A group of prominent scientists and doctors want the European Medicines Agency (EMA) to answer “urgent” safety questions about the three COVID-19 vaccines authorised for use in the EU, or withdraw the vaccines’ authorisation.

In an open letter published this week, the group questioned “whether cardinal issues regarding the safety of the vaccines were adequately addressed prior to their approval” by the EMA.

The EMA, which is the EU equivalent of the U.S. Food and Drug Administration,  approved three vaccines for emergency use in the EU: the Pfizer-BioNtech, Moderna and Oxford-AstraZeneca vaccines.

In their letter, 12 scientists and doctors noted a “wide range of side effects” is reported following vaccination of previously healthy younger individuals with the gene-based COVID-19 vaccines.

They wrote:

“Moreover, there have been numerous media reports from around the world of care homes being struck by COVID-19 within days of vaccination of residents. While we recognise that these occurrences might, every one of them, have been unfortunate coincidences, we are concerned that there has been and there continues to be inadequate scrutiny of the possible causes of illness or death under these circumstances, and especially so in the absence of post-mortems examinations.”

In their original letter, sent Feb. 28 via email to the EMA, the group asked the EMA to provide responses to seven safety-related issues within ”seven days and address all our concerns substantively. Should you choose not to comply with this reasonable request, we will make this letter public.”

The authors, led by Dr. Sucharit Bhakdi, professor emeritus of medical microbiology and immunology, and former chair, Institute of Medical Microbiology and Hygiene, Johannes Gutenberg University of Mainz, have not yet received a response from the EMA.

In a written statement Wednesday, the group said:

“Therefore, as a starting point, we believe it is important to enumerate and evaluate all deaths which have occurred within 28 days of vaccination, and to compare the clinical pictures with those who have not been vaccinated.

“More broadly, with respect to the development of COVID-19 vaccines, the Parliamentary Assembly of the Council of Europe has stated in their Resolution 2361, on 27th January 2021, that member states must ensure all COVID-19 vaccines are supported by high quality trials that are sound and conducted in an ethical manner. EMA officials, and other regulatory bodies in EU countries, are bound by these criteria. They should be made aware that they may be violating Resolution 2361 by applying medical products still in phase 3 studies. 

“Under Resolution 2361, member states must also inform citizens that vaccination is NOT mandatory and ensure that no one is politically, socially, or otherwise pressured to become vaccinated. States are further required to ensure that no one is discriminated against for not receiving the vaccine.”

Bhakdi also issued this video statement, in which he says, “The time for governments to act, the time for everyone to act, is now:”

These are the seven “urgent” safety issues the group wants the EMA to address:

1. Following intramuscular injection, it must be expected that the gene-based vaccines will reach the bloodstream and disseminate throughout the body. We request evidence that this possibility was excluded in preclinical animal models with all three vaccines prior to their approval for use in humans by the EMA.
2. If such evidence is not available, it must be expected that the vaccines will remain entrapped in the circulation and be taken up by endothelial cells. There is reason to assume that this will happen particularly at sites of slow blood flow, i.e. in small vessels and capillaries. We request evidence that this probability was excluded in preclinical animal models with all three vaccines prior to their approval for use in humans by the EMA.
   
3. If such evidence is not available, it must be expected that during expression of the vaccines’ nucleic acids, peptides derived from the spike protein will be presented via the MHC I — pathway at the luminal surface of the cells. Many healthy individuals have CD8-lymphocytes that recognize such peptides, which may be due to prior COVID infection, but also to cross-reactions with other types of Coronavirus. We must assume that these lymphocytes will mount an attack on the respective cells. We request evidence that this probability was excluded in preclinical animal models with all three vaccines prior to their approval for use in humans by the EMA. 
4. If such evidence is not available, it must be expected that endothelial damage with subsequent triggering of blood coagulation via platelet activation will ensue at countless sites throughout the body. We request evidence that this probability was excluded in preclinical animal models with all three vaccines prior to their approval for use in humans by the EMA.
5. If such evidence is not available, it must be expected that this will lead to a drop in platelet counts, appearance of D-dimers in the blood, and to myriad ischaemic lesions throughout the body including in the brain, spinal cord and heart. Bleeding disorders might occur in the wake of this novel type of DIC-syndrome including, amongst other possibilities, profuse bleedings and haemorrhagic stroke. We request evidence that all these possibilities were excluded in pre-clinical animal models with all three vaccines prior to their approval for use in humans by the EMA.
6. The SARS-CoV-2 spike protein binds to the ACE2 receptor on platelets, which results in their activation. Thrombocytopenia has been reported in severe cases of SARS-CoV-2 infection. Thrombocytopenia has also been reported in vaccinated individuals [8]. We request evidence that the potential danger of platelet activation that would also lead to disseminated intravascular coagulation (DIC) was excluded with all three vaccines prior to their approval for use in humans by the EMA.
7. The sweeping across the globe of SARS-CoV-2 created a pandemic of illness associated with many deaths. However, by the time of consideration for approval of the vaccines, the health systems of most countries were no longer under imminent threat of being overwhelmed because a growing proportion of the world had already been infected and the worst of the pandemic had already abated. Consequently, we demand conclusive evidence that an actual emergency existed at the time of the EMA granting Conditional Marketing Authorisation to the manufacturers of all three vaccines, to justify their approval for use in humans by the EMA, purportedly because of such an emergency.

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