France’s Drug Regulation Agency Admits Role of Pfizer in Cases of Myocarditis

ER Editor: France’s ANSM is the National Agency for the Safety of Medicines and Health Products (L’Agence nationale de sécurité du médicament et des produits de santé) which has jurisdiction over pharmaceuticals, biological products, medical devices, and cosmetics released to the public.

We remind readers that studies show that only 1%, possibly up to 10%, of adverse reactions to vaccines are ever reported. So the numbers reported below are extremely low.

Europe1, taking its reporting from Agence France Presse, is thoroughly MSM. We’re publishing this to show official French acknowledgement of problems with the Pfizer vaccine.

For what this cardiac problem looks like for the young after taking mRNA vaccines (Pfizer & Moderna), we recommend the following articles from Children’s Health Defense:

19-Year-Old College Freshman Dies From Heart Problem One Month After Second Dose of Moderna Vaccine

CDC to Convene Emergency Meeting on 226 Reports of Heart Inflammation After COVID Vaccine in People Under 30

Exclusive: Athlete Who Recovered From COVID Facing ‘Very Different Future’ After Second Dose of Pfizer Vaccine Triggers Myocarditis

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Cases of myocarditis: the ANSM recognizes a “possible role” of the Pfizer vaccine

The French drug agency (ANSM) said Friday that Pfizer/BioNTech’s Covid-19 vaccine has a “possible role” in the occurrence of rare cases of heart inflammation in young adults. The ANSM had classified this adverse reaction as a “potential signal” for pharmacovigilance of this vaccine at the end of April after similar cases were reported in Israel.

EUROPE1

Pfizer and BioNTech’s Covid-19 vaccine (Comirnaty) has a “possible role” in the occurrence of rare cases of heart inflammation in young adults, the French drug agency (ANSM) said Friday. The monitoring committee of the ANSM “is looking at the hypothesis of a possible role of the Comirnaty vaccine in the occurrence of myocarditis,” said its weekly monitoring point of adverse events of vaccines against Covid. Last week, the same committee had indicated the “need to continue monitoring the potential signal”.

A “potential signal”

At the end of April, the ANSM had classified this adverse reaction as a “potential signal” of pharmacovigilance of the Pfizer/BioNTech vaccine after the reporting of similar cases in Israel. Out of 29 cases reported since the beginning of the follow-up in France, 14 were retained “in view of the level of completeness of the clinical data collected”, and for nine of them, the clinical and pharmacological expertise concluded to a probable imputability of the vaccine, details the ANSM. The majority of the patients were men (9 out of 14), with a median age of 28 years, and the vast majority (93%) were “recovered or in the process of recovery”.

25,983 cases of adverse events were analyzed

In total, since the beginning of the vaccination with Pfizer/BioNTech, 25,983 cases of adverse events have been analyzed, mostly “expected and non-serious” events such as pain at the injection site or headache, out of more than 32.9 million injections performed as of June 10. In February, the ANSM already listed a “confirmed signal” concerning the Comirnaty vaccine: cases of increased blood pressure, immediately after vaccination or delayed, of short duration and favorable evolution.

Other adverse events that are “potential signals” or are “under surveillance” include the occurrence of heart rhythm disturbances, shingles, and macrophage activation syndromes, a rare condition related to inappropriate stimulation of these immune system cells. For AstraZeneca’s vaccine (Vaxzevria), reserved for people over 55 years of age, 2 additional cases of atypical thrombosis were reported between June 4 and 10, with a similar profile to the previous cases (median age 61 years, as many women as men), and no deaths.

This brings the total number of these atypical thromboses in France to 52, including 13 deaths. 18,723 cases of adverse events have been analyzed for this vaccine, mostly flu-like syndromes, out of approximately 5.7 million doses injected in France as of June 10.

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Source

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