Vaccines to protect against coronavirus are being developed around the world. Development work has proceeded at a record pace and several marketing authorisation reviews are currently being conducted by the European Medicines Agency (EMA). The first vaccine is expected to receive marketing authorisation in Finland before the end of the year.
Despite the rapid development schedule, the development of coronavirus vaccines involves all the same steps as in normal circumstances. No stage has been left out and thoroughness has not been compromised. It has been possible to accelerate the timetable and make it more flexible by combining development stages. Normally, the research stages come after each other but now, different stages have been carried out in parallel to save time.
In addition, the authorities have started their vaccine assessments early on. Coronavirus vaccines are assessed in an accelerated “rolling review” procedure, in which the authorities review the information obtained from the investigations as it become available. Normally, the review would only be carried out once all the research data is available.
Strict criteria for granting marketing authorisation
Extensive and in-depth studies have been carried out on all coronavirus vaccines included in the marketing authorisation review. The authorities carefully analyse the data on the development of the vaccines. The quality, safety and efficacy of the vaccine are assessed with the same criteria as in the normal marketing authorisation process. In order to be eligible for marketing authorisation, the benefits of the vaccine must be much greater than the potential risks and disadvantages.
Very rare adverse effects can never be completely excluded until the vaccine is in wider use. Therefore, despite extensive studies, there is always a small chance that a vaccine will produce an adverse effect. After marketing authorisation has been granted, it is important to monitor the effectiveness and safety of vaccines in order to identify any rare adverse effects.
Finland adopts COVID-19 vaccine strategy
The Government adopted a resolution on Finland's COVID-19 vaccination strategy on Thursday 10 December 2020. The evidence-based strategy has been prepared on medical grounds and in consultation with national experts. Finland's objective is to protect the entire population when an authorised product is available. Taking the vaccine will be voluntary and it will be offered free of charge to anyone who wishes to be vaccinated.
Finland is taking part in the European Union’s joint vaccine procurement. The European Commission has negotiated agreements on six different coronavirus vaccines and Finland is party to all six agreements. In other words, Finland has the opportunity to receive different types of vaccines, which will enable a vaccination strategy that best suits people in different population, age and risk groups. This will help ensure that the most suitable vaccination is available for everyone.
It is estimated that the first vaccines will arrive in Finland in early 2021, after which the vaccination process will begin as soon as possible. The Ministry of Social Affairs and Health and the Finnish Institute for Health and Welfare THL have carried out a medical risk assessment to determine which groups of people will have vaccination priority, as not everyone can be vaccinated simultaneously. The first to be offered the vaccine will be healthcare and social welfare staff treating coronavirus patients and care home staff. After this, the vaccine will be offered to the elderly and persons at high risk of severe coronavirus disease due to underlying health conditions.
The vaccination of healthcare and social welfare staff will mainly take place during January–March. After this, or possibly at the same time, the vaccination programme will be extended to the next target groups. The vaccination of children will not be started until the target group studies are completed.
The municipalities will be responsible for organising vaccinations in their area. The municipalities will be able to cooperate with the hospital districts in their areas, and the hospital districts will coordinate the practical arrangements related to the vaccination. Vaccination should be planned so that vaccination data is entered in real time to the national vaccination register maintained by the Finnish Institute for Health and Welfare. The register is used to monitor the implementation, effectiveness and safety of vaccinations.
Vaccination plans to be specified later
More and more data is becoming available on the vaccines and it will only be possible to make the final decisions on vaccination once the vaccines have been authorised and are available. The order and timetable of vaccinating the elderly, risk groups and the rest of the population will be specified in early 2021. As more data is accumulated, the locations where vaccinations will be provided and other details will also be specified.
The duration of the immunity the vaccines give is not yet known and will not be known until after the vaccines have been in use for a longer time. Consequently, the need for booster doses will also become clear later on.
- How are vaccines developed?
- Fourth coronavirus vaccine being reviewed for marketing authorisation – authorisation requirements are very strict
- Keksinnöstä lääkkeeksi – rokotekehitystä keskellä pandemiaa -webinar 9.12.2020 (SOSTE & Lääketeollisuus ry)
- Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU. Virtual event 11.12.2020 (EMA)
- Government adopts resolution on Finland’s COVID-19 vaccine strategy