International approval for Covaxin delayed: US Drug Authority refuses to grant emergency approval, Bharat Biotech now has the option of biological license

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  • Coronavirus Covaxin Vaccine Approval Delay Update | USA FDA Denies Bharat Biotech Covaxin Emergency Use Approval

New Delhi12 minutes ago

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India’s indigenous vaccine Covaxin may get delayed in getting international approval. The US Food and Drug Administration (USFDA) has refused emergency approval to Covaxin after the number of corona cases decreased in the US. The USFDA is in no mood to approve any new vaccine.

Now Bharat Biotech Company, which makes covaxin, is left with the option of getting a biological license. The company has given a clarification after the controversy about not getting visas of many countries to people who got the vaccine. Bharat Biotech said that they are trying to get biological license. This is considered a kind of approval only. It will be processed by their subsidiary company, Occugen Inc.

14 countries have given emergency approval
The company will have to conduct additional clinical trials to get a biological license. Let us inform that 14 countries including Iran, Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay and Zimbabwe have given emergency approval to Covaxin, while the company’s application is pending in 50 countries. Shankar Musunuri, CEO, Occugen Inc., a subsidiary of Bharat Biotech, said that we are very close to filing an application for biological licence.

Ongoing talk of issuing vaccine passport
Actually, now gradually many countries are giving entry to the people who have got the vaccine. In many countries, there is also talk of issuing a separate vaccine passport. In such a situation, it is very important for Covaxin to get international recognition.

There was criticism for not sharing the data of Phase-3 trials
The controversy surrounding Bharat Biotech came to the fore when the company was criticized for not sharing data from Phase-3 trials. Six months before this, Covaxin had received emergency approval in India. After this incident in January, the company had said that it would make its data public by March. Two days ago, the company has said to release the data in July. As soon as the data for the third phase is released, the company will also apply for the full license.

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CoveShield continues to make more antibodies after the first dose
A few days ago, a study claimed that the indigenous corona vaccine is capable of producing more antibodies after the first dose than Covashield. This was claimed in the initial study conducted by the Corona Virus Vaccine-Induced Antibody Titre (COVAT). The study included 552 healthcare workers. The study claimed that the seropositivity rate to the amount of anti-spike antibodies in people who received the CovaShield vaccine was significantly higher than those who received the first dose of CovaShield.

Higher in seropositivity rate and anti spike antibody coveshield
The study noted that CoVashield and Covaxin had a good response after both doses, but the seropositivity rate and anti-spike antibody were higher in CoVShield. The overall seropositivity rate after the first dose was 79.3%. The 456 healthcare workers surveyed were given the first dose of CovaShield and 96 were given the first dose of Covaxin.

Immune response of both vaccines is good
However, the study concluded that healthcare workers who had received both vaccines had a good immune response. The ongoing study of COVAT will shed more light on the immune response after receiving the second dose of both vaccines.

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