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 primary two-dose schedule for those over 18 years of age, administered at least 21 days apart.
"The authorization of an additional COVID-19 vaccine 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 offers adults in the US 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 for support emergency use authorization,” he added.
The FDA determined that Novavax’s adjuvanted 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 SARS-CoV-2 spike protein and the Matrix-M adjuvant. Adjuvants are incorporated into some vaccines to improve 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 aged 18 years 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. Overall, 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 aged 65 and older, the vaccine was 78.6% effective. The clinical trial was carried out before the appearance of the Delta and Ómicron 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. About 21,000 vaccine recipients had at least two months of safety monitoring after their second dose.
The fact sheet for healthcare professionals administering the vaccine (Vaccination Providers) includes a warning that data from clinical trials provide evidence of an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the vaccine). surrounds the heart) after administration of the Novavax COVID-19 vaccine with adjuvant.
The fact sheet for recipients and caregivers advises that in most people who have had myocarditis or pericarditis after receiving the vaccine, symptoms began within 10 days of vaccination and that vaccine recipients should seek medical attention immediately if you experience any of the following symptoms after vaccination: chest pain, shortness of breath, feeling of having a racing, fast or pounding heart.
As part of this authorization, the company, Novavax Inc., and vaccine suppliers are required to report to the Vaccine Adverse Event Reporting System (VAERS): serious adverse events, cases of multisystem inflammatory syndrome and COVID-19 cases resulting in hospitalization or death.
It is also required that vaccine providers notify VAERS of all vaccine administration errors of which they are aware and that Novavax Inc. include a summary and analysis of all identified vaccine administration errors in monthly safety reports. submitted to the FDA.
The FDA has evaluated the pharmacovigilance plan submitted by the company to monitor the safety of the Novavax adjuvanted COVID-19 vaccine, as it will be used under the EUA, to ensure that any safety concerns are promptly identified and evaluated. security. As a condition of authorization, the company will conduct trials to further evaluate its safety, including trials to further evaluate the risks of myocarditis and pericarditis.
Additionally, the FDA and the Centers for Disease Control and Prevention have several systems in place to continually monitor the safety of the COVID-19 vaccine and allow for timely detection and investigation of potential safety issues.
The FDA also expects Novavax to continue its clinical trials to obtain additional safety and efficacy data and obtain approval (licensing). The authorization will be valid as long as there are circumstances that justify the authorization of the urgent use of medicines and biological products for the prevention and treatment of COVID-19. The EUA may be reviewed or revoked if it is determined that it no longer meets the legal criteria for issuance.
