Major players in the COVID19 vaccine and therapeutics clinical trial analysis market are Pfizer, GlaxoSmithKline (GSK), Inovio Pharmaceuticals, Johnson & Johnson (J&J), Novavax Inc., Heat Biologics, Sanofi, BioNTech, Vaxart, and Vir Biotechnology.
The urgent need to develop vaccines or therapeutics in response to the outbreak of the 2019 Novel Coronavirus (COVID-19) has resulted in a significant increase in clinical trials worldwide. Many research institutes, healthcare organizations and biopharmaceutical companies worldwide are conducting clinical trials for COVID-19 vaccines and therapeutics. According to the ClinicalTrials.gov database, there are more than 1,300 clinical trials registered (195 in phase I, 817 in phase II, 442 in phase III, 188 in phase IV). For instance, ’Solidarity’ is an international clinical trial to help find an effective treatment for COVID-19 launched by the World Health Organization and its partners.
The COVID19 vaccine and therapeutics clinical trial analysis report consists of drugs and vaccines which are under clinical trials for the treatment of COVID 19. The various drugs and vaccines trials are categorized under 4 phases i.e. Phase I (drug or vaccine safety is tested on a small group of humans), Phase II (efficacy and safety are tested on a large group of humans), Phase III (efficacy and safety are tested on thousands of humans), and Phase IV (obtaining government approval and market launch, many vaccines undergo more monitoring).
By region, Europe registered the highest number of trials (616 trials), followed by the Americas (418). Asia-pacific registered around 158 trials, and the Middle-East and Africa registered about 137 trials.
The COVID19 vaccine and therapeutics clinical trial analysis covered in this report is segmented by product type into small molecules, biologics, blood & plasma derivatives, monoclonal antibodies, vaccines, others. It is also segmented by the phase of development into clinical phase I (active trial & discontinued trials), clinical phase II (active trial & discontinued trials), clinical phase III (active trial & discontinued trials), clinical phase IV (active trial & discontinued trials), by route of administration into oral, intravenous, subcutaneous, other routes of administration, and by type of sponsor into pharma/biotech company, academic research/institution, others (such as Government Organizations and CROs).
In June 2020, Moderna Inc. collaborated with Catalent to fill-finish manufacturing of Moderna’s COVID19 vaccine candidate. The collaboration is expected to utilize Catalent filling and packaging capacity and staffing for manufacturing operations for producing an initial 100 million doses of the vaccine. Moderna Inc is a clinical-stage biotechnology organization that spent significant time in messenger RNA (mRNA) therapeutics and immunizations to make another age of transformative drugs. Catalent is the main supplier of cutting-edge conveyance advances, improvement, manufacturing drugs, biologics, cell, and quality treatments.
The long and costly drug development process is anticipated to limit the growth of the COVID19 vaccine & therapeutics clinical trials in the coming days. The safety and efficacy of drugs and vaccines are tested in various stages of the clinical trials. A vaccine takes an average of two to five years to develop. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), the average cost of research and development of a new drug is approximately $2.6 billion. Moreover, the stringent regulations imposed by the various regulatory authorities such as European Medicines Agency and the US Food and Drug Administration (FDA) in regards with clinical trials during COVID19 outbreak attributing to the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity is a major challenge faced in COVID19 vaccine & therapeutics clinical trials.
The growing number of coronavirus cases across the globe together with an urgent requirement for vaccine or drug to curb the disease is a major driver for the growth of COVID19 vaccine & therapeutics clinical trials. According to the World Health Organization (WHO), there were 10,719,946 cases of COVID19 including 517,337 deaths globally reported to WHO as on 3rd July 2020, and this number is expected to grow in the near future. In many countries, dozens of vaccines or drugs are at various development phases of clinical trials. For instance, on 25th May 2020, the Union Health Ministry of India announced that four out of 14 COVID19 vaccine candidates from India may enter the clinical trial stage in the next three to five months. Therefore, the rising number of coronavirus cases along with an urgent need to treat COVID19 patients are projected to boost COVID19 vaccine & therapeutics clinical trials in the coming months.
New programs launched by companies and organizations to develop vaccines for protection against COVID19 are expected to be a major trend shaping the growth of the COVID19 vaccine and therapeutics clinical trials. For instance, in March 2020, Heat Biologics Inc., a clinical-stage biopharmaceutical company specializing in the development of therapeutic vaccines, announced the launch of a program within its subsidiary Zolovax, Inc. to develop a vaccine using its immune-activating gp96 vaccine platform for prevention and treatment against SARS-CoV-2 that causes coronavirus. Various programs being launched by the companies are likely to act as a key factor driving the COVID19 vaccines & therapeutics clinical trials in the coming days.
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