WASHINGTON - Howard University announces its participation as a Phase 3 COVID-19 clinical trial site to evaluate the safety and effectiveness of a new coronavirus vaccine developed by Maryland-biotechnology company, Novavax.
“We believe that diverse participation in COVID-19 trials will go a long way toward encouraging potentially life-saving vaccination when it is available,” said President Wayne A. I. Frederick, M.D., MBA, a practicing surgeon at Howard University Hospital. “Along with following COVID-19 prevention guidelines, effective vaccination is the most promising approach to mitigating and ending the pandemic. Our goal through participation is to ensure a safe and effective product is developed to address the needs of Black, Latino, and other minority communities.”
Along with other drug manufacturers, Novavax has been leading the way in the development of a safe and effective vaccine option to help end the COVID-19 pandemic.. This clinical trial expects to include proportional representation among diverse populations most vulnerable to COVID-19 distributed across race/ethnicity, age and those living with co-morbidities.
Howard University’s involvement as a clinical trial site was strongly motivated by concerns about Black, Latino, and other vulnerable populations. These groups have been especially at risk of contracting COVID-19 and dying at disproportinately higher rates. While these groups have suffered the most during the pandemic, to date they have not been well represented in the vaccine trials.
Recruitment for participation in the clinical trial through the Howard University location is beginning now. Howard will manage the trial at the Clinical Research Unit located at Howard University Hospital or through the Howard mobile unit that will be deployed to various community locations to enhance access. Volunteers can register to participate in vaccine trials at the national website www.preventCOVID.org or the Howard University Vaccine Study Site and indicate “HOWU” as the site-code in the registration form. Interested volunteers can also call the national registry site at 1-866-288-1919 and request information on the Howard University-managed clinical trial.
Eligible participants must be age 18 years or older and the trial aims to recruit people who are more likely to be exposed to COVID-19, including people with underlying medical conditions; people with greater chances of exposure at their job; those who live or work in elder-care facilities; older adults (65 years or more); or those who work in jails or prisons. Participants will be compensated for clinical trial participation.
To ensure active community involvement, the Howard University clinical trial team consults with a community advisory board whose members have raised pertinent questions about the research and offered guidance about appropriate ways to partner with the community.
“Black and Latino communities already have an unequal burden of chronic health conditions like cancer, heart disease, and hypertension. Oftentimes, individuals have more than one of these health problems. If the vaccine trials include significant numbers of people with these diverse medical histories, we can have greater confidence that vaccines will be safe for people with a wide range of health conditions,” said Dr. Siham Mahgoub, Medical Director of the Center of Infectious Diseases Management and Research and principal investigator for Novavax trial at Howard University.
Vaccination has played a critical role in the history in public health prevention, essentially eliminating polio, smallpox and other dreaded diseases. To date, four large scale vaccine COVID-19 prevention trials (Phase 3) have launched in the U.S. with more than 100,000 people participating.
The company has been working closely with the U.S. Food and Drug Administration to prepare for this clinical trial. Novavax was awarded $1.6 billion in funding from the U.S. government to meet its Operation Warp Speed goals to expedite the delivery of millions of doses of safe, effective vaccine for COVID-19. The award is funding the pivotal U.S. and Mexico Phase 3 trials and manufacturing scale-up.
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About Howard University
Founded in 1867, Howard University is a private, research university that is comprised of 13 schools and colleges. Students pursue studies in more than 120 areas leading to undergraduate, graduate and professional degrees. The University operates with a commitment to Excellence in Truth and Service and has produced one Schwarzman Scholar, three Marshall Scholars, four Rhodes Scholars, 11 Truman Scholars, 25 Pickering Fellows and more than 70 Fulbright Scholars. Howard also produces more on-campus African-American Ph.D. recipients than any other university in the United States. For more information on Howard University, visit www.howard.edu
Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undertaking clinical trials for NVX - CoV2373, its vaccine candidate against SARS - CoV - 2, the virus that causes COVID - 19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin - based Matrix - M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.
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