Emma Shardlow1, Caroline Linhart1, Sameerah Connor2, Erin Softely2, Christopher Exley3Affiliations
Background: Aluminium salts are the most common adjuvants in infant vaccines. The aluminium content of a vaccine is provided by the manufacturer and is indicated on the patient information leaflet. There is no independent verification, for example by the European Medicines Agency, of the aluminium content of infant vaccines.
Methods: We have measured the aluminium content of thirteen infant vaccines using microwave-assisted acid and peroxide digestion followed by transversely heated graphite furnace atomic absorption spectrometry. Our data are compared with manufacturer’s data using full statistical analyses including Bayesian methods.
Results: We found that only three vaccines contained the amount of aluminium indicated by the manufacturer. Six vaccines contained a statistically significant (P < 0.05) greater quantity while four vaccines contained a statistically significant (P < 0.05) lower quantity. The range of content for any single vaccine varied considerably, for example, from 0.172 to 0.602 mg/vaccine for Havrix.
Conclusions: The data have raised specific questions about the significance of the aluminium content of vaccines and identified areas of extremely limited information. Since aluminium is a known toxin in humans and specifically a neurotoxin, its content in vaccines should be accurate and independently monitored to ensure both efficacy and safety.
An alleged cache of email exchanges between EU officials and the European Medicines Agency show that the drug regulator was uncomfortable about fast-tracking approval for the Pfizer and Moderna Covid jabs, Le Monde has reported.
The EMA has claimed that the contents of the messages, which were obtained by hackers and published on the dark web, were tampered with in order to undermine confidence in the drugs, without providing further details. However, the agency acknowledged to the French newspaper that the correspondences reflect “issues and discussions” that took place in the lead-up to the decision to grant approval to the vaccines. The agency said it can’t specify which documents are genuine.
Some of the “discussions” appear to have been less than congenial. For example, in a document dated November 19, a senior EMA official described a “rather tense, sometimes even a little unpleasant” conference call with the European Commission regarding the review process for the drugs. The official said he felt there was a clear “expectation” that the vaccines would be approved. A day later, the same individual had an exchange with the Danish Medicines Agency in which he expressed surprise that Ursula von der Leyen, the president of the European Commission, had announced that the Moderna and Pfizer jabs could receive the green light before the end of the year.
“There are still problems with both,” the unnamed EMA official noted in the leaked correspondence.