- Ingrid Torjesen
- London, United Kingdom
Doctors in Norway were instructed to conduct more thorough assessments of very fragile elderly patients in line to receive the Pfizer BioNTec vaccine against covid-19, after the death of 23 patients shortly after receiving the vaccine.
“It may be a coincidence, but we are not sure,” said Steinar Madsen, medical director at the Norwegian Medicines Agency (NOMA). The BMJ. “There is no right connection between these deaths and the vaccine.”
The agency has investigated 13 of the deaths so far and concluded that common adverse reactions from mRNA vaccines, such as fever, nausea and diarrhea, may have contributed to fatal outcomes in some of the fragile patients.
“There is a possibility that these common adverse reactions, which are not dangerous in younger patients and in good physical shape and are not uncommon with vaccines, could worsen the underlying disease in the elderly,” said Madsen. “We are not alarmed or concerned about this, because they are very rare occurrences and occurred in very fragile patients with very serious illness,” he emphasized. “Now we are asking doctors to continue with the vaccination, but to make extra assessments of very sick 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 families to decide whether or not vaccination is the best course.
More than 20,000 doses of the vaccine have been administered in the past few weeks in Norway and about 400 deaths typically occur among residents of nursing homes every week.
The Paul Ehrlich Institute in Germany is also investigating 10 deaths shortly after the covid-19.1 vaccination
Asked if any deaths occurred in UK patients after vaccination, the UK Medicines and Health Products Regulatory Agency (MHRA) said details of all suspected reactions reported in association with approved covid-19 vaccines would be published along with your assessment of data on regularly in the future. Based on the published reports available from clinical trials, MHRA said it currently did not anticipate any specific safety concerns.
In a statement, Pfizer said: “Pfizer and BioNTech are aware of the deaths reported after the administration of BNT162b2. We are working with NOMA to gather all relevant information.
“Norwegian authorities have prioritized the immunization of residents in nursing homes, most of whom are very elderly with underlying medical conditions and some of whom are terminally ill. NOMA confirms that the number of incidents so far is not alarming and is in line with expectations. All reported deaths will be thoroughly assessed by NOMA to determine whether these incidents are related to the vaccine. The Norwegian government will also consider adjusting its vaccination instructions to take patients’ health into greater consideration.
“Our immediate thoughts are with the bereaved families.”