Re: Many vaccines have tiny amounts of inorganic matter, investigation finds
The European Medicines Agency would like to express its concerns over the publication of the news article “Many vaccines have tiny amounts of inorganic matter, investigation finds” on 3 February 2017, reporting on the findings of a study that calls into question the quality and safety of EU vaccines.
By providing an uncritical platform for propagating a study containing methodological flaws and unsubstantiated assertions, we feel that BMJ could inadvertently legitimise claims discredited long ago by the scientific community and which have led to parents not protecting their children from serious illness.
The study by Gatti and Montanari claims that many vaccines contain inorganic particles not listed as vaccine ingredients in the prescribing information, raising doubts on the quality control in place during vaccine manufacture. The study findings are not quantifiable and so cannot be used to question the quality of vaccines approved in the EU. In addition the lack of controls, the use of a technique to prepare samples that favours aggregation and particle formation, and the sampling of predominantly out-of-date batches are among other methodological flaws throwing doubt on the results.
On the basis of their findings, Gatti and Montanari proceed to unsubstantiated speculation that presence of these particles could have an impact on vaccine safety, particularly posing a risk of neurotoxicity. The evidence and supporting references presented do not substantiate their claims. In particular, we think it questionable to use a paper which refutes the link between MMR vaccination and autism as a reference to a statement raising the spectre of this now discredited theory.
The presence of minuscule trace amounts of certain inorganic particles in vaccines is not unexpected and the manufacturing process for all parenteral preparations is designed to ensure that any such traces are kept within safe limits. Following similar previous claims by Montanari the French medicines regulatory authority (ANSM) has published their experts’ analysis of metal particles in certain vaccines using, as well as a method similar to Gatti and Montanari, inductive coupled plasma mass spectrometry which allows quantification of inorganic elements. (http://ansm.sante.fr/var/ansm_site/storage/original/application/f7dbcc06..., http://ansm.sante.fr/var/ansm_site/storage/original/application/e35712db...) The ANSM concluded that the amounts of any particles found were exceedingly low. This indicates that the controls during manufacturing are keeping impurities within accepted limits. French experts further concluded that their findings are due to the presence of these types of particles everywhere in the environment and should not be considered a health risk.
Vaccine manufacturing in the EU follows strict quality control processes as required in the legislation, such as compliance with the European Pharmacopoeia, periodic inspections of manufacturing sites to ensure Good Manufacturing Practice and, as an additional requirement for vaccines, quality control testing of all vaccine batches by the network of EU Official Medicines Control Laboratories before release by national authorities.
EMA supports a transparent approach to medicines evaluation and welcomes independent research. It is our duty to engage with valid evidence regarding the benefits and risks of medicines, and take appropriate action. However, independent research is only valuable if valid conclusions can be drawn from it. This is not the case in the article in question. Vaccination has greatly reduced the prevalence of serious or fatal infectious diseases such as measles, rubella, diphtheria, polio and smallpox, and continues to be of prime importance for global health. Given the existing public misconceptions about vaccines, disseminating the conclusions of poorly designed research without evaluating it can only be damaging to public health.
Competing interests: No competing interests