Vaccines

Safe vaccines
Good quality, safe and effective vaccines are important in the fight against COVID-19. Despite the urgent need, no concessions are made to the usual strict requirements when making a vaccine against COVID-19 available. A vaccine against COVID-19 will 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. There are strict requirements for safety, quality and effectiveness. 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. Candidate vaccines that do not receive a MA are not allowed on the market and the contracts that were concluded beforehand will expire.

Quickly available for our citizens
Developing a vaccine takes an average of 7 to 10 years. The development of a vaccine has a high cost and a high risk of failure. Therefore, the different steps to market a vaccine are normally followed one by one. Given its enormous importance in the fight against COVID-19, several steps are now being taken simultaneously. The same strict requirements continue to apply at every step. 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 information. At the end of that process, of course, all the data needed in the slower procedure must also be present in the accelerated procedure. Investigators can also initiate proceedings for them scientific-technical advice (STA) applications, both at the FAMHP and at European level.

The last way to make the vaccine available as soon as possible is not to wait for the successful completion of all the steps and to arrange all logistical aspects at an early stage in order to be able to produce the vaccines in large quantities.

When will there be a vaccine and who gets it first?
The EMA uses rolling reviews to save time. So far, rolling reviews have been started for four vaccine candidates: AstraZeneca and University of Oxford, Pfizer/BioNTech, Moderna, Janssen (Johnson & Johnson).

On 01.12.2020, the first applications for a conditional marketing authorisation were submitted by Pfizer/BioNTech and by Moderna. On 21.12.2020, the EMA gave a positive opinion for the Pfizer/BioNTech vaccine.

However, the demand is enormous. There will not immediately be enough vaccines to vaccinate all Europeans. Deliveries will be phased. Priority groups have been defined based on scientific advice and a societal debate.

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

The purchase of vaccines
The European Commission negotiates on behalf of the Member States for the procurement procedures of vaccines against COVID-19 and submits contracts to the Member States. In Belgium there is one within the FAMHP advisory committee was founded that analyzes purchase files based on various criteria.

On 21.08.2020 there is an agreement for the purchase of the candidate vaccine from AstraZeneca.
On 19.10.2020 there is an agreement for the purchase of the candidate vaccine from Janssen (Johnson & Johnson).
On 18.11.2020 there is an agreement for the purchase of the candidate vaccine from Pfizer/BioNTech.
On 24.11.2020 there is an agreement for the purchase of the candidate vaccine from CureVac.
On 02.12.2020 there is an agreement for the purchase of the candidate vaccine from Moderna.

Manufacturer Number of vaccines ordered Number of doses**
AstraZeneca 7.5 million 2
Janssen (Johnson & Johnson) 5 milion 1 or 2
Pfizer/BioNTech 5 million (+ 7.5 millions doses) 2
CureVac 2.9 milllion* 2
Moderna 2 million* 2

* allocation on EU level not yet confirmed
** definitive number of required doses will be known after approval by the EMA

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. 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, as will apply to vaccines against COVIDs, MA holders must also prepare regular safety reports for evaluation by national and European authorities. 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.

Last updated on 12/01/2021