Swissmedic has approved Pfizer AG's applications to have the company’s COVID-19 vaccines – until now authorised temporarily subject to special conditions – authorised for five years. This decision was based on a large amount of data on the safety, efficacy and quality of the vaccines which the company has now submitted in compliance with the conditions set.
Three formulations (authorisation nos. 68225 and 68710, with 30 and 10 μg/dose) authorised for five years
To ensure that patients have rapid access to medicines for the treatment of life-threatening diseases, medicines may be authorised on a temporary basis subject to certain legal requirements. Unlike when a fully documented authorisation application for a new active substance is submitted, data from studies extending over lengthy periods may in these cases be submitted at a later stage. This means that an initial benefit-risk decision can be made earlier in the interests of the patients affected even while the volume of data is still limited.
Temporary authorisation is subject to certain special conditions being met. For instance, clinical trials that are still ongoing must be completed in good time – and, where necessary, further data obtained and evaluated so that outstanding questions can be answered – thus enabling Swissmedic to assess the preparation's ratio of benefits to risks on the basis of complete documentation within the given timeframe.
Based on the documentation that was now complete, Pfizer AG submitted an application in September 2022 to have the time limit on the authorisation of three vaccines for preventing COVID-19 disease removed. After examining all the documentation required for satisfying the conditions set, Swissmedic has approved the application and authorised the following preparations for a period of five years (as it does for all new active substances authorised for the first time):
- Comirnaty®, concentrate for dispersion for injection for persons aged 12 years and over (30 micrograms/dose, VIOLET cap, authorisation no. 68225)
- Comirnaty®, ready-to-use dispersion for injection for persons aged 12 years and over (30 micrograms/dose, GREY cap, authorisation no. 68710)
- Comirnaty®, concentrate for dispersion for injection for children aged between 5 and 12 years (10 micrograms/dose, ORANGE cap, authorisation no. 68710)
Ongoing safety monitoring
As part of the authorisation procedure, applicants are required to submit risk management plans. These must state how the authorisation holders intend to prevent or mitigate known medicinal product risks and how any newly arising risks are to be monitored and analysed in future. The companies must submit regular reports to Swissmedic on the safety of their medicinal products.
Swissmedic is continuing to closely monitor COVID-19 vaccines to ensure that any safety signals are identified as soon as possible and are correctly evaluated. Healthcare professionals are required by law to report serious and/or previously unknown adverse drug reactions to Swissmedic. This reporting of side effects or of any suspicion of such effects makes an important contribution to patient safety.
Temporary authorisation under Art. 9a of the Therapeutic Products Act (TPA)
Medicinal products for identifying, preventing or treating life-threatening diseases may be authorised temporarily in a simplified procedure if their use is expected to produce a major therapeutic benefit, if no equivalent medicinal product is available in Switzerland, and if obtaining and evaluating the data required for authorisation would take so long that irreversible harm would occur or be worsened as a result. With temporary authorisations, clinical documentation may be completed at a later stage. As a rule, temporary authorisations are issued for a period of two years and are subject to the applicants fulfilling certain conditions.