On 4 November, the company submitted an emergency use application to the World Health Organization. of COVID-19 in pregnancy, the likely benefits of vaccination in the local epidemiological context, and the current limitations of safety data in pregnant persons. Late last month the US company, with a factory on Teesside primed to manufacture doses, submitted final data to UK regulators and a positive decision is anticipated within days or weeks. Novavax CEO: FDA filing for COVID-19 vaccine is 'probably going to be next week'. It is great to see our world renowned medicines regulator approve another COVID-19 vaccine. Nuvaxovid was authorised for use by the MHRA for those aged 18 and over on 3 February 2022. But it is the emerging signs of reduced side-effects that could make Novavax particularly attractive. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Note: Information in this article was accurate at the time of original publication. [64][65], On 3 May 2021, Novavax initiated a pediatric expansion for the phase III clinical trial, with 3,000 adolescents 1217 years of age in up to 75 sites in the United States. The vaccine has been approved after meeting the required safety, quality and effectiveness standards. But when the vaccine was finally given medical approval in the UK in February 2022, it was on the basis that. [28] Overall efficacy against different SARS-CoV-2s was 90.4% and efficacy against moderate-to-severe disease was 100%. The accompanying condensed consolidated financial statements have been prepared assuming Novavax will continue as a going concern. The wait to make the Novavax jab available comes after the UK played a significant part in its development: government-funding helped support clinical trials and 15,000 British volunteers participated in the testing. Very rare serious adverse events of myocarditis and pericarditis have been observed though cases typically occurred within a few days after vaccination, and were generally mild. Novavax COVID-19 Vaccine | CDC