The Inter-ministerial Conference on Public Health andthe Government Commissioner for Corona give more details on the vaccination strategy.
The federal government and the federated entities work together to vaccinate at least 8 million Belgians.
The FPS Public Health and the FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified drug Nous-PEV (formed by the experimental drugs GAd-PEV and MVA-PEV) for the treatment of certain lung and skin cancers. The public consultation will run from 10 November 2020 to 10 December 2020.
Submission of dossiers during end-of-year period: final date is 15 December, except for COVID-19 dossiers
During the end-of-year period the FAMHP will be closed from Friday 25 December 2020 up to and including Sunday 3 January 2021. Deadlines have been set for the submission of different types of files.
After reviewing the benefit-risk ratio of the medicinal product ESMYA®, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the definitive revocation of its marketing authorisation (MA).
Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages
On 1 April 2020, the FAMHP took steps regarding a range of medicinal products in order to avoid any shortage. These measures have now been extended by one month.
The FAMHP continues to closely monitor the distribution of influenza vaccines and is currently conducting a survey among all pharmacies to determine to what extent the planned supply will be enough.
The European Medicines Agency (EMA) published the tenth ESVAC report (European Surveillance of Veterinary Antimicrobial Consumption) about the sale of antibacterial agents for veterinary use in 2018. Further efforts remain necessary, in Belgium as well.
The European Commission is holding negotiations on behalf of the Member States for procurement procedures for COVID-19 vaccines and is presenting contracts to the Member States. In Belgium, the Advisory Committee responsible for the analysis of the procurement files issued a positive recommendation for Janssen's (Johnson & Johnson) vaccine candidate. The Interministerial Conference (IMC) for Public Health has followed the advice. Belgium will buy the vaccine if a marketing authorisation is granted.
Influenza vaccine: one million doses are still expected and will be distributed to pharmacies between late October and early November
The FAMHP will continue to closely monitor their distribution. In order to provide patients, doctors and pharmacists with the best possible information, the FAMHP collected the most up-to-date information from the three authorisation holders concerned (Sanofi, Mylan, GSK) on the planned delivery dates to wholesaler-distributors. According to this, approximately one third of the planned vaccines must still be delivered.
Influenza vaccine: 10% of the stocks already distributed to the patients, two thirds still to be distributed to (hospital) pharmacies
The FAMHP makes a first assessment of the situation regarding the distribution of flu vaccines. More than half of the vaccines have yet to be placed on the market.