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 until 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 to 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 now 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. EMA started the first rolling reviews of candidate vaccines in the beginning of October.
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?
There are currently more than 200 studies on a COVID-19 vaccine under way around the world. Based on the information currently available to the FAMHP, we believe that these studies could lead to the approval of a dozen or so effective and safe vaccines of good quality. There will normally be a safe COVID-19 vaccine next spring (by the end of March 2021).
However, the demand is enormous. There will not immediately be enough vaccines to vaccinate all Europeans. Deliveries will be phased. For the first phase, 1.5 million vaccines are expected for Belgium.
The available vaccines will first be given to priority target groups The Belgian Supreme Health Council issued an opinion. Healthcare workers, all Belgians aged over 65 and patients aged between 45 and 65 with certain chronic diseases such as diabetes and serious illnesses of the heart, lungs, liver and kidneys will be vaccinated first.
Clinical trials of candidate vaccines in humans represent an important step towards marketing these vaccines. According to the World Health Organization (WHO), the first clinical trial for a vaccine to be approved in Belgium is the thirteenth clinical trial to be allowed worldwide for a candidate vaccine against COVID-19. Other clinical trials with candidate vaccines against COVID-19 in Belgium are planned or are currently being evaluated by the FAMHP.
The field of vaccines is one of the spearheads of the FAMHP. It is therefore logical that our experts actively support vaccine development by collaborating with national and international pharmaceutical companies, particularly through STAs, and also by collaborating at European level with the other competent authorities.
Currently, no vaccine has yet been licensed for COVID-19 in Europe. Several dozen vaccines are in preclinical evaluation and twenty-six of them are already in 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.
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).
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.
Liability and damages
Due to the strict MA procedure, only safe, effective and high-quality vaccines come onto the market. The responsibility for the vaccine remains entirely in the hands of the MA holder or therefore the company that markets the vaccine. Legislation must be respected, production must take place in accordance with good manufacturing practices (GMP, Good Manufacturing Practices) and the obligations for pharmacovigilance (such as monitoring side effects) must continue to apply. The MA holder always remains liable and is responsible for compensation if the above requirements are not respected or if it concerns deliberate errors.
Purchase contracts may include strictly defined clauses that reimburse the company for potential liabilities. For example, it concerns a “not-for-profit during the pandemic” clause. This means that the MA holder supplies the vaccine at cost price and therefore makes no profit. As vaccine candidates go through the marketing path very quickly and prompted by the urgent demand for vaccines and exceptional circumstances, participating Member States will in that case indemnify the marketing authorization holder against certain damage claims not arising from non-compliance with the legislation , GMP requirements or pharmacovigilance obligations.
Citizens 'and patients' rights remain equally strong and unchanged. The liability clauses only apply between the contracting parties, in particular the government and the MA holder. The citizen or patient can make full use of all his / her rights at all times.
List of news about vaccines against COVID-19
- 19.10.2020 - Coronavirus: Belgium agrees on procurement of Janssen's (Johnson & Johnson) vaccine candidate
- 07.10.2020 - Coronavirus: EMA starts first rolling reviews of COVID-19 vaccines
- 21.08.2020 - Coronavirus - Belgium joins Europe to purchase AstraZeneca's COVID-19 candidate vaccine
- 20.08.2020 - Coronavirus - Advisory committee for selection of COVID-19 vaccines examines first file
- 23.06.2020 - Coronavirus and the fight waged by the FAMHP: FAMHP facilitates and supports the development of treatments and vaccines for COVID-19
- 19.06.2020 - Coronavirus: license for first clinical trial with COVID-19 vaccine in Belgium
All communications from the FAMHP about the measures taken in the context of COVID-19.