¶ European Medicines Agency
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The European Medicines Agency (EMA) is a multination agency of the European Union in charge of the evaluation and supervision of medicinal products.
¶ History
The EMA contributed to the Global Vaccine Action Plan developed by the Decade of Vaccines Collaboration, endorsed by the 194 Member States of the World Health Assembly in May 2012, and published on the World Health Organization's website in February 2013.[1]
¶ COVID-19
The EMA is a collaborator in the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative.[2]
While in the process of evaluating the Pfizer–BioNTech COVID-19 vaccine (BNT162b2) in December 2020, the EMA suffered a cyberattack, resulting in the leak of classified regulatory documents to journalists, academics and the public via the dark web.[3][4][5] The documents revealed internal concerns about low production quality in the mRNA vaccine candidate, and regulators' efforts to have Pfizer and BioNTech rectify these deficiencies.[6][7][8] The EMA ultimately authorized the vaccine on December 21, 2020, satisfied that the product quality was "sufficiently consistent and acceptable."[9][10]
Covid Truths published a number of these files in April 2021, including copies of the Rapporteur's Assessment Reports.[11] On October 29, 2022, the Canadian Covid Care Alliance (CCCA) published a paper authored by Maria Gutschi based on the leaked EMA documents analyzing the manufacturing and quality issues underlying BNT162b2.[12] A video presentation of the investigation was also published to BitChute and the CCCA website.[13][14]
¶ Organization
The EMA is a member of the Joint Coordination Group of the Coalition for Epidemic Preparedness Innovations (CEPI),[15] a benefactor-level member of Health Level Seven International (HL7),[16] as well as a member of the International Council for Harmonisation (ICH)[17] and the International Pharmaceutical Regulators Programme.[18] It is also a partner of the Society for Immunotherapy of Cancer[19] and the Vaccine Confidence Project.[20]
¶ Personnel
| Name | Position | Notes |
|---|---|---|
| Marco Cavaleri | Head of Biological Health Threats and Vaccines Strategy[21] | Chair of the EMA's COVID-19 Taskforce |
¶ External links
Annex 5: Countries and Organizations that Contributed to the Elaboration of the GVAP. World Health Organization. Retrieved June 3, 2023, from https://web.archive.org/web/20230603045157/https://cdn.who.int/media/docs/default-source/vaccines-and-immunization/gvap-annex5.pdf?sfvrsn=f3aa55e3_2 ↩︎
ACTIV. National Institutes of Health (NIH). Retrieved April 1, 2022, from http://archive.today/2022.01.11-042823/https://www.nih.gov/research-training/medical-research-initiatives/activ ↩︎
Stubbs, J. (2020, December 9). Hackers steal Pfizer/BioNTech COVID-19 vaccine data in Europe, companies say. Reuters. https://web.archive.org/web/20230916173447/https://www.reuters.com/article/us-ema-cyber-idUKKBN28J2Q7 ↩︎
Glanville, D. (2021, January 15). Cyberattack on EMA - update 5. European Medicines Agency. https://web.archive.org/web/20230916173203/https://www.ema.europa.eu/en/news/cyberattack-ema-update-5 ↩︎
Statement on EMA Cyberattack. (2020, December 9). Pfizer. https://web.archive.org/web/20230916173702/https://www.pfizer.com/news/announcements/statement-ema-cyberattack ↩︎
Tinari, S. (2021). The EMA covid-19 data leak, and what it tells us about mRNA instability. BMJ, n627. https://doi.org/10.1136/bmj.n627 ↩︎
Abbasi, J. (2021). Data Leak Exposes Early COVID-19 Vaccine Manufacturing Hiccups. JAMA, 325(14), 1385. https://doi.org/10.1001/jama.2021.5002 ↩︎
Lovett, S. (2021, March 11). European regulator raised concern over quality of early Pfizer vaccine batches, leaked emails show. The Independent. https://web.archive.org/web/20230916174105/https://www.independent.co.uk/news/science/covid-pfizer-vaccine-doses-uk-latest-b1815398.html ↩︎
Committee for Medicinal Products for Human Use (CHMP). (2021, February 19). European public assessment report (EPAR) - Comirnaty, INN-COVID-19 mRNA Vaccine (nucleoside-modified). European Medicines Agency. https://web.archive.org/web/20230912122645/https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf ↩︎
Kansteiner, F. (2021, March 15). Pfizer’s COVID-19 vaccine faced EMA manufacturing concerns ahead of emergency nod: report. Fierce Pharma. https://web.archive.org/web/20230710140521/https://www.fiercepharma.com/manufacturing/pfizer-s-covid-19-vaccine-subject-to-ema-manufacturing-concerns-ahead-december ↩︎
EMA Leaked Papers. (2021, April 17). Covid Truths. https://web.archive.org/web/20221110200241/https://www.covidtruths.co.uk/2021/04/ema-leaked-papers/ ↩︎
Gutschi, L. M., Speicher, D. J., Natsheh, S., Oldfield, P., Britz-Mckibbon, P., Palmer, M., Karrow, N., Massie, B., Mallard, B., Chan, G., & Pelech, S. (2022). An Independent Analysis of the Manufacturing and Quality Issues of the BNT162b BioNTech/Pfizer Quasi-vaccine based on the European Medicines Agency’s Public Assessment Report (EPAR). Canadian Covid Care Alliance. https://web.archive.org/web/20221110200231/https://www.canadiancovidcarealliance.org/wp-content/uploads/2022/11/22OC29_EMA-Analysis-of-BNT162b-Manufacture.pdf ↩︎
DRWR2021. (2022, November 2). Quality issues with mRNA Covid vaccine production. BitChute. https://www.bitchute.com/video/muB0nrznCAC4/. Archived version available at http://archive.today/2022.11.08-112519/https://www.bitchute.com/video/muB0nrznCAC4/ ↩︎
An Independent Analysis of the Manufacturing and Quality Issues of the BNT162b BioNTech/Pfizer Vaccine (Video). Canadian Covid Care Alliance. Retrieved November 9, 2022, from https://web.archive.org/web/20221109043439/https://www.canadiancovidcarealliance.org/media-resources/an-independent-analysis-of-the-manufacturing-and-quality-issues-of-the-bnt162b-biontech-pfizer-vaccine-video/ ↩︎
Who we are. CEPI. Retrieved October 19, 2022, from https://web.archive.org/web/20221019165747/https://cepi.net/about/whoweare/ ↩︎
Benefactors of Health Level Seven. HL7 International. Retrieved June 1, 2023, from https://web.archive.org/web/20230601080537/http://www.hl7.org/about/benefactors.cfm ↩︎
Members & Observers. International Council for Harmonisation. Accessed April 24, 2022, from http://archive.today/2022.04.24-053337/https://www.ich.org/page/members-observers ↩︎
Members & Observers. International Pharmaceutical Regulators Programme. Retrieved April 23, 2022, from http://archive.today/2022.04.24-064614/https://www.iprp.global/members ↩︎
Cancer Immunotherapy Partnerships and Collaborations. Society for Immunotherapy of Cancer. Retrieved March 27, 2023, from https://web.archive.org/web/20230327191240/https://www.sitcancer.org/aboutsitc/partnerships#champions ↩︎
Partnerships. The Vaccine Confidence Project. Retrieved April 28, 2022, from https://web.archive.org/web/20220428122506/https://www.vaccineconfidence.org/partners-funders ↩︎
Kouassi, V. Marco Cavaleri. REVIVE. Retrieved March 8, 2023, from https://web.archive.org/web/20230308225834/https://revive.gardp.org/marco-cavaleri/ ↩︎