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How the Pharmaceutical Industry Is Approaching a COVID-19 Vaccine
With the coronavirus pandemic showing few signs of slowing, pharmaceutical companies are collaborating to accelerate the development of a COVID-19 vaccine.
Johnson & Johnson recently announced that its Janssen Pharmaceutical Companies have partnered with Beth Israel Deaconess Medical Center (BIDMC) to enhance COVID-19 drug discovery.
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The coronavirus outbreak has disrupted individuals and the entire population around the world, significantly impacting economies and straining healthcare resources. As the pandemic rolls on, biotechnology and pharmaceutical companies are partnering to launch clinical trials for potential COVID-19 vaccines and leveraging compounds formerly tested on other viral pathogens such as SARS, MERS, Ebola, and HIV.
Additionally, companies are currently exploring ways to implement tools such as artificial intelligence that provide the ability to expedite production and distribution once a possible vaccine is identified.
Janssen and BIDMC have started preclinical testing of various vaccine prospects with the intent to identify possible treatments by the end of the month. Janssen’s goal is to initiate a Phase 1 clinical study of a potential vaccine by the end of the year and is preparing to significantly boost production capacities to meet global needs.
“It is critical to work with the best scientific minds as we look to rapidly identify and develop solutions to the COVID-19 outbreak,” Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, said in the announcement. “We are grateful for talented and experienced collaboration partners like Dan Barouch and his team at BIDMC. By mobilizing our collective resources, we believe we can leverage the top science and cutting-edge capabilities to respond to this pandemic.”
Janssen will leverage its Janssen AdVac and PER.C6 technology that was also used to develop vaccines for other viruses, including Ebola, Zika, RSV, and HIV. The research and collaboration for Zika and HIV at the Center for Virology and Vaccine Research and Beth Israel Deaconess Medical Center is vital to further potential COVID-19 vaccine discovery.
“We are currently evaluating a series of potential vaccine candidates for COVID-19. This collaboration with Janssen is aimed at the development of a COVID-19 vaccine that would allow for rapid development, large-scale manufacturing, and global delivery,” said Dan Barouch, MD, PhD, director of the Center for Virology and Vaccine Research at BIDMC and the Ragon Institute.
Additionally, the company is working closely with global strategic partners to screen its library of antiviral molecules to enhance discovery of potential COVID-19 treatments and provide relief for people around the world.
Roche Launches Phase III Clinical Trial of Potential Drug For Patients with Severe COVID-19 Pneumonia
Roche recently announced that it is initiating a randomized Phase III clinical trial to uncover the safety and efficacy of Actemra/RoActemra (tocilizumab) plus standard care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.
Working with FDA and the Biomedical Advanced Research and Development Authority (BARDA), the double-blind, placebo-controlled trial is the first global study of Actemra/ RoActemra in this setting and is expected to begin enrolling nearly 300 patients as soon as early next month. The goal is to find clinical status, mortality, mechanical ventilation, and intensive care unit (ICU) variables.
"We are initiating a clinical trial to study Actemra/RoActemra for the treatment of people hospitalized with COVID-19 pneumonia, so that we can better establish the potential role for Actemra/RoActemra in fighting this disease," said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development.
“In these unprecedented times, today’s announcement is an important example of how industry and regulators can collaborate quickly to address the COVID-19 pandemic, and we will share the results as soon as possible.”
Although there are currently various independent clinical trials uncovering the safety and efficiency of Actemra/RoActemra for COVID-19 pneumonia, the new trial is crucial because there are no well-controlled studies and limited published evidence of the efficacy of the drug.
The drug is not currently approved by FDA, but Actemra/RoActemra has been included in the 7th updated diagnosis and treatment plan for COVID-19 issued by China’s National Health Commission (NHC) on March 3, 2020, the announcement highlighted.
Mylan Boosts US Production of Hydroxychloroquine Sulfate Tablets to Meet COVID-19 Patient Needs
Mylan announced last week that it will restart production of hydroxychloroquine sulfate tablets at its West Virginia manufacturing facility for COVID-19 patients in the US.
FDA approved the tablets for the treatment of malaria, lupus erythematous, and rheumatoid arthritis. The World Health Organization also listed the drug as under investigation for a potential COVID-19 treatment.
“We will continue to focus our efforts on protecting our employees, producing critically needed medications, and turning our scientific and operational expertise towards identifying additional ways we may be able to assist in the massive prevention, diagnosis, and treatment efforts needed to counter the spread of COVID-19,” Mylan said in the announcement.
The company will begin supplying the tablet by mid-April and the company anticipates manufacturing nearly 50 million tablets, as the active pharmaceutical ingredient that is currently abundant, The company is also taking steps to initiate production of the tablets outside of the US in the near future.
“The growing global threat of COVID-19 requires a commitment by everyone involved in public health. Mylan takes its responsibility seriously and is committed to continuing to work with governments, partners and others to identify areas of need where our global R&D, regulatory and manufacturing expertise and capacity can be of service,” Mylan stressed.
“We look forward to working with governments and health authorities globally to ensure patient access to this medicine as and where needed.”
