Italian Medicines Agency

The vaccination campaign will be carried out at subsequent phases, with citizens being invited to get vaccinated according to an order of priority defined by the risk for people to be infected and develop the disease with serious consequences, the social function of some professional categories (teachers, law enformcement staff); then the elderly (over 65 years) and finally the remaining population.

In the initial phase, priority was given to healthcare professionals as well as staff and guests of retirement homes; in February the second phase has started of the vaccination plan with tiered priorities for people with serious illnesses and for the elderly under 80 years of age. At the same time, the vaccination has begun of social services staff (law enforcement and teachers).

Before vaccination, healthcare professionals will ask the person who is going to receive the vaccine a series of precise and simple questions, using a standardised form. Based on the answers given by the person, healthcare professionals will consider whether vaccination should be carried out or postponed. In addition, healthcare professionals shall verify whether there are contraindications or special precautions need to be taken, as reported in the vaccine data sheet.

The vaccination is free for everyone.

No, currently available vaccines will only be used in the facilities identified by the Vaccination Plan and will not be available in pharmacies or on the private market. People are highly discouraged to try to obtain the vaccine through alternative channels or on the Internet. These channels give no guarantee on the quality of the product, which could be harmful for health as well as ineffective.

As any invasive health procedure, also vaccine injection shows a minimal risk due to handling of sharp objects such as needles: despite numerous national, European and WHO guidelines and regulations, the risk due to needle stick still displays significant numbers in Italy; therefore, it is deemed advisable to recall the Law Decree 19 February 2014 no. 19, providing regulations aimed at preventing these risks and namely Article 286 sexies, which expressly prohibits re-capping of the needle after injection, also providing for immediate disposal of the entire syringe, with the needle, in the special puncture-proof containers.

Through European procedures, the Italian government has booked the purchase of over two hundred million doses of COVID-19 vaccines from six different manufacturers. The person receiving the vaccine cannot freely choose which vaccine to receive: the vaccine available at the relevant time and place will be offered by the vaccination centres with a full guarantee of equivalent safety and efficacy.

According to the priority scheme defined in the Vaccination Plan, all people will be vaccinated who are present on the Italian territory, residents with or without a residence permit pursuant to Article 35 of Consolidated Law on Immigration.

A valid identity document and health card (tessera sanitaria) are required. It may be useful to show any health documentation helping the vaccinating healthcare professional to assess the person’s physical condition.

Based on Article 32 of the Italian Constitution and pursuant to the provisions of Article 35 of the Consolidated Law on Immigration, the required documents comprise any document (including expired ones) stating the identity of the person receiving the vaccine, the health card (tessera sanitaria), the European Health Insurance Card, the STP code (straniero temporaneamente presente – Temporarily present foreign person) and the ENI code (Europeo non iscritto – Non registered European citizen).

Like all adverse reactions to medicinal products, adverse reactions to the vaccine can be reported to general practitioners/family doctors and to local health authorities (ASL), in agreement with the pharmacovigilance system in place. Moreover, anyone can report an adverse reaction to the vaccine by using the forms published on the AIFA website. For further details, please refer to the pharmacovigilance section on COVID-19 vaccines with vaccines reports on the results of pharmacovigilance activities published on a monthly basis.

RNA viruses such as SARS-CoV-2 are subject to frequent mutations, most of which do not significantly alter the structure, components and behaviour of the virus. The variants reported so far in England, Brazil and South Africa are the result of a series of surface protein mutations and assessments of the effects that these may have on the course of the epidemic and on the effectiveness of vaccination are ongoing.

Vaccination against the virus that causes COVID-19 is a right for all, however the risk of contracting the virus and developing the disease in a severe form is not the same for everyone, and, currently, the availability of doses is not the same for all vaccines. Therefore, in order to ensure maximum fairness, it is necessary to follow a strategic plan that takes into account all needs and conditions. The strategic plan for COVID-19 vaccination has been developed by the Ministry of Health, and can be consulted here.

According to the opinion expressed by the Scientific Technical Committee on 4 March 2021, it is advisable to try to obtain as many doses as possible from each vial of vaccine, provided that the correct dose is injected into each subject and that suitable syringes are available.It is agreed that residues from different vials should not be mixed.

People with prior SARS-CoV-2 infection confirmed by molecular or antigenic test, regardless of whether with symptomatic COVID-19 or not, are vaccinated with a single dose after at least 3 months but no later than 6 months after diagnosis of infection. Except for:

• Subjects with immunodeficiency (also those receiving immunosuppressive therapy) who should be vaccinated with two doses within the first 3 months of diagnosis of SARS CoV-2 infection,
• Those who develop SARS CoV-2 infection after the first dose of the vaccine, as they do not have to receive the second dose.

The uselessness of serological or molecular tests before and after vaccination is reiterated.

In the majority of the population, the first dose of the vaccine prompts an initial immune response providing only partial protection. Depending on the type of vaccine, protection starts after about 2-3 weeks from the first dose, thus keeping the risk of COVID-19 still consistent, albeit reduced.

The second dose of vaccine is therefore required to increase the immune response and obtain optimal vaccine protection.

In the case of people with SARS-CoV-2 infection/disease confirmed by a third generation molecular or antigen test after the first dose of the vaccine, the infection itself represents a powerful stimulus for the immune system, which adds to the one provided by the first dose of vaccine.

In light of this and considering that natural infection initiates a specific immune response to the virus, it is not recommended to administer the second vaccination dose to these people. Partial vaccination and subsequent infection do not preclude a possible booster dose of COVID-19 vaccination in the future, if data on duration of immune protection indicate such need.

Since these people are most at risk of developing a serious condition in case of SARS-CoV-2 infection, they will be given priority for receiving the vaccine.

People who suffer or have suffered from respiratory allergy can be vaccinated, remaining under observation, like everyone, for 15 minutes after the injection. Any ongoing antiallergic treatment, including specific immunotherapy, shall not be suspended.

For those suffering from severe persistent bronchial asthma, vaccination is recommended under medical supervision in a protected environment (hospital). In the case of uncontrolled asthma, the administration of the vaccine should be postponed until the clinical situation is again under control.

People with food allergies can be vaccinated by remaining under observation, like everyone, for 15 minutes after the injection. Should you have previously experienced severe allergic reactions (anaphylaxis) to food, you shall remain under medical supervision for 60 minutes. If severe persistent bronchial asthma is associated with food allergy, vaccination should be performed in a protected environment (hospital).

People with drug allergies can be vaccinated remaining under observation, like everyone else, for 15 minutes after the injection. Should you have previously experienced severe allergic reactions (anaphylaxis) to medicines, you shall must remain under medical supervision for at least 60 minutes. If severe persistent bronchial asthma is associated with drug allergy, vaccination should be performed in a protected environment (hospital). People with allergy to polyethylene glycol (PEG), macrogol and polysorbate excipients, should not receive mRNA vaccines.

People having previously experienced contact dermatitis can be vaccinated, remaining under observation, like everyone, for 15 minutes after the injection.

No, people having previously experienced severe, allergic and non-allergic reactions, to the first dose, should not be administered the second dose, but should contact a referral centre with experience on reactions to vaccinations, to receive specialist information.

For vaccination of people with mastocytosis it is recommended, as with routine vaccines, oral anti-histamine coverage from 1 day before to 5 days after vaccination, and to remain under medical supervision for at least 30 minutes after the injection. In case of previous anaphylactic reactions to any substance, the supervision period should be extended to 60 minutes.

People suffering from celiac disease or organ-specific autoimmune diseases can be vaccinated, as these diseases are not a contraindication to vaccination.

People on anticoagulant therapy can be vaccinated without stopping their ongoing treatment. Vaccination shall be carried out before taking the therapy. For intramuscular injection, the use of a fine needle (less than or equal to 23 gauge) is recommended and compression shall be performed on the injection site for 5 minutes. A check of the injection area is recommended after 2-4 hours to detect the possible occurrence of any hematoma.

People with coagulation disorders (e.g., haemophilia, Von Willebrand's disease) should be carefully assessed before administering intramuscular vaccines against the risk of bleeding. Whenever possible, disease control should be optimized prior to vaccination. In patients on replacement therapy, vaccination should be scheduled shortly after therapy administration. For intramuscular injection, the use of a fine needle (25-27 gauge) is recommended and compression shall be performed on the injection site for at least 10 minutes. A check of the injection area is recommended after 2-4 hours to detect the possible occurrence of any hematoma.

People with autoimmune diseases who have no contraindications can receive the vaccine. The data relating to use in immunocompromised people (i.e., whose immune system is weakened) are limited in number. While these people may not respond as well to the vaccine, there are no particular safety concerns. Immunocompromised people can be vaccinated in that they may be at high risk for COVID-19.