CM – Novavax applies for emergency approval of its Covid vaccine in India

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US-based vaccine maker Novavax has filed government applications for an emergency permit in India. Filing was made through its partner, the Serum Institute of India (SII), which also makes the Covishield vaccine administered in the country, to the Drugs Controller General of India (DCGI).

Aside from India, Novavax also has the regulatory authorities in Indonesia and the Philippines asked to allow its COVID-19 vaccine to be used in an emergency. Later this month, the US vaccine maker plans to take advantage of the World Health Organization review to become part of the COVAX global vaccine program. Stanley Erck, CEO of Novavax, called the filings an « important step towards accessing millions. » of doses of a safe and effective vaccine for countries in dire need of pandemic control. ”In India, the US pharmaceutical giant has teamed up with the Serum Institute of India to manufacture, develop and sell the vaccine. Novavax and SII have cumulatively committed to deliver more than 1.1 billion doses to the COVAX facility.

“SII and Novavax have now completed submission of all modules required by regulators in India, Indonesia and the Philippines required for the start of the vaccine review, including preclinical, clinical and chemical, manufacturing and control dates, « the vaccine manufacturer said in a statement.

 » A filing to the World Health Organization (WHO) for an Emergency Department (EUL) based on the DCGI application is expected to be submitted in August. The issuance of the EUL by the WHO is a prerequisite for export to numerous countries participating in COVAX. Facility that was set up to distribute and distribute vaccines fairly to the participating countries and economies, ”it said.

The Novavax- The Covovax branded two-dose vaccine is likely to be more expensive than Covishield, the CEO of NDTV announced in an exclusive interview in June.

Mr. Erck had also said that Covovax is known to be working on Covid variants, the data against its effectiveness However, the Delta variant is not yet known.

Although Novavax has shown 90 percent effectiveness against Covid, further data are required as to whether it protects against the Delta variant, a virulent and rapidly spreading mutation, discovered in India and leading to new cases in parts of the world.

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