It is essential to monitor the post-authorisation safety and efficacy of new COVID-19 vaccines

We welcome today’s approval of the Pfizer/ BioNTech COVID-19 vaccine by the UK’s medicines regulator, the MHRA. This is wonderful news and a triumph for biomedical science. However approval by medicines regulators is a milestone in the development of the vaccines, not the end of the process. An essential component of the development of all new medicines and vaccines takes place after they are approved: this is the process of monitoring the safety and effectiveness of the new products once they are being used in “real-life” by the UK population. While these post-authorisation studies are essential for all new vaccines and medicines, they are even more important for the new COVID-19 vaccines which have been fast-tracked through the clinical trial stages of development prior to approval. Post-authorisation safety studies must be fully transparent, report quickly in as near real time as possible and be conducted independently rather than by the vaccine manufacturer. Assessment of benefit-risk is a continuum between pre- and post-authorisation phases.

Once the COVID-19 vaccines are approved, it is important to monitor their safety and effectiveness in the UK population in several different ways. These include:

1. Enhancing spontaneous reporting (the Yellow Card Scheme).
2. Active surveillance, in which any potential side effects are captured directly from vaccinated patients across the UK. Any serious events or events of special interest (AESI) reported by patients can be validated with GPs.
3. Studies that use secondary electronic data. The NHS provides the UK with an enviable opportunity to conduct nationwide studies.  We have data sources such as the Clinical Practice Research Datalink (CPRD) and NHS Digital which will allow researchers to conduct studies on the safety and effectiveness of COVID-19 vaccines. While there is a time lag for obtaining outcomes from secondary data sources, they have an important role in understanding the safety and effectiveness of COVID-19.
4. Add-on studies such as ecological studies (secular trends), nested case-control studies and self-control case series
5. Exploratory ‘biological studies’ to understand the pathophysiological mechanism and effects of some adverse drug reactions. In these studies, scientists will need to examine the genotype as well as phenotype changes (both clinical and laboratory). Other methods (spontaneous reporting, active surveillance and secondary data sources studies) can provide affected vaccinees and comparator controls for these studies.

The Drug Safety Research Unit in Southampton is planning to conduct an active surveillance study, which will capture the all-important reporting by vaccinees and enable near real-time signal detection evaluation and communication.  This will provide reassurance to the public that the safety and efficacy of COVID-19 vaccines have not only been subjected to rigorous assessment by the MHRA but are also under continuous monitoring so that prompt action can be taken if concerns arise.

In summary, we strongly recommend conducting a range of post authorisation safety studies for COVID-19 vaccines to understand not only the effects of the vaccines itself, but also the effectiveness of the UK vaccination programme.

2^nd December 2020