “clinical trial mode” tag was removed and regular EUA was granted by the Indian government in March.
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.
The CDC decision came even as WHO once again put off its decision on granting EUL to Covaxin till November 3 after its technical advisory group (TAG) met in Geneva on Tuesday.
“TAG met on October 26, 2021, and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine. 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 on Wednesday, 3 November,” a WHO spokesperson told TOI in an emailed response.
Meanwhile, according to the CDC website, “Airlines and airline operators must confirm that any ‘covered individual’ claiming this exception has official documentation (clinical trial letter, participant card, or modified vaccination card) of clinical trial participation.”
The first criterion laid down to avail of this exception is that “the passenger has participated or is participating in a Phase-3 Covid-19 vaccine trial with a qualifying vaccine candidate list … that meets CDC criteria for the exception”. The second criterion is that the “passenger received the full series of an active (non-placebo) Covid-19 qualifying vaccine candidate or an EUL vaccine and lists the name of the vaccine product and the date received”.
However, this clearance comes with a rider. CDC has put Covaxin on the list of qualifying Covid-19 vaccine candidates that meet its criteria for exception under the category of “Participants in certain Covid-19 vaccine trials”, as stated on the CDC website.
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.
It is also unclear if the eligibility extends to those who received Covaxin after it was granted restricted EUA under “clinical trial mode” by the Indian drug regulator in January this year while its Phase-3 trials were underway. The “clinical trial mode” tag was removed and regular EUA was granted by the Indian government in March.
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.
The CDC decision came even as WHO once again put off its decision on granting EUL to Covaxin till November 3 after its technical advisory group (TAG) met in Geneva on Tuesday.
“TAG met on October 26, 2021, and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine. 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 on Wednesday, 3 November,” a WHO spokesperson told TOI in an emailed response.
Meanwhile, according to the CDC website, “Airlines and airline operators must confirm that any ‘covered individual’ claiming this exception has official documentation (clinical trial letter, participant card, or modified vaccination card) of clinical trial participation.”
The first criterion laid down to avail of this exception is that “the passenger has participated or is participating in a Phase-3 Covid-19 vaccine trial with a qualifying vaccine candidate list … that meets CDC criteria for the exception”. The second criterion is that the “passenger received the full series of an active (non-placebo) Covid-19 qualifying vaccine candidate or an EUL vaccine and lists the name of the vaccine product and the date received”.
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