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Pfizer and Moderna vaccines against Covid: "potential signal" on "very rare" cases of hearing loss


The National Agency for the Safety of Medicines has looked into the episodes of deafness, more or less strong, notified to pharmacovigilance

A new potential adverse effect of messenger RNA vaccines against Covid-19 has been identified by pharmacovigilance.

In two reports published on Thursday, the National Agency for the Safety of Medicines (ANSM) reports a "potential signal" after analyzing in detail "very rare" cases of hearing loss post-vaccination Pfizer-BioNTech or Moderna.

“At this stage, the causal link between this vaccine and the cases of deafness is not established” but it “cannot be excluded for a certain number of cases”, one can read.

A total of 251 cases were notified to pharmacovigilance: 191 following vaccination with Pfizer and 60 post-vaccination Moderna.

144 of them were documented and analyzed: 115 post-Pfizer injection and 29 post-Moderna injection.

These figures are to be related to the nearly 130 million injections carried out with one or the other of these two vaccines for a year and a half.

Of the 115 people vaccinated with Pfizer-BioNTech with documented hearing loss, two-thirds are between the ages of 30 and 65.

87 of these occurred within 21 days of the vaccine injection.

Among them, more than half suffered from “mild” or “medium 1st degree” deafness, the two lowest levels.

The benefit/risk balance not questioned

Conversely, 10 people in total suffered from "cophosis", that is to say total deafness.

“The evolution was favorable for half

(of them)

with known regression times in four cases varying from 1 to 4 months”, we read in the report.

Five of them considered or even made a device.

Read alsoNo death “attributable” to anti-Covid vaccines?

What the data really says

This analysis was carried out "in close collaboration with two ENT specialists who assessed both all of these serious cases until February 2022 and analyzed the data from the scientific literature".

In conclusion, the authors note that “the incidence of notification of cases of deafness suggests a very rare frequency of occurrence of these disorders”.

This new “potential signal” does not therefore call into question the positive benefit/risk balance of vaccination.

The report also specifies that “the risk of deafness occurring after Covid-19 infection” has been documented.

However, several elements, such as “the time to onset of less than 21 days in 73% of cases” and “the absence of documented audiological, otological and cardiovascular history in 62% of cases” mean that the role of the vaccine in the loss of hearing "cannot be ruled out".

Other analyzes will make it possible to establish it, or not.

Source: leparis

All life articles on 2022-06-30

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