Influenza vaccination at the time of Covid-19: From the Italian case history to the “EU Flu Day”
Mariano Votta*, Maira Cardillo
Active Citizenship Network, c/o Cittadinanzattiva APS, Via Cereate, 6 - 00183 Rome, Italy

*Correspondence to: Mariano Votta, Active Citizenship Network, Cittadinanzattiva APS. Via Cereate, 6 – 00183, Rome, Italy, Email: m.votta@cittadinanzattiva.it.  

Abstract

Seasonal influenza poses a significant but often under-recognized challenge to national health systems across Europe. Despite influenza vaccines being available for decades, influenza still has one of the highest and recurring impacts on incidence and mortality among vaccine-preventable diseases. It is estimated to cause up to 70,000 deaths in the EU each year, particularly among older adults and other at-risk groups [1].
The Covid-19 pandemic during influenza seasons highly threatened healthcare systems, also due to clogged hospitals, shortage of doses, and lack of transparency. In this regard, what about the situation across Europe? How did the Italian Regions equip themselves? To make a point of the situation of how the Italian Regions equipped themselves, a civic survey on the supply of flu vaccine doses across the country, which collected information from ten Italian Regions, was promoted by Cittadinanzattiva. The results emerged from the survey show more than ever the importance of involving EU and national policymakers to address the challenges European and national health authorities face in view of the Covid-19 pandemic’s spill-over effect on routine vaccination. This is the primary goal of the EU Flu Day 2021, celebrated on the 14th of October 2021 with the event titled "One voice to protect populations from flu in the age of COVID-19", with the ambition of being able to establish itself on the European agenda as a fixed appointment.

Introduction

The 2020-2021 flu season saw remarkably low rates of flu circulation due to the lockdown and social distancing measures taken to combat the pandemic. As societies are opening up again with Covid-19 vaccination rollouts, the risk of a severe flu season is high. Therefore, it is even more important that flu vaccination campaigns are strengthened, especially to protect vulnerable populations. 
Influenza will continue to place a considerable burden on health systems in any normal season, but we are also facing new types of challenges. While the risk of complacency is growing due to the low flu circulation, world leading experts are simultaneously warning about severe challenges in our ability to predict the epidemiology of the upcoming flu season. 
For these reasons, it is essential, on the one hand, to plan flu vaccination campaigns 2021-2022 in the best possible way and, on the other hand, to spare no effort to ensure massive adherence to the campaigns.

Methods

Since 2020, even more than the previous years, the importance of flu and anti-pneumococcal vaccination is crucial to cope with the Covid-19 emergency. For this reason, Cittadinanzattiva [2] carried out in September 2020 a civic survey [3] on the supply of vaccines by the Regions through the instrument of generalized civic access called “FOIA-Freedom of Information Act” (known as “Italian FOIA”), that allows individual citizens and civic associations as Cittadinanzattiva to ask the Public Administration for data held by them, as they must be made accessible to all. Administrations have 30 days to respond to requests, which is just one and not four months, as it happened in the case of the Region of Molise, which has been condemned by the Administrative Court for its delay.  
The Regions have been submitted a set of specific questions on the tender for the purchase of vaccines and more general questions on the provisions that they were adopting to anticipate the vaccination campaign compared to previous years, as well as questions on how they were planning to apply the guidelines provided by the Minister of Health on June 4, 2020 [4]. The Regions had the opportunity to respond by October 3, 2020, and the data processing considered the responses received by October 7, 2020. 

Results

Early flu vaccination campaigns, which began between 1 and 15 October, and in some cases extended up to 31 January 2021; percentage increases in the purchase of vaccines up to three figures, but seriously the lack of vaccines in pharmacies: this is – in a nutshell - how the various Regions in Italy have equipped themselves to fight influenza at the time of Covid-19. 
In particular, it must be said that, almost inevitably, the answers provided were uneven, starting from the procedures for the purchase of vaccines, which started late, where dates of the tenders opened between April (Lazio, Puglia, Campania, Emilia) and September (Abruzzo) and closed between May and September 2020.
A discrepancy was also found in the number of doses, where several regions showed significant dose increases, such as Puglia +320%, Lazio +112%, Tuscany +68%, Sicily +65%, while others showed less marked increases, such as Campania and Emilia (+20%).
In addition, with regards to measures aimed at addressing a possible shortage of doses for the people not at risk, there was a commitment by the Regions to ensure a minimum quota of 1.5% of vaccines to be redistributed to pharmacies. However, it is a totally inadequate amount if we think that in Italy, in 2019, were purchased about 900,000 doses of vaccine in pharmacies directly from citizens. During 2020, rightly, the forecast was much higher for the dutiful campaigns that invited everyone to get vaccinated against influenza in this difficult year because of Covid-19 and to avoid complications in order not to clog hospitals. The response of the Regions was to make available in pharmacies 250,000 doses, about a quarter of those of last year. Thus, this was clearly the first weakness. 
A second weakness was linked to the lack of transparency. In fact, only 10 out of 20 Italian Regions (Abruzzo, Campania, Emilia Romagna, Lazio, Marche, Puglia, Sicilia, Toscana, Umbria, Valle d’Aosta) responded to our request of data. This is not acceptable at all, especially in this period, in which maximum transparency is necessary, also to dispel doubts about who has faced the need to get supplies of flu vaccines in time and be able to intervene promptly to support the populations of those Regions where this has not yet happened or has happened only partially.

With respect to measures facilitating access to vaccination, the Italian Regions have made many provisions along 2020, from the involvement of general practitioners and family paediatricians to the choice of auditoriums and arenas to deliver the vaccinations while respecting the distance. In detail: 
•   Sicily extended the opening hours of vaccination centers both in the morning and in the afternoon and on Saturdays at least in the initial phase of the flu vaccination campaign and provided for the execution of vaccination upon discharge from health facilities and the co-administration of anti-pneumococcal and flu, a measure also provided for in Umbria.
•   Campania provided for the establishment of itinerant trucks to support GPs.
•   Lazio provided for the opening of Drive-in, mobile stations, vaccinations in pharmacies, the organization of vaccination days in schools, hospitals, sporting events.
•  Marche provided for the possibility of moving the vaccination centers in the Auditorium to allow the delivery, in compliance with Covid-19, of a large number of vaccines in a few hours/days.
•    Tuscany provided healthcare companies premises free of charge to general medicine.
•    Emilia Romagna provided the possibility to use large facilities such as gyms and sports facilities.
•   Valle D'Aosta, in addition to signing specific agreements with General Practitioners and Paediatricians of free choice aimed at encouraging vaccination through these figures, has also provided for the vaccination poles made available by the local health authority, which were attended by the doctors of the structure of Hygiene and Public Health of the Department of Prevention.
Since April 2020, we have been talking about anticipating the flu vaccination campaign, but, on balance, the Cittadinanzattiva survey shows how the Italian Regions have moved differently; and not for reasons of strategy but only because the procedures for the purchase have started late. All this is also serious because, with Covid-19, we cannot afford a crowding of hospitals due to influenza. In short, Italy could have done better, even though – as it emerges from the Regions that have responded and that have to be thanked for this act of transparency - a significant part of the country can count on a good capacity for planning and organization, even in realities that in the past have not given these demonstrations (Insert Figure 1).

Civic Recommendations and goals achieved in Italy

According to Cittadinanzattiva, data from the survey suggest the following priorities:
1.    Guarantee all categories of citizens "at-risk", over 60 and vulnerable target groups, to have equal access to flu vaccines in every corner of the country. To this end, it is necessary to apply a principle of solidarity between regions, including the sharing of vaccines with regions facing shortages particularly. This is the right time to demonstrate responsibility and solidarity, and to do so, transparency is the precondition.
2.    After ensuring maximum coverage for at-risk groups, it was necessary to make available, including through the channel of pharmacies, vaccines for the entire population, so that even people not at risk can buy them. In this regard, we are glad to note that, as announced in September 2021 [5], pharmacies will also take part in the vaccination campaign. The pharmacists, who have already followed the training course for the anti-Covid vaccine, will also extend their activity against influenza. They will be able to inoculate the vaccine to people aged 18 and over. The service will also concern those who are entitled to the free vaccine: vulnerable target groups and over 60. 
3.    To the Regions, we also ask to move together in the purchase of vaccines, and start the vaccination campaign homogeneously, avoiding differences between citizens and too uneven actions. About it, in July 2021, seven Italian Regions have already decided to use together the new “negotiation tool” made available by the National Public Administration (Consip [6]), which allows Regions to negotiate tenders in a faster and totally electronic way.
4.    Reduction from 65 to 55 years of the free administration of the flu vaccine: for 2021, we have been able to obtain the free administration for the over 60s.

From a national to a European perspective: towards the “EU Flu Day”

With this activity, Cittadinanzattiva confirms its high commitment on the topic [7], not only at the national level but also at the EU level thanks to its branch Active Citizenship Network (ACN) [8]. In this regard, on the occasion of the EU Flu Day 2021, ACN has launched an EU survey [9] focused on this new influenza vaccination campaign and the concomitant deployment of COVID-19 vaccination.
Furthermore, always during 2021, ACN was invited to be part of the Steering Group on Influenza Vaccination with the aim to collaborate for the establishment of the EU Flu Day as a fixed event on the European agenda. About it, on the first annual EU Flu Day promoted by Vaccines Europe [10], which took place in October 2020, a distinguished panel of speakers from across the field reiterated the importance of seasonal influenza vaccination as a public health measure during the Covid-19 pandemic and contributed to the communication campaigns that took place across the EU to help limit any additional burdens on healthcare systems already under extreme pressure. (Insert Figure 2)

Joint Statement on Healthcare Professionals Vaccination 

In 2020, Vaccines Europe drafted a Joint Statement on the “Implementation of an influenza vaccination campaign in 2021-2022” [11], emphasizing the dangerous overlapping between the risk factors and the populations at risk for both Covid-19 and influenza. This combination of the two reinforces the need to remind governments and their populations of the importance of protecting older people and those with underlying conditions through vaccination, not only from Covid-19 but also influenza. The Joint Statement also underlines the need to intervene in order to, through early planning and forecasting for future seasons, as well as dialogue and anticipation of policy changes and agreements with the vaccines manufacturers and the healthcare distributors, ensure a timely vaccine supply. This goal is necessary for such a crucial time to both increase and sustain demand and supply for influenza vaccines in the long-term, not only in the interest of public health and security, but also as a key element in increasing pandemic preparedness. Moreover, along 2021, discussion on Covid-19 booster jabs raised a number of possible issues in the context of parallel rollouts of flu and Covid-19 vaccination campaigns. These ranged from logistics around distribution, administrative burdens on health professionals and systems, as well as the hurdle for citizens to make two vaccination appointments. (Insert Figure 3) 

All these issues encourage EU Member States to demonstrate strong political leadership and to take the necessary policy measures to emphasize the importance of influenza vaccination to the public and healthcare professionals (HCPs) while balancing the considerations of implementing concomitant influenza and COVID-19 vaccination programs. Furthermore, it is fundamental to highlight the need to raise with EU and national policymakers the threat that influenza poses annually as well as in times of Covid-19 and share expertise on how to address it. This has been the main objective of the EU Flu Day 2021, which has been organized by the “Steering Group on Influenza Vaccination” with the support of Vaccines Europe. In particular, the event realized the 14th of October 2021 and titled "One voice to protect populations from flu in the age of COVID-19", focused on the various challenges European and national health authorities are still facing in view of the Covid-19 pandemic’s spill-over effect on routine vaccination and pointed out to the best practices undertook from across Europe to tackle those challenges. In particular, on the occasion of the EU Flu Day 2021, the Steering Group on Influenza Vaccination, of which Active Citizenship is a part of, has realized a Joint Statement on the importance of healthcare professionals’ (HCP) vaccination [12] with the aim to highlight the importance of strengthened efforts at the EU level to ensure healthcare professionals across Europe are protected in the very unpredictable influenza season ahead. Increasing coverage rates among HCPs will benefit not only individuals but also wider society by shielding vulnerable populations and helping to ease pressure on already overstretched healthcare systems. 
The Joint Statement has called on the European Commission to: support information campaigns in local languages to spread awareness about the upcoming influenza season among target groups; encourage the EU Member States and regions to ensure the involvement of HCPs in all stages and levels of vaccination programmes, which will also help create advocates to promote influenza vaccination uptake; facilitate best-practice sharing between national, regional and local authorities; call on the ECDC to develop an influenza vaccination tracker system to monitor vaccination uptake in the eligible population and support national public health measures to reach recommended targets. (Insert Figure 4)

  
Discussion and Conclusion

The crucial importance of influenza vaccination, especially for at-risk populations, the importance of a coordinated approach between EU and the Member States, the role of efficient public communication, the opportunity to facilitate access in local communities as well as the need to ensure adequate training of health workers to tackle vaccine hesitancy and properly communicate the value of influenza vaccination: how central will these issues be in the implementation of the National Recovery Plans across Europe? How much weight will the European Institutions give to prevention? From the importance that will be given to health-related topics in this European political framework, we will understand if "the necessity to create a stronger European Health Union” – as underlined by the European Commission President Ursula von der Leyen in her “State of the Union” statement [13] – is merely a claim or the actual direction taken by the European institutions, and the kaleidoscope with which we’ll evaluate their work.
The ambition is to make the EU Flu Day become part of the official calendar of European Institutions, to achieve its annual celebration across Europe, and over time, its consolidation in the culture of many actors, both institutional and not, engaged in promoting the usefulness of the flu vaccine and more generally the value of vaccination throughout life. On this, the contribution Cittadinanzattiva-Active Citizenship Network’s experience will give will also be very valuable, as it has been able to launch and affirm across Europe since 2002 the European Patients’ Rights Day [14], each year celebrated by PAGs & civic organizations, healthcare professionals, providers, local and national health institutions in hundreds of initiatives, demonstrating how the European Patients’ Rights Day is recognized as a milestone for the ones who advocate for public health as a common good. 

Acknowledgements

The authors would like to thank the colleagues of Cittadinanzattiva, starting with Valeria Fava and Isabella Mori, who contributed to the creation and realization of the civic survey carried out in Italy in the second half of 2020 entitled "Civic survey on the supply of flu vaccine doses". The authors would also like to thank Sibilia Quilici, Executive Director at Vaccines Europe, and its members, for recognizing the organized civil society as a stakeholder and an ally for a more effective policy and advocacy activity at the EU level in the field of immunization policies.