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The US Food and Drug Administration (FDA) released a review of the vaccine on Tuesday, where they had not found any particular safety issues with the vaccine from US Pfizer and Germany’s BioNTech.
Everything indicates that it will be approved urgently by an FDA committee on Thursday and thus obtain the green light for its use in the United States. It has already been approved in the UK where the first residents were vaccinated on Tuesday.
Signs that the vaccine is working
The most common side effects reported by BioNTech and Pfizer are considered mild and moderate. The most common is pain at the injection site.
84.1 percent of those tested reported this. Then, weakness / fatigue (62.9 percent), headache (55.1 percent), and muscle pain (28.3 percent).
Most common side effects of the Pfizer vaccine
Pain at the injection site: 84.1 percent.
Looseness: 62.9 percent
Headache: 55.1 percent.
Muscle pain: 38.3 percent
I am cold: 31.9 percent.
Joint pain: 23.6 percent.
Fever: 14.2 percent.
Nausea: Less than 10 percent.
Source: FDA
– These common side effects are unpleasant to have, but above all they are a sign that the vaccine is working. says vaccine researcher Gunnveig Grødeland from the University of Oslo to NRK.
She notes that it is important for the body’s immune system to react to the vaccine, and that these common side effects are often a sign of that.
Margaret Keenan, 90, became the first in the UK to be vaccinated against COVID-19. Photo: Jacob King / AP
Serious Side Effects Monitors
The manufacturer’s vaccine is given in two installments at approximately three-week intervals. Reactions after the second injection have tended to be slightly stronger than after the first round. This is common.
It has also been important to find out if the vaccine can have rarer but more serious side effects. Some of these may only show up after a long time, so it’s something you specifically monitor.
– The role of side effects is one of many questions that will be attempted to answer during the adjustment of the vaccine trial data. This work is now in full swing in the EU, Norwegian Medicines Agency medical director Steinar Madsen tells NRK.
According to the FDA report, the most common of the listed serious side effects is appendicitis. This was reported by 0.04 percent of the test subjects. These were such small numbers for such a common condition that the vaccine was considered not to affect incidence.
Two died during the test
There were also two deaths among those over 21,000 who took the vaccine and four deaths among those who received placebo. This from a total of 43,448 test people who participated in the trial for half a year.
The two who received the vaccine died of a heart attack 62 days after the second vaccination and of atherosclerosis (arteriosclerosis) three days after the first vaccination, respectively. Both were considered elderly people and it has been concluded that the deaths were natural and had nothing to do with the vaccine.
“All deaths represent incidents that occur in the general population in the respective age groups in which they occurred, with a similar incidence,” the report states.
