THL issues instructions that men under 30 years of age should only be offered the Comirnaty coronavirus vaccine
The Finnish Institute for Health and Welfare (THL) has instructed municipalities to offer boys and men aged under 30 only the Biontech-Pfizer Comirnaty coronavirus vaccine. According to a Nordic follow-up study, the relative occurrence of myocardial inflammation is higher for Moderna's Spikevax vaccines than for Biontech-Pfizer's Comirnaty vaccine, and the risk of myocardial inflammation after vaccination is higher in young men than in women.
The study found that myocardial inflammation from coronavirus vaccines is nevertheless rare overall. Cases of myocardial inflammation occur all the time as a result of various infections also in unvaccinated people.
The highest occurrence of myocardial inflammation after vaccination has been observed in young men within two weeks of receiving the second mRNA vaccine dose. The risk for women and older men is significantly lower for both mRNA vaccines.
According to THL's guidelines, Spikevax can be offered to all women aged 30 or over and also to women aged under 30. Comirnaty can be offered, as before, to all age groups receiving vaccination. In Finland, all those aged 12 or over can receive vaccination against coronavirus.
THL's guideline on the age limit for the Spikevax vaccine is a precautionary measure and will be reviewed in November as the results of the study become clear.
‘The results now obtained are still preliminary. We are currently analysing them and assessing whether they give cause for more permanent changes to the recommendations for coronavirus vaccination in Finland,’ explains Hanna Nohynek, Chief Physician at the Finnish Institute for Health and Welfare.
Boys and men aged under 30 have received in Finland more than 95,000 first doses of the Moderna coronavirus vaccine and more than 42,000 second doses.
Young men having received Spikevax to get Comirnaty for their second dose
If a male under 30 years of age has received Moderna’s Spikevax as his first dose of coronavirus vaccine, Biontech-Pfizer's Comirnaty is offered for their second dose.
‘The research results obtained in Finland and other countries on the administration of different vaccine products show that those who have received two different vaccines are at least as well protected against coronavirus as those who have received the same product on both occasions,’ Nohynek explains.
‘Taking the second dose is still very important to ensure that protection against serious coronavirus disease is as strong and long-lasting as possible.’
The Finnish Institute for Health and Welfare has previously issued instructions that third vaccine doses should not be offered at all to men under 30 years of age, as there is still insufficient data on the connection between third doses and the risk of myocardial inflammation. An exception is made, however, for strongly immunodeficient persons whose risk of serious coronavirus disease is significantly higher than in other people of the same age. The Finnish Institute for Health and Welfare has also instructed that men under 30 years of age with strong immunodeficiency should for the time being be offered only the Biontech-Pfizer vaccine as their third dose.
THL has instructed municipalities on giving third doses of coronavirus vaccine to persons vaccinated with short dose interval
The risk for women and men aged over 30 of developing myocardial inflammation after vaccination is significantly lower than for young men, which means that both vaccinations can continue to be offered to them as before. However, the Finnish Institute for Health and Welfare notes that the municipality should offer the Comirnaty vaccine to the person being vaccinated if they do not want to take Spikevax and it is possible to offer them Comirnaty instead.
Information from other Nordic countries supports Finnish findings
The Nordic follow-up study has made use of health care register data from Sweden, Denmark, Finland and Norway, and the Finnish Institute for Health and Welfare has participated in this research. Information obtained from other Nordic countries on the number of cases of myocardial inflammation treated in hospital is in line with the results previously obtained in Finland.
The Finnish Institute for Health and Welfare has examined the incidence of myocardial inflammation requiring hospital care in different age groups. Male vaccine recipients in Finland aged between 12 and 39 years of age have been diagnosed with a total of 6 cases of myocardial inflammation from among the 381,000 doses of Comirnaty administered, and under 5 cases for the 49,000 doses of Spikevax administered. There have been fewer than five cases of myocardial inflammations in girls and women in the same age group, and the prevalence of myocardial inflammations among these women and girls after vaccination has not deviated from the normal occurrence in the population as a whole.
The cases included in the analysis carried out by THL were those that were identified within four weeks of the person receiving the second dose of vaccine. The cases diagnosed within this age group have usually been mild, and those who have had such symptoms have recovered well.
‘In Finland too, the risk of myocardial inflammation seems to be both higher for Spikevax recipients than for Comirnaty recipients and higher for men than for women, once other background factors for the vaccinated people are also taken into account,’ says Petteri Hovi, Senior Researcher at the Finnish Institute for Health and Welfare.
‘Nordic cooperation in the safety monitoring of coronavirus vaccines is important, as cases of rare adverse effects such as myocardial inflammation are relatively small in each country. The age limit of 30 years for Spikevax has been determined on the basis of data collected jointly from the Nordic countries, as reliable conclusions can only be drawn from examining a large number of vaccine recipients.’
The results of the Nordic follow-up study are still preliminary and have been submitted to the European Medicines Agency (EMA) to support the safety monitoring of coronavirus vaccines. Nordic cooperation will be continued in order to determine the prevalence of pericarditis (pericardial inflammation) in those who have received a coronavirus vaccine. The preliminary results are expected to be available in December.
Fimea and the Finnish Institute for Health and Welfare are working together closely to investigate myocardial inflammations and assess the need for official measures.
Further information:
Hanna Nohynek
THL
Head Physician
[email protected]
Petteri Hovi
THL
Senior Researcher
[email protected]
