To date, it has analyzed data from 13 of those individuals.
The Norwegian Medicines Agency concluded that common adverse reactions to mRNA vaccines, including fever and nausea, could have contributed to deaths in elderly and frail patients.
The agency said in a statement that it had expected deaths close to the time of vaccination, given its plan to vaccinate elderly patients, many of whom have “serious underlying diseases.” Some 400 people in Norway die each week in nursing homes and long-term care facilities.
While it is clear that elderly individuals have a higher risk of mortality from all causes, it will take time to determine what role a vaccine might play, said Updesh Dosanjh, practice leader of technology solutions at IQVIA, in a November interview. “You need to do some of the soft analysis that starts looking into the patient history,” he said. Organizations looking into such data also might compare the mortality rates of vaccinated people who are, say, 95 and above versus those who are slightly younger. “That kind of second-level analysis is why it often takes three months to get to the point of knowing whether there’s a risk,” Dosanjh said.
In any event, individuals 85 and older have the highest risk of severe illness from COVID-19, according to the CDC. Some 80% of U.S. deaths linked to the virus involved individuals 65 or older.
Although there were no suspected fatal reactions in the Pfizer-BioNTech Phase 3 clinical trial of the vaccine, few participants were over 85. In the study, two recipients died in the treatment group out of a pool of 21,621 volunteers. Conversely, there were four deaths in the placebo group of 21,631 participants.
Of the two deaths in the vaccine arm, both involved individuals greater than 55 years old. One patient had a cardiac arrest 62 days after the second vaccination and died three days later. The other individual died from arteriosclerosis three days after receiving the first vaccine dose.
Officials in the U.S. are also investigating the death of a Florida physician who developed a blood disorder after receiving the Pfizer-BioNTech vaccine.
Filed Under: clinical trials, Drug Discovery, Infectious Disease