Stringent checks provide for safe vaccine use

Finland's national vaccination programme provides immunization against 11 diseases. The content of the vaccination program is always the outcome of a lengthy and complex evaluation process. "The selection criteria are essentially threefold," explains Chief Medical Officer at the MSAH Taneli Puumalainen. "The preventable disease burden must be significant, the vaccine must be sufficiently safe and the financial investment must be acceptable in proportion to the health benefits."

The MSAH is responsible for overall decision-making concerning the national vaccination programme together with the National Institute for Welfare and Health (THL). Municipalities handle the practical aspects of providing vaccinations. THL kicks off the selection process by evaluating the development of infectious diseases and of new vaccination needs for the national vaccination programme.

The National Advisory Committee on vaccination (KRAR) decides whether there is sufficient scientific evidence for recommending a new vaccine into use. In addition, a working group dealing with a specific vaccine can also investigate the matter examining the disease burden in question and estimating the possible impact of using a vaccine, can also investigate the matter. These investigations can easily take a year or two.

This expert scrutiny may result in a vaccine not being recommended for the programme. For instance, the vaccination for hepatitis B was not taken into general use through the vaccination programme as the disease burden caused by the virus is small in Finland and focused on a narrow risk group within the population.

"It could be that if everyone was vaccinated for this, the adverse effects would outweigh the benefits," observes Puumalainen.

People in certain risk groups may however be vaccinated against particular diseases, as is the case with the hepatitis viruses and tuberculosis.

When KRAR decides to recommend that a vaccine is put on the national vaccination programme, the matter is passed to the Advisory Board on Infectious Diseases, an expert body of the MSAH. If it corroborates the recommendation to put a vaccine into use, the matter then shifts to the policy decision-making arena.

"Decision-makers have to compare the impact of vaccination on public health with the outcomes of other health care interventions," says Puumalainen. "The things that are chosen for implementation are those expected to produce the greatest benefit."

Legislation on infectious diseases puts the state in charge to procuring vaccines and distributing them to the municipalities, which carry out the practical immunization activities. The majority of vaccines are those given to infants and children at child welfare clinics, in addition to which health centres provide vaccinations for people in risk groups. The defence force also runs a vaccination programme for conscripts. All vaccines in the national programme are given free of charge.

Vaccination programmes are quite similar in all EU countries, though in many funding for them derives from insurance cover. Puumalainen says that there are many benefits with state funding for vaccination programmes.

"The state can tender for vaccine procurements whereby the price will generally drop to less than half of pharmacy wholesale prices. The vaccination programme also reaches the whole population. If vaccines came under social security insurance, as has sometimes been suggested, the pharmacy price would certainly drop but it would still be an obstacle for low-income parents."

At EU level, the European Centre for Disease Prevention and Control (ECDC) provides much guidance on vaccine use and data from surveillance of disease trends and developments. Member states or the EU Commission may task the ECDC with convening scientific panels to provide guidance for policymakers in the area of public health. These panels analyze the available evidence on a particular question in order to help EU members to make policy choices.

Vaccination coverage in Finland is extremely high. Some 98 percent of children are covered by vaccines belonging to the national vaccination programme, discounting the seasonal influenza vaccine. The national programme protects people in Finland from many of the diseases prevalent in other countries.

"Many people are unaware that the long-lasting measles epidemic in Europe has put thousands of people in hospital and also resulted in fatalities. The epidemic has threatened to reach Finland too, but our high immunization coverage has kept it at bay."

Puumalainen believes that there is still some understanding of the danger posed by infectious diseases. Older members of the population recall people dying of diphtheria during the war years and how even in the 1960s rubella caused blindness in children and people died of measles. But this understanding is in danger of being lost.

"Vaccines have been so effective that many diseases have simply disappeared here. When the benefits are no longer so obvious but the side-effects sometimes associated with vaccinations are apparent, people's enthusiasm for being covered by them can wane."

While the good immunisation coverage existing in Finland also protects those few not vaccinated, this is hardly sufficient in the era of globalisation. Increasingly, the younger generations are liable to go abroad, in addition to which infectious diseases generally do not respect national borders.

Coupled with the precarious state of immunization in many parts of the world beyond the highly industrialised countries, the safety of high-level national vaccination safeguards cannot be counted on indefinitely.

"In most parts of the world the vaccination situation is much worse than here, and so there are more epidemics," says Puumalainen. "When people do not have immunity due to previous illness or are not vaccinated, they are more readily exposed to infection."

Paula Mannonen and Mark Waller