version fran├žaise

Procedures for cancerogenicity and genotoxicity studies at the EMA

Following the opinion of doctors and scientists on the need for cancer safety studies, a procedure before the CJEU (Court of Justice of the European Union) was initiated as well as corteous exchanges with the EMA (European Medical Agency) so that these safety studies could be carried out to reassure the vaccinated and, if an outcome was unfortunate, actions could be carried out to screen, mitigate consequences and protect those who need it.
The EMA has responded with various administrative/legal arguments to explain the absence of these studies. Amongst these arguments:
  1. The resources required for these studies (It takes time and it is expensive)
  2. The limitation to a low dose of exposure related to only 2 injections of ALC0159 for the Pfizer vaccine which the EMA comments conditionally as "risk should be low" with 2 injections.
  3. They are not aware of any other biologically plausible mechanisms of concern... .
The EMA's arguments were answered by another letter
  1. Reminding biodistribution studies, the size of the campaign and the younger target
  2. Reminding the multiplication of injections, with ALC 0159 increasing the risk, given the contracts between the EU and Pfizer suggesting possibly 7 injections until 2023 in the face of a risk that has only been evaluated by experts... without any quantification
  3. Biological mechanisms that create concern for performing these safety studies (interference of spike with P53 and BRCA tumor suppressors as well as suggested effects of vaccines on innate immunity)
  4. Recalling the literature and situations where carcinogenicity studies should be conducted in the face of treatments.
In response to the EMA, it was also requested in the last letter the risk-benefit assessment grid stratified by age and immune status (having had covid or not) taking into account the safety data at 6 months, the knowledge acquired in the countries and the variants.

These exchanges are meant for transparent information of a scientific, social and cultural nature with the aim of respect for a better safety and protection of all, particularly the vaccinated...In many cases, early detection of tumors improves the prognosis.... These studies would give eventual indications for screening

Make your opinion "Is it better to do these studies to learn more and act accordingly or is it better not to do them?" What do you think, what do your friends and family think after reading these exchanges?
For information, in parallel with the ongoing referral to the CJEU