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- Ingrid Torjesen
- London, United Kingdom
Norwegian doctors have been urged to conduct further assessments of elderly, very frail patients for the Pfizer BioNTec covid-19 vaccine, following the deaths of 23 patients shortly after receiving the vaccine.
“It may be a coincidence, but we are not sure,” said Steinar Madsen, medical director of the Norwegian Medicines Agency (NOMA). BMJ. “There is no definite link between these deaths and the vaccine.”
The agency has investigated 13 of the deaths to date and concluded that common side effects of mRNA vaccines, such as fever, nausea and diarrhea, may have contributed to fatal outcomes in some of the fragile patients.
“It is possible that these common side effects, which are not dangerous in younger fit patients and which are not unusual with vaccines, may worsen the underlying disease in the elderly,” Madsen said. “We are not alarmed or worried about this, because these are very rare events and they have occurred in very fragile patients with very serious illness,” he said. “We are now asking doctors to continue with the vaccination, but to conduct further evaluation of very ill people whose underlying condition could be made worse by it. This assessment includes discussing the risks and benefits of vaccination with the patient and their family to decide whether vaccination is the best solution.
More than 20,000 doses of the vaccine have been administered in recent weeks in Norway and around 400 deaths normally occur among residents of health centers each week.
The Paul Ehrlich Institute in Germany is also investigating 10 deaths shortly after vaccination against covid-19.1
When asked whether deaths have occurred in UK patients after vaccination, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) said details of any suspicious reactions reported in association with covid vaccines -19 approved would be released along with its assessment data on a regular basis in the future. Based on the published reports available on clinical trials, the MHRA said it does not currently anticipate any specific safety concerns.
In a statement, Pfizer said, “Pfizer and BioNTech are aware of the reported deaths following administration of BNT162b2. We are working with NOMA to bring together all the relevant information.
“The Norwegian authorities have prioritized the vaccination of residents of nursing homes, most of whom are very old with underlying medical conditions and some of whom are terminally ill. NOMA confirms that the number of incidents to date is not alarming and in line with expectations. All reported deaths will be carefully evaluated by NOMA to determine if these incidents are vaccine-related. The Norwegian government will also consider adjusting its vaccination instructions to better take into account the health of patients.
“Our immediate thoughts are with the bereaved families.”
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