The Pfizer / BioNTech coronavirus sting is unrelated to reported post-vaccination deaths and no new side effects, the EU Medicines Agency said on Friday, based on initial data from the vaccine’s launch.
The update from the Amsterdam-based European Medicines Agency followed reports that dozen of mostly elderly people in Norway and other European countries had died after receiving an initial shot of the vaccine.
The EMA said it looked into the deaths and “found that the data are unrelated to vaccination with Comirnaty (the name of the vaccine) and the cases do not raise any safety concerns.”
In its first security update since the EU’s vaccination campaign began in December, the watchdog said the data overall “is consistent with the known safety profile of the vaccine and no new side effects have been identified”.
“Comirnaty’s benefits in preventing COVID-19 continue to outweigh any risks, and there are no recommended changes to how the vaccine is used,” the EMA said.
The EU watchdog has so far approved Pfizer / BioNTech and Moderna vaccines.
Later on Friday, AstraZeneca will issue its verdict on a third verdict. Germany recommended on Thursday that the AstraZeneca vaccine should only be given to those under 65.
In many countries, the frail and elderly are the top priority for vaccination.
In Norway in particular, 33 deaths have been recorded among around 20,000 senior citizens’ homes who received their first dose of the Pfizer BioNTech vaccine.
Concern grew as a number of countries, including France, as well as Denmark, Finland, Iceland and Sweden, made similar reports.
Pre-existing diseases
Oslo said earlier this month it had not made a link but advised doctors to consider the general health of the most vulnerable before giving them the sting.
The EMA said it was “considering reports of deaths of people of all ages after receiving the sting, given the concerns raised in Norway”. “In many cases where people were over 65 years old, the progression of (multiple) pre-existing illnesses seemed a plausible explanation for death,” it said.
The EMA found that clinical trials with the Pfizer vaccine included people aged 75 and over.
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