A vial of Pfizer / BioNTech's vaccine against Covid-19.

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Marcin Bruniecki / Shutterstock / SIPA

  • From data from the European database EudraVigilance, which compiles reports of adverse reactions likely to be linked to drugs, Internet users deduce that the vaccine from Pfizer and BioNTech has caused deaths, or is even more dangerous than Covid-19 .

  • The European Medicines Agency (EMA) refutes these conclusions and tells

    20 Minutes

     that some data "are incorrect and lead to misinterpretation of the data".

  • In its pharmacovigilance report on this vaccine published at the end of January, the EMA believes that its benefits "continue to outweigh the risks".

Could Pfizer and BioNTech's coronavirus vaccine cause hundreds of deaths?

This is the conclusion that Internet users draw from a table circulating on social networks.

"Only for the Pfizer vaccine on January 30, 2021 we are at 739 deaths or 2.8% of the 26,849 side effects reported", indignant on Twitter a man who presents himself as a doctor in his description.

Screenshot of the Twitter account relaying the painting.

- Screenshot

A second slide presents data from the EudraVigilance database, which brings together reports of adverse reactions likely to be linked to medicinal products and is managed by the European Medicines Agency (EMA).

Graphs show, in particular, the number of deaths recorded in vaccinated patients according to the causes (heart problems, infections, immune system disorders).

In a post on Facebook, this same table is repeated: “Pfizer vaccine at European level.

For the month of January 2021 […].

739 deaths.

Or 2.8%.

"The user concludes:" The coronavirus kills less than that.

"

FAKE OFF

Current data do not allow to establish a cause and effect link between the Pfizer-BioNTech vaccine and the deaths recorded after vaccination, indicate the European Medicines Agency (EMA) and a professor of epidemiology, contacted by

20 Minutes

.

These data list all the “reactions” recorded after administration of the vaccine, in order to ensure pharmacovigilance on this drug.

The table shared on social networks seems to borrow information from the EudraVigilance database (number of individual cases for a given reaction).

While the figures for January 30 are no longer online, the data is consistent with the update on February 6.

Questioned by

20 Minutes

, the European Medicines Agency however refutes the conclusions drawn by Internet users: "The total number of deaths and the total number of cases for the consequence of the reactions [hospitalization or not, death] are incorrect and lead to a bad interpretation of data.

"

In particular, the EMA specifies that a deceased person may be counted twice in its databases if they have experienced several reactions.

For example, a patient who vomited and had a headache will be counted in the reaction group “gastrointestinal disorders” and “nervous system disorders”.

To better decipher the database, the Agency advises to refer to its section "Consulting an electronic report".

The benefits outweigh the risks

Importantly, the EMA points out to

20 Minutes

 that the numbers in the death column ("fatal") "do not necessarily mean that the events reported were caused by the vaccine".

In a press release published on January 29, the European Medicines Agency also pointed out, after updating the pharmacovigilance report, "that no particular safety problem has been identified in frail elderly people who have been vaccinated" .

“The benefits of Comirnaty [the name under which the Pfizer-BioNTech vaccine is marketed] continue to outweigh the risks in preventing Covid-19,” she adds.

Moreover, was the initial reasoning relevant?

"The author confuses event that occurred by co-incidence, following vaccination, and harmful effect of vaccination", points out Judith Mueller, professor of epidemiology at the School of Advanced Studies in Public Health and attached to the Emerging Diseases Epidemiology Unit at the Institut Pasteur.

"Confirming that an event is really caused by vaccination implies having the usual risk of death in the population (age, comorbidities) targeted by vaccination and demonstrating that the risk of death after vaccination is greater," she explains. .

In the absence of these data - and the author does not present them - nothing can be said.

"

"No fatal side effects have been confirmed"

She adds: “Currently, apart from allergic reactions, no potentially fatal side effects have been confirmed for anti-Covid-19 vaccines including Pfizer.

"The professor believes that it is however necessary to remain" cautious "because, in the very fragile elderly," a fever caused by vaccination could have serious consequences ".

Last point, raised both by the European Medicines Agency and Judith Mueller: we must not forget that people over 75 years of age are the target groups for vaccination in Europe today.

"It is therefore probable that most of the reports relate to this population", estimates the professor of epidemiology.

However, “around 12,000 people die every day in Europe, 83% of whom are over 65,” reports the EMA.

Just because someone dies after receiving the vaccine does not mean that that death is related to the vaccine.

Authorities in the European Union are carefully reviewing all reports to determine if there is a possible link to the vaccine.

"

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