Demande d’accès aux documents relatifs aux études de génotoxicité du vaccin Kostaive (ARCT-154) conformément au règlement (CE) n° 1049/2001
Cher Agence européenne des médicaments,
Objet : Demande d’accès aux documents relatifs aux études de génotoxicité du vaccin Kostaive (ARCT-154) conformément au règlement (CE) n° 1049/2001
Madame, Monsieur,
L’association BonSens.org ,composée de citoyens français et européens préoccupés par la sécurité des vaccins, que je représente en tant qu’avocat, souhaite obtenir des informations détaillées sur les études de génotoxicité mentionnées dans le Plan de gestion des risques (RMP) du vaccin Kostaive (ARCT-154), autorisé par la Commission européenne le 14 février 2025.
Le RMP indique qu’aucune étude de génotoxicité n’a été réalisée pour Kostaive, mais que des études négatives sur un produit similaire (ARCT-810), un LNP vide, et une analyse in silico pour ATX-126 concluent à l’absence de risque génotoxique. Compte tenu de la nouveauté de la technologie ARNm auto-amplifiant et des préoccupations publiques sur les risques à long terme, l’accès à ces données est crucial pour garantir la confiance dans l’évaluation de l’EMA.
Conformément au règlement (CE) n° 1049/2001 et à la politique de transparence de l’EMA (politique 0043), l’association BonSens.org demande l’accès aux documents suivants :
• Les rapports complets des études de génotoxicité réalisées pour ARCT-810, incluant le test d’Ames, le test in vitro sur lymphocytes humains, et le test in vivo sur micronoyaux de rongeurs, avec les protocoles, résultats bruts, et analyses statistiques.
• Les rapports des études de génotoxicité sur le LNP vide (sans ARNm) contenant un lipide similaire à celui de Kostaive, incluant les mêmes tests mentionnés ci-dessus.
• Les résultats détaillés de l’analyse in silico pour ATX-126, incluant les méthodologies, logiciels utilisés, et critères d’évaluation de la mutagénicité bactérienne.
Je vous demande de m’adresser ces documents sous format électronique dans un délai de 15 jours ouvrables conformément aux dispositions du règlement (CE) n° 1049/2001.
En cas de refus, je vous remercie de me fournir une explication détaillée et de m’ indiquer les recours disponibles. Je vous remercie pour votre engagement renouvelé en faveur de la Transparence et je reste à votre disposition pour toute clarification.
Je vous prie de croire, Monsieur/Madame, à l'assurance de mes salutations distinguées,
Diane Protat, avocat, pour le compte de l'association BonSens.org : https://bonsens.info/
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Original Message Details
Created Date: 5/29/2025 2:49:15 PM
Sender Address: [FOI #15958 email]
Recipient [EMA request email]
Address:
Accès à l'information demande - Demande d’accès aux
Subject: documents relatifs aux études de génotoxicité du vaccin
Kostaive (ARCT-154) conformément au règlement (CE) n°
1049/2001
Error Details
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References
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Cher Agence européenne des médicaments,
Merci de me dire pourquoi ma demande n'est pas traitée dans les temps ? Je ne comprends pas, il s'agit à mon sens d'un cas de mauvaise administration.
J'attends votre retour.
Je vous prie de croire, Monsieur/Madame, à l'assurance de mes salutations distinguées,
Diane Protat
Your message to [EMA request email] couldn't be delivered.
info wasn't found at ema.europa.eu.
ask+request-15958-bb. . . Office 365 info
Action Required Recipient
Unknown To address
How to Fix It
The address may be misspelled or may not exist. Try one or more of the
following:
• Send the message again following these steps: In Outlook, open this
non-delivery report (NDR) and choose Send Again from the Report
ribbon. In Outlook on the web, select this NDR, then select the link
"To send this message again, click here." Then delete and retype the
entire recipient address. If prompted with an Auto-Complete List
suggestion don't select it. After typing the complete address, click
Send.
• Contact the recipient (by phone, for example) to check that the
address is correct.
• The recipient may have set up email forwarding to an incorrect
address. Ask them to check that any forwarding they've set up is
working correctly.
• Clear the recipient Auto-Complete List in Outlook or Outlook on the
web by following the steps in this article: [1]Fix email delivery
issues for error code 5.1.1 in Office 365, and then send the message
again. Retype the entire recipient address before selecting Send.
Was this helpful? [2]Send feedback to Microsoft.
══════════════════════════════════════════════════════════════════════════
More Info for Email Admins
Status code 554 5.4.14
Typically this error occurs because the recipient email address is
incorrect or doesn't exist at the destination domain. This can usually be
fixed by the sender. However, sometimes the issue needs to be fixed by the
recipient or the recipient's email admin. If the steps in the How to Fix
It section above don't fix the problem, and you're the email admin for the
recipient, try one or more of the following:
The email address exists and is correct - Confirm that the recipient
address exists, is correct, and is accepting messages.
Synchronize your directories - If you have a hybrid environment and are
using directory synchronization make sure the recipient's email address is
synced correctly in both Office 365 and in your on-premises directory.
Errant forwarding rule - Check for forwarding rules that aren't behaving
as expected. A forwarding rule can be configured by an admin via mail flow
rules or mailbox forwarding address settings, or by the recipient via the
Inbox Rules feature.
Mail flow settings and MX records are not correct - Misconfigured mail
flow settings or MX records can cause this error. Check your Office 365
mail flow settings to make sure your domain and any mail flow connectors
are set up correctly. Also, work with your domain registrar to make sure
the MX records for your domain are configured correctly.
Mail loop detected - This error also indicates that the receiving
organization's email settings are misconfigured, creating a mail loop when
a message is sent to an address that isn't found in their directory. This
usually won't disrupt mail flow for recipients that actually exist, but
the recipient's email admin should fix the misconfiguration to reduce the
chance of any other mail flow issues. A common cause for this loop is that
the recipient's domain is configured as "Internal Relay" when it should be
"Authoritative." Another common cause for the loop is that both the sender
and recipient are part of the same organization, but the sender's mailbox
is hosted by Office 365, while the recipient's mailbox is hosted
on-premises, and an outbound connector from Office 365 to the on-premises
email servers is missing or misconfigured. To fix this, the recipient's
email admin should create a correctly configured outbound connector in
Office 365 to route the message to the on-premises mailbox.
For more information and tips to fix this problem, see [3]Fix email
delivery issues for error code 5.4.14 in Office 365.
Original Message Details
Created Date: 7/1/2025 1:25:09 PM
Sender Address: [FOI #15958 email]
Recipient [EMA request email]
Address:
Revue interne de Accès à l'information demande - Demande
Subject: d’accès aux documents relatifs aux études de génotoxicité
du vaccin Kostaive (ARCT-154) conformément au règlement
(CE) n° 1049/2001
Error Details
Error: 554 5.4.14 Hop count exceeded - possible mail loop ATTR34
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Message AM3PEPF00009B9F.mail.protection.outlook.com
rejected by:
Notification Details
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Message Hops
HOP TIME FROM TO WITH RELAY
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7/1/2025 local (Exim 4.94.2) (envelope-from
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7/1/2025 esmtps (TLS1.3) tls
2 1:25:09 mstr002sova.srv.mysociety.org mslb001sova.srv.mysociety.org TLS_ECDHE_RSA_WITH_AES_256_GCM_SHA384 (Exim *
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7/1/2025 Microsoft SMTP Server (version=TLS1_3,
3 1:25:10 mslb001sova.srv.mysociety.org DU6PEPF0000A7DE.mail.protection.outlook.com cipher=TLS_AES_256_GCM_SHA384) 1 sec
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7/1/2025 Microsoft SMTP Server (version=TLS1_3,
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7/1/2025 Microsoft SMTP Server (version=TLS1_2,
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7/1/2025 Microsoft SMTP Server (version=TLS1_3, 1 min,
6 1:26:14 EUR05-VI1-obe.outbound.protection.outlook.com DU2PEPF00028D08.mail.protection.outlook.com cipher=TLS_AES_256_GCM_SHA384) 4 sec
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7/1/2025 Microsoft SMTP Server (version=TLS1_3,
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7/1/2025 Microsoft SMTP Server (version=TLS1_2,
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7/1/2025 Microsoft SMTP Server (version=TLS1_3,
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