WASHINGTON — Phase three for yet another vaccine trial is underway in the United States. Novavax, the Gaithersburg-based company, has begun enrolling adult volunteers.
On Tuesday, Howard University announced its participation as a clinical trial site to evaluate the safety and effectiveness of Novavax's new coronavirus vaccine.
Novavax is the fifth company to launch a large scale trial in the U.S. The two-shot vaccine won't need to be kept at extremely cold temperatures, or require special freezers, making it much more accessible.
Novavax researchers are looking for 30,000 volunteers to participate in this trial. They are looking for those who are the most at-risk.
“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 Howard University President Dr. Wayne A. I. Frederick,, 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.”
Participation by minority communities has been a focus of vaccine trials in the past, and also a focus as vaccines become available. Vaccine hesitancy is an issue Dr. Fredrick told WUSA9 in the past could lead to larger issues down the road. He is worried about what the future may look like for Black Americans if mindsets do no not shift around the COVID-19 vaccine.
“If we take the vaccine in smaller percentages as a community, you could get to the end of the spring where over 100 million Americans have taken the vaccine and the percentage of African-Americans is small – they now become a very concentrated focus group that continues to get infected, continues to be hospitalized, continues to die. That could really have a very long-term impact on African-Americans,” Dr. Frederick told WUSA9.
In its release Tuesday, the university said its involvement is strongly motivated by concerns about Black, Latino, and other vulnerable populations.
“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.
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 HU Vaccine 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.
Two-thirds of the trial volunteers will receive the actual vaccine, with the rest receiving a placebo. The Novavax vaccine trial is already underway in the U.K. and South Africa, with results expected in January. The results in the U.S. are expected sometime in the spring.