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Laryngorhinootologie 2021; 100(08): 603-607
DOI: 10.1055/a-1509-8916
Leitlinien und Empfehlungen

COVID-19-Impfungen: Replizierend oder Nichtreplizierend?

Der Vektor in Sputnik-V
L. Klimek
1   Zentrum für Rhinologie und Allergologie, Wiesbaden
,
A. M. Chaker
2   HNO-Klinik und Zentrum für Allergie und Umwelt, TUM School of Medicine, Klinikum rechts der Isar, Technische Universität München
,
M. Cuevas
3   Klinik für Hals-, Nasen- und Ohrenheilkunde, Kopf- und Halschirurgie, Universität Tübingen
,
S. Becker
4   HNO-Universitätsklinik Tübingen
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Zusammenfassung

Innovative und wirksame Impfstrategien entwickeln sich zum wichtigsten Hebel zur Bekämpfung der durch SARS-COV-2 ausgelösten globalen Pandemie. Innerhalb weniger Monate wurden durch Wissenschaftler weltweit vielversprechende neue Vakzine entwickelt; hierbei nutzen mehrere Impfstoffe das Prinzip adenoviraler Vektoren zum Einbringen der eigentlich immunogenen Moleküle des SARS-Coronavirus zum Auslösen einer Immunantwort. Die vom russischen Gamaleya-Institut entwickelte COVID-19-Vakzine Sputnik V (Gam-COVID-Vac) nutzt die adenoviralen Vektoren 26 und 5, um das vollständige SARS-Spike-Protein zur Impfung einzubringen, wobei die unterschiedlichen adenoviralen Vektoren mögliche neutralisierende Effekte gegen Adenoviren umgehen und dadurch eine ausreichende Immunogenität auch bei der Zweitimpfung (booster) gewährleisten. Die bisher veröffentlichten Studien werden teils kontrovers diskutiert, u. a. wegen kleiner Fallzahlen in Phase II und früher klinischer Endpunkte in der Phase III. Auch die bisher fehlende Verfügbarkeit der vollständigen Studienprotokolle und Datensätze wurde in der wissenschaftlichen Gemeinschaft zur Kenntnis genommen. Vulnerable Patientengruppen könnten durch eine wie in Brasilien beschriebene erhaltene Vermehrungsfähigkeit der Ad5-Adenoviren oder wie in der Slowakei beobachtete fehlende Chargenreproduzierbarkeit gefährdet werden, ein Wirksamkeitsverlust der Impfung bei Gesunden ist möglich. Die finale Bewertung in einem geordneten Zulassungsverfahren (z. B. EMA) bleibt daher abzuwarten.

Abstract

Innovative and effective vaccination strategies are the most important lever to address the global SARS-COV2 pandemic. Within months scientists all over the world have developed promising new vaccines, many of which use adenoviral vectors to incorporate immunogenic molecules of SARS-coronavirus in order to elicit effective immune responses. The Gamaleya institute developed the COVID-19 vaccine named Sputnik (Gam-COVID-Vac) using adenoviral vectors ad 26 and ad5 to incorporate a full SARS-Spike Protein for vaccination. Two differing vectors enable so called prime-boost, thus avoiding neutralizing effects against the vector itself, ensuring proper immunogenicity against the vaccine. Current available published evidence has raised controversy among small sample sizes in phase II and early endpoints in phase III studies with Sputnik and scientific community took notice that full study protocols and clinical data haven’t been made available yet. Patient subgroups and vaccination efficacy in healthy vaccinated may be at risk in case of partial viral replication of Ad5 vectors or when batch to batch reproducibility is not warranted, as concerns from authorities in Brazil and Slovakia have recently been raised. Final approval by governing health authorities (e. g. EMA) should therefore be awaited.

Schlüsselwörter

SARS-CoV-2 - Sputnik V - Vektorimpfstoffe - COVID-19

Key words

SARS-CoV2 - Sputnik V - Vector-Vaccines - COVID-19


Publication History

Article published online:
27 May 2021

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