The vaccine will be produced by SII under the brand name Covovax and is authorised for active immunisation for preventing Covid-19 in adults aged 18 years and above
NVX-CoV2373 demonstrated encouraging safety and tolerability profile in both trials. (Credit: Gerd Altmann from Pixabay)
Novavax and Serum Institute of India received emergency use authorisation (EUA) from the Thailand Food and Drug Administration (Thai FDA) for Novavax’s protein-based Covid-19 vaccine, NVX-CoV2373.
The vaccine, created from the genetic sequence of the initial SARS-CoV-2 virus strain, is formulated with Novavax’s saponin-based Matrix-M adjuvant.
It will be produced by SII under the brand name Covovax and is authorised for active immunisation for preventing Covid-19 in adults aged 18 years and above.
The authorisation is based on the totality of preclinical, manufacturing and clinical trial data submitted to the FDA for assessment.
This submission includes results from two Phase III clinical trials: PREVENT-19 in the US and Mexico and a UK trial.
NVX-CoV2373 demonstrated encouraging safety and tolerability profile in both trials.
Novavax said that a reduced number of serious and severe adverse events were reported, which were balanced between vaccine and placebo arms.
Headache, nausea, myalgia, arthralgia and tenderness/pain at the injection site, among others were the most common adverse reactions observed in the trials.
The vaccine is currently being assessed using real-world data, including the assessment of safety and variant evaluation, as the shot is supplied.
The World Health Organization granted Emergency Use Listing (EUL) for the vaccine in December last year while it also received EUA in India, Indonesia, the Philippines, and Bangladesh.
Recently, the vaccine received authorisation from Drugs Controller General of India use in adolescents.
Novavax president and CEO Stanley Erck said: “Novavax looks forward to delivery of the first protein-based Covid-19 vaccine option for the people of Thailand.
“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.”