COVID-19 Vaccines New
Marketing authorisation holder: BioNTech
Date of marketing authorisation: 21 December 2020
On 8 January 2021, the Summary of Product Characteristics (SmPC) was updated in order to allow to extract 6 (instead of previously 5) doses per container.
On 30 March 2021, short-term storage at -25 °C to -15 °C was approved (see SmPC item 6.3).
Marketing authorisation holder: Moderna
Date of marketing authorisation: 06 January 2021
Marketing authorisation holder: AstraZeneca
Date of marketing authorisation: 29 January 2021
On 29 March 2021, the name was changed from AstraZeneca to Vaxzevria Injection Suspension.
Marketing authorisation holder: Janssen-Cilag
Date of marketing authorisation: 11. March 2021
The European Medicines Agency (EMA) reconfirmed on 07.04.2021 that there continues to be a positive risk-benefit balance for the use of AstraZeneca's COVID-19 vaccine, as also confirmed by the World Health Organisation (WHO) on 17.03.2021. On 08.04.2021, the National Vaccination Panel, following the assessment of the EMA, also advocated that the vaccination programme be continued unchanged, taking into account the epidemiological situation and the available vaccines. The benefits of the vaccine in combating the still widespread threat of COVID-19, which can itself cause clotting problems and be fatal, continue to outweigh the risk of side effects. There is no evidence of a problem associated with individual batches of the vaccine or with specific manufacturing sites. Individuals vaccinated with COVID-19 vaccine, particularly from AstraZeneca, should be advised of a possible risk of thromboembolic events (blood clots)/thrombocytopenia (reduction in blood platelets).
The weekly updated report on reports of suspected adverse reactions is available for download on the website of the Federal Office for Safety in Health Care (BASG).
In temporal connection with COVID-19 vaccinations, a certain form of thrombo-embolic events (clotting disorders) has been observed in Europe in very rare cases. In women under 55 years of age, there is a signal of a very small risk (less than 1:100,000) of a rare form of clotting disorder with blood clots after vaccination against COVID-19, which should be pointed out before vaccination. This involves blood clots in the large veins in the brain, a so-called sinus vein thrombosis, which has also been associated with a decrease in blood platelets in isolated cases. A corresponding warning will be included in the product information of the vaccine.
Not every sign of illness that occurs in connection with a vaccination can be related to the vaccination. When vaccines are administered to a large number of people, there is an increased likelihood of symptoms occurring after vaccination that were not triggered by the vaccination but by other causes, such as another illness that occurred at the same time or shortly afterwards.
In Austria, the Federal Office for Safety in Health Care (BASG) records all suspected adverse reactions to medicinal products and vaccines that have occurred in Austria and are reported by health professionals or patients. In Austria, patients and their relatives can voluntarily report adverse drug reactions directly to the BASG. Physicians, pharmacists and other health professionals are legally obliged to report adverse drug reactions.
After processing and assessment, the data is forwarded to the European Medicines Agency (EMA) in accordance with the applicable European laws and directives. The data are thus available to the national medicines authorities responsible for these marketing authorisations and also to all other European medicines regulatory authorities for ongoing safety monitoring.
In close cooperation with the EU network of authorities, the risk-benefit balance of all authorised medicinal products is continuously monitored. The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) analyses all aspects relevant to the safety and efficacy of a vaccine. If necessary, new side effects are included in the technical information and directions for use of the respective vaccine or other measures are taken to ensure safe and effective use.
According to the recommendation of the National Vaccination Committee, a vaccination schedule consisting of 2 doses with the same vaccine as mentioned in the product information is recommended. The use of different vaccines for the first and second dose is neither intended nor recommended. Currently, no data are available on the use of different vaccines in the context of initial immunisation.
As with use after other medications, individuals should be advised to monitor their health status after COVID-19 vaccinations. If side effects persist for more than 3 days after vaccination or if new ones occur (e.g. dizziness, headache, visual disturbances, nausea/vomiting, shortness of breath, acute pain in the chest, abdomen or extremities, leg swelling), further medical diagnostics should be carried out to clarify thromboembolic events (blood clots)/thrombocytopenia (reduction of blood platelets) as a precaution.
At this stage, there is not enough data to identify individual groups at increased risk. At the moment, therefore, there is a positive benefit-risk profile for all groups covered by the marketing authorisation. A tendency or history of thrombo-embolism is not a reason for exclusion from vaccination.
As a preventive measure, paracetamol can be taken about 6 hours after vaccination - if needed repeated every further 6 hours for the following 24 to 48 hours. This can reduce common side effects to the vaccine. In any case, please consult your doctor whether paracetamol is suitable for your individual situation.