AERZTE Steiermark | April 2021

Ærzte Steiermark || 04|2021 31 Impfen weltweit dern ist oft nur ein Produkt zugelassen. Je nach politischer Ausrichtung sind es vor allem Sputnik V, AstraZeneca oder einer der chinesischen Impf- stoffe. Das Zulassungs- Ranking Die meisten Zulassungen weltweit hat der Impfstoff von BioNTech/Pfizer zu verzeich- nen – nämlich 62. Auf 56 Zulassungen kommt Sputnik V des russischen Gamaleya Research Institute. Der As- traZeneca-Impfstoff kommt unter beiden Markennamen (AZD1222 und Covishield) auf 50 Zulassungen. Janssen und Moderna erreichen je- weils 34 Zulassungen. Mit 18 Zulassungen ist das Beijing Institute of Biological Pro- ducts der Zulassungs-Spit- zenreiter unter den chine- sischen Impfstoff-Herstellern, gleichauf mit dem Serum Institute of India, das nicht nur Partner von AstraZe- neca ist, sondern als nach produzierten Impfstoffdosen weltweit größter Impfstoff- Hersteller auch ein eigenes Produkt am Markt hat. Da- nach folgt das ebenfalls in- dische Unternehmen Barath Biotech mit vier Zulassungen, danach kommen weitere chi- nesische, noch ein russischer und weitere Hersteller, die nur in einem Land (natürlich oft dem Standort entspre- chend) zugelassen sind. Die WHO hat über ihr Emer- gency use listing (EUL) bis- lang vier Impfstoffe zugel- assen: die von AstraZeneca, BioNTech/Pfizer, Janssen und Serum Institute of India. Wei- tere vier könnten noch im April folgen. Dazu kommt noch eine ganze Reihe von Hoffnungsträgern. Stand: 30. 3. 2021 Quelle: UNICEF/WHO  Vaccines Guidance Document 23 March 2021 Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process Manufacturer Name of Vaccine NRA of Record Platform EOI accepted Pre-submission meeting held Dossier accepted for review* Status of assessment** Anticipated decision date*** 1. BNT162b2/COMIRNATY Tozinameran (INN) EMA Nucleoside modified mNRA Finalized 31/12/20 2. AZD1222 Core – EMA Non- COVAX Recombinant ChAdOx1 adenoviral vector encoding the Spike protein antigen of the SARS-CoV-2. Accepted core data of AZ – non-Covax Data for Covax expected in March 2021 Non-Covax Core data. Awaited NA April 2021 3. SK BIO AZD1222 MFDS KOREA Recombinant ChAdOx1 adenoviral vector encoding the Spike protein antigen of the SARS-CoV-2. Finalized 15 Feb 2021 4. Serum Institute of India Covishield (ChAdOx1_nCoV- 19) DCGI Recombinant ChAdOx1 adenoviral vector encoding the Spike protein antigen of the SARS-CoV-2. Finalized 15 Feb 2021 5. Ad26.COV2.S EMA Recombinant, replication- incompetent adenovirus type 26 (Ad26) vectored vaccine encoding the (SARS-CoV-2) Spike (S) protein Core data (US +NL sites) Finalized 12 March 2021 6. SARS-CoV-2 Vaccine (Vero Cell), Inactivated (lnCoV) NMPA Inactivated, produced in Vero cells In progress Earliest April 7. SARS-CoV-2 Vaccine (Vero Cell), Inactivated NMPA Inactivated, produced in Vero cells In progress Earliest April 8. mRNA-1273 EMA mNRA-based vaccine encapsulated in lipid nanoparticle (LNP) In progress Use abridged procedure relying on EMA Earliest April 9. Sputnik V Russian NRA Human Adenovirus Vector-based Covid-19 vaccine Additional information submitted Several meetings held. “Rolling” submission of clinical and CMC data has started. Clinical and CMC review ongoing Additional data expected. Will be determined when all data is submitted. 10. Ad5-nCoV NMPA Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Rolling data starting April 2021 11. EMA No pre-submission meeting yet. Submitted EOI on 23 Feb To be planned in April based on company request. Sinopharm / BIBP 1  Vaccines Guidance Document 23 March 2021 Manufacturer Name of Vaccine NRA of Record Platform EOI accepted Pre-submission meeting held Dossier accepted for review* Status of assessment** Anticipated decision date*** 12. Vector State Research Centre of Viralogy and Biotechnology EpiVacCorona Russian NRA Peptide antigen Letter received not EOI. Reply sent on 15/01/2021 13. Zhifei Longcom, China Recombinant Novel Coronavirus Vaccine （ CHO Cell) NMPA Recombinant protein subunit Response to 2 nd EOI sent 29 Jan 2021. Additional information requested. 14. IMBCAMS, China SARS-CoV-2 Vaccine, Inactivated (Vero Cell) NMPA Inactivated Not accepted, still under initial development 15. Inactivated SARS-CoV-2 Vaccine (Vero Cell) NMPA Inactivated, produced in Vero cells 16. Bharat Biotech, India COVAXIN DCGI SARS-CoV-2 Vaccine, Inactivated (Vero Cell) Requested meeting to discuss details of submission/timelines 17. Clover Biopharmaceuticals SCB-2019 EMA Novel recombinant SARS-CoV-2 Spike (S)-Trimer fusion protein In discussion on submission strategy and timelines 1. Beijing Bio-Institute of Biological Products Co-Ltd 2. Wuhan Institute of Biological Products Co Ltd * Dossier Submission dates: more than one date is possible because of the rolling submission approach. Dossier is accepted after screening of received submission. **Status of assessment: 1. Under screening; 2. Under assessment; 3. Waiting responses from the applicant. 4. Risk-benefit decision 5. Final decision made *** Anticipated decision date: this is only an estimate because it depends on when all the data is submitted under rolling submission and when all the responses to the assessors’ questions are submitted. Sinopharm / WIBP 2  Vaccines Guidance Document 23 March 2021 Manufacturer Name of Vaccine NRA of Record Platform EOI accepted Pre-submission meeting held Dossier accepted for review* Status of assessment** Anticipated decision date*** 12. Vector State Research Centre of Viralogy and Biotechnology EpiVacCorona Russian NRA Peptide antigen Letter received not EOI. Reply sent on 15/01/2021 13. Zhifei Longcom, China Recombinant Novel Coronavirus Vaccine （ CHO Cell) NMPA Recombinant protein subunit Response to 2 nd EOI sent 29 Jan 2021. Additional information requested. 14. IMBCAMS, China SARS-CoV-2 Vaccine, Inactivated (Vero Cell) NMPA Inactivated Not accepted, still under initial development 15. Inactivated SARS-CoV-2 Vaccine ( ero Cell) NMPA Inactivated, produced in Vero cells 16. Bharat Biotech, India COVAXIN DCGI SARS-CoV-2 Vaccine, Inactivated (Vero Cell) Requested meeting to discuss details of submission/timelines 17. Clover Biopharmaceuticals SCB-2019 EMA Novel recombi ant SARS-CoV-2 Spike (S)-Trimer fusion protein In discussion on submission strategy and timelines 1. Beijing Bio-Institute of Biological Products Co-Ltd 2. Wuhan Institute of Biological Products Co Ltd * Dossier Submission dates: more than one date is possible because of the rolling submission approach. Dossier is accepted after screening of received submission. **Status of assessment: 1. Under screening; 2. Under assessment; 3. Waiting responses from the applicant. 4. Risk-benefit decision 5. Final decision made *** Anticipated decision date: this is only an estimate because it depends on when all the data is submitted under rolling submission and when all the responses to the assessors’ questions are submitted. Sinopharm / WIBP 2 17 Impfstoffe befinden sich im „Emergency“-Zulassungsverfahren der Weltgesundheitsorganisation WHO. 4 Impfstoffe sind bereits zugelassen, 4 weitere könnten noch im April 2021 zugelassen werden, die anderen sind noch nicht so weit. Das Zulassungs-Procedere der WHO ersetzt andere supranationale Verfahren, wie das der EMA, genausowenig wie nationale Zulassungen. Aber es ist ein Indiz dafür, wie bewegt der globale Impfstoffmarkt ist. Quelle und Grafik: WHO