Novavax and SII Receive EUA for Novavax' COVID-19 Vaccine in Thailand

11 April 2022 | Monday | News

The vaccine, also known as NVX-CoV2373, is manufactured and marketed by SII under the brand name Covovax™.
Image Source : Public Domain

Image Source : Public Domain

 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, 8th April  announced that the Thailand Food and Drug Administration (Thai FDA) has granted emergency use authorization (EUA) for Novavax' protein-based vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

"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. For additional information on Covovax, please visit the following websites:

Authorized Use of Novavax' COVID-19 Vaccine in Thailand 
The Thailand Food and Drug Administration (Thai FDA) has issued Emergency Use Authorization (EUA) for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg to induce immunity against SARS-CoV-2 to prevent COVID-19 for adults 18 years old and above.

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