Chamber of deputies, Luxembourg Parliament (Chambre des Députés) Copyright (c) 2020 JackKPhoto/Shutterstock. No use without permission.

Chamber of deputies, Luxembourg Parliament (Chambre des Députés) Copyright (c) 2020 JackKPhoto/Shutterstock. No use without permission.

Pfizer’s Paxlovid antiviral drug will initially only be dispensed in hospitals, health minister Paulette Lenert (LSAP) announced. The pill was authorised by the European Medicines Agency (EMA) last week.

Paxlovid will need to be given early in the infection to be effective, within the first 5 days to be exact, Lenert said in answer to a parliamentary question from déi Lénk MP Nathalie Oberweis. the drug will primarily be given to patients considered ‘vulnerable’ or at risk of developing complications.

The official recommendations to general practitioners for the treatment of Covid-19, as for the vast majority acute viral respiratory infections, remains symptomatic treatment (antipyretics, painkillers, cough suppressants, etc.) in its paucisymptomatic and benign forms, the health minister said.

A communication will be sent to all doctors and a training webinar will also be offered to interested physicians.

Luxembourg is due to receive 20,000 treatment courses, although Pfizer has not yet specified a delivery date, Lenert said.

Paxlovid for conditional marketing in the EU after previously giving countries the go-ahead to start using the medicine while the authorisation procedure was pending.

The European Council adopted a regulation revising the mandate of the European Medicines Agency on 25 January. Following the formal signing of the regulation by the European Parliament and the Council, it will come into force on 1 March, according to an internal European Commission email.

A reinforced mandate

Thanks to a reinforced mandate, the Agency can facilitate a coordinated EU-level response to health crises by:

- monitoring and mitigating the risk of shortages of critical medicines and medical devices;

- providing scientific advice on medicines that may have the potential to treat, prevent or diagnose the diseases causing those crises;

- coordinating studies to monitor the effectiveness and safety of medicinal products intended to treat, prevent or diagnose diseases related to the public health crisis;

- coordinating clinical trials for medicinal products intended to treat, prevent or diagnose diseases related to the public health crisis;

- transferring the expert panels of the Medical Device Regulation to the Agency.

Luxembourg also participates in the Joint Procurement Agreements (JPA) of the European Union in order to acquire the anti-COVID-19 drugs.

Several treatments in Luxembourg

In relation to treatments for the virus, the health minister said that “during the course of the pandemic, other therapeutic options were added for the most vulnerable patients, who are at risk of developing complications. These are antibodies monoclonals and direct antivirals.”

Monoclonal antibodies are administered by intravenous infusion and the patient must therefore go to the National Service for Infectious Diseases located at the Centre Hospitalier de Luxembourg.

Two antiviral drugs Ronapreve, which has been available in Luxembourg since December 2021, and Regkirona, which is not currently available in Luxembourg, are ineffective against the omicron variant, reveals Lenert in her parliamentary statement. Lagevrio is another antiviral medicine available in Luxembourg.

The recommendations for the use of Paxlovid are drawn up by the Scientific Council for health and the conditions of use are decided by the Division of Pharmacy and Medicines of the Department of Health.