Monday, June 14, 2021
Results from a phase 3 clinical trial involving 29,960 adult volunteers in the United States and Mexico show that the investigational vaccine known as NVX-CoV2373 has been shown to be 90.4% effective in preventing symptomatic disease of COVID-19. The candidate has shown 100% protection against moderate and severe disease. In people at high risk of developing complications from COVID-19 (people 65 years of age or older and people under 65 years of age with certain co-morbidities or probably regularly exposed to COVID-19), the vaccine has shown an efficacy of 91 , 0% in the prevention of symptomatic disease of COVID-19. .
Safety data indicate that the investigational vaccine was generally well tolerated. Mild to moderate pain and tenderness at the injection site were the most common local symptoms in participants, and fatigue, headache, and muscle pain lasting less than two days were the most common systemic symptoms.
Novavax, Inc., of Gaithersburg, Maryland, developed the investigational vaccine and led the clinical trial known as PREVENT-19. The Biomedical Advanced Research and Development Authority (BARDA), a component of the HHS Office of the Assistant Secretary for Preparedness and Response, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, provided financial support. for trial as part of the federal COVID-19 response.
The PREVENT-19 trial began in late December 2020 and recruited adult volunteers at 119 study sites, including those in the NIAID-supported COVID-19 Prevention Network (CoVPN). Participants were randomized to receive two injections, 21 days apart, of either the experimental vaccine or a saline placebo. Randomization occurred in a 2: 1 ratio with two volunteers receiving NVX-CoV2373 for each receiving placebo. Because the trial was blinded, neither the investigators nor the participants knew who had received the candidate vaccine.
PREVENT-19 was designed to assess whether NVX-CoV2373 can prevent symptomatic COVID-19 disease seven or more days after the second injection compared to placebo. The results shared today are based on 77 cases of symptomatic COVID-19 that investigators observed among trial participants from January 25 to April 30, 2021. Investigators recorded 63 cases among the roughly 10,000 participants who have received a placebo and 14 cases among the approximately 20,000 participants who received the experimental vaccine. Of the 63 cases of COVID-19 in the placebo group, investigators classified 10 as moderate and four as severe. There were no cases of moderate or severe illness in the experimental vaccine group.
NVX-CoV2373 is a subunit vaccine made from a stabilized form of the coronavirus spike protein using the company’s recombinant protein nanoparticle technology. The purified protein antigens in the vaccine cannot replicate or cause COVID-19. The vaccine also contains a proprietary adjuvant, MatrixM ™. Adjuvants are additives that enhance the desired responses of the immune system to the vaccine. NVX-CoV2373 is administered by injection in liquid form and may be stored, handled and distributed at temperatures above the freezing point (35 to 46 ° F). A single dose of vaccine contains 5 micrograms (mcg) of protein and 50 mcg of adjuvant. The vaccine is given as two intramuscular injections 21 days apart. The technology used for this vaccine was developed under a long-standing contract with the Ministry of Defense.
Results from a Phase 3 clinical trial involving 15,000 adults in the UK showed that a two-dose regimen of NVX-CoV2373 was very effective in preventing symptomatic COVID-19 overall and also demonstrated high efficacy against the Alpha variant strain of SARS-CoV-2.
An independent Data and Safety Oversight Board (DSMB) oversees PREVENT-19 to ensure the safe and ethical conduct of the study. All Phase 3 clinical trials of vaccine candidates supported by the federal COVID-19 response are overseen by a joint DSMB convened by the NIAID.
In May 2021, PREVENT-19 was expanded to assess the safety, efficacy and immunogenicity of NVX-CoV2373 in adolescents aged 12 to 17 years. Adolescent registration was recently completed with 2,248 participants. For more information on PREVENT-19, see preventcovid.org, see the trial protocol, or visit ClinicalTrials.gov and search for ID NCT04611802.
About the COVID-19 Prevention Network: The COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the United States National Institutes of Health to respond to the global pandemic. Through CoVPN, NIAID is leveraging the infectious disease expertise of its existing research networks and global partners to address the urgent need for SARS-CoV-2 vaccines and antibodies. CoVPN will work to develop and conduct studies to ensure rapid and in-depth assessment of vaccines and antibodies for the prevention of COVID-19. The CoVPN is headquartered at the Fred Hutchinson Cancer Research Center. For more information on CoVPN, visit: coronaviruspreventionnetwork.org.
About HHS / ASPR / BARDA: HHS strives to improve and protect the health and well-being of all Americans, by providing effective health and human services and by promoting advances in medicine, public health, and social services. ASPR’s mission is to save lives and protect Americans from the health security threats of the 21st century. Within ASPR, BARDA invests in innovation, cutting-edge research and development, procurement and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools and non-pharmaceuticals necessary for combat threats to health security. To date, the products supported by BARDA have obtained 60 approvals, licenses or authorizations from the FDA. To learn more about BARDA’s COVID-19 portfolio and BARDA’s COVID-19 response, visit www.medicalcountermeasures.gov/.
About the National Institute of Allergy and Infectious Diseases: NIAID conducts and supports research – at NIH, across the United States, and around the world – to study the causes of infectious and immune diseases, and to develop better ways to prevent, diagnose, and treat these diseases. Press releases, fact sheets and other materials related to NIAID are available on the NIAID website.
About the National Institutes of Health (NIH):The NIH, the national agency for medical research, comprises 27 institutes and centers and is part of the US Department of Health and Human Services. The NIH is the principal federal agency that conducts and supports basic, clinical, and translational medical research, and studies the causes, treatments, and cures for common and rare diseases. For more information about the NIH and its programs, visit www.nih.gov.
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