Novavax, Serum Institute Get Emergency Use Authorization For Covid Vaccine In Thailand

(RTTNews) - Novavax, Inc. (NVAX), and vaccine manufacturing major Serum Institute of India Pvt. Ltd. (SII), said on Friday that the Thailand Food and Drug Administration or Thai FDA has granted emergency use authorization or EUA for Novavax' protein-based vaccine against Covid-19 in Thailand.

With this move, the Thai regulator has granted EUA for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg to stimulate immunity against SARS-CoV-2 to prevent Covid-19 in adults 18 years age or above.

The vaccine, also known as NVX-CoV2373, is made and sold by Serum Institute under the brand name Covovax.

The Thai FDA's decision follows the totality of preclinical, manufacturing, and clinical trial data submitted for review.

This includes two pivotal Phase 3 clinical trials including PREVENT-19, which enrolled around 30,000 participants aged 18 years and older in the U.S. and Mexico and a trial with almost 15,000 participants in the U.K.

Covovax has received emergency use listing from the WHO, as well as EUA in India, Indonesia, the Philippines, and Bangladesh.