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      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 - H2020

      Impact

      Science Impact, Ltd.

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          Abstract

          The I-MOVE+ Consortium includes European Union (EU) Public Health Institutes, SME and Universities. It aims at measuring and comparing the effectiveness (VE) and impact (VI) of influenza and Pneumococcal vaccines and vaccination strategies in the elderly population in Europe. The goal is to develop a sustainable platform of primary care practices, hospitals and laboratory networks that share validated methods to evaluate post marketing vaccine performances. The objectives are to identify, pilot test, and disseminate in EU the best study designs to measure, on a real time basis, VE (direct effect) and the VI of vaccination programmes (indirect and overall effect) against laboratory confirmed cases of influenza (types/subtypes) and pneumococcal disease (serotypes), and clinical outcomes. Cost effectiveness analysis will be conducted. Results will allow to understand factors affecting specific VE, the duration of protection of influenza and pneumococcal vaccines, the interaction between vaccines, the role of repeated vaccinations, the occurrence of serotype replacement (pneumococcus); identify vaccine types and brands with low VE; guide the decision of the WHO committees on vaccine strain selection (influenza); provide robust benefit indicators (VE and VI) and cost benefit and effectiveness results; guide vaccination strategies (schedules, doses, boosters). This EU member state collaboration will respond to questions that require studies based on large sample sizes and sharing of expertise that cannot be achieved by one country alone. It will allow the best methods to be used and results to benefit to all EU countries whatever their current public health achievements. Results will be shared with international partners.

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          Author and article information

          Journal
          Impact
          impact
          Science Impact, Ltd.
          2398-7073
          December 31 2018
          December 31 2018
          : 2018
          : 12
          : 82-86
          Article
          10.21820/23987073.2018.12.82
          © 2018

          This work is licensed under a Creative Commons Attribution 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/

          Earth & Environmental sciences, Medicine, Computer science, Agriculture, Engineering

          Comments

          We are responding to  the recent article authored by Alain Moren and Jim McMenamin that appeared in the January issue of IMPACT about the IMOVE project. We do so in our capacity as members of the Independent Scientific Committee (ISC) that oversees the scientific integrity  of the EU funded project entitled Development of Robust and Innovative Vaccine Effectiveness (DRIVE) for influenza vaccines – part of the EU Innovative Medicines Initiative (IMI). Moren and McMenamin describe the excellent collaborative work done via the IMOVE project in evaluating influenza vaccine effectiveness but in the last paragraph they express strong concerns about other projects designed to evaluate the effectiveness of vaccines in cooperation with manufacturers. This challenges the very basis of the EU funded Innovative Medicines Initiative as described at the attached website https://www.imi.europa.eu/.

          The IMI supports public-private partnerships and a number of these are centred around vaccines with the aim of improving public health through obtaining better understanding of immune responses to vaccines, identification of vaccine candidates and post-marketing evaluation of safety and effectiveness. For IMI post-marketing vaccine evaluations (such as ADVANCE and DRIVE) a critical element of the work is devoted to establishing procedural  rules and memoranda of understanding to ensure such evaluation is not “incentivised to produce results required by regulatory obligation” as claimed by Moren and McMenamin. The negative views they express in their last paragraph where they use terms such as “pointless science” and “wasted effort” are prejudicial to the success of such IMI projects since they may encourage a knee jerk reaction by others to reject the findings as necessarily biased without engaging in the detail of how such projects protect against conflicts and potential biases to ensure the independence and quality of their scientific outputs.

          As members of the DRIVE ISC we oversee the work package that analyses data from public health surveillance networks to derive brand-specific influenza vaccine effectiveness estimates. We have been selected on the basis of our scientific expertise and  do not receive any payment for our work, nor do we represent any institution or organisation. The European Medicines Agency (EMA) recently required influenza vaccine manufacturers to produce post-licensure estimates of their own brand’s effectiveness as a condition for continued licensure and seasonal authorization. To minimize and control conflicts of interest and bias, the EMA recommends that applicants should  liaise with institutions and public health authorities who have   functioning infrastructure to conduct multicentre studies. (Guideline on Influenza Vaccines, in  effect since February 2017). DRIVE was specifically initiated as a result of this call to provide brand-specific effectiveness estimates that are generated by public health networks with processes and reviews which are overseen by the ISC and not influenced by the manufacturers. Indeed, some members of IMOVE are also contributing to DRIVE. The procedures and processes that guarantee and describe this scientific independence are publicly available on the DRIVE website (https://www.drive-eu.org/index.php/governance/).   We do not believe that Moren and McMenamin reviewed these detailed processes to have made what we consider to be spurious claims. 

          Prof Elizabeth Miller, Dr. Mark Miller, Dr. Stefania Salmaso, Prof. Marianne van der Sande

          On behalf of the DRIVE ISC  https://www.drive-eu.org/index.php/governance/independent-scientific-committee/

           

           

          2019-03-10 13:50 UTC
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