With the funds from the US manufacturer Moderna, a second corona vaccine has now also been approved in the EU. The EU Commission decided to do this on the recommendation of the Medicines Authority EMA. She had concluded that the vaccine was effective and that there were no major safety concerns.
However, that does not mean that the vaccine, which is given in two doses, is free from side effects. Nine out of ten people who received the Moderna vaccine in the clinical trials had reported side effects. In the most common cases these were mild or moderate and only lasted one to three days.
It is normal for vaccines to have side effects as the syringe triggers an immune response in the body. By and large, these reactions are certainly uncomfortable, but not threatening.
The most common side effects of the vaccine were:
- Injection site pain (91.6 percent)
- Fatigue (68.5 percent)
- Headache (63 percent)
- Muscle pain (59.6 percent)
- Joint pain (44.8 percent)
- Chills (43.4 percent)
The Moderna vaccine appears to have slightly more common and more serious side effects by comparison than that of Biontech and Pfizer. There, the most common reactions to the vaccine were pain at the injection site (84 percent), tiredness (63 percent), headache (55 percent), muscle pain (38 percent), chills (32 percent), joint pain (24 percent) and fever (14 percent) Percent).
The extensive clinical studies – in each of which tens of thousands of people took part – have shown that both vaccines offer very good protection against Covid-19. Pfizer’s vaccination is 95 percent effective, Moderna’s 94 percent. It is still unclear whether the vaccines will also prevent the virus from being transmitted. In addition, it is not known how long their protection lasts.
16.5 percent of people who received the Moderna vaccine complained of severe side effects
Although most of the side effects reported were mild or moderate, in some cases the vaccinated people experienced severe reactions.
16.5 percent of those who received the Moderna vaccine reported more severe side effects. These were either reactions at the injection site, such as pain or swelling, or systemic reactions to the vaccine, such as fever, nausea and vomiting. In these individuals, the reactions were strong enough to interfere with activities of daily living. Still, they weren’t unexpected – responses to vaccinations typically vary.
For the majority, the reactions lasted two or three days. However, some participants had side effects for more than a week. Twelve percent reported typical physical side effects, such as tiredness or headaches, that lasted longer than seven days – compared with ten percent in the placebo group.
About four percent of people had injected arm-related reactions that lasted more than a week after the injection. In comparison, only one percent reported this in the placebo group. The most common side effects were pain and swelling of the lymph nodes in the armpit.
According to the FDA, a connection with Bell’s palsy “cannot be ruled out” at this point in time.
The FDA also noted several other undesirable side effects that could be related to the vaccine. However, these side effects were very rare. Hence, it is difficult to say whether they were actually vaccine-related or a coincidental product.
Three people who received the Moderna vaccine subsequently developed what is known as Bell’s palsy. This is a weakening of the facial muscles that is typically temporary. Compare this to a person with the paralysis who received the sham vaccination.
One such case of Bell’s palsy was particularly severe: A 67-year-old woman with diabetes was hospitalized with a stroke from new facial paralysis 32 days after vaccination, according to the FDA report. “This case has been reported as cured.”
“The information currently available is insufficient to determine a causal relationship with the vaccine,” wrote the FDA on the cases of Bell’s palsy.
Nevertheless, the authorities’ scientists emphasize that a connection with the vaccine and Bell’s palsy “cannot be ruled out” at the moment. Once the vaccine is released to the general public, this should be closely monitored.
There were four cases of Bell’s palsy in the study on the vaccine from Pfizer, but none in the placebo group. When the two studies were combined, nearly 40,000 people received either Moderna or Pfizer vaccine, seven of whom developed Bell palsy – a frequency less than 0.1 percent.
Younger people reacted more strongly to the vaccination
Overall, the side effects were more common and severe in younger people. In the Moderna study, this includes all persons under 65 years of age.
Otherwise, the safety profile for Moderna vaccination was generally similar for all sexes and races. Younger people experienced increased transient and expected side effects from the vaccine, such as fatigue and headaches.
Injection site pain was also most commonly observed in this younger group of subjects: nine out of ten reported pain and 4.6 percent reported severe pain. Typically, this pain persisted for two or three days after the injection.
This article was translated from English and edited by Ilona Tomić. You can read the original here.