U.S. The Food and Drug Administration (FDA) has denied its request for emergency use.
New Delhi. Kovacin, a vaccine from India’s home country Corona, has been shipped to the U.S. Is not allowed for emergency use by. This is a big tweak for India. India has also applied for recognition from the World Health Organization for the vaccine. U.S. The Food and Drug Administration (FDA) has denied its request for emergency use.
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Fawcett said the vaccine was effective
However, Biden’s chief principal adviser to the US president, Dr. Fauchi acknowledged the effectiveness of the vaccine. It is feared that this attitude of the US has dealt a major blow to India’s campaign, with the help of which it has been engaged in gaining recognition from the World Health Organization. Occugen, a U.S. partner of Bharat Biotech, applied for an Emergency Use Author Thoracic (EUA) vaccine with the FDA.
Occugen says he will no longer seek emergency approval for the vaccine. Attempts will now be made to get approval for his anti-covid shots. According to Occugen, the decision was made on the recommendation of the US FDA.
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The FDA asked Bharat Biotech to conduct a second clinical trial so that it could file for a Biologics License Application (BLA). This is important to get full approval.
Additional clinical trial data is required
Occugen says additional clinical trial data will be required regarding the marketing application submission of covacin. “We may be late in getting the vaccine, but we are fully committed to bringing the vaccine to the United States,” said Dr. Shankar Musunuri, Ocugen’s chief executive officer.
Occugen is a U.S. Is a biopharma company based in the U.S. Kovasin for the market is working with Hyderabad-based Biotech for production. Recently, O’Keefe acquired the exclusive rights to sell the vaccine in Canada.
Both vaccines from China have been approved by the World Health Organization. However, this vaccine is not being used in the United States. If emergency use of covasin is allowed in the US, it will be a great success for India’s indigenous vaccine.