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Coronavirus and COVID-19

Pagination

COVID-19 Vaccines

Overview of authorised Vaccines

Comirnaty

Comirnaty is a mRNA vaccine to protect against infections with the SARS-CoV-2 virus. It has been authorised in the EU since 21 December 2020. The authorisation holder is BioNTech Manufacturing GmbH.

Product Information

Product Information: Comirnaty
European Public Assessment Report: Comirnaty
Information sheet and anamnesis and consent sheet for the COVID-19 vaccination

Chronology

Date Title
21.06.2022 Rolling Reviews Have Started for Adapted COVID-19 mRNA Vaccines from BioNTech (Comirnaty) and Moderna (Spikevax)
03.06.2022 Antibody Response to Omicron and Other Virus Variants Effectively Replenished after 3rd and 4th COVID-19 Vaccination
25.04.2022 Suspected Cases of Adverse Reactions and Vaccination Complications after Vaccination with Comirnaty in Children aged 5 to 11 Years from Germany
21.04.2022 COVID-19 Vaccine Comirnaty – Shelf Life Extended to 12 Months
01.03.2022 EU Commission Follows CHMP Recommendation: Booster Vaccination with COVID-19 Vaccine Comirnaty for Children and Adolescents 12 years and up
10.02.2022 European Evaluation Process for Booster Vaccination with COVID-19 Vaccine Comirnaty in 12 to 15-Year-Olds
02.02.2022 Comirnaty COVID-19 mRNA Vaccine – Shelf Life Extended for Additional Formulations
10.12.2021 Use of Comirnaty for 5- to 11-Year-Old Children - Important Information for Medical Doctors
08.12.2021 Omicron Variant - Possible Protection after Booster Vaccination
29.11.2021 EU Commission Authorises Indication Extension of COVID-19 Vaccine Comirnaty to 5- to 11-Year-Olds
25.11.2021 Committee for Medicinal Products for Human Use (CHMP) recommends Extension of Marketing Authorisation for BioNTech/Pfizer's COVID-19 Vaccine Comirnaty for Children aged 5 to 11
20.11.2021 Booster Vaccinations with Spikevax or Comirnaty are Equivalent
05.11.2021 Statement: Clinical Trial of Comirnaty from BioNTech
20.10.2021 Start of the Evaluation Process for the Approval Extension of the COVID-19 Vaccine Comirnaty for Children from 5 Years of Age
01.10.2021 COVID 19 mRNA Vaccine Comirnaty – Shelf Life Extended
10.09.2021 European Variation Procedure Begins for Booster Vaccination with the COVID-19 Vaccine Comirnaty
19.07.2021 Rote-Hand-Brief: BioNTech und Moderna zu den Impfstoffen Comirnaty und Spikevax (19.07.2021)
01.06.2021 EU Commission Authorises Indication Extension of COVID-19 Vaccine Comirnaty for 12- to 15-year-olds
28.05.2021 CHMP at EMA recommends Marketing Authorisation Extension for BioNTech/Pfizer’s COVID-19 Vaccine Comirnaty for Children aged 12 to 15
07.05.2021 COVID-19 Vaccine for Persons Aged 12 and Above – Evaluation Procedure for the Marketing Authorisation Extension of Comirnaty has now Started
29.12.2020 Corona Vaccination in Individuals Suffering from Allergies
26.01.2021 Comirnaty (COVID-19-mRNA-Impfstoff, Tozinameran) Schulungsmaterial:
Information für medizinische Fachkräfte - Spritzen und/oder Kanülen mit geringem Totvolumen (Entnahme von 6 Dosen pro Durchstechflasche) (German Only)
23.12.2020 Paul-Ehrlich-Institut Releases First Batches of BioNTech/Pfizer's COVID-19 Vaccine Comirnaty for German and European Markets
21.12.2020 European Commission grants Marketing Authorisation for BioNTech/Pfizer's COVID-19 Vaccine for the European Union
21.12.2020 The Committee for Medicinal Products for Human Use at the EMA recommends Conditional Marketing Authorisation for the COVID-19 Vaccine from BioNTech/Pfizer
07.12.2020 Authorisation of a COVID-19 Vaccine in the UK
06.10.2020 European Medicines Agency (EMA) has started Second Rolling Review Procedure of a COVID-19 Vaccine Candidate for Europe
09.09.2020 Phase II/III Study of the RNA Vaccine Candidate BNT162b2 from BioNTech Approved in Germany

Spikevax - COVID-19 Vaccine Moderna

Spikevax (COVID-19 Vaccine Moderna) is a mRNA vaccine to protect against infections with the SARS-CoV-2 virus. It has been authorised in the EU since 6 January 2021. The authorisation holder is Moderna Biotech Spain, S.L..

Product Information

Product Information: Spikevax (COVID-19 Vaccine Moderna)
European Public Assessment Report: Spikevax (COVID-19 Vaccine Moderna)
Information sheet and anamnesis and consent sheet for the COVID-19 vaccination

Chronology

Date Title
21.06.2022 Rolling Reviews Have Started for Adapted COVID-19 mRNA Vaccines from BioNTech (Comirnaty) and Moderna (Spikevax)
04.03.2022 EU Commission Follows CHMP Recommendation: Marketing Authorisation Extension of Moderna's COVID-19 Vaccine Spikevax for Use in Children Aged 6 Years and up
14.01.2022 COVID-19 Vaccine Spikevax – Shelf Life Extended
20.11.2021 Booster Vaccinations with Spikevax or Comirnaty are Equivalent
10.11.2021 COVID-19 Vaccine from 6 Years of Age – Evaluation Process for Authorisation Extension of Moderna's Spikevax has Started
04.10.2021 Evaluation Process for Booster Vaccination with the COVID-19 Vaccine Spikevax has Started
23.07.2021 Committee for Medicinal Products for Human Use at the EMA recommends extending authorisation of Moderna's COVID-19 vaccine Spikevax for those aged 12 and over
19.07.2021 Rote-Hand-Brief: BioNTech und Moderna zu den Impfstoffen Comirnaty und Spikevax (19.07.2021)
15.06.2021 COVID-19 Vaccine from 12 Years of Age - Evaluation Process has started for the Marketing Authorisation Extension of COVID-19 Vaccine Moderna
06.01.2021 European Commission Grants Marketing Authorisation for COVID-19 Vaccine from Moderna for the European Union
06.01.2021 EMA’s Committee for Medicinal Products for Human Use recommends Conditional Marketing Authorisation for Moderna’s COVID-19 Vaccine

Jcovden - COVID-19 Vaccine Janssen

Jcovden (COVID-19 Vaccine Janssen) is a vector vaccine to protect against infections with the SARS-CoV-2 virus. It has been authorised in the EU since 11 March 2021. The authorisation holder is Janssen-Cilag International NV.

Product Informaton

Product Information: Jcovden (COVID-19 Vaccine Janssen)
Jcovden (COVID-19 Vaccine Janssen) European Public Assessment Report
Information sheet and anamnesis and consent sheet for the COVID-19 vaccination

Chronology

Date Title
16.12.2021 Committee for Medicinal Products for Human Use (CHMP) recommends approval of booster vaccination with Janssen's COVID-19 Vaccine
23.11.2021 European Evaluation Procedure for Booster Vaccination with Janssen COVID-19 Vaccine Started
13.10.2021 Rote-Hand-Brief: COVID-19 Vaccine Janssen (13.10.2021)
19.07.2021 Rote-Hand-Brief: COVID-19 Vaccine Janssen (19.07.2021)
26.04.2021 Rote-Hand-Brief: COVID-19 Vaccine Janssen (26.04.2021)
23.04.2021 COVID-19 Vaccine Janssen – Possible Relation to very rare Cases of unusual Blood Clots in Combination with a reduced Platelet Count
11.03.2021 European Commission Grants Conditional Marketing Authorisation for COVID-19 Vaccine by Janssen-Cilag N.V. for the European Union
11.03.2021 Committee for Medicinal Products for Human Use (CHMP) Recommends Conditional Marketing Authorisation of the COVID-19 Vaccine by Janssen-Cilag International N.V.
22.02.2021 Janssen-Cilag International N.V. applies for a Conditional Marketing Authorisation of its COVID-19 Vaccine
03.12.2020 European Medicines Agency EMA has Launched Third Rolling Review of a COVID-19 Vaccine Candidate for the EU
08.09.2020 Phase II Clinical Trial of a COVID-19 Vaccine Authorised in Germany

Vaxzevria - COVID-19 Vaccine AstraZeneca

Vaxzevria is a vector vaccine to protect against infections with the SARS-CoV-2 virus. It has been authorised in the EU since 29 January 2021. The authorisation holder is AstraZeneca AB, Sweden.

Product Information

Product Information: Vaxzevria (COVID-19 Vaccine AstraZeneca)
EPAR: Vaxzevria (COVID-19 Vaccine AstraZeneca)
Information sheet and anamnesis and consent sheet for the COVID-19 vaccination

Chronology

Date Title
13.10.2021 Rote-Hand-Brief: Vaxzevria / COVID-19 Vaccine AstraZeneca (13.10.2021)
23.06.2021 Rote-Hand-Brief: Vaxzevria / COVID-19 Vaccine AstraZeneca (23.06.2021)
02.06.2021 Rote-Hand-Brief: Vaxzevria / COVID-19 Vaccine AstraZeneca (02.06.2021)
15.04.2021 COVID-19 vaccine Vaxzevria (AstraZeneca) – Review on scientific questions performed at EU level
15.04.2021 COVID-19 Vaccine Vaxzevria (AstraZeneca) - Possible Link with Very Rare Cases of Unusual Blood Clots in Combination with Lowered Platelet Counts
13.04.2021 Rote-Hand-Brief: Vaxzevria / COVID-19 Vaccine AstraZeneca (13.04.2021)
24.03.2021 Rote-Hand-Brief: COVID-19 Vaccine AstraZeneca (24.03.2021)
22.03.2021 Occurrence of Cerebral Venous Thrombosis after Vaccination with COVID-19 Vaccine AstraZeneca
19.03.2021 19 March 2021: Information for Medical Doctors - COVID-19 Vaccine AstraZeneca
08.04.2021 COVID-19 Vaccine AstraZeneca – Safety Assessment Result: The Vaccine is Safe and Effective in the Fight against COVID-19
16.03.2021 The Paul-Ehrlich-Institut informs - Temporary Suspension of Vaccination with COVID-19 Vaccine AstraZeneca
11.03.2021 COVID-19 Vaccine AstraZeneca
18.02.2021 Safety and Efficacy of the COVID-19 Vaccine AstraZeneca
29.01.2021 European Commission grants conditional marketing authorisation for COVID-19 Vaccine Astra Zeneca for the European Union
29.01.2021 Committee for Medicinal Products for Human Use Recommends Conditional Marketing Authorisation for the COVID-19 Vaccine from AstraZeneca
18.01.2021 EMA receives Application for Conditional Marketing Authorisation of COVID-19 Vaccine of AstraZeneca
05.10.2020 European Medicines Agency (EMA) has started First Rolling Review Procedure of a COVID-19 Vaccine for Europe
10.09.2020 Statement: Clinical Trial of AstraZeneca put on hold

Nuvaxovid

Nuvaxovid (NVX-CoV2373) is a protein-based vaccine to protect against infections with the SARS-CoV-2 virus. It has been authorised in the EU since 20 December 2021. The authorisation holder is Novavax CZ a.s..

Product Information

Product Information Nuvaxovid
European Public Assessment Report: Nuvaxovid
Information sheet and anamnesis and consent sheet for the COVID-19 vaccination

Chronology

Date Title
05.07.2022 Suspected Adverse Reactions Reported in the First Three Months since Start of Vaccination with Nuvaxovid
24.06.2022 The EMA Committee for Medicinal Products for Human Use Recommends the Authorisation of Novavax’s COVID-19 Vaccine Nuvaxovid for Adolescents Aged 12 to 17 Years
22.02.2022 Nuvaxovid (Novavax) – Protein-based COVID-19 Vaccine Available on a Limited Basis in Germany
20.12.2021 European Commission Grants Conditional Marketing Authorisation for Novavax's COVID-19 Vaccine Nuvaxovid
17.11.2021 Conditional Marketing Authorisation Application submitted for Novavax's COVID-19 Vaccine Nuvaxovid
29.03.2021 CHMP starts Rolling Review for the first Virus-like Particle Vaccine against COVID-19

COVID-19 Vaccine (inactivated, adjuvanted) Valneva

COVID-19 Vaccine (inactivated, adjuvanted) Valneva is an inactivated and adjuvanted whole virus vaccine to protect against infection with the SARS-CoV-2 virus. It has been authorised in the EU since 24 June 2022. The authorisation holder is Valneva Austria GmbH.

Product Information

Product Information: COVID-19 Vaccine (inactivated, adjuvanted) Valneva
COVID-19 Vaccine (inactivated, adjuvanted) Valneva European Public Assessment Report
Information sheet and anamnesis and consent sheet for the COVID-19 vaccination

Chronology

Date Title
24.06.2022 The Committee for Medicinal Products for Human Use at the EMA Recommends Authorisation of Valneva's Inactivated, Adjuvanted, Whole Virus COVID-19 Vaccine
19.05.2022 Application Submitted for Conditional Marketing Authorisation of the COVID-19 Vaccine VLA2001 from Valneva
02.12.2021 Committee for Medicinal Products for Human Use has Started the Rolling Review Process for a Whole Virus Vaccine Candidate against COVID-19

Updates of the STIKO vaccination recommendations (German Only)

Vaccines in Development or Authorisation

WHO - Draft Landscape of COVID-19 Candidate Vaccines
EMA - COVID-19 Vaccines: under Evaluation
COVID-19 Vaccines – Overview of Vaccine Types Authorised or in the Process of Authorisation in Europe

Content

  1. Role of the Paul-Ehrlich-Institut
  2. COVID-19 Vaccines
  3. Proof of vaccination within the meaning of the Infection Protection Act (IfSG)
  4. FAQ Coronavirus
  5. Biomedicines
  6. Safety of COVID-19 Vaccines
  7. Research Work
  8. SARS-CoV-2 Test Systems