Vaccine research

The Central Review Decree (Besluit Centrale Beoordeling Medisch-wetenschappelijk Onderzoek met mensen – BCB – in Dutch)  states that ‘for medical research directed at the development of a vaccine' CCMO is the designated review committee. Since 2009, this means that CCMO only assessed research with one or more unauthorised vaccines. From 1 March 2022, CCMO only assesses research with one or more unauthorised prophylactic vaccines.

Prophylactic and therapeutic vaccines

The definition of prophylactic vaccines is based on the European Pharmacopoeia (Ph. Eur.):

Vaccines for human use are preparations containing antigens capable of inducing a specific and active immunity in man against an infecting agent or the toxin or antigen elaborated by it. Immune responses include the induction of the innate and the adaptive (cellular, humoral) parts of the immune system.

Other vaccines are usually called therapeutic vaccines. Examples of therapeutic vaccines are peptide or subunit vaccines against cancer or Alzheimer's disease. Research into therapeutic vaccines may be assessed by an accredited MREC. An exception is made for research into therapeutic vaccines that also fall within the scope of another category that must be assessed by CCMO, such as ATMPs.

Authorised and unauthorised prophylactic vaccines

CCMO only assesses research with prophylactic vaccines that have not yet been authorised, i.e. vaccines that do not have an RVG (nationally registered medicinal product) or an EU (European registered medicinal product) number.

There are two exceptions to this rule:

• Non-therapeutic intervention research with vaccines in minors and/or incapacitated adult research subjects. In this case it does not matter if the vaccine has not been authorised: research with an authorised vaccine that you wish to carry out in this target group will be assessed by the CCMO. An example is research into an authorised travelers vaccine in children in the Netherlands.
• Mock-up flu vaccines. If a new influenza stem is introduced in an authorised mock-up vaccine, the CCMO does not view this mock-up vaccine to be registered until it has been re-authorised. Until that has been realised the study will be assessed by the CCMO. If the mock-up vaccine is used with the influenza stem for which it is already authorised, then the vaccine is of course registered. In this case the research will be assessed by an accredited MREC.

If research is carried out into an extension of the indication or a different dosage within the current registration dossier and no new RVG or EU number follows, the vaccine is considered to be registered and the study will be assessed by an accredited MREC, unless one of the above exceptions applies.