The EUA was based on the P-III (PREVENT-19) trial to evaluate two-dose of NVX-CoV2373 in ~30,000 patients aged ≥18yrs. with COVID-19 in the US & Mexico
The results showed 90.4% vaccine efficacy over PBO with a reassuring safety profile, solicited AR in vaccinated patients aged 18 – 64yrs. included site pain/tenderness (82.2%), fatigue/malaise (62.0%), muscle pain (54.1%) headache (52.9%), joint pain (25.4%), nausea or vomiting (15.6%), site redness & swelling (7.0% & 6.3% & fever (6.0%)
Adults aged ≥65yrs. administered the vaccine regimen, solicited AEs were observed at lesser rates. The WHO & multiple regulatory bodies incl. the EC have listed the COVID-19 vaccine for emergency use & granted it conditional authorization for use in patients aged ≥18yrs.
Ref: PRNewswire | Image: Novavax
