A top doctor from the Norwegian Agency for Medicines Regulation suggested on Friday that side effects of the Pfizer / BioNTech coronavirus vaccine contributed to deaths in some elderly patients.
Dr. Sigurd Hortemo, chief physician at the Norwegian Medicines Agency, said in a statement that common side effects such as fever and nausea could lead to serious consequences and deaths among elderly, debilitated patients shortly after vaccination.
According to the Norwegian Medicines Agency, as of Thursday, reports of 23 suspected deaths have been sent to the Norwegian ADR Health Register, including 13 reports reviewed by health officials.
“We cannot rule out that adverse reactions to the vaccine that occur within the first few days after vaccination (such as fever and nausea) may contribute to a serious course and fatal outcome in patients with severe underlying disease,” the agency said in the statement. said.
CORONAVIRUS TO SEND OUR LIFE EXPECTATIONS OVER A YEAR
The statement noted that Pfizer’s major clinical trials had not tested the vaccine on patients with serious illnesses or older than 85.
Prior to the U.S. Food and Drug Administration’s emergency approval, a committee advising the agency endorsed the product and found no specific safety issues among subgroup analyzes, but did list a number of unknowns that need further investigation, including the duration of the immunity, efficacy in certain high-risk populations, those previously infected, as well as efficacy under asymptomatic infection, 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 worried about the small number of incidents.
CORONAVIRUS IN THE US: STATE-BY-STATE DISTRIBUTION
“Our immediate thoughts are with the grieving families,” Pfizer wrote in an email to Fox News. “Pfizer and BioNTech are aware of the deaths reported after BNT162b2 administration. We are working with the Norwegian Medicines Agency (NOMA) to gather all the relevant information. The Norwegian authorities have prioritized the vaccination of residents in nursing homes, most of whom are elderly people with underlying medical conditions and some who are terminally ill. “
“NOMA has confirmed that the number of incidents so far is not alarming, and in line with expectations,” the statement continued. “All reported deaths will be thoroughly evaluated by NOMA to determine if there is any connection with the vaccine. The Norwegian government will also consider adjusting their vaccination instructions to take into account the patients’ health.”
Nevertheless, the medical director of the Norwegian Medicines Agency advised against recommending attenuated patients receiving the vaccine.
“If you are very debilitated, you probably should not be vaccinated,” Steinar Madsen at the Norwegian Medicines Agency told Norway Today by reporter on Thursday.
GET THE FOX NEWS APP
COVID-19 vaccines usually require a few weeks before the body builds up enough immunity to protect against the disease.
Pfizer’s shot has been reported to cause non-serious side effects, such as injection site pain, fatigue, headache, muscle aches, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise, and lymphadenopathy. Experts say that these symptoms usually resolve on their own a few days after vaccination.
Neither the statement, nor a related report, specified when the deaths occurred after vaccination. Fox News has asked the Norwegian Medicines Agency for further comment.
Fox News’ Alexandria Hein contributed to this report.