Vaccines | FAMHP

Safe vaccines
Good quality, safe and effective vaccines are important in the fight against COVID-19. Despite the urgent need, no concessions are made on the usual strict requirements for safety, quality and efficacy. A vaccine against COVID-19 will only not be allowed on the European market once it has received a marketing authorization (MA). This MA is only granted after a thorough analysis of the benefits versus the risks. For vaccines, the European Medicines Agency (EMA) grants the MAs. The contracts for the purchase of vaccine candidates against COVID-19 by the Belgian government are independent of the MA procedure. Vaccines candidates that do not obtain a MA are not allowed on the market and the contracts that were concluded beforehand will expire.

Quickly available for citizens
Worldwide priority has been given to the development of COVID-19 vaccines. Usually, during the development of a vaccine, all steps to investigate the safety and efficacy are taken one by one. Therefore, the development of a vaccine takes seven to ten years on average. Given the enormous importance in the fight against COVID-19, several research phases were now started in parallel. At each step, the same stringent requirements continue to apply. Several phases of research have started in parallel and, thanks to significant funding from the European Commission and Member States, the greater financial risks of this accelerated operation are shared.

A second way to speed up the development of a COVID-19 vaccine is consultation between researchers and the competent authorities such as the FAMHP and the EMA from the start of the procedure. There is the “rolling review”, in which not all data must be available from the start of the MA application. The researchers gradually provide the authorities with all the necessary data. At the end of the process, of course, all the data needed in the slower procedure must also be present in the accelerated procedure. Researchers can also request scientific-technical advice (STTAs) before starting a procedure, both from the FAMHP and at a European level.

The final way to make the vaccine available as soon as possible is not to wait for all the steps to be successfully completed and to get all the logistical aspects in order at an early stage so that the vaccines can be produced in large quantities. As soon as the vaccine is licensed, all the batches that have already been produced in anticipation can be distributed.

Clinical trials
All vaccines in development can be found on the WHO website. The list of approved clinical trials for vaccines and medicines against COVID-19 in Belgium is available from the clinical trials database.

Which vaccines are already available?

There are currently four COVID-19 vaccines approved by the EMA and available in Belgium:

The Pfizer/BioNTech (Comirnaty) vaccine was approved on 21 December 2020
The Moderna vaccine was approved on 6 January 2021
The vaccine of AstraZeneca and the University of Oxford (Vaxzevria) was approved on 29 January 2021
Janssen's vaccine was approved on 11 March 2021

The EMA website lists all vaccines for which a rolling review has been started.

In Belgium an advisory committee was set up within the FAMHP to analyse the procurement dossiers on the basis of various criteria. On 12 February 2021, Professor Dirk Ramaekers, the chairman of the Task Force for Operationalisation of the Vaccination Strategy, was appointed as the Belgian representative to the European Steering Group. From that date onwards, the coordination of activities relating to public procurement has been transferred to the Governmental Commission for Corona

Follow-up of vaccines on the market
All medicines and vaccines on the market are continuously monitored. Reports of possible side effects can be reported by healthcare professionals and patients to the FAMHP via www.eenbijwerkingreken.be or www.notifieruneffetindesirable.be. These side effects are evaluated by experts from the FAMHP and the findings are shared at European and even global level. By aggregating the data on a large scale, signals are discovered more quickly.

In addition, MA holders must also prepare regular safety reports for evaluation by national and European authorities, this will apply to vaccines against COVIDs. Both at the national level (Safety Board) and at the European level (Pharmacovigilance Risk Assessment Committee, PRAC) there are expert groups that evaluate potential problems. The necessary measures can be taken on the basis of all this information.

List of news about vaccines against COVID-19

More information
All communication from the FAMHP on the measures taken in the context of COVID-19.