Johnson & Johnson withdraws accelerated approval of its Covid vaccine in India

Johnson & Johnson withdraws accelerated approval of its Covid vaccine in India

Johnson & Johnson said in April seeking approval to conduct clinical studies bridging from Janssen Covid-19 vaccine candidates in India. A line in the record of the drug regulator recently said that the company pulled its proposal without providing details.

Indian drug regulators said on Monday that Johnson & Johnson pulled the proposition of seeking accelerated approval of the Covid-19 vaccine in the country, without providing additional details.

“The company has told that they attract their proposals,” a line in the drugstore of the standard control organization (CDSCO) at the meeting held an accelerated approval process. The meeting was held on July 29.

The US-based company said in April had been seeking approval to conduct clinical studies bridging from Janssen Covid-19 vaccine candidates in India.

In accordance with data available until July 31, Johnson & Johnson have not asked for full approval for his shots with Food and Drug Administration (FDA), while Pfizer Inc., Bionech SE, and Moderna Inc. have been looking for full approval of their vaccines with the FDA.

Johnson & Johnson has claimed that their vaccines produce strong and continuous response activities against other usual Delta and Coronavirus strains. The neutralizing antibodies, according to the company, took place at least eight months. Health care companies add that the vaccine is 85 percent effective and can also help prevent hospitalization and death.

Johnson & Johnson are in the eyes of the storm in the United States for rare autoimmune disorders. About 100 preliminary reports of the Guillain-Barré (GBS) syndrome has been detected in the United States after vaccination with J & J shots, mostly in men, many of them are 50 or more.

India has so far approved four vaccines – Astrazeneca’s Covishield, Bharat Biotech’s Covaxin, Sputnik V vaccine and Russian Gamaleya Institute Vaccine.

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