FDA defends Moderna’s COVID-19 vaccine after three Scandinavian countries suspend use of the injections
The US Food and Drug Administration (FDA) is defending the Moderna COVID-19 vaccine after three Scandinavian countries halted some of the injection’s rollout due to cases of rare heart inflammation.
Denmark, Finland and Sweden restricted the use of Moderna in younger people after data showed that some men under the age of 30 developed myocarditis after the injection.
The vaccine is the second most widely used vaccine in the US and has been administered more than 152 million times since it received emergency use from the FDA in December.
Officials said they are aware of the concerns but still support the use of the vaccine because the potential benefits outweigh the risks.
“The FDA is aware of this data,” an FDA official said in a statement, Fox News reports.
“At this time, the FDA continues to discover that the known and potential benefits of vaccination outweigh the known and potential risks to the Moderna COVID-19 vaccine.”
A representative of Moderna did not immediately respond to DailyMail.com’s request for comment.
Use of the Moderna vaccine has been paused in Sweden and Finland for people under 30 and in Denmark for people under 18. The FDA backs the vaccine’s use in the United States, saying the benefits outweigh the risks of receiving the injections (file photo)
The Moderna vaccine has been linked to cases of heart inflammation, especially in young people, leading officials in Denmark, Finland and Sweden to halt its use in some populations. Pictured: A woman in Ishoej, Denmark, receives a dose of a COVID-19 vaccine on September 11
All three Scandinavian countries decided last week to suspend the use of the vaccine in young people.
The Finnish Institute of Health and Welfare said on Thursday that authorities will not give the vaccine to men under the age of 30, and that they will instead receive the Pfizer-BioNTech vaccination.
The government agency said it found that young men and boys had a slightly higher risk of developing myocarditis.
In Sweden, the Moderna shot will no longer be available to persons born after 1990, or to persons aged 30 and under.
Denmark has restricted access to the vaccine to anyone under the age of 18.
Norway, another Nordic country, has not taken as drastic action as its neighbours, with health officials urging people under 30 to opt for the Pfizer vaccine instead.
All four countries based their decision on an unpublished study in collaboration with the Swedish Public Health Agency, which said it signals “an increased risk of side effects such as inflammation of the heart muscle or the pericardium” – the double-walled bag with the heart and roots of the main ships.
It added: “The risk of being affected is very small.”
Myocarditis and pericarditis, both types of heart inflammation, are known side effects of the Covid vaccines, and the Centers for Disease Control and Prevention (CDC) even warn that the condition can develop in young men after vaccination.
However, heart inflammation is also a symptom of many viral infections such as COVID-19, and the chances of developing the inflammation after infection are much higher than after vaccination.
The Swedish Health Service said it would discontinue use of the injection for people born in 1991 and later, as data indicated an increase in myocarditis and pericarditis among youth and young adults who had been vaccinated.
The break lasts until December 1.
Those conditions involve inflammation of the heart or its lining.
“The connection is especially clear when it comes to Moderna’s vaccine Spikevax, especially after the second dose,” the health agency said.
A spokesperson for Moderna said in an email that the company was aware of the decisions made by regulators in Denmark and Sweden to suspend the use of its vaccine in younger individuals due to the rare risk of myocarditis and/or pericarditis.
“These are usually mild cases and individuals tend to recover within a short time after standard treatment and rest,” they wrote.
“The risk of myocarditis is significantly increased for those who contract COVID-19, and vaccination is the best way to protect against it.”
According to a US study that has not yet undergone peer review, young men under 20 are to six times more likely to develop myocarditis after contracting COVID-19 than those who have been vaccinated.
Denmark said that while it used the Pfizer-BioNTech vaccine as the main option for people aged 12 to 17, it had decided to interrupt the administration of the Moderna vaccine to people under the age of 18 on a “precautionary principle.”
In June, the CDC warned that young men were at an increased risk of myocarditis after receiving the vaccine.
The label for both the Pfizer and Moderna vaccines was changed in the US to reflect the warning, although use was never discontinued.
Cases of post-vaccination inflammation are rare, although they are common enough to worry regulators.
A recent study by Kaiser Permanente Southern California found that about seven in a million people who receive a dual COVID-19 vaccine will develop myocarditis.
People who receive the Covid vaccine are seven times more likely to develop heart inflammation after the second dose of the injection compared to the first, a recent KPSC study finds. However, those who are not vaccinated are significantly more likely to develop myocarditis
The same study found that 47.5 in every million Covid patients experience heart inflammation.
While myocarditis often goes away on its own, it can be dangerous.
Heart inflammation can often lead to fatigue, shortness of breath and chest pain in patients.
People with an inflamed heart are at a higher risk of heart failure, heart attacks, and stroke.
Attempting strenuous physical activity with an inflamed heart can also potentially lead to sudden cardiac arrest or even death.