As the world grapples with the coronavirus pandemic, many pharmaceutical companies, and research organizations are racing to develop an effective vaccine against the novel coronavirus, called the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Human trials are now being conducted to determine candidate vaccine efficacy and safety. Currently, there are 21 candidate vaccines in clinical evaluation, and 139 candidate vaccines in preclinical evaluation across the world.
Clinical vaccine trials
In an attempt to recruit many volunteers, the National Institute of Allergy and Infectious Diseases (NIAID) has established a new clinical COVID-19 Prevention Trials Network (COVPN) that aims to enroll thousands of volunteers to test various investigational vaccines against the SARS-CoV-2 infection.
The new website went live, allowing residents in the United States to register to become a part of clinical trials for the coronavirus vaccine. The residents will register for four extensive vaccine studies, which are expected to commence this summer or fall. This comes after the country’s infection toll has exceeded three million confirmed cases.
Interested participants can fill out a survey on the website, which would include some personal questions, including their location, job, past and present health history, and contact information.
Volunteers are expected to visit research and trial sites at least ten times throughout one to two years. This time will be allotted to monitor any symptoms that may occur. Some people may also be rejected for the trial, as the researchers want to determine the effectiveness of the vaccine, those who are staying at home may not be included.
Further, COVPN plans to conduct the trial in communities, churches, organizations, and workplaces, where the workers or constituents are at a high risk of contracting SARS-CoV-2. COVPN also plans to have 40 percent of the participants who are more than 65 years old or with underlying health conditions, including diabetes, hypertension, morbid obesity, and lung disease since they are at a high risk of getting sick with COVID-19.
The initial Phase III trial will be for a vaccine developed by NIAID scientists, in collaboration with Moderna, a biotechnology company. The mRNA-1273 vaccine trial is expected to run this summer season.
“Establishing a unified clinical trial network is a key element of President Trump’s Operation Warp Speed, which aims to deliver substantial quantities of a safe, effective vaccine by January 2021,” Alex Azar, HHS Secretary, said in a statement.
“Starting this summer, this new network will leverage existing infrastructure and engage communities to secure the thousands of volunteers needed for late-stage clinical trials of promising vaccines,” he added.
The vaccine testing will be led by the Fred Hutchinson Cancer Research Center in Seattle, headed by Dr. Larry Corey, and Kathleen Neuzil of the University of Maryland School of Medicine.
The network will utilize a harmonized vaccine protocol developed by the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. More than 100 clinical trial sites will be managed by the network across the country and even abroad.
“Each of Phase 3 clinical trials that the COVPN will conduct will require thousands of volunteers. Community engagement, particularly with the communities most vulnerable to COVID-19’s severe outcomes, will be critical to the success of this research endeavor,” Dr. Francis Collins, NIH Director, said.
Six months after the novel coronavirus first emerged in China, candidate vaccines have reached the last stage of human trials, which will determine if the vaccine is safe and effective in warding off the coronavirus disease.
Aside from Moderna’s vaccine, China’s Sinovac Biotech is going to test its vaccine in Brazil in a Phase III trial. It is one of the three companies that has reached the last stage of human trials. The vaccine will be tested in partnership with Brazilian vaccine producer, the Instituto Butantan. The trial will recruit about 9,000 healthcare workers in COVID-19 facilities.
Meanwhile, AstraZeneca’s COVID-19 vaccine, which was developed by scientists at the University of Oxford and the China National Pharmaceutical Group (Sinopharm), is also in its Phase III trial. If these vaccines are proven to be safe and effective, they can be distributed to many countries worldwide.
The coronavirus disease has now reached 188 countries and territories, and the number of cases is skyrocketing, which means that the pandemic is far from over.