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Dear Sir/Madam **ASK-157379 - (MC-REH)Questions regarding the Rapporteur’s Rolling Review assessment report of 19.11.2020 [#293382] received on 27/11/2023** Thank you for your message and your interest in the European Medicines Agency. Your request has been given the reference number ASK-157379. We will reply to you as soon as we can. For complex queries, it may take longer to answer. In any case we will write back to you within 2 months from the date of receipt. **Please do not reply to this email**, this is an automated response to confirm that we have received your request. If you need to contact us again about the same matter, please use the form on our website and mention the reference number. Kind regards **European Medicines Agency** Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands Send us a question. Go towww.ema.europa.eu/contact ( http:://www.ema.europa.eu/contact ) Telephone: +31 (0)88 781 6000 ____________________________________________________________ We received your question(s) on: **27/11/2023** Subject of your enquiry: **(MC-REH)Questions regarding the Rapporteur’s Rolling Review assessment report of 19.11.2020 [#293382]** Your question(s): **

Dear << Antragsteller:in >> << Antragsteller:in >> Thank you for your questions about Comirnaty. Please see our responses below. 1. Page 15/78 states: "The functional elements of the pST4-1525 are sufficiently described in graphic and tabular formats and the sequence is included." Did the EMA ever independently verify the provided sequence contains the claimed functional elements? Did EMA ever independently sequence the MCBs/WCBs? *EMA does not carry out sequencing of materials. EMA assesses information provided by companies and, in conjunction with national authorities, ensures that manufacturing is carried out in line with Good Manufacturing Practices (GMP). You can find more information in the link below:* https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice ( https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice ) 2, Does the document 3.2.S.2.3. "Control of Materials - Source, History and Generation of Plasmids" make any mention of "SV-40", or describe the promotors driving the antibiotic resistance genes' expression? I assume the document is entirely withheld due to trade secrets, yet the question is justified due to the presence of this promotor in all pfizer-biontech vials thus sequenced by third parties. *While the full DNA sequence of the plasmid starting material was provided in the initial marketing authorisation application for Comirnaty, the applicant did not specifically highlight the SV40 sequence, as it was considered to be a non-functional part of the plasmid. They have since clarified this information in response to questions raised by EMA.* 3. How does the EMA explain the difference between pST4-1525 and the verified-by-replication sequencing results? How can there be differences between the regulatory filings and the product released onto the market? *As stated above, the full sequence was provided with the application for marketing authorisation. Companies cannot make changes to their products when placing them on the market without submitting the necessary applications to amend or extend the marketing authorisation.* We hope you find this helpful. On behalf of Juan Garcia Burgos Head of Public and Stakeholder Engagement Department __ **We would be grateful if you could take part in a short survey on our service. Please access the survey through the following link: https://ec.europa.eu/eusurvey/runner/AskEMASurvey5137ad0a-8a76-4425-26ed-93ab3c955448** **European Medicines Agency** Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands Send us a question. Go to www.ema.europa.eu/contact ( http:://www.ema.europa.eu/contact ) Telephone: +31 (0)88 781 6000 **_____________________________________________________** **We received your question(s) on**:27/11/2023 **Subject of your enquiry**:(MC-REH)Questions regarding the Rapporteur’s Rolling Review assessment report of 19.11.2020 [#293382] **Your question(s)**: