The Communicable Diseases Act (SFS 2004:168) stipulates that a communicable disease shall be covered by a national vaccination programme if the vaccination against the disease is expected to:
- effectively prevent communicable diseases from spreading amongst the population
- be socioeconomically cost effective
- be sustainable from an ethical and humanitarian point of view.
The corresponding Ordinance regulates the 13 factors that the Public Health Agency of Sweden must account for when proposing changes in the national vaccination programme to the Government. All factors are significant, but in preparation of a recommendation to change the national vaccination programme, they can be given different levels of importance.
- The burden of the disease on society, in the healthcare sector and for individuals.
- The expected impact of vaccinations on the burden of the disease and on the epidemiology of the disease.
- The number of doses that are required to achieve the desired effect.
- The target groups who will be offered the vaccination.
- The safety of the vaccine.
- The effect of vaccinations on the activities of county councils, municipalities and private healthcare providers.
- The suitability of combining the vaccine with the other vaccines in the national vaccination programme.
- The general public's ability to accept the vaccine, and its effect on attitudes towards vaccinations in general.
- Which other accessible, preventative measures or treatments can be performed or provided as an alternative to the vaccination in the national vaccination programme.
- An economic assessment of the vaccination's cost-effectiveness and an assessment of expenses and income for the state, municipalities and county councils.
- The opportunities to monitor the vaccination's effect in the ten above-stated points and the state's estimated costs for follow-up.
- The need for information initiatives in relation to the general public and healthcare providers, and the cost of this.
- Medical ethics and humanitarian considerations.
The Public Health Agency of Sweden has developed a working process for proposing changes to national vaccination programmes that strives to be clear, open and structured. A process for health-economic evaluations has also been developed.
A reference group for national vaccination programmes has been appointed, that is tasked with proposing and prioritizing which changes to the national vaccination programme need to be investigated.
Changes under consideration
The Public Health Agency of Sweden is currently conducting the following investigations that may lead to changes of national vaccination programmes:
- Extending the vaccination programme for children against human papillomavirus (HPV) to boys
- Advancing the first dose of combined vaccine against measles, mumps and rubella (MMR).
In February 2017 the Public Health Agency of Sweden concluded that vaccination against rotavirus infection fulfilled the requirements of the Communicable Diseases Act and should be included in the national vaccination programme for children.
In April 2016 the Public Health Agency of Sweden suggested to the government to create four selective vaccination programmes for risk groups against hepatitis B, tuberculosis, influenza and pneumococcal infections, respectively. At present, these vaccinations are regulated by recommendations. If selective programmes are started, the county councils will be obliged to offer these vaccinations to the risk groups free of charge. The vaccinations will also be eligible for registration in the national vaccination registry, which will improve the Agency's monitoring.
The National Board of Health and Welfare has previously suggested to the government to extend the national vaccination programme for children with vaccinations against hepatitis B.
The suggestions above are currently under consideration by the government.