On February 26, 2021 the world of healthcare had a big reason to celebrate. As the number of reported COVID cases crept ever closer to 30 million in the United States, New Brunswick, NJ-based Johnson & Johnson officially got emergency approval from the FDA for its single-dose vaccination. It is the third vaccine to become authorized in the U.S., following the two-shot vaccines by Pfizer (that also has a significant footprint in New Jersey) and Moderna.
The news of the J&J vaccine was met with optimism, but it represents only part of the innovation that has occurred in New Jersey during the pandemic. Dozens of companies in New Jersey have made a difference during the past year, a true example of companies coming together at a time of unprecedented need.
The Approval of a Single Dose Vaccine
The United States FDA approved the Johnson & Johnson single-dose COVID-19 vaccine through Emergency Use Authorization, for use in individuals over the age of 18. At 85% effective against the most significant potential symptoms of the coronavirus, it compares well to the two-shot vaccines previously released. The FDA has deemed it equally safe and effective across racial groups, with protection from the virus emerging around 14 days. By 28 days, there were no reported hospitalizations or deaths from within the vaccination group.
The major benefits, however, will be found in the different requirements for both injection and vaccine storage. Unlike the previous two vaccines, Johnson & Johnson’s can stay viable for 2 hours at room temperature, 3 months in a standard refrigerator, or 2 years if stored at -4°F (-20°C). By being a single-dose injection that does not require the ultra-cold storage conditions, the world is now equipped with a vaccine that could significantly speed up the timeline for vaccinating the entire population and ultimately help truncate the greatest aspects of COVID-19’s impact.
Historically, vaccines have taken extensive amounts of time to develop, usually in the range of approximately 10 years. The fastest previous vaccine development on record was for the mumps, which took four years. Even with an urgent timetable set because of the disruptive potential and lethality of coronavirus, experts still projected that a vaccine would be done in 12 to 18 months.
In March 2020, Johnson & Johnson announced they had identified a vaccine candidate and that they expected the vaccine to be ready for distribution in early 2021. They delivered, but the frenetic 12-month journey to approval was a master class in research, development, supply chain logistics, and collaboration. Leading up to the identification of the candidate, the company worked closely with other healthcare companies, governments, regulatory authorities, and scientists across the globe. Over $1 billion was contributed by Johnson & Johnson through the Biomedical Advanced Research and Development Association (BARDA) to co-fund research, development, testing, and manufacturing. Starting in April 2020, Johnson & Johnson began forming manufacturing partnerships with facilities in the US, Europe, and Africa. By August 2020, manufacturing was ready to begin, and an agreement was made with the US government for both manufacturing and distribution domestically. Testing would follow, with 44,000 adults in the US, Latin America, and South Africa being the very first to receive the single-dose vaccination. By January 2021, process performance qualification was completed for the FDA, the last step before an investigational vaccine candidate may be submitted for Emergency Use Authorization. Finally, the vaccine was ready for FDA approval, which came about a month later. At the start of March, President Joe Biden announced that Kenilworth, NJ-based Merck Pharmaceuticals would help manufacture the vaccine.
New Jersey Companies Accelerate COVID-19 Innovation
By the end of 2021, it will be safe to say that the majority of the country will have been positively impacted by the COVID-related efforts of a New Jersey company. According to Alex Gorsky, Chairman & CEO of Johnson & Johnson “I have never seen a moment so rich in collaboration, ingenuity and acts of bravery”. Johnson & Johnson’s vaccine, Pfizer’s vaccine, and Merck’s research and manufacturing assistance stand as New Jersey’s three-pronged effort to fight COVID-19. All three companies have a strong footprint within the State; of the 20 largest pharmaceutical companies in the world, 13 in total have a New Jersey address. But they represent only a portion of the contributions that have occurred here. Several dozen New Jersey-based biopharma and medical technology companies, healthcare facilities, and manufacturers have stepped up during pandemic.
The following companies are examples of how New Jersey has aided in fighting the coronavirus pandemic.
● BioAegis Therapeutics (North Brunswick, NJ) discovered a key link between severe COVID-19 cases and patients having low levels of the protein “gelsolin.” It is currently in Phase 2 trials for a potential therapeutic for coronavirus.
● OncoSec (Pennington, NJ) is In Phase 1 trial of CORVax12 vaccine candidate. The first subjects were tested at the end of January.
● Bellerophon Therapeutics (Warren, NJ) Is in the process of developing a Nitric Oxide therapy utilizing an inhalant. In Phase 3 trials, Nitric oxide was shown in previous studies to help prevent viral replication and arterial oxygenation of SARS-CoV, which is 82% related to COVID.
● electroCore (Basking Ridge, NJ) successfully received EUA from the FDA for the use of its gammaCore Sapphire CV vagus nerve stimulator to help treat asthma-related symptoms exacerbated by coronavirus.
● Admera Health (South Plainfield, NJ) developed the ability to deep sequence the virus’s entire genome, a key ingredient in drug and vaccine development that will prove doubly valuable as the virus mutates.
● PTC Therapeutics (South Plainfield, NJ) is currently in the second stage of Phase ⅔ clinical trials for its experimental cancer drug, PTC299, being utilized as an oral treatment for COVID-19 that inhibits viral replication and reduces inflammation post-infection.
● Cellularity (Florham Park, NJ) announced the testing of a stem-cell treatment that uses “Natural Killer” white blood cells, called CYNK-001. Clinical trials are underway for its use in treatment in COVID-19 patients, while the FDA has also fast-tracked the treatment for use with glioblastoma multiforme, a form of cancer that affects the brain and spine (The Cancer Center, 2021).
● Hackensack Meridian Health (Edison, New Jersey) teamed up with Merck to collaborate on identifying treatment candidates for the virus. Also created the COVID Recovery Center, aimed to provide care and study patients that are experiencing long-term complications from the virus. Several other healthcare entities have set up similar programs within the state, including the Deborah Heart and Lung Center, University Hospital in Newark and St. Peter’s University Hospital. The latter has teamed up with the Mayo Clinic, to share data as part of its Convalescent Plasma Therapy Research Program.
As home to several leading research universities, New Jersey has seen multiple contributions come from its higher education institutions as well.
● Rutgers University
RUCDR Infinite Biologics (now Infinity BiologiX) was granted EUA to produce the first ever saliva-based, at-home COVID test for general use. The test helped protect health care professionals who were previously at risk of infection performing swab-testing of the nose and throat, as well as made testing less invasive.
● Princeton University
Princeton University alumni and local startup Optimeos Life Sciences inc., developed a nanoparticle technology that could help introduce five times as much vaccine into recipients’ cells, which would further enhance any vaccination’s effectiveness (Nuwer, 2021).
● Rowan University
Medical students and engineers helped manufacture a design and produce a 3D-printed mask for protecting against COVID. Rather than wait to find a solution to mass production, the university made the plans available on its website, where anyone that owns a capable 3D printer can access.
● New Jersey Institute of Technology
From the depths of its Makerspace, an ecosystem created by the university to help facilitate innovation, invention, and product realization, the NJIT community collaborated to design and fabricate face shields to combat the diminished supplies for emergency workers. The shield used HDPE plastic specifically to combat pathogens clinging to the mask.
Innovate in a State that Makes a Difference
Over the course of a single year, New Jersey’s ecosystem has shown itself capable of not just answering the call when needed, but playing a major role in saving lives. Choose New Jersey’s goal is to help companies see their potential in our State. As a non-profit economic development organization, we are able to provide you with free and confidential insight to assist you in market intelligence, site selection assistance, state resource information, and more. Are you in the life science, healthcare, or manufacturing industries? Contact us today to learn more about joining those that already found success in New Jersey.
Geneseeq, Illumina to develop and commercialize comprehensive cancer in-vitro diagnostic NGS kit in China. (2021, March 19). The Cancer Letter.
Nuwer, R. (2021, March 16). Princeton technology could help Improve COVID-19 VACCINES. Retrieved April 06, 2021.
Learn more, visit https://innovation.choosenj.com/life-sciences
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