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Coronavirus and COVID-19

Pagination

COVID-19 Vaccines

COVID-19 vaccines in the EU/EEA (As of 27 June 2025) Source: Paul-Ehrlich-Institut

Overview of authorised Vaccines

Short Overview COVID-19 Vaccine Products

In coordination with the pharmaceutical companies, the Paul-Ehrlich-Institut has prepared a short overview, which presents the most important characteristics of the different centrally procured vaccine products with regard to the presentation of the available multi-dose containers, dosage, and storage in a compact and clear format.

Bimervax

Bimervax (COVID-19 Vaccine HIPRA) is a protein-based vaccine (recombinant, adjuvanted) to protect against COVID-19. It has been authorised in the EU since 30 March 2023. The authorisation holder is HIPRA Human Health, S.L.U., Spain.

Product Information

Product Information: Bimervax
European Public Assessment Report: Bimervax
Information sheet and anamnesis and consent sheet for the COVID-19 vaccination (German only)

Chronology

Date Title
31.03.2023 COVID-19 Vaccine Bimervax Approved for Booster Vaccinations
29.03.2022 Rolling Review for COVID-19 Booster Vaccine HIPRA Has Begun

Comirnaty

Comirnaty is a mRNA vaccine to protect against COVID-19. It has been authorised in the EU since 21 December 2020. The authorisation holder is BioNTech Manufacturing GmbH.

The following type II variations of Comirnaty vaccines adapted to the Omicron virus variant have been approved in the EU:

  • Comirnaty Original/Omicron BA.1
  • Comirnaty Original/Omicron BA.4-5
  • Comirnaty Omicron XBB.1.5
  • Comirnaty JN.1
  • Comirnaty KP.2

Product Information

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

Chronology

Date Title
19.09.2023 COVID-19 mRNA Vaccine Adapted to the Omicron XBB.1.5 Variant Now Available
01.09.2023 Authorisation of Comirnaty COVID-19 Vaccine Adapted to the Omicron XBB.1.5 Variant
30.12.2022 COVID-19 Vaccine Comirnaty: Shelf Life Extended from 12 to 18 Months for Various Vaccine Products (Tris-Sucrose Formulation)
17.11.2022 CHMP Recommends Authorisation of Comirnaty Variant (BioNTech/Pfizer) Adapted to Omicron BA.4/BA.5 As Booster Vaccination for Children Aged 5 to 11 Years
20.10.2022 CHMP Recommends Marketing Authorisation Extension for COVID-19 Vaccines Comirnaty and Spikevax for Children 6 Months and Older
10.10.2022 CHMP Recommends Standard Marketing Authorisation for COVID-19 Vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna)
13.09.2022 CHMP Recommends Additional Authorisation Modification of Comirnaty (BioNTech/Pfizer) As a Bivalent Vaccine Adapted to Omicron BA.4/BA.5 for Booster Vaccinations
09.09.2022 COVID-19 Vaccine Comirnaty 30 Micrograms/Dose Concentrate – Shelf Life Extended to 15 Months
02.09.2022 The European Commission and the Committee for Medicinal Products for Human Use at the EMA Voted Positively for mRNA Booster Vaccinations from BioNTech/Pfizer and Moderna Adapted to the Omicron Virus Variant
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
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

Kostaive

Kostaive is a sa-mRNA vaccine to protect against COVID-19. It has been authorised in the EU since 12 February 2025. The authorisation holder is Arcturus Therapeutics Europe B.V., Netherlands.

Product Information

Product Information: Kostaive
European Public Assessment Report: Kostaive
Information sheet and anamnesis and consent sheet for the COVID-19 vaccination (German only)

Nuvaxovid

Nuvaxovid (NVX-CoV2373) is a protein-based vaccine to protect against COVID-19. It has been authorised in the EU since 20 December 2021. The authorisation holder is Novavax CZ a.s..

The following type II variations of the Nuvaxovid vaccine adapted to the Omicron virus variant have been approved in the EU:

  • Nuvaxovid XBB.1.5
  • Nuvaxovid JN.1

Product Information

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

Chronology

Date Title
01.11.2023 Authorisation Granted for Nuvaxovid XBB.1.5 Vaccine Adapted to Omicron XBB.1.5 Variant
12.07.2023 EU Commission Issues Standard Marketing Authorisation for COVID-19 Vaccine Nuvaxovid
13.09.2022 Committee for Medicinal Products for Human Use CHMP Recommends Marketing Authorisation of the COVID-19 Vaccine Nuvaxovid for Booster Vaccinations
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

Spikevax - COVID-19 Vaccine Moderna

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

The following type II variations of Spikevax vaccines adapted to the Omicron virus variant have been approved in the EU:

  • Spikevax bivalent original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax XBB.1.5
  • Spikevax JN.1

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 (German only)

Chronology

Date Title
19.09.2023 COVID-19 mRNA Vaccine Adapted to the Omicron XBB.1.5 Variant Now Available
15.09.2023 Authorisation Granted for Spikevax Vaccine adapted to Omicron XBB.1.5 Variant
03.05.2023 CHMP Recommends Marketing Authorisation Extension for the COVID-19 Vaccine Product Spikevax Bivalent Original/Omicron BA.4-5 for Use as Booster Vaccination for Children Aged 6 to 11 Years
20.12.2022 EU Marketing Authorisation for Spikevax and Omicron BA.1-Adapted Spikevax Variant as Booster Vaccination for Children Aged 6 to 11 Years
21.10.2022 CHMP Recommends Additional Authorisation Modification of Spikevax (Moderna) as a Bivalent Vaccine Adapted to the Omicron Variants BA.4/BA.5 for Booster Vaccinations
20.10.2022 CHMP Recommends Marketing Authorisation Extension for COVID-19 Vaccines Comirnaty and Spikevax for Children 6 Months and Older
10.10.2022 CHMP Recommends Standard Marketing Authorisation for COVID-19 Vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna)
02.09.2022 The European Commission and the Committee for Medicinal Products for Human Use at the EMA Voted Positively for mRNA Booster Vaccinations from BioNTech/Pfizer and Moderna Adapted to the Omicron Virus Variant
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

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
Authorised COVID-19 Vaccines

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. Safety of COVID-19 Vaccines
  6. Research Work
  7. SARS-CoV-2 Test Systems