Periodic Reporting for period 3 - I-MOVE-plus (I-MOVE+ Integrated Monitoring of Vaccines Effects in Europe: a platform to measure and compare effectiveness and impact of influenza and pneumococcal vaccines and vaccination strategies in the elderly)
Okres sprawozdawczy: 2017-11-01 do 2018-10-31
The I-MOVE+ (Integrated Monitoring of Vaccines in Europe) is a consortium of 29 European Union/European Economic Area (EU/EEA) partners (regional and national public health Institutes, SME, Universities). Its goal is to develop a sustainable platform of primary care, hospital and laboratory networks in the EU/EEA that can share and use validated standardised methods to serve the post marketing evaluation of existing and new vaccines programmes independently from commercial interests.
I-MOVE+ is based on a multi-country multidisciplinary network of clinicians, epidemiologists, laboratory specialists, statisticians, modellers and economists from a network of 16 EU/EEA Member States.
We measured at primary care and hospital level, early and late in the season, the direct effect (effectiveness) and indirect effect of various types of influenza vaccines against laboratory confirmed (PCR positive) outcomes
We measured the effectiveness of available vaccines and the impact of pneumococcal vaccination programmes against laboratory confirmed (serotype specific) cases of invasive pneumococcal disease (IPD) and a core set of clinically defined outcomes (pneumonia). We provided evidence on the occurrence and magnitude of serotype replacement following introduction of conjugate vaccination.
The cost-effectiveness of various vaccination strategies were measured.
I-MOVE+ is based on a multi-country multidisciplinary network of clinicians, epidemiologists, laboratory specialists, statisticians, modellers and economists from a network of 16 EU/EEA Member States.
We measured at primary care and hospital level, early and late in the season, the direct effect (effectiveness) and indirect effect of various types of influenza vaccines against laboratory confirmed (PCR positive) outcomes
We measured the effectiveness of available vaccines and the impact of pneumococcal vaccination programmes against laboratory confirmed (serotype specific) cases of invasive pneumococcal disease (IPD) and a core set of clinically defined outcomes (pneumonia). We provided evidence on the occurrence and magnitude of serotype replacement following introduction of conjugate vaccination.
The cost-effectiveness of various vaccination strategies were measured.
WP1:
- Meetings: Steering-Scientific Committee and Executive board, 8 technical and 3 annual meetings
- Two Grant agreement amendments
WP2:
- Protocols to measure influenza vaccine effectiveness (VE) (hospital and primary care level) and impact of vaccination programmmes
. Test-negative studies at primary care (11 studies) and hospital level (23 hospitals).
. Impact studies measuring the effect of vaccination programmes
- Training material on analysis of influenza VE test-negative design studies (using R:).
The results from the hospital and primary care networks suggest moderate to low influenza VE amongt those aged 65 years and over, At primary care level, VE ranged from 13% to 66% against A(H1N1)pdm09, from - 9% to 15% against A(H3N2) and from 9% to 27% against influenza B. VE against hospitalised influenza was 39% (95% CI: 17 to 56) against A(H1N1)pdm09 in 2015/16, 17% (95% CI: 1 to 31) against A(H3N2) in 2016/17, and, in 2017/18, was 24% (95%CI: 3 to 41) against A(H3N2) and 31% (95%CI: 17 to 42) against influenza B.
The low vaccination coverage in this age group resulted in imprecise estimates.
The impact studies underlined that, even with a sub-optimal vaccine effectiveness, influenza vaccination prevent cases in primary and secondary care and deaths amongst those aged 65 years and over.
The effect of previous vaccinations and natural immunity should be further studied in long term and larger studies to guide vaccination strategies in this population.
WP3:
- Generic protocols for effectiveness and impact of studies of pneumococcal vaccines
- Five sites have conducted feasibility studies on pneumonia using hospital discharge database
- Survey on data available for analyses relating to the role of influenza vaccination on IPD; feasibility studies conducted by six sites
We used a before/after study to measure the impact of childhood vaccination on the incidence of IPD, pneumococcal pneumonia and all-cause pneumonia in 65+ years age group.
Compared with 2009 (n=13 sites), the all-type IPD incidence decreased by 8% (95%CI: -5-9) in 2015, by 7% (-6-9) in 2016 and by 3% (-12-5) in 2017.
Compared to the expected incidence based on pre-vaccination trends (n=4 sites), the incidence of pneumococcal pneumonia decreased after PCV10/13 introduction (35% (95%CI: 14-51) in age group 65-69 years, 23% (-18-49) in age group 65+ in 2016). The incidence of all-cause pneumonia did not change.
PPV23 effectiveness (n=6 sites) was 29% (17-39), overall and ranging 19-48% by high-risk condition type. PPV23 effectiveness was higher when associated with PCV13 vaccination. The results suggest that PPV23 vaccination protects around a third of elderly vaccinated individuals.
WP4 (electronic registries) :
- Generic protocols to measure influenza VE (hospitalm primary care level) using electronic registries
- influenza VE studies using test-negative and screening methods at primary care level and test-negative, cohort and screening methods at secondary care level.
- The impact of the three previous year’s vaccination history on current year’s vaccine effectivenessestimated.
The work conducted within WP4 suggest:
1. Using the same database, Influenza VEs was consistently higher in the test-negative design than in the cohort design.
2. Similar VE estimates and confidence intervals were obtained when using a traditional covariate adjusted model and a propensity score adjusted model.
3. In general, when estimating the effect of previous influenza vaccines no common pattern could be observed within a season between care setting (primary and second care) from the same study site or between study designs (TND and cohort) from the same study site.
4. Taking into account either 3 or 5 previous seasons to define a study subjects vaccination history yield similar VE estimates both in the cohort and test-negative design
WP5
. Cross-country comparison of pneumococcal disease burden, Generic cost-effectiveness model
. Report on the potential indirect effect of childhood influenza vaccination programme on the diseases burden among the elderly
- Cost-effectiveness analysis of vaccination children and/or the elderly against influenza
For pneumococcal infection the results suggest that in a country without existing pneumococcal elderly vaccination programme and with PCV10 in the childhood vaccination programme (when there is no ongoing replacement with vaccine-types not included in PCV13) the best use of public funds may be to focus on changing the childhood programme from PCV10 to PCV13. When there is ongoing replacement (as observed in many countries) this decision becomes less clear. In that case PPV23 might be the preferred option for the elderly, depending on the VE.
The findings for influenza support that the elderly are best protected from influenza by introducing a universal paediatric vaccination programme. Despite the added benefits of switching to an alternative vaccine than the current non-adjuvanted, non-high-dose inactivated trivalent vaccine for the elderly, the adoption of a paediatric vaccination programme is the key to getting the most value-for-money from a seasonal influenza mass vaccination programmes.
- Meetings: Steering-Scientific Committee and Executive board, 8 technical and 3 annual meetings
- Two Grant agreement amendments
WP2:
- Protocols to measure influenza vaccine effectiveness (VE) (hospital and primary care level) and impact of vaccination programmmes
. Test-negative studies at primary care (11 studies) and hospital level (23 hospitals).
. Impact studies measuring the effect of vaccination programmes
- Training material on analysis of influenza VE test-negative design studies (using R:).
The results from the hospital and primary care networks suggest moderate to low influenza VE amongt those aged 65 years and over, At primary care level, VE ranged from 13% to 66% against A(H1N1)pdm09, from - 9% to 15% against A(H3N2) and from 9% to 27% against influenza B. VE against hospitalised influenza was 39% (95% CI: 17 to 56) against A(H1N1)pdm09 in 2015/16, 17% (95% CI: 1 to 31) against A(H3N2) in 2016/17, and, in 2017/18, was 24% (95%CI: 3 to 41) against A(H3N2) and 31% (95%CI: 17 to 42) against influenza B.
The low vaccination coverage in this age group resulted in imprecise estimates.
The impact studies underlined that, even with a sub-optimal vaccine effectiveness, influenza vaccination prevent cases in primary and secondary care and deaths amongst those aged 65 years and over.
The effect of previous vaccinations and natural immunity should be further studied in long term and larger studies to guide vaccination strategies in this population.
WP3:
- Generic protocols for effectiveness and impact of studies of pneumococcal vaccines
- Five sites have conducted feasibility studies on pneumonia using hospital discharge database
- Survey on data available for analyses relating to the role of influenza vaccination on IPD; feasibility studies conducted by six sites
We used a before/after study to measure the impact of childhood vaccination on the incidence of IPD, pneumococcal pneumonia and all-cause pneumonia in 65+ years age group.
Compared with 2009 (n=13 sites), the all-type IPD incidence decreased by 8% (95%CI: -5-9) in 2015, by 7% (-6-9) in 2016 and by 3% (-12-5) in 2017.
Compared to the expected incidence based on pre-vaccination trends (n=4 sites), the incidence of pneumococcal pneumonia decreased after PCV10/13 introduction (35% (95%CI: 14-51) in age group 65-69 years, 23% (-18-49) in age group 65+ in 2016). The incidence of all-cause pneumonia did not change.
PPV23 effectiveness (n=6 sites) was 29% (17-39), overall and ranging 19-48% by high-risk condition type. PPV23 effectiveness was higher when associated with PCV13 vaccination. The results suggest that PPV23 vaccination protects around a third of elderly vaccinated individuals.
WP4 (electronic registries) :
- Generic protocols to measure influenza VE (hospitalm primary care level) using electronic registries
- influenza VE studies using test-negative and screening methods at primary care level and test-negative, cohort and screening methods at secondary care level.
- The impact of the three previous year’s vaccination history on current year’s vaccine effectivenessestimated.
The work conducted within WP4 suggest:
1. Using the same database, Influenza VEs was consistently higher in the test-negative design than in the cohort design.
2. Similar VE estimates and confidence intervals were obtained when using a traditional covariate adjusted model and a propensity score adjusted model.
3. In general, when estimating the effect of previous influenza vaccines no common pattern could be observed within a season between care setting (primary and second care) from the same study site or between study designs (TND and cohort) from the same study site.
4. Taking into account either 3 or 5 previous seasons to define a study subjects vaccination history yield similar VE estimates both in the cohort and test-negative design
WP5
. Cross-country comparison of pneumococcal disease burden, Generic cost-effectiveness model
. Report on the potential indirect effect of childhood influenza vaccination programme on the diseases burden among the elderly
- Cost-effectiveness analysis of vaccination children and/or the elderly against influenza
For pneumococcal infection the results suggest that in a country without existing pneumococcal elderly vaccination programme and with PCV10 in the childhood vaccination programme (when there is no ongoing replacement with vaccine-types not included in PCV13) the best use of public funds may be to focus on changing the childhood programme from PCV10 to PCV13. When there is ongoing replacement (as observed in many countries) this decision becomes less clear. In that case PPV23 might be the preferred option for the elderly, depending on the VE.
The findings for influenza support that the elderly are best protected from influenza by introducing a universal paediatric vaccination programme. Despite the added benefits of switching to an alternative vaccine than the current non-adjuvanted, non-high-dose inactivated trivalent vaccine for the elderly, the adoption of a paediatric vaccination programme is the key to getting the most value-for-money from a seasonal influenza mass vaccination programmes.
I-MOVE+ assembled the largest ever network of study sites in the EU/EEA allowing to strengthen evaluation research in vaccinology between Member States.
I-MOVE+ independent studies on pneumococcal and influenza vaccines provided evidence for decision making on elderly vaccination.
I-MOVE+ underlined the importance of maintaining independent publice funding for evaluating vaccines.
The I-MOVE+ influenza VE results contributed to guidethe WHO vaccine strain selection committee on strains to be included in the influenza vaccines and to increase the number of influenza viruses reported to the European virological surveillance system and WHO Global Flunet.
I-MOVE+ articles and communications provided a better understanding of the impact and effectiveness of influenza and pneumococcal vaccines in the elderly.
I-MOVE+ independent studies on pneumococcal and influenza vaccines provided evidence for decision making on elderly vaccination.
I-MOVE+ underlined the importance of maintaining independent publice funding for evaluating vaccines.
The I-MOVE+ influenza VE results contributed to guidethe WHO vaccine strain selection committee on strains to be included in the influenza vaccines and to increase the number of influenza viruses reported to the European virological surveillance system and WHO Global Flunet.
I-MOVE+ articles and communications provided a better understanding of the impact and effectiveness of influenza and pneumococcal vaccines in the elderly.