Vaccine manufacturers’ safety commitment emphasises importance of post-authorisation safety and effectiveness monitoring

Saad Shakir writes:

The chief executives of nine manufacturers of COVID-19 vaccines have pledged to only seek government approval once enough data has been collected to ensure the vaccines are safe and effective.

The pledge underlines the fact that even during expedited vaccine development as necessitated during a pandemic, there must be a non-negotiable commitment to ensuring public health is protected via maintaining high levels of safety and efficacy. In the UK, we are very fortunate to have one of the best medicines regulators in the world, the MHRA, which will not allow crucial safety standards to be compromised.

While the four commitments of the pledge all relate to pre-marketing safety, monitoring safety at the post-authorisation stage is key to understanding how the vaccine will work in real world conditions. Since 2012 all authorised medicinal and vaccine products in the EU/UK are required to have post-marketing risk management plans (RMP) to address all important potential and identified risks as well as any missing information. In addition, RMPs are required to detect any unexpected safety signals. The need for RMPs doesn’t mean that there are deficiencies in premarketing development. No matter how extensive the clinical trials programme for a new drug or vaccine, there remains information that is only available when the product is used by large number of people in real world settings. The very large numbers of users and the diversity of their demographic and clinical characteristics are simply unavailable during premarketing development. Understanding the efficacy and safety of medicines and vaccines during pre- and post-marketing development is a continuum. They are complementary to each other. At the post-authorisation stage, it is important not only to further understand safety and effectiveness but also to allay the concerns of the public, with facilities for rapid reporting and monitoring safety at frequent intervals. This ensures that any potential issues are identified in near real-time so that action can be taken swiftly.

Our One Million Study for the post-authorisation safety of COVID-19 vaccines in the UK is designed to do exactly that: to monitor the safety and effectiveness of COVID-19 vaccines in real-world conditions by recruiting newly vaccinated patients and requesting feedback from them frequently. Intensive preparation is underway, involving our COVID-19 Vaccine Consortium and other stakeholders, to ensure that we are ready to begin post-authorisation safety monitoring as soon as the COVID-19 vaccines are rolled out to the UK public.