Luxembourg's Ministry of Health has confirmed that, on 29 January 2021, the European Medicine Agency (EMA) issued a positive opinion for the conditional marketing authorisation of AstraZeneca's SARS-CoV-2 coronavirus vaccine (AZD122); this vaccine is the third vaccine to obtain marketing authorisation in the EU after the mRNA vaccines from BioNTech / Pfizer and Moderna.
AstraZeneca's vaccine product is for immunisation against COVID-19 and is authorised from those aged 18+ years. The vaccination consists of 2 doses of 0.5 ml each, spaced 4 to 12 weeks apart.
Although the benefit / risk ratio of the AstraZeneca vaccine is clearly favourable for the European Medicines Agency, the lack of data relating to its efficacy in the elderly has prompted various national advisory bodies not to recommend the use of this vaccine in people aged 65+ years.
On Thursday 4 February, Luxembourg's Superior Council of Infectious Diseases (CSMI) issued recommendations aimed at clarifying the conditions of administration of this vaccine. The CSMI has also clarified the positioning of this vaccine within the framework of the country's vaccine strategy.
The CSMI has stressed in its opinion that mortality and hospitalisation due to COVID-19 infection mainly affects (very) elderly people (aged 75+ years) and people with immunosuppression (such as an organ transplant, haematopoietic stem cell transplant, cancer or leukemia under treatment with chemo-, radio- and / or immunotherapy) or congenital immune deficiency.
While emphasising that the efficacy of AstraZeneca vaccine against severe forms (hospitalisation) and death is excellent, regardless of age group - no cases were reported among participants in the vaccinated group, from 21 days post-1st dose - the CSMI also noted that vaccine efficacy data for certain target groups are currently limited.
These considerations led the CSMI to recall that, in the current context where other vaccine products are available, such as those from BioNTech / Pfizer and Moderna, for which the efficacy data in the elderly or immunosuppressed are more solid, it is preferable to give priority to vaccination of people aged 65+ years and to people with immunosuppression by mRNA vaccines from BioNTech / Pfizer and Moderna, and to offer vaccination with the AstraZeneca product to younger people and to people who are not affected by an immune deficiency.
Only in the event of a vaccine shortage would the CSMI recommend the use of AstraZeneca vaccine for all age groups and risk groups.
Based on the prioritisation of the different target groups, as adopted by the Government Cabinet, the CSMI has recommended not to use the AstraZeneca vaccine, but to vaccinate preferably with an mRNA-based vaccine, such as BioNTech / Pfizer or Moderna, the following groups of people:
• Residents of elderly accommodations, regardless of their age (phase 1)
• All people covered by phase 2, i.e. people aged 75+ years (phase 2a), and people who are highly vulnerable due to a pre-existing state of health (phase 2b)
• People aged 70 - 74 years (phase 3a);
• Some people in phase 3b, namely those significantly vulnerable due to an acquired immunodeficiency
• People aged 65 - 69 years (phase 4a).
However, AstraZeneca vaccine is recommended for the following people:
• Health professionals and staff in health and care establishments (hospitals, accommodation structures for the elderly and assistance and care networks), (phase 1b);
• People who are significantly vulnerable due to a disease other than acquired immunodeficiency (phase 3b);
• People who are moderately vulnerable due to a pre-existing state of health (phase 4b):
• Diabetes with or without insulin, with cardio-neuro-vascular complications
• Complicated arterial hypertension, with sequelae of stroke or associated heart disease
• Neuromuscular disease with clinical repercussions.
For people covered by phases 5 and 6, no preferential allocation according to one or the other vaccine product is recommended.
At its meeting on Friday 5 February 2021, Luxembourg's cabinet agreed with the recommendations of the CSMI of the previous day.
Vaccine efficacy studies in relation to AstraZeneca's product are still ongoing. Therefore, when new data on its effectiveness with regard to the various target groups become available, the recommendations of the CSMI are likely to be adapted.
