The four anti-Covid vaccines used in France are safe, the drug agency reaffirmed on Tuesday in its latest report on adverse effects, specifying in particular that no link with Lou Gehrig's disease has been established following a reported case post-vaccination.
The new results of the pharmacovigilance surveys by the French National Agency for the Safety of Medicines (ANSM), based on data from January 2023 to February 2024, "once again show that Covid-19 vaccines are safe," it summarized in a press release.
These surveys - including one dedicated to pregnant and breastfeeding women - analyze the reports of adverse effects for the four Covid-19 vaccines - Comirnaty from Pfizer/BioNTech, Spikevax (Moderna), Nuvaxovid (Novavax, since replaced by Nuvaxovid XBB) and Vidprevtyn Beta (Sanofi/GSK) - available in France.
No new risk signals for "pregnant and breastfeeding women" have emerged regarding the Nuvaxovid vaccines - very little used in France - and Vidprevtyn Beta - whose marketing authorization was subsequently revoked in March 2024.
To date, "more than 152 million doses" of anti-Covid vaccines "have been administered" in France, and 13 billion doses worldwide - and some "163,000 reports of suspected potential adverse effects have been recorded" in France, Mehdi Benkebil, director of surveillance at the ANSM, told AFP.
"All these cases have been analyzed at the regional and national levels. For comparison, we receive around 40,000 cases annually for all medications!" he explains, highlighting the "colossal analytical work" involved in the "enhanced surveillance" of anti-Covid vaccines.
While the benefit/risk of Covid vaccines is very positive, certain side effects or adverse effects have been highlighted, most frequently benign, or rare when they are more impressive.
- Disinformation -
Apart from the most common side effects related to the body's immediate reaction to the injection, rare cases of peripheral facial paralysis (partial loss of function of part of the facial muscles), myocarditis/pericarditis (inflammation of the heart muscle), heavy menstrual bleeding, and erythema multiforme (skin rash) have been identified.
In its review of the new and previously unreported effects, the ANSM notes that "very rare cases" of "burning-type pain, mainly in the feet and lower limbs (small fiber neuropathies), have appeared" with the Pfizer vaccine, and other cases, also "very rare," of chronic fatigue, with the Spikevax vaccine.
They are "the subject of further investigations" which could lead to "measures adapted to the nature and level of the risk, in conjunction with the European Medicines Agency (EMA)," the agency said.
"Recently reported after vaccination with the Pfizer vaccine," a case of Lou Gehrig's disease (ALS) was analyzed and "the data available to date" do not "allow us to establish a link" between the occurrence of the disease and the vaccine, writes the ANSM, after a "collegial review with the regional pharmacovigilance centers."
This case is that of a thirty-year-old woman from Allier, whose family and a victims' association have communicated widely on social networks and in the regional press around a supposed "official recognition" of a causal link between her illness and this vaccination.
The regional pharmacovigilance center sent a letter stating that the case report had been "recorded, generating a file" for "expert work," but "no causal link was made" between the disease and the vaccine, Professor Joëlle Micallef, a pharmacologist who heads one of the 10 regional centers (Paca-Corsica) to assess cases across France, told AFP.
Already in 2022, the ANSM had examined around fifteen reports of post-vaccination ALS, reports this expert.
"If these patients were indeed suffering from ALS," the vaccine cause had been ruled out, in particular "because medically and pathophysiologically, Charcot's disease cannot be triggered in such a short time," she specifies.
"With this (latest) case as well, there is currently no data, no arguments, to suggest the direct or indirect role of the vaccine in the occurrence of this disease," she concludes.
Since the start of vaccination, the adverse effects of Covid vaccines have been widely highlighted by their opponents, who have sometimes relayed messages of misinformation.
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