National COVID-19 vaccination plan
“Vaccine day”, on 27 December 2020, marked the official start of the COVID-19 vaccination campaign across Europe. In Italy, vaccine distribution started on 31 December 2021.
Vaccination is offered to people based on international and European recommendations and local epidemiology, as well as values and principles of equity, reciprocity, legitimacy, protection, promotion of health and well-being, and considering factors such as risk of disease, types of authorized vaccines and their actual availability, in line with the general strategy developed by the European Commission.
Coordination with the European strategy
In June 2020, the European Commission and the Member States agreed on a centralized approach to ensure appropriate support for the development, production and supply of vaccines. The Commission had exclusive responsibility for negotiating with vaccine companies and acted on behalf of the Member States to secure supply of the vaccine doses needed to protect the entire population of Europe. The Commission has committed to financing part of the expenses and upfront costs incurred by vaccine producers in exchange for the right to purchase a certain number of doses at an agreed price over a specified period of time: a sort of advance payment on the vaccine doses that will actually be purchased by the individual Member States. This will help reduce business risk for the companies and accelerate and increase production.
The strategic plan in Italy
On 12 March 2021, the Ministry of Health issued a Decree adopting the new National strategic plan for the prevention of SARS-CoV-2 infections and the implementation of a national vaccination campaign, developed by the Ministry itself, the Special Commissioner for the COVID-19 health emergency, the Istituto Superiore di Sanità, the National Agency for Regional Healthcare Services (AGENAS) and the Italian Medicines Agency (AIFA).
The plan consists of the document Elements of preparation and implementation of the vaccination strategy (pursuant to the Decree of 2 January 2021) and the Interim recommendations on the target groups of the SARS-CoV-2/COVID-19 vaccination programme (10 March 2021), which redefined the population categories to be vaccinated and the priority groups.
The available scientific studies show that age and pre-existing medical conditions are the main variables associated with mortality from COVID-19. The updated order of priority for vaccination was therefore as follows:
- category 1: very frail people, i.e. people with severe physical, sensory, intellectual or mental disabilities or extremely vulnerable individuals with conditions that can become life-threatening with COVID-19 (for a detailed list, see Table 1 on page 42 of the document)
- category 2: people aged 70 to 79 years, for whom the COVID-19 case fatality rate is 10%
- category 3: people aged 60 to 69 years, for whom the COVID-19 case fatality rate is 3%
- category 4: people under 60 years of age with comorbidities that are not of the same severity as those affecting people in category 1; most of the conditions are the same, but their level of severity is considered to be lower (for a detailed list, see Table 4 on page 44 of the document)
- category 5: other people under 60 years of age.
The following categories were also identified as priority groups, regardless of age and pre-existing medical conditions:
- school and university staff (teaching and non-teaching)
- armed forces, law enforcement agencies and emergency services: Armed Forces, State Police, Financial Police, Coast Guard, Fire Department, Local Police, Civil Protection
- prison services: prison police, prison staff, prisoners
- other residential health and social care facilities (civil, religious, etc.)
In light of the updated recommendations on the Vaxzevria vaccine (previously COVID-19 Vaccine AstraZeneca), included in the Ministry of Health circular of 7 April 2021, and confirming the need to urgently vaccinate the groups most vulnerable to the SARS-CoV-2 virus, the Special Commissioner for the COVID-19 health emergency established (Order of 9 April) the following order of priority for vaccination:
- people over 80 years of age
- very frail people and (where required by the specific guidelines for category 1, included in Tables 1 and 2 of the Interim recommendations) members of their household, caregivers, parents/guardians/foster parents
- people aged 70 to 79 years and, after them, individuals aged 60 to 69 years, using predominantly the Vaxzevria vaccine (previously COVID-19 Vaccine AstraZeneca) as per AIFA recommendations.
At the same time, vaccination should be completed for all social and health care workers on the frontline of the COVID-19 response, and all people working on-site at public or private social and health care facilities.
After that, vaccination will be offered to the remaining priority categories identified by the national plan and the other age groups, in the specified order.
People who have already received one shot will be offered the same vaccine for the second dose.
Areas of activity
Developed in accordance with the National strategic plan of the Ministry of Health, and officially presented on 13 March 2021, the Special Commissioner’s vaccination plan sets out the areas of activity needed to complete the vaccination campaign as quickly as possible. Once the plan is fully implemented, the goal is to administer 500,000 vaccine doses a day across the country, and reach a vaccination rate of at least 80% of the population by September 2021. The 3 areas of activity of the campaign are:
- supply and distribution: about 52 million doses were expected to be delivered by the end of June, and an additional 84 million doses before the autumn
- constant monitoring of needs: a vaccine reserve of about 1.5% of the total doses will be created to quickly meet unforeseen requirements, and the necessary resources will be concentrated on small and cluster areas, if particular needs are identified
- widespread vaccine administration: thanks to specific agreements, the number of vaccinators will be expanded by involving additional general practitioners (up to 44,000), dentists (up to 60,000), doctors in postgraduate training (up to 23,000) and, possibly, also members of the Italian Federation of Sports Medicine, private doctors affiliated with the National Health Service and pharmacists. Recruitment of on-call healthcare staff and, in case of emergency, mobile teams will continue. The vaccination network (currently consisting of 1,700 vaccination sites) will also be expanded to include production sites, large-scale retailers, gyms, schools, and the facilities of the Italian Episcopal Conference and other associations/organizations. In addition, new IT solutions will be implemented to improve the booking and vaccine administration processes.
- COVID-19 vaccines plan - Ministry of Health
- Special Commissioner’s vaccination plan (13 March 2021)
- Decree of 12 March 2021 “Approval of the Vaccine national strategic plan for the prevention of SARS-CoV-2 infections”, consisting of the document “Elements of preparation and implementation of the vaccination strategy” (pursuant to the Decree of 2 January 2021) and the “Interim recommendations on the target groups of the SARS-CoV-2/COVID-19 vaccination programme” (10 March 2021)
- Order n. 6/2021 of the Special Commissioner for the Covid-19 health emergency (9 April 2021)
- ECDC-EMA update on COVID-19 (4 August 2021)
- Updated recommendations on the vaccination of people previously infected with SARS-CoV-2 (Ministry of Health circular, 21 July 2021)
- COVID-19 vaccination report: since 31 December 2020, an interactive dashboard has been collecting real-time data and statistics on vaccine administrations across the country (international data are also available). The dashboard data have been available online in an open format since 5 January 2021: COVID-19 Vaccine Opendata
- ICMRA statement on vaccines and regulatory processes (AIFA, 21 January 2021)
- Procedure for submitting marketing authorization applications for COVID-19 vaccines (State control for each batch) (AIFA, 30 December 2020)
- AIFA sets up a Scientific Committee for the surveillance of COVID-19 vaccines (AIFA, 15 December 2020)
- “Vaccine day” in Italy and Europe on 27 December (Ministry of Health)
- Coronavirus: Commission unveils EU vaccines strategy (European Commission, 17 June 2020)
- Coronavirus vaccines strategy (European Commission)
- Securing future COVID-19 vaccines for Europeans (European Commission fact sheet)
- Key aspects regarding the introduction and prioritisation of COVID-19 vaccination in the EU/EEA and the UK (ECDC, 26 October 2020)
- Overview of COVID-19 vaccination strategies and vaccine deployment plans in the EU/EEA and the UK (ECDC, 2 December 2020)
- Questions and Answers: COVID-19 vaccination in the EU (European Commission)
- Frequently asked questions on COVID-19 vaccination (Ministry of Health)
- Pharmacovigilance of COVID-19 vaccines: questions and answers (AIFA)
- Sars-CoV-2 vaccines: questions and answers (ISS).