Fourth in the US | 14 JUL 22
It can be administered in people from 18 years of age in a two-dose primary scheme. Contains the SARS-CoV-2 Spike protein and Matrix-M adjuvant.
The US Food and Drug Administration (FDA,), authorized the emergency use (EUA) of the Novavax vaccine against COVID-19 and thus became the fourth vaccine available in that country for the disease.
The Novavax Vaccine may be used in a two-dose primary schedule for those over 18 years of age, administered at least 21 days apart.
“The authorization of an additional vaccine against COVID-19 expands the vaccine options available for the prevention of COVID-19, including the most serious outcomes that can occur, such as hospitalization and death,” said FDA Commissioner, Dr. Robert M. Califf.
“Today’s authorization gives U.S. adults who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, efficacy, and manufacturing quality necessary to support emergency use authorization,” he added.
The FDA determined that the adjuvanted Novavax COVID-19 vaccine met the legal criteria for issuance of an EUA. The data support that the known and potential benefits of the vaccine outweigh its known and potential risks in people 18 years of age and older.
The vaccine contains the spike (or Spike) protein of SARS-CoV-2 and the adjuvant Matrix-M. Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated person. The spike protein in this vaccine is produced in insect cells; Matrix M adjuvant contains saponin extracts from the bark of the Soapbark tree, which is native to Chile.
FDA Evaluation of Available Efficacy Data
The vaccine was evaluated in an ongoing, randomized, blinded, placebo-controlled trial conducted in the United States and Mexico. Efficacy was evaluated in clinical trial participants 18 years of age and older who had no evidence of SARS-CoV-2 infection up to 6 days after receiving the second dose of the vaccine.
Among these participants, approximately 17,200 received the vaccine and approximately 8,300 received a saline placebo. Usually, the vaccine was 90.4% effective in preventing mild, moderate, or severe COVID-19, with 17 cases of COVID-19 in the vaccine group and 79 cases in the placebo group. No cases of moderate or severe COVID-19 were reported in participants who received the vaccine, compared to 9 cases of moderate COVID-19 and 4 cases of severe COVID-19 reported in placebo recipients. In the subset of participants 65 years and older, the vaccine was 78.6% effective. The clinical trial was carried out before the appearance of the Delta and Omicron variants.
FDA Evaluation of Available Safety Data
The safety of the vaccine was evaluated in approximately 26,000 clinical trial participants who received the vaccine and approximately 25,000 who received the placebo. The most common side effects 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.
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