By Bradford Mason
As the COVID-19 pandemic continues, the search for a vaccine is getting more aggressive than ever. The New Jersey medical community has joined the effort to find a vaccine to get things back to some form of normalcy.
The Garden State’s largest network, Hackensack Meridian Health, has treated more COVID-19 patients than any other health system in New Jersey. The healthcare provider is now enrolling individuals in a COVID-19 vaccine clinical trial.
The national COVE Trial aims to study the mRNA-1273 vaccine, co-developed by Moderna and the NIH, in 30,000 individuals. Hackensack University Medical Center, the network’s flagship academic medical center, is one of several hospitals in the state and nearly 90 sites around the country assessing its safety and effectiveness.
“Hackensack Meridian Health has been at the forefront of delivering innovative breakthroughs in the pandemic and offering high-quality compassionate care in the most challenging circumstances,” said Robert C. Garrett, FACHE, chief executive officer of Hackensack Meridian Health. “We are proud to support the development of a vaccine to fight this global menace.”
“Our health network has been involved in virtually every facet of COVID-19 research,” said Ihor Sawczuk, M.D., FACS, president of Hackensack Meridian Health’s Northern Market, and the chief research officer of the network. “We’re eager to do our part with vaccines, which have such enormous potential for millions of people.”
The SARS-CoV2 virus binds to the human cells via its spike protein, causing the viral fusion and cell entry that leads to infection. The novel vaccine candidate aims to capitalize on that spike protein. The vaccine uses a messenger RNA (mRNA) delivery system. The vaccine is expected to trigger the immune system to mount a response by encoding for a protein that targets against the binding receptor on the spike protein (the antibodies) and also stimulates the host T cells to clear the infection quicker. If the person who is vaccinated then gets exposed to the SARS CoV-2 virus, the immune system could potentially quickly recognize the virus and be able to prevent, and/or lessen, the intensity of the disease.
The vaccines being tested are made from the genetic code of the virus copied from SARS-CoV-2, not the whole virus. Therefore, the vaccines cannot cause infection or cause COVID-19 illness. This is a phase III study to test the safety and efficacy of the vaccine.
Hackensack Meridian Health investigators expect to enroll 300 individuals. These individuals are required to be older than 18 years of age, must not be pregnant or breast feeding, must not have had the SARS-CoV2 infection (COVID-19), and must not have some conditions like certain bleeding disorders, active infection or other immune disorders. The randomization of the groups will be stratified based on age and risk factors.
Members of diverse communities are especially sought, to ensure the enrollment group is representative of a wide variety of people – in order to understand how it works in different groups, especially those at highest risk for COVID-19.
“We are eager to be a part of this very crucial and important work,” said Bindu Balani, M.D., senior attending physician at Hackensack University Medical Center’s Division of Infectious Diseases, and a faculty physician at Hackensack Meridian School of Medicine. “I think social distancing and doing the due diligence of personal protection is very important throughout this pandemic, but this study has the opportunity of being one of the solutions to this pressing issue.
Newark Mayor Ras Baraka released a statement about Black New Jerseyans being skeptical about vaccines and clinical trials due to historic instances of scientific racism on African-Americans. NJ Urban News previously reported that nearly 60% of African Americans in a recent survey conducted by BlackDoctor.org would not take a COVID-19 vaccine.
Rutgers New Jersey Medical School and University Hospital are also recruiting healthy adults for the COVID-19 vaccine clinical trial sponsored by Moderna. Baraka emphasized that Newark residents don’t have to participate in any clinical trials if they feel uncomfortable.
“If you are considering enrolling in the clinical trial, gather as much information as you can and inquire about how it can affect you,” Baraka said. “The trial is 100% voluntary and you have the right to say no. The reality is that COVID-19 is still hurting and killing people of color, which makes the entire scenario problematic. Please, if you are not one to volunteer for the sake of science, please do not volunteer in the clinical trial.”