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."
As more coronavirus patients were admitted to intensive care, Drayton Hammond, a clinical pharmacist in Chicago, Illinois, frantically tried to order more sedatives. At one point, his hospital was down to a single day’s supply of propofol, one of the main anesthetics used to keep Covid-19 patients comfortable while they’re connected to ventilators in intensive care. The hospital’s use of this drug had increased fivefold since the pandemic hit, forcing staff to ration supplies and use alternative drugs with worrying side effects.
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.
When Joana Opoku-Darko’s daughter Anna was 18 months old, she came down with malaria, a disease common in Ghana and especially deadly for children.
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.
COVID-19 has paralysed the world. Apart from directly affecting the lives of people globally, the pandemic has led to a domino effect on other health outcomes. With the lockdown of entire countries, global supply chains of health commodities are at risk. This could lead to shortages of medicines across the world, including treatments for critical illnesses, as highlighted by the US Food and Drug Administration.
Fifty pharmaceutical manufacturing facilities have shuttered their operations in Baddi, Himachal Pradesh, Asia’s largest pharmaceutical hub, while others are operating at significantly reduced capacities after the region was declared a containment zone, raising concerns about the shortage of supply of medicines in the country.
Today, thanks to modern air travel, the mobility of populations is greater than it has ever been in history, such that viruses can spread in hours rather than months. However, improved capabilities for disease surveillance and breakthroughs in genetic sequencing mean we can also detect and understand pandemic disease with speed and accuracy. This gives us the tools to manufacture and deliver lifesaving vaccines at a global scale.