It is increasingly clear that to end the COVID-19 pandemic, we must guarantee timely and equitable access to quality medicines. To meet this goal, we need resilient pharmaceutical supply chains backed by strong regulatory systems to ensure the safety of future COVID-19 drugs and to limit the spread of substandard and falsified medical products.
As large numbers of candidate drugs and vaccines for potential use in the Covid‐19 pandemic are investigated, medicines regulators globally must now make urgent, informed, contextually risk‐based decisions regarding clinical trials and marketing authorizations. They must do this with the flexibility demanded by the pandemic while maintaining their core risk assessment and public safety functions. We lay out the critical role of regulators in the current crisis and offer eight “pandemic best regulatory practices."
When we started this coalition in 2018, we knew quality and trust were at the center of every health system and the key to achieving our collective health goals. However, we could not have predicted what these two years would look like. Our work is far from over.
The new coronavirus has exposed the staggeringly uneven distribution of life-saving medical equipment across the world. Ventilators are an essential tool in the treatment of respiratory illnesses, including severe cases of Covid-19, yet across 41 African countries there are fewer than 2,000 apparatus serving hundreds of millions of people.
Scientists from across the globe are racing to develop effective vaccines and therapeutics for coronavirus disease 2019 (COVID-19). On March 16, phase 1 clinical trials started with a vaccine candidate developed by a US-based company, supported by the National Institutes of Health and the Coalition of Epidemic Preparedness Innovations (CEPI). The next day, a Chinese biotechnology firm announced government authorization to begin clinical trials. Eight vaccine candidates are in clinical trials and more than 100 more are in preclinical development in more than 12 countries. Dozens of therapeutics are also in preclinical and clinical development.
In the race to develop a vaccine to end the COVID-19 pandemic, governments, charities and Big Pharma firms are sinking billions of dollars into bets with extraordinarily low odds of success.
Today, patients in the United States and around the world depend on medicines—and the ingredients used to make those medicines—sourced from and manufactured around the globe. This global supply chain for medicines, while providing some inherent risk mitigation, has numerous vulnerabilities that can be challenged by acute disruptions. When such a disruption occurs, concerns arise regarding the quality and safety—as well as shortages—of medicines, particularly those used for critical treatments. Unfortunately, the COVID-19 pandemic brought these impacts into sharp focus.
We are living in unprecedented times. As COVID-19 continues to spread, the pandemic has exposed gaps in the global pharmaceutical supply chain and has stretched national health systems thin. Around the world, reports of falsified medicines and unproven treatments are circulating. Now, more than ever, we must raise our collective to voice to call for safe, quality care for everyone, everywhere.
Emergency efforts are underway to find optimum medical products to prevent infection and diagnose and treat patients during the coronavirus disease 2019 (COVID-19) pandemic. Production and supply chains for COVID-19 candidate drugs (such as chloroquine and hydroxychloroquine), and for many other essential medical products, are being impaired by this crisis.1 Supply chains for vital drugs for other diseases (such as systemic lupus erythematosus) are being disrupted because they are being repurposed to use against COVID-19, without adequate supporting evidence.
As the world searches for a way to end the coronavirus pandemic, the race is on to find and produce a vaccine. Some optimistic forecasts suggest that one could be available in 12–18 months — but researchers are already warning that it might not be physically possible to make enough vaccine for everyone, and that rich countries might hoard supplies.