86% of suspected EU adverse drug reactions in infants transmitted through breastfeeding are linked to C-19 vaccines
The paper concludes by stating that COVID-19 vaccines provide “benefits” to infants…
APR 7
A new paper came out on April 6, 2025 in the British Journal of Clinical Pharmacology titled “EudraVigilance insights: Suspected adverse drug reactions in infants through breastfeeding” with some startling new information regarding COVID-19 vaccination in infants.
To begin, the paper discusses the EudraVigilance system, which serves as the European Union’s centralized system for managing and analyzing information on suspected adverse reactions to medicines. Operated by the European Medicines Agency (EMA), it plays a critical role in pharmacovigilance, ensuring the safety of medicines authorized or being studied in clinical trials within the European Economic Area (EEA).
EudraVigilance facilitates the electronic submission and exchange of Individual Case Safety Reports (ICSRs), documenting suspected adverse drug reactions (ADRs). The case reports are submitted by national regulatory authorities, marketing authorization holders, healthcare professionals, patients, and clinical trial sponsors. You can think of it as somewhat like the CDC VAERS system, and it has similar problems.
The paper’s abstract is as follows:
Aims: We aimed to describe suspected adverse drug reactions (ADRs) in infants resulting from medications transmitted through mothers’ milk, as reported to the European ADR database, EudraVigilance. The research sought to understand the frequency, seriousness and nature of these ADRs to assess potential risks associated with maternal medication use during breastfeeding.
Methods: Data from EudraVigilance were analysed. The study included all reported ADRs suspected to be related to medications transmitted through mothers’ milk from 1 January 2013 to 1 July 2023. The data were categorized by reporting time, infant age and sex, seriousness and type of ADR, and the medications involved.
Results: A total of 922 suspected ADRs were reported in breastfed infants. Serious ADRs accounted for 133 cases (14%), with 15 reported fatalities, primarily associated with methadone (n = 11) and diamorphine (n = 3). COVID-19 vaccines were linked to half of the suspected ADR reports (n = 479, 52%), while serious ADRs were mainly associated with nervous system drugs (n = 73, 43%), particularly anticonvulsants and opioids. Most cases (n = 511, 55%) occurred in infants aged between 1 month and 1 year.
Conclusions: The reporting of 922 ADRs in breastfed infants over a decade, compared to the estimated millions of infants exposed to medications via mothers’ milk annually in Europe, suggests a very low reporting rate of suspected ADRs. This finding emphasizes the significant challenges in postmarketing surveillance and suggests that underreporting remains a critical concern in pharmacovigilance.
The results section discusses the COVID-19 vaccination drug adverse events, written as follows:
RESULTS
In total, 922 ADRs in breastfed infants were reported to EudraVigilance between 1 January 2013 and 1 July 2023. Among the ADR reports, 355 (39%) were reported in boys, 323 (35%) in girls and 244 (26%) did not have the sex specified. The number of ADR reports varied significantly over the years, with a notable surge in 2021 and 2022. This increase was primarily driven by reports related to COVID-19 vaccinations, which were introduced to the market in 2020 but accounted for 52% (479 out of 922) of the total reports over the 10-year period (Figure 1).
Of interest is that the researchers buried the data that in 2021 and 2022, about 86% of all drug-infant adverse drug reactions transmitted from breastfeeding were linked to C-19 vaccines. Which, of course, is the first two years that the vaccines were introduced into the market!
The data speaks for itself:
Figure 1 on the paper calculated the adverse event ratio for the first two years of the COVID-19 vaccine release. My calculations cover what the authors apparently didn’t do – or the editors took out- are shown in the speech bubbles found on the figures from the paper as well as in bulleted points afterwards.
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