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A senior doctor from the Norwegian Medicines Regulatory Agency suggested on Friday that side effects from the Pfizer / BioNTech coronavirus vaccine may have contributed to the deaths of some older patients.
Dr Sigurd Hortemo, chief medical officer of the Norwegian Medicines Agency, said in a statement that common side effects such as fever and nausea soon after vaccination may have resulted in more serious outcomes and death in elderly and frail patients.
According to the Norwegian Medicines Agency, on Thursday, reports of 23 presumed deaths were sent to the Norwegian ADR Health Register, including 13 reports assessed by health officials.
“We cannot exclude that adverse reactions to the vaccine occurring in the first days after vaccination (such as fever and nausea) may contribute to a more serious and fatal course in patients with severe underlying disease” , the agency said in the statement.
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The statement noted that Pfizer’s large clinical trials did not test the vaccine on patients with severe illness or over 85 years of age.
Indeed, prior to emergency approval from the US Food and Drug Administration, a committee advising the agency approved the product and found no specific safety concerns among the subgroup analyzes, but listed several unknowns that will need to be further investigated, including duration of immunity, efficacy. in some high-risk populations, those previously infected, as well as efficacy among asymptomatic infections, long-term effects of COVID-19 disease, mortality and transmission of SARS-CoV-2. The trial tested patients up to 85 years old.
According to Pfizer, the Norwegian agency is not alarmed by the small number of incidents.
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“Our immediate thoughts are with the bereaved families,” Pfizer wrote to Fox News in an emailed statement. “Pfizer and BioNTech are aware of the reported deaths following administration of BNT162b2. We are working with the Norwegian Medicines Agency (NOMA) to bring together all the relevant information. Norwegian authorities have prioritized the immunization of residents of nursing homes, most of whom are very elderly with underlying health problems and some terminally ill. “
“NOMA has confirmed that the number of incidents to date is not alarming and in line with expectations,” the statement continued. “All reported deaths will be carefully evaluated by NOMA to determine if there is a relationship to the vaccine. The Norwegian government will also consider adjusting its vaccination instructions to take into account the health of patients.
However, the medical director of the Norwegian Medicines Agency has advised frail patients not to receive the vaccine.
“If you are very fragile, you probably should not be vaccinated,” Steinar Madsen of the Norwegian Medicines Agency told reporters on Thursday, per Norway Today.
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COVID-19 vaccines typically take several weeks before the body builds enough immunity to protect against the disease.
Injection of Pfizer has been reported to cause non-serious side effects such as injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, swelling at the injection site, redness injection site, nausea, malaise, and lymphadenopathy, although experts say these symptoms usually resolve on their own several days after vaccination.
Neither the statement, nor a related report, specifies when the deaths occurred after vaccination. Fox News has requested further comment from the Norwegian Medicines Agency.
Alexandria Hein of Fox News contributed to this report.
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