MEDBOX | Toolbox Vaccine Candidates & Research

NEW

Medicines and Healthcare products Regulatory Agency (MHRA) UK (2021) CC

REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS

Tags: UK, vaccine, Astra Zeneca, regulation, COVID-19,

Source: https://assets.publishing.service.gov.uk

NEW

Paul Ehrlich Institute (2021) CC

Ausführliche Informationen zu klinischen Prüfungen und Risiken für bestimmte Gruppe sowie zu Wechselwirkungen und Nebenwirkungen.

Tags: Imfpung, COVID-19, SARS-CoV-2, Impfstoffe, Impfentwicklung, mRNA, Sicherheit, Risikogruppen, Nebenwirkungen,

Source: https://www.pei.de/DE/newsroom/dossier/c

Roadmap for Evaluation of Janssen Ad26.COV2-S (recombinant) vaccine against COVID-19

World Health Organization WHO (2021) C_WHO

In the context of the current public health emergency, regulatory alignment and collaboration are some of the key components that will help to facilitate equitable access to safe and effective vaccines that meet international quality and manufacturing standards. In addition to its procedures for prequalification (PQ) and emergency use listing (EUL) of vaccines, WHO has also developed principles for regulatory collaboration during the scientific review of any vaccine submitted to WHO for assessment

Tags: vaccine candidates, research, phase III,

Source: https://www.who.int/docs/default-source/

NEW

Janssen Vaccines & Prevention B.V. (2021) C1

Study protocol 29 Janaury 2021

Tags: COVID-19, vaccine trial, phase III, vaccine candidates, study,

Source: https://www.jnj.com/coronavirus/covid-19

World Health Organization WHO (2021) C_WHO

13 April 2021 To ensure the latest information is available, the landscape will be updated twice a week These landscape documents have been prepared by the World Health Organization (WHO) for information purposes only concerning the 2019-2020 global of the novel coronavirus. Inclusion of any particular product or entity in any of these landscape documents does not constitute, and shall not be deemed or construed as, any approval or endorsement by WHO of such product or entity (or any of its businesses or activities). While WHO takes reasonable steps to verify the accuracy of the information presented in these landscape documents, WHO does not make any (and hereby disclaims all) representations and warranties regarding the accuracy, completeness, fitness for a particular purpose (including any of the aforementioned purposes), quality, safety, efficacy, merchantability and/or non-infringement of any information provided in these landscape documents and/or of any of the products referenced therein. WHO also disclaims any and all liability or responsibility whatsoever for any death, disability, injury, suffering, loss, damage or other prejudice of any kind that may arise from or in connection with the procurement, distribution or use of any product included in any of these landscape documents

Tags: vaccine, research, COVID-19,

Source: https://www.who.int/publications/m/item/

Organisation Mondiale de la Santé OMS (2021) C_WHO

10 février 2021

Tags: Astra Zeneca, vaccine, vaccine candidates, COVID-19,

Source: https://apps.who.int/iris/bitstream/hand

Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination

Greinacher, A., et al. (2021) CC

New England Journal of Medicine April 9, 2021 DOI: 10.1056/NEJMoa2104840

Tags: Astra Zeneca, side effects, thrombocytopenic disorder, covid-19, Vaccination,

Source: https://www.nejm.org/doi/full/10.1056/NE

AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets

European Medicines Agency EMA (2021) CC

7 April 2021

Tags: Astra Zeneca, side effects, blood clots, vaccine, COVID-19,

Source: https://www.ema.europa.eu/en/news/astraz

Vygen-Bonnet S, Koch J, Bogdan C, et al. (2021) C1

Epidemiologisches Bulletin 16 | 2021 22. April 2021 (online vorab). Die STIKO empfiehlt die Impfung gegen COVID-19 mit einem der beiden zugelassenen mRNA-Impfstoffe (Comirnaty von BioNTech/Pfizer, COVID-19-Vaccine von Moderna) oder einem der beiden zugelassenen Vektor-basierten Impfstoffe (COVID-19 Vaccine AstraZeneca, COVID-19 Vaccine Janssen). Wie im Epidemiologischen Bulletin 16/2021 ausgeführt, werden die Impfstoffe hinsichtlich des Individualschutzes und der Bekämpfung der Pandemie als gleich geeignet beurteilt. Die beiden mRNA-Impfstoffe und die COVID-19 Vaccine Janssen können in allen Alters- und Indikationsgruppen eingesetzt werden, für die sie zugelassen sind. Eine begonnene Impfserie muss gegenwärtig mit demselben Produkt abgeschlossen werden; eine Ausnahme gilt bei der Impfung von Personen < 60 Jahren, die bereits eine erste Dosis der COVID-19 Vaccine AstraZeneca erhalten haben. Bis entsprechende Daten vorliegen, empfiehlt die STIKO, bei diesen Personen anstelle der zweiten AstraZeneca-Impfstoffdosis eine Dosis eines mRNA-Impfstoffs 12 Wochen nach der Erstimpfung zu verabreichen

Tags: Impfungen, COVID-19, Strategie, Verteilung, Ethik, Risikogruppen, Priorisierung, Deutschland, mRNA, vector-basierter Impfstoff, Astra Zeneca, Moderna, pfizer, Risiko, Sinusvenenthrombosen, Zweitimpfung,

Source: https://www.rki.de/DE/Content/Infekt/Epi

Recommandations provisoires pour l’utilisation du vaccin anti-COVID-19 mRNA-1273 de Moderna

Organisation Mondiale de la Santé OMS (2021) C_WHO

Ces orientations provisoires ont été élaborées sur la base de l’avis émis par le Groupe stratégique consultatif d’experts (SAGE) sur la vaccination lors de sa réunion extraordinaire du 21 janvier 2021

Tags: Moderna, vaccine, COVID-19, mRNA, OMS,

Source: https://apps.who.int/iris/bitstream/hand

	Information for Healthcare Professionals on COVID-19 Vaccine AstraZeneca NEW Medicines and Healthcare products Regulatory Agency (MHRA) UK (2021) CC View PDF(13) Download (19) Add to my MEDBOX REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS Tags: UK, vaccine, Astra Zeneca, regulation, COVID-19, Source: https://assets.publishing.service.gov.uk
	FAQ COVID-19-Impfstoffe Entwicklung und Zulassung NEW Paul Ehrlich Institute (2021) CC Open external link (85) Add to my MEDBOX Ausführliche Informationen zu klinischen Prüfungen und Risiken für bestimmte Gruppe sowie zu Wechselwirkungen und Nebenwirkungen. Tags: Imfpung, COVID-19, SARS-CoV-2, Impfstoffe, Impfentwicklung, mRNA, Sicherheit, Risikogruppen, Nebenwirkungen, Source: https://www.pei.de/DE/newsroom/dossier/c
	Roadmap for Evaluation of Janssen Ad26.COV2-S (recombinant) vaccine against COVID-19 World Health Organization WHO (2021) C_WHO View PDF(4) Download (3) Add to my MEDBOX In the context of the current public health emergency, regulatory alignment and collaboration are some of the key components that will help to facilitate equitable access to safe and effective vaccines that meet international quality and manufacturing standards. In addition to its procedures for prequalification (PQ) and emergency use listing (EUL) of vaccines, WHO has also developed principles for regulatory collaboration during the scientific review of any vaccine submitted to WHO for assessment Tags: vaccine candidates, research, phase III, Source: https://www.who.int/docs/default-source/
	A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older NEW Janssen Vaccines & Prevention B.V. (2021) C1 View PDF(5) Download (2) Add to my MEDBOX Study protocol 29 Janaury 2021 Tags: COVID-19, vaccine trial, phase III, vaccine candidates, study, Source: https://www.jnj.com/coronavirus/covid-19
	Draft landscape and tracker of COVID-19 candidate vaccines World Health Organization WHO (2021) C_WHO Open external link (355) Add to my MEDBOX 13 April 2021 To ensure the latest information is available, the landscape will be updated twice a week These landscape documents have been prepared by the World Health Organization (WHO) for information purposes only concerning the 2019-2020 global of the novel coronavirus. Inclusion of any particular product or entity in any of these landscape documents does not constitute, and shall not be deemed or construed as, any approval or endorsement by WHO of such product or entity (or any of its businesses or activities). While WHO takes reasonable steps to verify the accuracy of the information presented in these landscape documents, WHO does not make any (and hereby disclaims all) representations and warranties regarding the accuracy, completeness, fitness for a particular purpose (including any of the aforementioned purposes), quality, safety, efficacy, merchantability and/or non-infringement of any information provided in these landscape documents and/or of any of the products referenced therein. WHO also disclaims any and all liability or responsibility whatsoever for any death, disability, injury, suffering, loss, damage or other prejudice of any kind that may arise from or in connection with the procurement, distribution or use of any product included in any of these landscape documents Tags: vaccine, research, COVID-19, Source: https://www.who.int/publications/m/item/
	Orientations provisoires pour l’utilisation du vaccin anti-COVID-19 AZD1222 (‎ChAdOx1-S [‎recombinant]‎)‎ développé par l’Université d’Oxford et AstraZeneca Organisation Mondiale de la Santé OMS (2021) C_WHO View PDF(0) Download (0) Add to my MEDBOX 10 février 2021 Tags: Astra Zeneca, vaccine, vaccine candidates, COVID-19, Source: https://apps.who.int/iris/bitstream/hand
	Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination Greinacher, A., et al. (2021) CC Open external link (3) Add to my MEDBOX New England Journal of Medicine April 9, 2021 DOI: 10.1056/NEJMoa2104840 Tags: Astra Zeneca, side effects, thrombocytopenic disorder, covid-19, Vaccination, Source: https://www.nejm.org/doi/full/10.1056/NE
	AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets European Medicines Agency EMA (2021) CC Open external link (24) Add to my MEDBOX 7 April 2021 Tags: Astra Zeneca, side effects, blood clots, vaccine, COVID-19, Source: https://www.ema.europa.eu/en/news/astraz
	Beschluss der STIKO zur 4. Aktualisierung der COVID-19-Impfempfehlung und die dazugehörige wissenschaftliche Begründung Vygen-Bonnet S, Koch J, Bogdan C, et al. (2021) C1 View PDF(8) Download (7) Add to my MEDBOX Epidemiologisches Bulletin 16 \| 2021 22. April 2021 (online vorab). Die STIKO empfiehlt die Impfung gegen COVID-19 mit einem der beiden zugelassenen mRNA-Impfstoffe (Comirnaty von BioNTech/Pfizer, COVID-19-Vaccine von Moderna) oder einem der beiden zugelassenen Vektor-basierten Impfstoffe (COVID-19 Vaccine AstraZeneca, COVID-19 Vaccine Janssen). Wie im Epidemiologischen Bulletin 16/2021 ausgeführt, werden die Impfstoffe hinsichtlich des Individualschutzes und der Bekämpfung der Pandemie als gleich geeignet beurteilt. Die beiden mRNA-Impfstoffe und die COVID-19 Vaccine Janssen können in allen Alters- und Indikationsgruppen eingesetzt werden, für die sie zugelassen sind. Eine begonnene Impfserie muss gegenwärtig mit demselben Produkt abgeschlossen werden; eine Ausnahme gilt bei der Impfung von Personen < 60 Jahren, die bereits eine erste Dosis der COVID-19 Vaccine AstraZeneca erhalten haben. Bis entsprechende Daten vorliegen, empfiehlt die STIKO, bei diesen Personen anstelle der zweiten AstraZeneca-Impfstoffdosis eine Dosis eines mRNA-Impfstoffs 12 Wochen nach der Erstimpfung zu verabreichen Tags: Impfungen, COVID-19, Strategie, Verteilung, Ethik, Risikogruppen, Priorisierung, Deutschland, mRNA, vector-basierter Impfstoff, Astra Zeneca, Moderna, pfizer, Risiko, Sinusvenenthrombosen, Zweitimpfung, Source: https://www.rki.de/DE/Content/Infekt/Epi
	Recommandations provisoires pour l’utilisation du vaccin anti-COVID-19 mRNA-1273 de Moderna Organisation Mondiale de la Santé OMS (2021) C_WHO View PDF(0) Download (2) Add to my MEDBOX Ces orientations provisoires ont été élaborées sur la base de l’avis émis par le Groupe stratégique consultatif d’experts (SAGE) sur la vaccination lors de sa réunion extraordinaire du 21 janvier 2021 Tags: Moderna, vaccine, COVID-19, mRNA, OMS, Source: https://apps.who.int/iris/bitstream/hand

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