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FDA suspends the entry of Indian COVID-19 vaccines into the U.S. market
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FDA suspends the entry of Indian COVID-19 vaccines into the U.S. market.
The Covaxin vaccine is placed on clinical hold by the FDA in the United States, and according to Ocugen’s statement, “FDA will find a’specific defect’”.
Covaxin was developed by Ocugen in cooperation with Indian biotechnology company Bharat Biotech, and the vaccine has been vaccinated more than 100 million times in adults outside the United States.
It is really bad news for Ocugen. It was revealed in the early morning after Thanksgiving that the FDA had put its COVID-19 vaccine on hold.
After the FDA took action, the drug must now wait to enter the US market.
According to a statement on November 26, the agency has ordered the suspension of the third phase of the Ocugen vaccine, which is called BBV152 in the United States and Covaxin in countries where it has been approved.
The Pennsylvania-based biopharmaceutical company remained silent on the relevant details, but pointed out that the FDA will find “specific flaws”, thus forming a reason for shelving.
Ocugen expects the FDA to provide formal written information and will work with the agency to “solve its problems as quickly as possible.”
At the time of this announcement, the Omicron mutant virus has taken root in many countries around the world, and it has sounded another alarm in the pandemic of the past two years.
Ocugen has not yet established a firm foothold in the US COVID-19 vaccine market, which has been covered by Pfizer and Moderna for nearly 12 months, and Johnson & Johnson has covered it for about 9 months.
But the company’s vaccine has been vaccinated more than 100 million times in adults outside the United States, and the vaccine is called Covaxin outside the United States, and has emergency use licenses in 17 countries.
In addition, applications from 60 countries/regions are under review and are also on the World Health Organization’s “Emergency Use List” vaccine list for pandemics.
In July, in the Phase 3 clinical trial conducted in India, the vaccine was effective in 77.8% of patients with mild, moderate and severe COVID-19.
At the time, the vaccine was also 65.2% effective against the rapidly spreading Delta variant.
In December of last year, Ocugen announced that it will co-develop Covaxin, the latter’s COVID-19 vaccine candidate, with Indian biotechnology company Bharat Biotech.
Ocugen will be responsible for clinical development, registration and commercialization in the US market.
FDA suspends the entry of Indian vaccines into the U.S. market.
(source:internet, reference only)