SII, Novavax get emergency use nod for Covovax in Thailand
Covovax is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
Pune: Serum Institute of India Pvt. Ltd. (SII) and Novavax, Inc. have 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. 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. 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. NVX-CoV2373 has not yet been authorized for use in the U.S. by the U.S. FDA.
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India (SII), the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain.
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