The process of obtaining regulatory approval for India’s indigenous Covid vaccine, Covaxin, is at an intriguing stage. While India Biotech, the vaccine maker, has been unable to present a strong enough case for emergency approval by the WHO, a recent conditional approval by the CDC in the US has added to the mystery surrounding international approval of Covaxin.
As reported in the Times of India, the CDC’s approval isn’t clear on whether it covers all people who have been given Covaxin or only those who got it as participants in clinical trials. Is.
At this point, the Indian government will have to hold onto the situation. Covaxin is an intellectual property of the Government of India as it was developed by the National Institute of Virology. The Supreme Court was informed by the Government of India that it receives royalties from the sale of Covaxin.
Delays in international regulatory approvals have a negative impact on India’s vaccination campaign, people who are given the vaccine and need to travel, and the country’s vaccine industry.
The Government of India needs to step in to get to the bottom of the problem here. It is in our great interest.
Also read: Covaxin Approval – WHO Seeks Additional Clarification For Final ‘Risk-Benefit Assessment’
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