In response to the Coronavirus Disease 19 (COVID-19) pandemic, the scientific community, industry, and regulatory agencies are pulling together to facilitate the development of diagnostic tests, drugs, and vaccines to help prevent the spread of the disease. The timelines for development of new drugs and vaccines normally take years. In light of the situation, however, developments are moving rapidly — and on March 16, a healthy volunteer in Seattle was the first person in the US to receive a dose of an experimental coronavirus vaccine as part of a new clinical trial.
The level of collaboration in the scientific community has been unprecedented. Elsevier, a global research and analytics publishing business, has set up a Novel Coronavirus Information Center that is updated daily with the latest research, clinical data, and public health information on the virus. The business has made it openly available via PubMed Central and other public health databases free of charge while the emergency is ongoing.
Global regulatory authorities are now doing everything they can to support any companies who are developing potential diagnostics, treatments or vaccines for SARS-CoV-2 (the virus responsible for COVID-19), and they are urging developers to come forward and discuss programs with them.
In light of the public health emergency, the Food and Drug Administration (FDA) has issued a “Guidance on Conduct of Clinical trials during COVID-19 Pandemic” (Docket Number FDA-2020-D-1106) regarding the considerations that should be made during ongoing studies and processes that need to be considered to maintain patient safety.
A policy for diagnostic tests for coronavirus disease-2019 has also been released (Docket Number FDA-2020-D-0987).The FDA has been issuing emergency use authorizations for diagnostic tests for COVID-19, and to date, these have been issued to three companies so far.
The Pandemic and All-Hazards Preparedness Reauthorization Act allows authorities to have mechanisms in place for the emergency use of approved medicinal products as a result of emerging infectious disease threats. These measures include extending the expiration dating, allowing the Centers for Disease Control and Prevention (CDC) to create and issue emergency use instructions, and permitting the FDA to waive some manufacturing requirements to accommodate emergency demands.
The European Medicines Agency (EMA) has activated its plan for managing emerging health threats and has urged developers of potential medicines or vaccines to contact them as soon as possible. EMA can provide fast-track scientific advice — now free of charge for potential COVID-19 treatments or vaccines — and they have a number of mechanisms available to speed up development, such as the Priority Medicines (PRIME) scheme, accelerated assessment, and conditional marketing authorization procedures.
The Medicines and Healthcare products Regulatory Agency (MHRA) is ensuring that any clinical trial applications relating to COVID-19 are dealt with in an expedited manner. The National Institute for Biological Standards and Control (NIBSC) is developing biological reference materials that are needed to support infection diagnosis and evaluate vaccines and treatment effectiveness. The Health Research Authority has issued guidance for sites, sponsors, and researchers on how changes may be made to ongoing studies as a result of the impact of COVID-19, as well as an expedited process for studies relating to COVID-19.
The Spanish Agency of Medicines and Medical Devices (AEMPS) has enabled the resources to authorize clinical trials of new molecules and evaluate novel uses of already authorized drugs in very short timeframes. The agency offers scientific and regulatory advice to all types of sponsors. The aim is to simultaneously channel and unite everyone’s efforts in clinical trials with multiple arms of different treatments that support the generation of evidence.
The Italian Medicines Agency (AIFA) has taken action to encourage early access to therapies (e.g., off-label use of some drugs to treat SARS-CoV-2 infection) and facilitate clinical trials on potential new therapies for the treatment of COVID-19 disease.
The European Commission has provided €140 million (approximately $164 million) in funds for research on vaccines, diagnostics, and medicines for COVID-19. New funding of €47.5 million (approximately $55.5 million) for COVID-19 research has been allocated to the EU Horizon 2020 program, and support has also been allocated to the Innovative Medicines Initiative, a research project between the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Commission.
In the US, the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS), is providing funding for development of diagnostics and treatment for COVID-19 and has already provided a total of more than $1.2 million toward this goal.
With the outbreak of COVID-19 on a global scale, it’s clear that the need for related treatments, diagnostics, and vaccines is urgent. If your company requires support for COVID-19 development programs or advice on the regulatory pathways available for such programs, please contact our COVID-19 Task Force.