28 April 2020 - Authored by:Megan McMellon
Covid-19 coronavirus has seen medical regulators across the globe take action in order to support the pandemic response effort. In the UK, the Medicines and Healthcare Products Regulatory Agency (the MHRA) has worked with the Department of Health and Social Care and other stakeholders to identify where regulatory flexibilities are possible and guidance can be developed to support industry in its response to Covid-19. Key regulatory flexibilities and guidance introduced include:
- Expedited assessments – there will be expedited assessment for clinical trial applications for potential Covid-19 treatments, as well as for national variations and initial marketing authorisation applications that impact the medicines supply chain.
- Clinical trials – although regulatory timelines for safety reporting must still be met, the MHRA will take a flexible approach to clinical trials during this time. Where appropriate, remote monitoring is supported. It is expected that there will be an increase in protocol deviations – this will not constitute a serious breach where such deviations result from Covid-19, but they must be well documented internally. A similar approach has been taken for clinical investigations in respect of medical devices.
- Medical devices – with a focus on Covid-19 testing, personal protective equipment and respiratory devices, the MHRA has streamlined the derogation process and may authorise supply of a non-CE marked device in the interest of the protection of health. Specifications for use during the Covid-19 outbreak have been published for CPAP systems and ventilators, together with guidance for the off-label use of anaesthesia machines. The MHRA has already approved an adapted CPAP device, built by a team of University College London and Mercedes Formula One engineers and clinicians. Regulated as in vitro diagnostics, the MHRA has also released initial specifications to assist manufacturers to design antibody tests for use by healthcare professionals and at home.
It is important to note that the MHRA’s regulatory flexibilities are temporary, designed for exceptional circumstances and will be kept under review. All stakeholders should monitor information released by the MHRA to ensure continued compliance.
Whilst encouraging regulators to take a pragmatic approach, Covid-19 has prompted large number of stakeholders to collaborate, both in the private and public sector. These collaborations span a wide range of areas including vaccines, antigen or antibody testing, preventative or therapeutic medicines and respiratory devices:
- GSK and Sanofi are collaborating to develop an adjuvanted Covid-19 vaccine, combining Sanofi’s S-protein COVID-19 antigen and GSK’s adjuvant technology, which is expected to enter clinical trials in the second half of 2020. GSK is also collaborating with the University of Queensland, Clover Biopharmaceuticals and Xiamen Innovax Biotech Co., Ltd. Sanofi is also collaborating with BARDA and Translate Bio.
- Pzifer and BioNTech are collaborating to co-develop a COVID-19 vaccine, which aims to quickly advance multiple vaccine candidates into human testing based on BioNTech’s proprietary mRNA vaccine platforms. The first clinical trials are expected to begin as early as the end of April 2020.
- Johnson & Johnson and BARDA are co-funding vaccine research, development and clinical testing, with human clinical studies of J&J’s lead vaccine candidate expected to start at the latest by September 2020.
- AstraZeneca, GSK and the University of Cambridge are collaborating to set up a new testing laboratory. AstraZeneca and GSK are also providing process optimisation support to existing UK national testing centres.
- AbCellera and Eli Lilly are co-developing antibody products for the treatment and prevention of COVID-19 using blood from one of the first US patients who recovered from COVID-19, combining AbCellera’s pandemic response platform and Eli Lilly’s global capabilities for rapid development of therapeutic antibodies.
- Metran and Kromek are working together to support the COVID-19 response. Based on technology licensed-in from Metran, a Japan-based leading developer of respiratory medical devices, Kromek will manufacture and sell medical ventilators in the UK. Subject to regulatory approval, production is expected to commence before the end of April 2020.
It is clear from the collaborations announced so far, and a study relating to the search for a Covid-19 vaccine by the Coalition for Epidemic Preparedness Innovations, that many of the developers are small or inexperienced in large-scale pharmaceuticals. This increases the importance of collaboration across the industry, with pharma giants able to support smaller players in speeding up research processes and scaling up manufacture and distribution. Tech companies also have a part to play – as I said in my previous post, any technology that can reduce the time, cost or uncertainty of development will be hugely beneficial.
Perhaps most importantly, significant international co-operation will be needed with governments, public health bodies and regulators to ensure that the complex legal and regulatory framework is not a barrier to market. Although regulatory flexibility presents challenges, both now and in the future, it is likely to be the only way that successful innovations can be brought to the global market both safely and quickly.