The current regulation too limits the possibilities of the Department of Health and Welfare to make recommendations according to the current situation.
Coronavirus as vaccinations to control have progressed, puzzling medical dilemmas have come to the fore. Health concerns must be taken seriously by health authorities, while ensuring that the rate of vaccination is not slowed down too much.
Vaccines are subject to the same general requirements of pharmaceutical legislation as other medicines. The vaccine can be granted a marketing authorization if the pharmacovigilance authority considers the vaccine to be effective and sufficiently safe.
So far, the EU has granted conditional marketing authorizations for four coronavirus vaccines. They are based on two different technologies: rna vaccines (Biontech and Pfizer, Moderna) and adenovirus vaccines (Astra Zeneca, Johnson & Johnson).
Government may lay down by regulation the details of the implementation of vaccinations. The December decree only defines the vaccines to be used at a general level. However, under that Regulation, authorized vaccines must be used “on the basis of medical evidence and an approved indication”. The indication for use of the vaccine, ie the definition of the intended use, states, among other things, the age at which the vaccine is suitable.
The main rule for all medicines is that the terms of the marketing authorization must be adhered to. On the other hand, a doctor may prescribe a medicinal product for a purpose other than that for which it is authorized, if this is medically justified. The legal liability of a doctor is emphasized if he deviates from the marketing authorization.
The details of the marketing authorization were deviated from shortly after the vaccinations began: after a short period of uncertainty, one vial of Biontech and Pfizer vaccine was dared to take six doses instead of the five specified in the marketing authorization.
Then the health authorities had to take a stand on an already more difficult problem. In marketing authorizations for RNA vaccines, the dosing interval is three or four weeks. There is no individual medical justification for extending the dose interval. However, the effort to provide the first injection quickly to more people led to the Department of Health and Welfare (THL) ending up recommending an extension.
In the current situation THL will have to assess even more difficult issues. There are indications that authorized adenovirus vaccines may be associated with some very rare venous thrombosis. Astra Zeneca is not currently given to people under 65 years of age. Johnson & Johnson has not yet delivered its own vaccines to Europe during further investigations.
In the case of Astra Zeneca, THL has also had to be assessed separately whether a booster dose of rna can be given to those under 65 years of age who have already received the first dose.
Legally, the issue is challenging. If the vaccination series is designed to give an adenovirus vaccine in the first vaccine and an rna vaccine as a booster dose, it is a combination of two different medicines. The same interpretation seems likely if a change is decided after the first vaccination.
Marketing Authorizations according to which the use of vaccines must comply with official recommendations. Now, however, the THL has to take into account in its recommendations the December regulation, which binds the guidelines to the indication specified in the marketing authorization for the vaccine. If two different products are used in the same vaccination series, this is the policy related to the indication.
In outlining the details of the vaccination program, THL has a greater legal responsibility for deviating from the details specified in the marketing authorizations. The guidelines may be medically and epidemiologically justified, but the THL cannot recommend anything contrary to the regulation.
The regulation should be updated so that the THL is sufficiently competent and able to make recommendations appropriate to the situation on the basis of the best available information. The regulation does not need to include a reference to the indications for vaccines, except for age groups.
The author is a lawyer specializing in medical and healthcare law.
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