Call for action to all EU citizens concerned about the safety of mRNA vaccines, requiring transparency from EMA and independent scientific re-evaluation
Call for action to all concerned EU citizens about mRNA vaccines for transparency and scientific re-evaluation
EU citizens demand transparency
The Transparency4Safety Initiative invites EU citizens to submit an access-to-documents request to the European Medicines Agency (EMA), frequently called an “EU-FOIA”.
The request concerns the authorisation and safety documentation for Comirnaty, Spikevax and other mRNA-LNP-based products against infectious diseases. It seeks full transparency based on an overriding public interest, independent scientific reassessment, and the highest possible health-protection standards, which demand the immediate suspension of the mRNA vaccine authorisations.
The initiative was initially launched in February 2025 by 2,100 requesters, including EU citizens and organisations. To date, EMA has not opened the relevant market-authorisation dossiers in full. The background and legal reasoning can be read here.
T4S is now re-activated and expanded across the EU. Citizens submit access-to-documents requests; independent experts will submit overriding public interest reports, which will be published on this Substack together with further updates - please subscribe below.
Please join the T4S initiative and file an access-to-documents request to EMA
I. Information for new participants
If you are an EU citizen (a national of an EU Member State, or resident in EU) and believe that mRNA products require full transparency, independent scientific review, the highest health-protection standards and, where safety concerns remain unresolved, precautionary suspension for reassessment, please join this initiative by submitting a legal request for transparency to EMA, also known as an ‘EU-FOIA’.
Please find instructions in English below, followed by other EU languages, on how to join this initiative under Reg 1049/2001 on public access to EU documents.
Easy step-by-step guidance
Only join if you are genuinely interested in following this initiative to its successful conclusion:
1. Open the EMA contact form to “Send a question”: https://www.ema.europa.eu/en/about-us/contacts-european-medicines-agency/send-question-european-medicines-agency
2. Fill in the online form. Choose, for example, the category “Patient and consumer” → “I want an unpublished document”. As the subject of inquiry, enter “Transparency4Safety” or any other appropriate subject. Not all fields may require an entry. The request text is the decisive element.
3. Copy and paste the following request text in English, or use the version in your preferred EU language further below. You are also welcome to formulate some sentences of your own - Text:
“EU Citizen Request – Transparency4Safety
Within the framework of the Transparency4Safety (T4S) Initiative, I request, pursuant to Reg 1049/2001 and in accordance with the original request submitted by 2,100 EU citizens and organisations in February 2025, the full and unredacted disclosure of all essential marketing-authorisation data concerning Comirnaty and Spikevax (all versions), and, where applicable, further authorisation data concerning other mRNA-LNP-based products such as Kostaive and mNEXSPIKE.
If any releases are redacted or withheld, I expressly request that all procedural rights under Reg 1049/2001 be fully respected. It is publicly documented that, to date, EMA has neither opened a lawful procedure for the requesters of the T4S initiative nor issued new releases or unredacted re-releases of the requested documents, and that the European Ombudsman has not provided an effective remedy.
I expressly invoke an overriding public interest in disclosure under Article 4(2) of Reg 1049/2001. This interest arises from documented safety concerns regarding biologically inadequate regulatory standards, the need for independent scientific and regulatory reassessment due to the novelty of the technology and the inadequacy of applied regulatory safety standards for mRNA-LNP products, the Union’s obligation to ensure a high level of human health protection, and the precautionary principle that requires the initiation a procedure under Article 20 of Reg 726/2004.
I request immediate access, through a publicly accessible database, to all releases made under Reg 1049/2001.
I further request to participate in the dedicated public meeting as proposed to EMA via livestream. At the meeting, renowned independent experts should discuss the overriding public interest reports with the competent EMA committees, with concrete outcomes aimed to reassess and strengthen the applicable safety standards.”
After submission, please wait for EMA’s confirmation eMail and save the ASK number. his step is very important, because the ASK number enables you to participate and exercise your procedural rights versus the EMA for the entire duration of the T4S initiative. EMA procedures can be very slow, so please keep your ASK number, monitor your inbox and spam folder and be prepared to send follow-up communication if EMA does not reply within X days.
PLEASE subscribe to stay informed and receive further updates and expert ‘overriding public interest reports’ of our T4S initiative:
Information & request text in all EU official languages:
Bulgarian / Български, Croatian / Hrvatski, Czech / Čeština, Danish / Dansk, Dutch / Nederlands, English, Estonian / Eesti keel, Finnish / Suomi, French / Français, German / Deutsch, Greek / Ελληνικά, Hungarian / Magyar, Italian / Italiano, Latvian / Latviešu, Lithuanian / Lietuvių, Maltese / Malti, Polish / Polski, Portuguese / Português, Romanian / Română, Slovak / Slovenčina, Slovenian / Slovenščina, Spanish / Español, Swedish / Svenska
II. Information for follow-up participants
If you are one of the 2.100 initial participants and you already have a pending request at EMA, please re-activate your submission:
How to send a follow-up request to EMA
Open the EMA contact form “Send a question”:
https://www.ema.europa.eu/en/about-us/contacts-european-medicines-agency/send-question-european-medicines-agencyFill in the online form. Choose, for example:
Patient and consumer → I want an unpublished document; as the subject of inquiry, enter: Transparency4Safety – Follow-up to ASK [insert ASK number].In case you lost your initial ASK number, state “I submitted an access-to-documents request in 2025 and would be grateful if EMA could resend me the original ASK number.” Please change the text below accordingly or write it in your own words!
Example text:
”I refer to my access-to-documents request, registered under ASK [insert ASK number].I am still waiting for the full and unredacted disclosure of the requested documents concerning Comirnaty, Spikevax and other mRNA-LNP-based products. I request that EMA immediately starts a lawful procedure and provides the requested documents in full and without redactions.
To date, EMA has violated my procedural rights as guaranteed under Union legislation by failing to properly administer my request, disclose the requested documents, or issue a lawful and reasoned decision with access to the confirmatory stage.
I maintain that there is an overriding public interest in disclosure, as will be further documented by overriding public interest reports under the framework of this initiative and expressly ask EMA to initiate a procedure for suspension of the relevant market authorisations.”
Please keep the new ASK number that EMA will send to your inbox.
Follow-up information in all EU languages here
• Bulgarian / Български • Croatian / Hrvatski • Czech / Čeština • Danish / Dansk • Dutch / Nederlands • Estonian / Eesti keel • Finnish / Suomi • French / Français • German / Deutsch • Greek / Ελληνικά • Hungarian / Magyar • Italian / Italiano • Latvian / Latviešu • Lithuanian / Lietuvių • Maltese / Malti • Polish / Polski • Portuguese / Português • Romanian / Română • Slovak / Slovenčina • Slovenian / Slovenščina • Spanish / Español • Swedish / Svenska
Please subscribe to this Substack to receive further updates and new information!
Thank you for joining the initiative from the beginning and for your perseverance in this important effort. This is our chance to demand transparency, accountability and stopp and re-evaluate the mRNA-vaccine safety!
Thanks, you make the change!!!!
Transparency enables scrutiny, not substitutes for it. Unredacted authorisation dossiers are the correct evidentiary starting point. Passive reports raise signals but cannot replace controlled data.
mRNA–LNP products are a distinct platform, yet were reviewed through a conventional vaccine lens, risking under‑emphasis of distribution kinetics.
Regulation 1049/2001 disclosure supports independent evaluation of dose/route rationale, rate‑based evidence, and the separation of mechanistic hypotheses from clinical outcomes. Transparency enables scrutiny, not substitutes for it.