For immediate posting:

Spanish

Today, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine, intended 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 authorization of an additional COVID-19 vaccine expands the vaccine options available to prevent COVID-19, including the more serious outcomes that can occur such as hospitalization and death,” said Robert M. Califf, FDA commissioner. In the United States who have not yet received a COVID-19 vaccine, there is another option that meets the Food and Drug Administration’s strict standards for safety, efficacy, and manufacturing quality needed to support an emergency use authorization. COVID-19 vaccines remain the best preventive measure against severe illness caused by COVID-19 and I encourage anyone who is eligible for a COVID-19 vaccine, but who has not yet received a COVID-19 vaccine, to consider doing so.”

The U.S. Food and Drug Administration (FDA) has determined that Novavax’s COVID-19 vaccine, Adjuvanted has met the legal criteria for an EUA release. The data support that the known and potential benefits of the vaccine outweigh its known and potential risks in people 18 years of age or older, and that this vaccine may be effective in preventing COVID-19. In making this decision, the FDA can reassure the public and the medical community that a thorough analysis and evaluation of the available safety and efficacy data and manufacturing information has been performed.

The Novavax COVID-19 vaccine, Adjuvanted, is given as an initial series of two doses, three weeks apart. The vaccine contains the spike protein SARS-CoV-2 and the Matrix-M adjuvant. Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual. The spike protein contained in this vaccine is produced in the cells of insects. The adjuvant Matrix M contains saponins extracts from the bark of the Soapbark tree, which is native to Chile.

“After extensive analysis and evaluation of the data, assessment of manufacturing processes and information, as well as input from the FDA’s Committee of Independent External Advisers, the FDA’s medical and scientific experts determined that the vaccine meets the FDA’s high standards,” said Peter Marks, MD. Director of the Food and Drug Administration Center for Evaluation and Research of Biology, “Safety and Efficacy of Emergency Use Authorization.” Novavax COVID-19 Vaccine, Adjuvanted provides another alternative for adults and adds another vaccine to the U.S. COVID-19 vaccine supply. The American public can be confident that this The vaccine, like all vaccines used in the United States, has undergone rigorous and comprehensive scientific and regulatory review by the Food and Drug Administration.”

FDA evaluation of available efficacy data

The vaccine was evaluated in an ongoing randomized, blinded, placebo-controlled study conducted in the United States and Mexico. Vaccine efficacy was evaluated in clinical trial participants 18 years of age and older who had no evidence of SARS-CoV-2 infection within 6 days after receiving the second vaccine dose. Of these participants, approximately 17,200 received the vaccine and approximately 8,300 received saline placebo. Overall, the vaccine was 90.4% effective in preventing mild, moderate or severe COVID-19, with 17 cases of COVID-19 occurring in the vaccine group and 79 cases in the placebo group. No cases of moderate or severe COVID-19 were reported in the participants who received the vaccine, compared to 9 cases of moderate COVID-19 and 4 cases of severe COVID-19 reported in the placebo recipients. In the subgroup of participants 65 years of age and older, the vaccine was 78.6% effective. The clinical trial was conducted before the appearance of the delta and omicron variants.

Food and Drug Administration assessment of available safety data

The safety of the vaccine has been evaluated in approximately 26,000 clinical trial participants who received the vaccine and about 25,000 people who received a placebo. The most common side effects reported by vaccine recipients included pain/tenderness, redness and swelling at the injection site, fatigue, muscle aches, headache, joint pain, nausea/vomiting and fever. Nearly 21,000 vaccine recipients obtained at least two months of safety follow-up after the second dose.

The fact sheet for healthcare providers administering the vaccine (providers of the vaccine) includes a warning that clinical trial data provide evidence of an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) after the administration of Novavax COVID-19 additive vaccine. The fact sheet for recipients and caregivers informs that in most people who developed myocarditis or pericarditis after receiving vaccination, symptoms began within 10 days after vaccination and that vaccine recipients should seek medical attention immediately if they experience any of the following symptoms after vaccination: Pain Chest, shortness of breath, feeling like heart palpitations, palpitations or palpitations.

As part of this authorization, the Company and Novavax Inc. Vaccination providers will report the following to the Adverse Event Reporting System (VAERS): serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death.

It is also essential for vaccination providers to report all vaccine administration errors to VAERS of which they have become aware and Novavax Inc. To include a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted to the Food and Drug Administration.

The US Food and Drug Administration has evaluated the company’s pharmacovigilance plan to monitor the safety of the Novavax COVID-19 vaccine, as it will be used under the EUA to ensure that any safety concerns are identified and evaluated in a timely manner. As a condition of licensing, the company will conduct studies to further evaluate its safety, including studies to assess the risks of myocarditis and pericarditis.

In addition, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention have several systems in place to continuously monitor the safety of the COVID-19 vaccine and allow potential safety concerns to be discovered and investigated in a timely manner.

The FDA also expects Novavax Inc. to continue. Its clinical trials for additional safety and efficacy data and follow-up approval (licensing). An EUA issued to Novavax Inc. The authorization will be in effect until the declaration of circumstances that justify authorizing the emergency use of drugs and biological preparations for the prevention and treatment of COVID-19 is terminated. The EUA may be revised or revoked if it is determined that the EUA no longer meets the legal criteria for issuance.

Related information

###

boiler

The Food and Drug Administration, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and veterinary medicines, vaccines, and other biological products for human use and medical devices. The agency is also responsible for the safety and security of our nation’s food, cosmetics, and dietary supplement supplies, products that emit electronic radiation, and for regulating tobacco products.