India to open fast-track approval mechanism for foreign Covid vaccines

New Delhi, Apr 13 (EFE).- The Indian government announced on Tuesday that it was opening a fast-track mechanism to quickly approve the use of anti-Covid vaccines that have already been approved in other countries, in an attempt to boost the vaccination rate among the country’s vast population.

“The vaccines for COVID-19, which have been developed & are being manufactured in foreign countries and which have been granted emergency approval for restricted use (…) may be granted emergency use approval in India,” the Indian health ministry said in a statement.

The measure, which opens the door for the vaccines developed by labs such as Moderna, Pfier and Johnson & Johnson, ends the policy that required clinical trials to be carried out on Indians as a pre-condition for applying for a vaccine license.

This includes vaccines approved by the United States’ Food and Drugs Administration (FDA), the European Medicine Agency, the United Kingdom’s Medicine and Healthcare products Regulatory Authority, Japan’s Pharmaceuticals and Medical Devices Agency, or those that have been included in the WHO’s emergency use list, the statement specified.

The human trial prerequisite can now be fulfilled with a post-approval clinical trial.

India, which has so far been exclusively using domestically produced vaccine and also supplying them globally, will now be able to start importing the necessary doses to satisfy the demand among its around 1.35 billion inhabitants.

“This decision will facilitate quicker access to such foreign vaccines by India & would encourage imports,” the ministry said.

The world’s second most affected country by the pandemic has made massive efforts to speed up vaccination among people above the age of 45, aiming to prevent deaths amid the second wave of the pandemic, with daily caseload touching a record high of over 160,000 infections.

The decision comes soon after Russian vaccine Sputnik V was approved for emergency used in India.

Sputnik will start being manufactured in the country in five local facilities, with a production target of 850 million doses within a year.

The Drugs Controller General of India has also authorized the use of imported Sputnik vaccines, making it the first foreign-made anti-Covid vaccines to be allowed in the country.

So far, India has been manufacturing and using just two vaccines: Covishield, jointly developed by British-Swedish lab AstraZeneca and the University of Oxford, which is being manufactured through an agreement with the Serum Institute of India, and the indigenous Covaxin, developed by Indian lab Bharat Biotech.

As of Tuesday, India had administered more than 107 million doses, most of them manufactured by the Serum Institute, which is the largest vaccine manufacturer in the world in terms of volume.

The pressure to increase the vaccination rate has triggered concerns over the availability of stocks, and over the fulfillment of global commitments of India, known as the “world’s pharmacy.” EFE


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