Novavax’s NVX-CoV2373 Receive the US FDA’s EUA for COVID-19 in Patients Aged ≥18 Years
Shots:
- 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
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
