Initial COVID-19 vaccination programme arrangements
As soon as the leading manufacturers started to communicate the development of candidate vaccines in 2020, the Italian Ministry of Health initiated discussions with other European partners to proceed with joint negotiations to secure the availability of enough doses to immunize citizens.
On 3 June 2020, Italy joined forces with France, Germany and the Netherlands within the “Inclusive Vaccine Alliance” in negotiations with potential developers and manufacturers of a coronavirus vaccine. The EU Commission and the Member States later signed an agreement under which the negotiations with the manufacturing companies were entrusted exclusively to the Commission, aided by a group of seven negotiators (including one from Italy) representing the Member States, and by a Steering Board that takes the final decisions, made up of representatives from all Member States. The European Union initially secured around 1.3 billion doses from various companies. Such doses will be distributed to the Member States based on the size of their respective populations (that is, 13.46% of the doses purchased on behalf of all EU Member States are destined for Italy).
Given the possible availability of vaccines in the short term, an inter-sectoral working group was set up on 4 November at the Italian Ministry of Health to provide the country with an interim national plan for COVID-19 vaccination, with the aim of defining vaccination strategies, possible organizational models, including staff training, logistics, information system supporting vaccination activities, communication, vaccine vigilance and surveillance, impact models and economic analysis. On 12 November 2020, the Extraordinary Commissioner for the COVID-19 Emergency announced that the first administrations of the COVID-19 vaccine by Pfizer would begin by the end of January 2021 and initially cover 1.7 million Italians. Priority was to be given to healthcare workers, the elderly and the most fragile groups of the population.
On 2 December 2020, the Ministry of Health, the Extraordinary Commissioner for the COVID-19 Emergency, the National Health Institute (ISS), the Italian Medicines’ Agency (AIFA) and the Italian National Agency for Regional Healthcare Services (AGENAS) presented to Parliament the “Strategic Plan for vaccination against SARS-CoV-2/COVID-19”.
The plan is structured around 8 axes:
1) The vaccine will be managed centrally and provided free of charge as a common good and a right that must be guaranteed to everyone, regardless of income or geographical location.
2) Based on EU agreements, Italy will be provided with a total of 224 million doses of vaccines distributed as follows:
- AstraZeneca: 40.16 million doses
- Johnson & Johnson: 26.57 million doses
- Sanofi: 40.38 million doses
- Pfizer/BNT: 65.76 million doses
- CureVac: 29.89 million doses
- Moderna: 21.24 million doses
3) Authorization timings will depend on the scientific community’s safety measures and protocols.
4) Priority will be given to health and social health workers, residents, the elderly and nursing home staff.
5) Logistics, procurement, storage and transport will be of competence of the Extraordinary Commissioner.
6) The governance of the vaccination plan will be continuously coordinated between the Ministry of Health, the Extraordinary Commissioner, the Regions and Autonomous Provinces.
7) The vaccination campaign will be supported by an informative system for integrity, safety and transparency.
8) Pharmacovigilance and immunological surveillance will be set up throughout the vaccination campaign.
In terms of logistics and administration of vaccines, the administration has been planned in phases, structured according to the stratification of the population on the base of age groups and risk exposure:
- Phase I (Pfizer/Moderna): healthcare professionals, people aged above 80, nursing home employees and residents were identified as priority categories and vaccinated in 293 national hospital hubs (or on-site for nursing homes).
- Phase II (Pfizer/Moderna) : vulnerable groups - independent of age, people aged from 70 to 79 and people from 50 to 69 without specific risks;
- Phase III (Astrazeneca): school and university personnel, armed forces, penitentiaries;
- Phase IV (the vaccine will depend on available supply): general population above 16.
Regions have organized already existing large space facilities like community hospitals, public grounds, sport halls, barracks and airport terminals. This phase is coordinated by the Extraordinary Commissioner, the Regions and the Department of Civil Protection, also mobilizing the armed forces and Red Cross volunteers. The Ministry of Defense is converting drive-throughs previously used for swab testing into vaccinations centres. The national goal is to reach an administration capacity of half a million doses per day, starting from April 2021 and to also use local level resources such as GPs, pediatricians and pharmacies. In Rome, for example, the military base “Cecchignola” has been fully operational from 22 February 2021 and available first to vaccinate military personnel and then citizens. It will be able to administer 2,500 doses per day with the support of the Lazio Regional Health Authorities in close collaboration with the Local health Unit Roma 2 and the National Institute for Infectious Diseases “L. Spallanzani”.
Moreover, the Stability Law 2021 enacted at the end of 2020 set aside a budget of EUR 400 million to purchase COVID-19 vaccines and drugs for the treatment of patients with COVID-19, such as monoclonal antibodies (for example bamlanivimab and etesevimab). Coverage is provided with the resources of the Next Generation EU Program.
Following the advice of the National Health Council, on 3 March 2021, the Ministry of Health issued a circular stating that non-immunodeficient individuals who have been already infected by COVID-19 can be given one single dose of the COVID-19 vaccine, provided that the vaccination is conducted between 3 and 6 months from positivity. Furthermore, in accordance with WHO indications, the circular states that conducting serological tests (or other types of tests) to assess the presence of antibodies should not interfere with the decision to be vaccinated.
Measures concerning vaccines that have accessed the Italian Market
On 12 March 2021, the Italian Medicines Agency, AIFA, authorized the use of the vaccine developed by the Janssen (Johnson & Johnson group), for people aged 18 and over.
On 7 April 2021, following European Medicines Agency announcements and the AIFA committee’s evaluations on the Vaxzevria (formerly AstraZeneca) vaccine’s possible link to rare cases of unusual blood clots, the Ministry of Health issued a circular recommending this vaccine for people over 60 (since evidence shows very rare cases of thrombosis in younger people). Individuals who have already received the first dose of the Vaxzevria vaccine can complete their vaccination course with the same vaccine.
Measures concerning healthcare professionals’ role in the vaccination campaign
On 29 March 2021, the Government, the Regions, Federfarma and Assofarm signed a Memorandum of Understanding (MoU) for the administration of vaccines in pharmacies that will follow the priority criteria indicated by the Government. To administer vaccinations, pharmacists must have followed specific training programs organized by the National Health Institute. Structural requirements for premises to ensure patient safety include, for example, adequate ventilation and the ability to physically separate vaccination activities from other pharmacy activities.
Legislation on 1 April 2021 set out a national regulatory framework for the vaccination process, including rules applying to the medical indemnification of health professionals who administer vaccinations. Furthermore, vaccination is compulsory and free for all health professionals who carry out their activities in both public and private health and social health facilities, pharmacies, para-pharmacies and medical offices. Being vaccinated becomes, therefore, an essential requirement for practice, unless the professional has specific certified clinical conditions. All Professional Associations are required to send a list of their members to the Regions, so that local authorities can verify their vaccination status. Suspension of pay and of the authorization to practice will occur for non-vaccinated healthcare professionals, until the obligation is fulfilled. Employers can, however, re-assign employees to other (non-medical) tasks.
Measures concerning the logistics of administering vaccinations in vaccination centres
With the aim of providing a useful organizational model to support regions and municipalities in setting-up and running vaccination centres uniformly throughout the country, on 24 March 2021, the Department of Civil Protection released a set of non-binding guidelines, detailing organizational requirements for the “Extraordinary Local Vaccination Points”. First of all, existing large common areas (gyms or supermarket parking lots, for example) are to be identified and integrated with the health facilities already involved in the vaccination campaign.
With the aim of administering up to 750 vaccinations every 12 hours, vaccination centers must be open 12 hours, every day and should normally be located in areas that are easily accessible by local public transport services – and with access for people with disabilities. It will be necessary to have well-defined paths for acceptance, administration and post-immunization observation with adequate personnel, ensuring timings of 10 minutes from entry to vaccination and 15 minutes for post-vaccination observation. There are three types of vaccination points, according to structural and functional requisites: two of the stationery types differ in size and capacity but both must be open 2 hours a day, 7 days a week. Mobile Vaccination Points must operate 8 hours a day, 7 days a week. They can be structures such as mobile units or tents, which are close to public spaces and have access to toilets.
Since mid-2021, national legislation has regularly released regulatory frameworks to manage the vaccination process, and planned new phases by following stratifications of the population on the base of age groups and risk exposure.
According to the circulars and regulations of the Ministry of Health, adolescents aged 12 years of age and over were included for the primary course, and suitable groups were gradually included for an additional or booster dose (“The third dose”).
From 7 December 2021, additional provisions with specific operational directives extended the primary course with Comirnaty Vaccine to the paediatric population (children from 5 to 12 years of age).
Furthermore, the Circular of the Italian Ministry of Health of 20 February 2022 provided indications on the administration of the fourth dose (or second booster) to people with an impaired immune response. The Ministry of Health subsequently recommended it to elderly over 80 and frail people over 60 with comorbidities. Two days later, the Ministry released a Circular on the use of the Anti-COVID-19 Nuvaxovid vaccine (Novavax).
The Italian Medicines Agency published a Pharmacovigilance Report on anti-COVID-19 vaccines, collecting and analyzing data concerning the suspected adverse reactions that were registered between 27 December 2020 and 26 March 2022 for the five vaccines used in the ongoing vaccination campaign.
Decree Law No. 24 of 24 March 2022 ended the appointment of the “Extraordinary commissioner” and established a Temporary Unit for the completion of the vaccination campaign until 31 December 2022. This decree also updates the provisions relating to mandatory vaccination and relevant categories.
The vaccination campaign has been particularly successful as more than 95% of the total population over the age of 12 has completed the primary course and more than 93% of suitable groups have been given the booster dose.