Novavax and Serum Institute of India Pvt. Ltd. (SII) have been granted emergency use authorization (EUA) by the Thailand Food and Drug Administration (Thai FDA) for Novavax’ protein-based vaccine for COVID-19 in individuals 18 years of age and older.
The vaccine, also known as NVX-CoV2373, is manufactured and marketed by SII under the brand name Covovax™.
“Novavax looks forward to delivery of the first protein-based COVID-19 vaccine option for the people of Thailand,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We remain committed to helping fight the global pandemic by offering an additional vaccination option built on a well-understood platform used in other vaccines for decades.”
The Thai FDA decision was based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the U.S. and Mexico and was published in the New England Journal of Medicine (NEJM); and a trial with almost 15,000 adult participants in the U.K. which was also published in NEJM.
In both trials, the vaccine demonstrated efficacy and a reassuring safety and tolerability profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups.
The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. NVX-CoV2373 will continue to be analyzed using real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.
Covovax has received Emergency Use Listing (EUL) from the World Health Organization, as well as EUA in India, Indonesia, the Philippines, and Bangladesh. It is also authorized for use in adolescents aged ≥12 to <18 years in India.
