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Updated June 4th, 2021 at 21:47 IST

COVID-19: US students administered Covaxin or Sputnik V jabs asked to get re-vaccinated

Indian students in the US who got themselves vaccinated with Covaxin or Sputnik V have been asked to get themselves re-vaccinated citing lack of WHO approval

Reported by: Digital Desk
US students
IMAGE: AP/ANI | Image:self
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As Autumn Semester is set to begin in the United States, over 400 colleges and universities have asked students to get vaccinated against COVID-19, and the Indian students who got themselves vaccinated with Bharat Biotech's Covaxin or Russian Sputnik V have been asked to get themselves vaccinated again as the two vaccines have not been approved by the World Health Organisation (WHO).

Colleges and universities proposing revaccination have caused anxiety among students with the issue of medical and logistical complications as there is no data available on whether combining vaccines from different makers are safe.

Speaking on the issue of taking vaccine from two different makers, Centers for Disease Control and Prevention (CDC) spokesperson Kristen Nordlund said, "Since COVID-19 vaccines are not interchangeable, the safety and effectiveness of receiving two different COVID-19 vaccines have not been studied."

He further advised that people vaccinated outside the US with a vaccine not authorised by WHO should wait for a minimum of 28 days before taking the first dose of one of the Food and Drug Administration (FDA) approved vaccines.

According to The New Times report, a 25-year-old student from India, who is due to start her master's program in Columbia University's School of International and Public Affairs has been told by the University that she needs to be revaccinated after she arrives at the campus. American students have access to vaccines developed by Pfizer, Moderna and Johnson & Johnson vaccines, which are among the eight vaccines authorised by the WHO.

Bharat Biotech seeks WHO approval

Bharat Biotech is in advanced negotiations with the US FDA (Food and Drug Administration) for conducting small-scale phase-III clinical trials of Covaxin in the US, sources close to the development said last month. The Indian vaccine maker has also held extensive bilateral consultations with Hungary & Brazil too for seeking regulatory approvals for Covaxin in the respective countries.

Bharat Biotech has submitted 90% of the documents to the WHO for obtaining the emergency use listing for the Covaxin. WHO has sought "more information" from Bharat Biotech. According to PTI, the remaining documents are expected to be submitted to WHO in June.

Bharat Biotech's American partner Ocugen has also submitted a 'Master File' to the US Food and Drug Administration in regards to the approval for Covaxin. Ocugen, which is evaluating the clinical and regulatory path for Covaxin in the United States is working on obtaining the EUA for its commercialization in the US.

In its 'Master File', it has submitted scores of data including preclinical studies, chemistry, manufacturing, and controls (CMC), and clinical studies to the FDA for review and input. This will be followed by seeking an EAU as well as a Biologic License Application (BLA) for the Indian vaccine. At present, Covaxin has been approved in eight other countries apart from India, which are - Iran, the Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay, Zimbabwe.

(With ANI inputs)

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Published June 4th, 2021 at 21:47 IST

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