July 13, The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
The Novavax COVID-19 Vaccine, Adjuvanted is administered as a two-dose primary series, three weeks apart. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual. The spike protein in this vaccine is produced in insect cells; the Matrix M-adjuvant contains saponin extracts from the bark of the Soapbark tree that is native to Chile.
The safety of the vaccine was assessed in approximately 26,000 clinical trial participants who received the vaccine and approximately 25,000 who received placebo. The most commonly reported side effects by vaccine recipients included pain/tenderness, redness and swelling at the injection site, fatigue, muscle pain, headache, joint pain, nausea/vomiting and fever. Approximately 21,000 vaccine recipients had at least two months of safety follow-up after their second dose.
The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) includes a warning that clinical trial data provide evidence for increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following administration of Novavax COVID-19 Vaccine, Adjuvanted. The Fact Sheet for Recipients and Caregivers informs that in most people who have had myocarditis or pericarditis after receiving the vaccine, symptoms began within 10 days following vaccination and that vaccine recipients should seek medical attention right away if they experience any of the following symptoms after vaccination: chest pain, shortness of breath, feelings of having a fast-beating, fluttering or pounding heart.
July19, U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend the use of the Novavax COVID-19 Vaccine.
Novavax COVID-19 Fact sheet
Novavax Letter of authorization
Source FDA