The Hague | Pfizer / BioNTech’s COVID-19 vaccine is unrelated to reported post-vaccination deaths, and shows no new side effects, the European Medicines Agency (EMA) said on Friday.
The update from the Amsterdam-based European Medicines Agency follows reports that dozens of people, mostly elderly, have died in Norway and other European countries, after receiving a first injection of the vaccine.
The European regulator said in a statement that it has looked at the deaths and “concluded that the data did not show a link to vaccination with Comirnaty and that the cases do not raise safety concerns.”
In its first vaccine safety update since the EU began its vaccination campaign in December, the EMA concluded that the data “are consistent with the known safety profile of the vaccine and that no new effects secondary has not been identified ”.
Reports of occasional severe allergic reactions do not go beyond what had already been discovered about this “known side effect”, the Amsterdam-based agency added.
“The benefits of Comirnaty in preventing COVID-19 continue to outweigh any risks, and there is no change from the recommended with regards to the use of the vaccine,” the EMA said.
The EU regulator has so far approved two vaccines, those from Pfizer / BioNTech and Moderna.
He is expected to deliver his verdict on a third vaccine on Friday, that of AstraZeneca and the University of Oxford.
The frail and the elderly are the first to be vaccinated in many countries
A number of countries, including Norway, Denmark, Finland, Iceland and Sweden, have reported deaths of people who received the vaccine developed by US laboratories Pfizer and German BioNTech, but no direct link to the vaccine. has not been established.
Norway has recorded 33 deaths among the elderly who received their first dose.
Oslo said earlier this month that it had not established a link with the vaccine, however, advising Norwegian doctors to consider the condition of the most fragile patients before deciding on an injection.
The EMA said that “in view of the concerns raised by Norway” it has looked at reports of deaths of people of all ages after receiving the vaccine.
“In many cases involving people over 65, the progression of (multiple) pre-existing diseases seemed to be a plausible explanation for the death,” the agency observed.
Some had already received palliative care before vaccination, she said.
The EMA has ruled that clinical trials of the Pfizer / BioNTech vaccine included people aged 75 and over.
The European regulator, however, said it had asked the company to continue to “thoroughly examine all reports of suspected side effects with fatal outcome.”