State of affairs on 21.12.2020
Context
COVID-19 is caused by the SARS-CoV-2 virus (Severe Acute Respiratory Syndrome CoronaVirus-2), which belongs to the Coronavidae family. This virus is the subject of numerous scientific research projects. There are more than 100,000 scientific publications worldwide on COVID-19. These different publications are not all scientifically equivalent. They must be sorted to keep the most methodologically solid and reliable results. This gives a better understanding of the virus and opens up new therapeutic and prophylactic perspectives.
The Sciensano website has published a regularly updated descriptive document of the disease based on the analysis of the relevant scientific literature.
At this stage, only one SARS-CoV-2 antiviral treatment is authorised in Europe, and several medicinal products are the subject of intense research. A list of different types of potential treatments has been published by the World Health Organization (WHO). Most of these potential treatments are currently undergoing clinical trials, some of them in Belgium.
Treatments currently under research target the moderate, severe and critical stages of the disease. On 21 December 2020, the international database of COVID-19 clinical trials lists 5,000 clinical trials.
A medicinal product must pass various tests before it can be authorised and placed on the market.
Clinical trials in Belgium related to COVID-19
By 21 December 2020, the FAMHP had already approved 32 clinical trials and 40 amendments, which potentially represents 3,000 patients who where or could be recruited at 43 different sites.
As early as March 2020, the FAMHP experts have collaborated with several institutions and research centres to rapidly publish national guidelines to complete the European guidelines on how to manage clinical trials during the COVID-19 pandemic.
The FAMHP validates and reviews clinical trial applications within four working days (except for clinical trials with Genetically modified organisms (GMOs) and Advanced Therapy Medicinal Product (ATMPs), for which the evaluation period has been shortened to ten working days.
The FAMHP has also published another national guideline on clinical investigations in addition to the guideline on clinical trials in the context of prevention or treatment of COVID-19 and other clinical trials underway in Belgium.
The list of approved clinical trials is available via the clinical trials database.
The initial results of this research will make it possible to gradually refine the therapeutic approach for COVID-19 patients and to discern, scientifically, the possible treatments. Some clinical results on promising treatments are nevertheless disappointing, but the scientific community is continuing its research. The progress of these various studies depends on the evolution of the epidemic. In order to study the different molecules, COVID-19 positive patients are necessarily needed; if the epidemic is declining, this paradoxically hinders research in this field. In parallel with the therapeutic treatments being investigated, various vaccines (so-called prophylactic treatments) are being developed, some of which are in clinical trials.
Compassionate use
When no marketed treatment can satisfactorily treat a patient, an unapproved medicinal product can be used via an urgent compassionate use notification, under two conditions:
1. the patient cannot be treated with a marketed drug;
2. the state of health of the patient does not allow to wait for importation or implementation of a compassionate use program.
The FAMHP has already received a number of urgent requests for compassionate use during the first and second peak of the pandemic. However, a compassionate use programme can be set up if a drug manufacturer wishes to make available a treatment for which it already has scientific results that allow it to demonstrate relative efficacy for a group of patients that cannot be treated satisfactorily. This procedure has also been developed in the context of the COVID-19 crisis.
Supporting research and development through scientific and technical advice
FAMHP experts have also set up accelerated procedures for scientific and technical advice, including regulatory advice (STAs), at national level. These procedures enable academic centres, biotechnology companies and medium/large companies to consult the FAMHP to support and accelerate the (non-)clinical development of their products and to make them available to patients as quickly as possible. Since mid-March 2020, 20 accelerated procedures for scientific and technical advice, at national level, have been processed or are in progress.
In this context, the FAMHP is also active in the European pilot project of the EU Innovation Offices Network (EU IN) concerning the implementation of the procedure for Simultaneous National Scientific Advice (SNSA) which also represents a new approach to accelerate the (non-)clinical development of innovative products and treatments against COVID-19 in a targeted manner. Since mid-March 2020, 15 accelerated procedures for scientific and technical advice, on a total of 18, have been processed under the SNSA procedure.
The FAMHP also participates in various scientific advices within the European Scientific Advices Working Party (SAWP) of the European Medicines Agency (EMA). An accelerated SAWP procedure is available.
Vaccines
The availability of safe and effective COVID-19 vaccines is an important objective in the fight against SARS-CoV-2. Clinical trials of candidate vaccines in humans are an important step towards the marketing authorisation for safe and effective vaccines against COVID-19.
One of the spearheads of the FAMHP is vaccines. It is therefore quite natural that our experts actively support the development of a vaccine by collaborating with national and international pharmaceutical companies, particularly through STAs, but also by collaborating at European level with other competent authorities.
More information on COVID-19 vaccines.
News related to research and development on COVID-19
- 21.12.2020 - Coronavirus: European Commission gives conditional market authorisation for vaccine against COVID-19
- 21.12.2020 - Coronavirus: the EMA gives a first positive opinion for COVID-19 vaccine
- 02.12.2020 - Coronavirus: the Inter-Ministerial Conference on Public Health agrees on the European procurement procedure for Moderna vaccine candidate and finalizes COVID-19 vaccination strategy
- 01.12.2020 - Coronavirus: EMA receives first two applications for conditional marketing authorisation of COVID-19 vaccines
- 27.11.2020 - Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages
- 25.11.2020 - Coronavirus: EMA organises public meeting on COVID-19 vaccines
- 24.11.2020 - Coronavirus: Belgium agrees on procurement of CureVac's vaccine candidate
- 16.11.2020 - The federal government and the federated entities work together to vaccinate at least 8 million Belgians
- 28.10.2020 - Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages
- 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
- 06.10.2020 - Coronavirus – a new validation procedure for serological tests
- 28.09.2020 - Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages
- 07.09.2020 - Coronavirus - Consultation between the FAMHP and the clinical labs about the serological tests for COVID-19
- 28.08.2020 - Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages
- 21.08.2020 - Coronavirus - Belgium joins Europe for the purchase of the vaccine candidate against COVID-19 from AstraZeneca
- 20.08.2020 - Coronavirus - Advisory committee on choice of COVID-19 vaccines treats first dossier
- 20.08.2020 - The COVID-19 serological tests bought by the government are reliable
- 06.08.2020 - Coronavirus: Evaluation of the use of saliva samples as an alternative to sampling via a deep nasal swab to detect SARS-CoV-2, the virus that causes COVID-19
- 30.07.2020 - Coronavirus: derogation for COVID-19 clinical trials of medicinal products containing or consisting of genetically modified organisms
- 13.07.2020 - Coronavirus: shorter deadlines for clinical trials
- 19.06.2020 - First COVID-19 vaccine trial authorised in Belgium
- 03.05.2020: National guideline for the management of clinical investigations for medical devices during the coronavirus pandemic
- 30.04.2020 - New version of Belgian directive for management of clinical trials during coronavirus pandemic
- 25.03.2020 - Belgian guideline for the management of clinical trials during the coronavirus pandemic
- 24.03.2020 - What medicinal products are used in the fight against COVID-19?
- 21.03.2020 - European guidelines for the management of clinical trials during the coronavirus pandemic
- 16.03.2020- Directive on the direct dispensing of medicinal products to patients in the context of clinical trials
More information
All information from the FAMHP concerning the measures taken during COVID-19.