Europe’s Medicines Agency Confirms 5,201 Post-Vaccination Deaths
The European Medicines Agency (EMA) published a safety update on July 14 that summarizes data available since each COVID-19 vaccine’s authorization.
The EMA is responsible for authorizing vaccines in the European Union (EU). It is the region’s equivalent of the U.S. Food and Drug Administration (FDA).
📢 The fact that someone has had a medical issue or died after vaccination does not necessarily mean that the death was caused by the vaccine.
Other reasons, for example underlying or emerging health problems not related to the vaccination, may have played a role. #EMAPresser
— EU Medicines Agency (@EMA_News) July 15, 2021
As of the first week of July, the EMA has issued safety updates and related deaths for the four authorized COVID-19 vaccines — Comirnaty, Spikevax; Vaxzevria, and COVID-19 Vaccine Janssen.
Comirnaty (Pfizer-BioNTech) – A total of 206,668 cases of suspected side effects with Comirnaty were spontaneously reported to EudraVigilance from EU/EEA countries. And 3,848 of these reported a fatal outcome. As a result, about 276 million doses of Comirnaty were given to people in the EU/EEA.
Vaxzevria – (AstraZeneca) – A total of 152,250 cases of suspected side effects with Vaxzevria were spontaneously reported to EudraVigilance from EU/EEA countries. And 938 of these reported a fatal outcome. Around that time, about 58.4 million doses of Vaxzevria had been given to people in the EU/EEA.
SpikeVax (COVID-19 Vaccine Moderna) – A total of 36,294 cases of suspected side effects with Spikevax were spontaneously reported to EudraVigilance from EU/EEA countries. And 347 of these reported a fatal outcome. Around that time, about 35 million doses of Spikevax had been given to people in the EU/EEA.
COVID-19 Vaccine Janssen – A total of 12,036 suspected side effects with COVID-19 Vaccine Janssen were spontaneously reported to EudraVigilance from EU/EEA countries. And 68 of these reported a fatal outcome. Around that time, about 8.5 million doses of COVID-19 Vaccine Janssen had been given to people in the EU/EE.
Each vaccine’s scientific evaluation needs to show that a vaccine’s benefits in protecting people against diseases are far greater than any potential risk, says the EMA.
Like any medicine, vaccines have benefits and risks. Although highly effective, no vaccine is 100% effective in preventing disease or safe in all vaccinated people.
After vaccine approval, certain rare or very rare side effects may emerge when millions of people are vaccinated. EU law requires that the safety of vaccines is monitored while they are in use.
The EMA says ‘These reports describe suspected side effects in individuals, i.e., medical events observed following the use of a vaccine. The fact that someone has had a medical issue or died after vaccination does not necessarily mean that the vaccine caused this.’
‘This may have been caused, for example, by health problems not related to the vaccination. The EU regulatory network continuously monitors EudraVigilance to detect any new safety issues.’
EudraVigilance relies on individual healthcare professionals and patients to report their own experience.
‘The monitoring detects unusual or unexpected patterns in the reports received for further investigation and risk assessment. EMA’s detailed assessments take into account all available data from all sources to draw a robust conclusion on the safety of the vaccine.’
‘These data include clinical trial results, reports of suspected side effects in EudraVigilance, epidemiological studies monitoring the safety of the vaccine, toxicological investigations, and any other relevant information.’
As of July 14, 2021, the U.S. FDA had issued three Emergency Use Authorizations (EUA) for COVID-19 vaccines — Comirnaty, SpikeVax, and COVID-19 Janssen.
The FDA has not formally approved any COVID-19 vaccine. An EU is not formal approval.