FDA grants emergency use of Novavax COVID-19 vaccine, adjuvanted in patients 12 years and older

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization of Novavax COVID-19 Vaccine, adjuvanted in patients 12 years and older with COVID-19, according to an announcement from the FDA.¹

Novavax joins the growing list of COVID-19 vaccines including vaccines from Pfizer-BioNTech, Moderna, and Johnson & Johnson’s Janssen.²

The Novavax COVID-19 vaccine, adjuvanted is comprised of the SARS-CoV-2 spike protein and Matrix-M adjuvant.

According to the FDA, adjuvants are integrated into vaccines to increase the immune response. In this particular vaccine, the spike protein is produced in insect cells. Moreover, the Matrix M-adjuvant includes saponin extracts from the bark of the native Chilean soapbark tree.

As with other available COVID-19 vaccines, there are some reported side effects. The most commonly reported side effects reported by Novavax vaccine recipients included redness and swelling at the injection site, pain/tenderness, fatigue, muscle pain, joint pain, headache, nausea/vomiting, and fever.

The vaccine is administered as a 2-dose primary series, with those 2 doses given 3 weeks apart.

For more information on the Novavax COVID-19 vaccine, adjuvanted, visit www.FDA.gov.

References:

1. Novavax covid-19 vaccine, adjuvanted. FDA. August 19, 2022. Accessed August 22, 2022. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/novavax-covid-19-vaccine-adjuvanted

2. COVID-19 Vaccination. Centers for Disease Control and Prevention. August 19, 2022. Accessed August 22, 2022. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html