Regulators set out data requirements for COVID-19 vaccine trials


  • Heather Mason
  • Univadis Medical News
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Outcomes from a virtual meeting held on the 18th March under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) have been reported, which outline the regulatory requirements for phase I COVID-19 trials.

Representatives from 20 medicines regulatory authorities in 17 countries, and experts from the WHO and European Commission, discussed the regulatory considerations related to the development of COVID-19 vaccine candidates.

The two key points were;

  • The pre-clinical data required to support first-in-human (FIH) clinical trials depends on the vaccine construct. If a platform technology utilised to manufacture a licensed vaccine or other investigational vaccines is well characterised, it is possible to use that toxicology data. It will be necessary to obtain animal data to characterise the immune response induced by COVID-19.
  • Secondly, the theoretical risk for vaccine-induced disease enhancement needs to be evaluated before FIH clinical trials.

Each participant acknowledged the urgent need for COVID-19 trials. A balance must be struck between rapid development and the generation of robust data to enable decision-making.

The meeting also encouraged the global exchange of information towards vaccine development through open dialogue through medicines regulatory authorities around the world. Different technologies and platforms including RNA, DNA, protein and viral vectored vaccines are being used.