Society calls for research to monitor the effectiveness and safety of COVID-19 vaccines

Today, the UK government has accepted the Medicines Healthcare products Regulatory Agency (MHRA) recommendation to approve Moderna’s COVID-19 vaccine(1). Although this vaccine will not be available until about March 2021, the UK now has three vaccines that will help prevent the loss of life, and way of life, that has been caused by the pandemic. The UK should take the opportunity to combine rapid roll-out of COVID-19 vaccines with well-funded research into their effectiveness and safety at scale.

The Society is calling for further research into COVID-19 vaccines, using different methodologies including randomised controlled trials, to fully evaluate the many questions which we urgently need answers to including (but not limited to) the reasons for vaccine failure, the effect of delayed interval dosing(2),(3), identification of rare adverse events (if any), long-term immunogenicity, mixing different vaccines, and take up by ethnic minority communities.

COVID-19 is a new disease, and efforts to find safe and effective therapeutics has demonstrated that well-designed clinical trials are the best way to navigate uncertainty and risk. Through the RECOVERY trial, the UK has demonstrated it has the expertise and capability to run such trials at scale, influencing treatment decisions globally(4). The UK also has excellent data surveillance infrastructure enabling it to assess the short- and long-term effectiveness and safety of vaccines.

The UK is leading the world with the RECOVERY trial, and now once again has the opportunity to use its clinical research excellence to inform decisions about vaccine policy and support global recovery from the pandemic. The rapid roll-out of the vaccines in the UK acts as the perfect vehicle to undertake COVID-19 vaccines research at scale, but needs to be supported by funding.

* The Society's President, Professor Sir Munir Pirmohamed chairs the Commission on Human Medicines (CHM) expert working group that makes recommendations to MHRA.

  1. Medicines and Healthcare products Regulatory Agency (2021) Moderna vaccine becomes third COVID-19 vaccine approved by UK regulator. (Accessed 8 January, 2021).
  2. BMJ (2021). Covid-19 vaccines: to delay or not to delay second doses. (Accessed 8 January, 2021).
  3. British Society of Immunology (2021) British Society for Immunology statement on COVID-19 vaccine dosing schedules.
  4. Lane, H. and Fauci, A., 2020. Research in the Context of a Pandemic. New England Journal of Medicine.

Published: 08 Jan 2021 in Policy statements