The impact of candidate influenza virus and egg-based manufacture on vaccine effectiveness: Literature review and expert consensus

Rajaram, Sankarasubramanian; Wojcik, Radek; Moore, D. J.; Lejarazu, Raúl Ortíz de; Lusignan, Simon de; Montomoli, Emanuele; Rossi, Alessandro; Pérez-Rubio, Alberto; Trilla, Antoni; Baldo, Vincenzo; Jandhyala, Ravi; Kassianos, George

doi:10.1016/j.vaccine.2020.06.021

Cited by 29 publications

(33 citation statements)

References 84 publications

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“…Viral evolution experiments can be conducted in eggs or cell culture ( 25 , 26 ); however, the host innate immune response plays an essential role in constraining virus evolution by decreasing the cells’ ability to support virus replication and by reducing the virus diversity on which selection can operate ( 3 ). For this reason, in a human challenge study in which volunteers were inoculated with viral stocks that had been grown in eggs and cell culture, many of the variants that had emerged through mutation during passage in culture were purged from the viral population during or shortly after inoculation due to host selection pressure ( 27 , 28 ).…”

Section: Discussionmentioning

confidence: 99%

Clinically Relevant Influenza Virus Evolution Reconstituted in a Human Lung Airway-on-a-Chip

Bai

et al. 2021

Microbiol Spectr

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The rapid evolution of viruses, such as influenza viruses and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is challenging the use and development of antivirals and vaccines. Studies of within-host viral evolution can contribute to our understanding of the evolutionary and epidemiological factors that shape viral global evolution as well as development of better antivirals and vaccines.

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Section: Discussionmentioning

confidence: 99%

Clinically Relevant Influenza Virus Evolution Reconstituted in a Human Lung Airway-on-a-Chip

Bai

et al. 2021

Microbiol Spectr

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“…Seasonal vaccination is the most effective strategy for the prevention of influenzaassociated outcomes [3]. Yet, vaccine effectiveness (VE)-the protection conferred by vaccination in real-world settings-for influenza remains suboptimal [7,8]. Observational studies have further demonstrated that influenza vaccine effectiveness (IVE) varies across influenza (sub)types [9] and is lower for influenza A(H3N2) compared to influenza A(H1N1) and influenza B viruses [10].…”

Section: Introductionmentioning

confidence: 99%

“…Despite being a similar phenomenon, egg adaptation changes of influenza virus have been known since the 1940 s [18], only recently gaining substantial from the scientific community. This form of drift caused by selective pressure that arises due to virus propagation in eggs is increasingly recognised as a significant cause of antigenic mismatch of influenza vaccine viruses [7]. Therefore, egg-based platforms, mainly used in the manufacturing of influenza vaccines, may play a significant role in contributing to the antigenic mismatch with circulating flu viruses [7,19].…”

Section: Introductionmentioning

confidence: 99%

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Estimation of Reduction in Influenza Vaccine Effectiveness Due to Egg-Adaptation Changes—Systematic Literature Review and Expert Consensus

Lejarazu¹,

Montomoli

Wojcik³

et al. 2021

Vaccines

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Background: Influenza vaccines are the main tool to prevent morbidity and mortality of the disease; however, egg adaptations associated with the choice of the manufacturing process may reduce their effectiveness. This study aimed to estimate the impact of egg adaptations and antigenic drift on the effectiveness of trivalent (TIV) and quadrivalent (QIV) influenza vaccines. Methods: Nine experts in influenza virology were recruited into a Delphi-style exercise. In the first round, the experts were asked to answer questions on the impact of antigenic drift and egg adaptations on vaccine match (VM) and influenza vaccine effectiveness (IVE). In the second round, the experts were presented with the data from a systematic literature review on the same subject and aggregated experts’ responses to round one questions. The experts were asked to review and confirm or amend their responses before the final summary statistics were calculated. Results: The experts estimated that, across Europe, the egg adaptations reduce, on average, VM to circulating viruses by 7–21% and reduce IVE by 4–16%. According to the experts, antigenic drift results in a similar impact on VM (8–24%) and IVE (5–20%). The highest reduction in IVE was estimated for the influenza virus A(H3N2) subtype for the under 65 age group. When asked about the frequency of the phenomena, the experts indicated that, on average, between the 2014 and 19 seasons, egg adaptation and antigenic drift were significant enough to impact IVE that occurred in two and three out of five seasons, respectively. They also agreed that this pattern is likely to reoccur in future seasons. Conclusions: Expert estimates suggest there is a potential for 9% on average (weighted average of “All strains” over three age groups adjusted by population size) and up to a 16% increase in IVE (against A(H3N2), the <65 age group) if egg adaptations that arise when employing the traditional egg-based manufacturing process are avoided.

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“…The cell culture-based vaccine also presents no risk to individuals who are allergic to eggs [2] . Most importantly, it circumvents concerns around the haemagglutinin mutations that occur during isolation, adaptation and propagation in eggs, which can alter viral antigenicity and are hypothesised to contribute to lower vaccine effectiveness (VE) [ 3 , 4 ].…”

Section: Introductionmentioning

confidence: 99%

Adverse events of interest following influenza vaccination, a comparison of cell culture-based with egg-based alternatives: English sentinel network annual report paper 2019/20

Lusignan

Tsang

Amirthalingam

et al. 2021

The Lancet Regional Health - Europe

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Background The cell-based quadrivalent influenza vaccine (QIVc) is now offered as an alternative to egg-based quadrivalent (QIVe) and adjuvanted trivalent (aTIV) influenza vaccines in the UK. While post-licensure studies show non-inferiority of cell-based vaccines, it is not known how its safety profile compares to other types of vaccines in real-world use. Methods We conducted a retrospective cohort study using computerised medical records from the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) sentinel network database. We used a self-controlled case series design and calculated the relative incidence (RI) of adverse events of interest (AEIs) over different risk periods. We then compared the RIs of AEIs within seven days of vaccination overall and between QIVc and QIVe in the 18–64 years age group, and between QIVc and aTIV in the ≥65 years age group. Findings The majority of AEIs occurred within seven days of vaccination, and a seasonal effect was observed. Using QIVc as the reference group, QIVe showed similar incidence of AEIs whereas live attenuated influenza vaccine (LAIV) and aTIV had lower incidence of AEIs. In the stratified analyses, QIVe and aTIV were associated with a 16% lower incidence of AEIs in the seven days post-vaccination in both the 18–64 years and ≥65 years age groups. Interpretation Routine sentinel network data allow comparisons of safety profiles of equally suitable seasonal influenza vaccines. The higher incidence of AEIs associated with QIVc suggest monitoring of several seasons would allow robust comparisons to be made. Funding Public Health England.

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The impact of candidate influenza virus and egg-based manufacture on vaccine effectiveness: Literature review and expert consensus

Cited by 29 publications

References 84 publications

Clinically Relevant Influenza Virus Evolution Reconstituted in a Human Lung Airway-on-a-Chip

Clinically Relevant Influenza Virus Evolution Reconstituted in a Human Lung Airway-on-a-Chip

Estimation of Reduction in Influenza Vaccine Effectiveness Due to Egg-Adaptation Changes—Systematic Literature Review and Expert Consensus

Adverse events of interest following influenza vaccination, a comparison of cell culture-based with egg-based alternatives: English sentinel network annual report paper 2019/20

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