The US-based vaccine manufacturer Novavax has availed for a regulatory submission for an emergency use authorization (EUA) for its double dose coronavirus vaccine in India. The appeal was made to the Drugs Controller General of India (DCGI) through its associate, Serum Institute of India (SII), which is known for manufacturing the much talked about the vaccine, “Covishield” which is being administered within the national boundaries.
In addition, Novavax has also approached regulators in Indonesia and the Philippines to permit emergency use of its COVID-19 vaccine in their respective countries. However, the US vaccine manufacturer plans to seek a review by the World Health Organization to be a part of the COVAX global vaccine programme.
Stanley Erck, the Novavax CEO, termed the submissions an “important step toward access to millions of doses of a safe and effective vaccine for countries with an urgent need to control the pandemic.”
“Novavax and SII have cumulative commitments to provide more than 1.1 billion doses to the COVAX Facility”, he added.
“SII and Novavax have now completed the submission of all modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of a review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls data,” the vaccine manufacturer asserted in a statement.
“A submission to the World Health Organization (WHO) for emergency use listing (EUL) based on the DCGI submission is expected to be filed in August. The grant of EUL by the WHO is a prerequisite for exports to numerous countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies,” he added on a brisk note.
While Novavax has displayed 90 per cent efficacy against Covid, more concrete data is required to prove that whether it will be propitious for the Delta variant, that has emerged significantly as one of the fastest spreading mutant waves in India.