Novavax’s protein-based Covovax vaccine for active immunisation against Covid-19 was approved for use by Thailand’s Food and Drug Administration, or FDA, on Friday. The FDA granted emergency use authorisation for the vaccine for individuals 18 years of age and older. The vaccine, known as NVX-CoV2373, is manufactured and marketed under the brand name Covovax.
The FDA’s decision was based on the preclinical, manufacturing and clinical trial data submitted for review. US based biotechnology company Novavax have conducted two pivotal Phase 3 clinical trials: PREVENT-19 included 30,000 participants aged 18 years and older in the US and Mexico and was published in the New England Journal of Medicine. Another trial was conducted with almost 15,000 adult participants in the UK which was published in the same journal.
In both trials, the vaccine demonstrated efficacy, safety and tolerability. Serious and severe adverse reactions were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed were headache, nausea, vomiting, myalgia, arthralgia, injection site tenderness, fatigue and malaise. The vaccine’s safety will continue to be monitored as the vaccine is distributed.
President and Chief Executive Officer of Novavax Stanley C. Erck made a statement…
“Novovax 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.”
Covovax has also been approved for emergency use authorisation in India, Indonesia, the Philippines and Bangladesh. It is authorised for use in children aged 12 to 18 years old in India. The vaccine has also received Emergency Use Listing from the World Health Organisation.
The vaccine has not yet been authorised for use in the US by the US FDA.
SOURCE: Novavax