HACKENSACK, N.J. — Hackensack Meridian Health investigators plan to enroll 300 volunteers  to participate in clinical trials for the Covid-19 vaccine at Hackensack University Medical Center, hospital officials announced in a press release Monday.

The volunteers are of various ethnic backgrounds, are older than 18, are not pregnant or breastfeeding, did not have Covid-19, and do not have bleeding disorders, an active infection or other immune disorders. 

The volunteers are from diverse communities so that doctors understand how the vaccine works in different groups, especially those at highest risk for COVID-19. According to The Guardian, African-Americans are dying at three times the rate of white people from Covid-19. 

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The randomization of the groups will be stratified based on age and risk factors, hospital officials said. 

The first volunteer to get the vaccine is Ihor S. Sawczuk, M.D., Hackensack Meridian Health’s regional president of the network’s Northern Market, today, at 11 a.m. 

 “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.” 

Since the potentially deadly virus, which originated in Wuhan, China back in December, made its way into the United States earlier this year, with the Garden State’s first confirmed case a Fort Lee resident in March, the virus has touched more than 6 million people and killed roughly 183,000 people. Worldwide, there are currently a reported 25.1 million cases of the virus and at least 844,000 deaths.    

Since the virus quickly spread in the last year, Hackensack Meridian Health, New Jersey’s largest and most comprehensive health network, has reportedly treated more COVID-19 patients than any other health system in the state.


 
Co-developed by Moderna and the National Institutes of Health, the national “COVE Trial” aims to study the mRNA-1273 vaccine in 30,000 individuals. HackensackUMC — the network’s flagship academic medical center — is one of about 90 sites around the country to conduct a phase III study 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.’’
 
How It Works

The novel coronavirus (SARS-COV2) binds to the human cells via its spike protein, causing the viral fusion and cell entry that leads to infection. This 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.

Those anonymously selected will receive two injections in the arm muscle, 28 days apart. Half of the enrolled patients will receive the vaccine, and the other half will receive a placebo as part of the randomized blinded, Phase III trial. Safety calls will be made and electronic diaries will be given to the subjects, to monitor for adverse events, and to surveil for COVID-19 infection. Anyone who does become infected with COVID-19-like illness will be assessed further with lab tests and will be assisted in getting care with their primary care provider, who will be given the results. 
 
“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. 

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