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Italian Medicines Agency Agenzia Italiana del Farmaco

FAQ - COVID-19 vaccines

FAQ - COVID-19 vaccines

 

9 May 2022

General information on COVID-19 vaccination

As of December 2020, the European Medicines Agency (EMA) has recommended the provisional granting of conditional marketing authorizations for COVID-19 vaccines. AIFA acknowledges the European decisions and therefore authorises the use of such vaccines in Italy.

The SARS-CoV-2 coronavirus, responsible for COVID-19, uses a protein (called 'Spike') which protrudes from its envelope to enter the human cells, where it then reproduces. The vaccines currently available have been developed to induce an immune response capable of blocking the Spike protein, thus preventing the virus from infecting cells. These vaccines introduce into some cells of the human body not the SARS-CoV-2 coronavirus, but the genetic information necessary to produce the Spike protein for a short time. The presence of this foreign protein will stimulate the immune system to react against it by producing antibodies that will prevent the virus from entering and infecting cells through binding to the Spike protein. The presence of the foreign Spike protein will also activate T lymphocytes driving antibody production and killing virus-infected cells. Some of these lymphocytes survive for several months ('memory lymphocytes') and allow the immune system of the immunized person to rapidly activate an extraordinary reaction against a possible SARS-CoV-2 invasion.

The studies that led to the development of COVID-19 vaccines did not skip any of the phases of verification of the efficacy and safety required for the development of a medicine; on the contrary, these studies saw the participation of a very large number of volunteers, about ten times higher than that of similar studies for the development of other vaccines. The rapid development and approval is due to new technologies, to the huge resources made available very quickly and to a new evaluation process by the regulatory agencies, which evaluated the results as they were obtained and not when all the studies were completed - as was previously the case.

At present, the exact duration of the protection offered by the vaccine is unknown. Clinical trials to establish it are still ongoing. Most clinical trials on authorised vaccines require vaccinated people to be monitored for 2 years to gather more information on the duration of protection.

Data from observational studies show a progressive decline in vaccine protection from approximately 5-6 months after completion of the initial vaccination course, so that the booster dose is expected to be administered during this period. To date, even vaccinated people are required to comply with the protective measures provided for.

The aim of the registration studies was to assess the vaccines efficacy in protecting from the COVID-19 disease. Studies are ongoing to determine whether asymptomatically infected vaccinated people can infect others. Since it is possible that, despite protective immunity, in some cases the virus may persist in the nasal mucosa, vaccinated people and those who are in contact with them must continue to take protective measures against COVID-19.

Vaccines protect the vaccinated person, but if many people are vaccinated, they can reduce the circulation of the virus, thus protecting also those who are not vaccinated. Vaccination protects those who are vaccinated, but it also helps protect the community where they live.

SARS-CoV-2 virus is subject to frequent mutations. The vaccine-induced immune response protects against most of these variants although protection might be less effective against some of them.

Vaccination against 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 the availability of doses is currently not the same for all vaccines. Therefore, with an aim to ensure maximum fairness, it is necessary to comply with the Strategic plan for COVID-19 vaccination developed by the Ministry of Health.

Recipients of COVID-19 vaccination

All persons residing or otherwise present on the Italian territory, with or without a residence permit or identity documents, including holders of the STP (Stranieri Temporaneamente Presenti) or ENI (European Non Iscritto) code, holders of the numerical tax code Codice Fiscale or those without one, holders of an expired health card and those who fall into the categories periodically updated by the Vaccination Plan.

In subjects who have had prior (symptomatic or asymptomatic) SARS-CoV-2 infection, the administration of a single dose of SARS-CoV-2/COVID-19 vaccine may be considered, provided that vaccination is carried out preferably within 6 months from the infection and no later than 12 months after its resolution.
Subjects with immunodeficiency conditions (either primary or secondary following pharmacological treatments) who have had a previous SARS-COV-2 infection are recommended to follow the planned vaccination schedule.

In people who have contracted a SARS-CoV-2 infection after being administered the first dose of a vaccine with a two-dose vaccine schedule, the following guidelines apply:

  • in case of confirmed infection (defined by the date of the first positive molecular test) within the fourteenth day from administration of the first dose of vaccine, the completion is recommended of the vaccination schedule with a second dose to be carried out within six months (180 days) from the documented infection (date of the first positive molecular test) (after this period of time, the vaccination schedule can still be completed, as soon as possible, with the second dose only);
  • in case of confirmed infection (defined by the date of the first positive molecular test) after the fourteenth day from the administration of the first dose of vaccine, the vaccination schedule is to be considered completed as the infection itself is equivalent to the administration of the second dose. However, the possible administration of a second dose is not contraindicated.

Before vaccination, healthcare staff ask the vaccinee a series of simple but precise questions, using a standardized form to assess whether the vaccination can be carried out or postponed. In addition, the healthcare professional checks for any contraindications or special precautions.

Adverse reactions to the vaccine can be reported to general practitioners or to any health professional, in agreement with the pharmacovigilance system in place. Moreover, anyone can report an adverse reaction to the vaccine by using any of tools provided on the AIFA website. For further details, please refer to FAQs on Pharmacovigilance on COVID-19 vaccines and monthly reports on adverse reactions. 

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.

NB. A "serious adverse reaction" means that it required hospitalization or prolonged treatment, or that it was a danger to life.

Laboratory studies on animal models using COVID-19 vaccines during pregnancy showed no harmful effects. In addition, several large post-authorisation observational studies showed no significant adverse events in pregnant women or in the newborn. Therefore, COVID-19 vaccines are not contraindicated during pregnancy. Pregnant women, especially in case of other risk factors such as diabetes, cardiovascular diseases and obesity, could be more exposed to risk of developing complications, including serious, in case of SARS-CoV-2 infection.

According to Ministry of Health’s Circular of 24 September 2021, vaccination against SARS-CoV-2/COVID-19 with mRNA vaccines is recommended for pregnant women in the second and third trimesters. For the first trimester, vaccination may be considered after assessing the potential benefits and risks with the reference healthcare professional. 

Through the Italian Obstetric Surveillance System, the Italian National Health Institute (Istituto Superiore di Sanità) has published a document aimed at supporting healthcare professionals and pregnant and breastfeeding women in the decision regarding vaccination  (“Indicazioni ad interim su Vaccinazione contro il COVID-19 in gravidanza e allattamento” - Interim guidance on COVID-19 vaccination during pregnancy and lactation). The updated guidance also takes into account new evidence relating to the increased spread and morbidity associated with the Delta variant, the spread of infection and the lowering of the average age of infected individuals.

As regards breastfeeding, although there are still no specific studies on breastfeeding, and since SARS-CoV-2 antibodies have been found in the milk of vaccinated women, it can be assumed that the infant might acquire additional protection against infection, the level of which is not known at the moment. 
Since the mRNA in Comirnaty and Spikevax is rapidly degraded without entering the cell nucleus and breast milk, as well as the viral vectors contained in Vaxzevria and Jcovden (ex COVID-19 Vaccine Janssen) are not able to replicate, it is biologically and clinically unlikely that there will be any risks for breast-fed infants.

Studies performed on animal models did not reveal any direct or indirect harmful effects on reproductive capacity following vaccination. In addition, preliminary literature data show no adverse effects of COVID-19 vaccination on female fertility.

Therefore, vaccination is also indicated in women of childbearing potential, including in case they are planning to become pregnant. 

Comirnaty (Pfizer/BioNTech) has been initially authorised for people aged 16 years and over, and has been subsequently approved for use in adolescents aged 12-15 years and, starting from 1 December, also in children aged 5-11 years. Spikevax (Moderna) has been initially authorised for people aged 18 years and over, and then has been approved for use also in adolescents aged 12-17 years. 

COVID-19 vaccination for adolescents aged over 12 years

Following an in-depth assessment, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) concluded that data on the use of Comirnaty and Spikevax in adolescents aged 12 to 17 years meet the established efficacy, safety and quality criteria. Therefore, the benefit/risk ratio is considered positive also for this age group (i.e. the benefits associated with vaccination clearly outweigh the potential risks associated with the use of the vaccine).

Those girls and boys who, due to diseases or pre-existing conditions, have an increased risk of progressing to serious COVID-19, will benefit most from the vaccination. In addition, the extension of vaccination to this population could be used to create a potential barrier of protection around those who cannot be vaccinated or may have a suboptimal immune response to the vaccine.

No, the method for administering the vaccines does not differ among age groups. In adolescents aged 12-15 years, each dose of Comirnaty is 0.3 mL and the vaccination course consists of two intramuscular injections administered at least 3 weeks apart and no more than 6 weeks apart. Each dose of Spikevax is 0.5 mL and the vaccination course consists of two intramuscular injections administered at least 4 weeks apart and no more than 6 weeks apart.

Vaccination with Comirnaty and Spikevax is contraindicated in all people with hypersensitivity to the active substance or to any of the excipients contained in the medicinal product. 
The second dose of the vaccine should not be given to those people who have experienced anaphylaxis (serious allergic reaction) at the first dose of Comirnaty or Spikevax.

Vaccination should be postponed in people suffering from acute serious/debilitating febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. 
The vaccine should be given with caution in people suffering from thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration. 
The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised people, including those receiving immunosuppressant therapy. The efficacy of the vaccines may be lower in immunosuppressed individuals.

As with adults, for adolescents aged 12-15 years too it is necessary to wait until 7 days after the second dose of the vaccine.

The safety profile of Comirnaty and Spikevax in adolescents was similar to that seen in young adults. The most frequent adverse reactions in adolescents were injection site pain, tiredness, headache, muscle and joint pain, chills and fever. Adverse reactions are usually mild or moderate in intensity and resolve within a few days after vaccination. 
In adolescents aged 12-17 years no new side effects were observed that had not been reported in older age groups.
The assessment of vaccine safety is carried out according to the usual pharmacovigilance activities.

Some events of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the heart membranes) have been reported after the administration of mRNA vaccines.
Most of these events occurred in the two weeks following vaccination, more often after the second dose and in younger men. Following vaccination, any signs indicative of myocarditis or pericarditis should be monitored, such as shortness of breath, palpitations or chest pain. If these occur, immediate medical attention should be sought.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) continues to monitor events and evaluate new data, including the results of clinical and literature studies, to update the information on the safety and efficacy of vaccines, as necessary.

As for Comirnaty, efficacy was assessed by analysing SARS-CoV-2 neutralising antibody titers one month after administration of the second dose. This showed that the antibody response observed in the 12-15 age group was not inferior to that observed in the 16-25 age group.
Additionally, to assess the efficacy of Comirnaty in adolescents aged 12-15 without evidence of prior infection at baseline, the ability of the vaccine to prevent the first outbreak of COVID-19 from 7 days after the second dose was analysed. There were no cases among participants (n=1,005) who received the vaccine, whereas 16 cases were identified among those who received placebo (n=978).
As for Spikevax, efficacy was assessed by analysing SARS-CoV-2 neutralising antibody titers one month after administration of the second dose. Data showed that the antibody response observed in the 12-17 age group was not inferior to that observed in the 18-25 age group.
Additionally, to assess the efficacy of Spikevax in adolescents aged 12-17 years, a secondary efficacy analysis was performed in 3,181 participants who received 2 doses of either Spikevax (n=2,139) or placebo (n=1,042) and had a negative baseline prior infection. No symptomatic COVID-19 cases were identified in people who received Spikevax, whereas 4 symptomatic cases were identified in those who received placebo.

Conditions for vaccination

NB: For further indications on management of subjects with severe allergies, autoimmune diseases and immunodeficiencies, it is advisable to refer to the recommendations of the periodically updated Learned Societies.

Since these people are most at risk of developing a serious condition in case of SARS-CoV-2 infection, it is important that they should be vaccinated.

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. During specific immunotherapy, the vaccine should be administered with a 48 hours interval.

For those suffering from severe persistent bronchial asthma, well controlled by therapy, vaccination is recommended remaining under supervision for 60 minutes. In the case of uncontrolled asthma, the administration of the vaccine should be postponed until the clinical situation is again under control. If asthma cannot be controlled by therapy, the vaccine shall be administered in a protected environment (hospital), remaining under medical supervision for 60 minutes.

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.

People with drug allergies can be vaccinated remaining under observation, like anyone else, for 15 minutes after the injection. Should you have previously experienced severe allergic reactions (anaphylaxis) to medicines, you shall remain under medical supervision for at least 60 minutes. People with suspected SERIOUS allergy to polyethylene glycol (PEG), macrogol and polysorbate excipients, shall be referred to an allergist before being administered the COVID-19 vaccine.

People having previously experienced contact dermatitis can be vaccinated.

Yes, because all COVID-19 vaccines currently in use do not contain latex. However, it is necessary to inform the vaccination centre that you are allergic to latex so that the vaccination is carried out with latex free material. In case of severe allergic reaction (anaphylaxis) from latex the observation time after vaccination is extended to 60 minutes.

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 60 minutes after the injection. In case of previous anaphylactic reactions to any or unknown substance, the vaccine should be administered in a protected environment (hospital).

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

People with autoimmune diseases who have no contraindications can receive the vaccine. The ongoing therapy can be adjusted to the specialist’s indications. There are few data on use in immunocompromised people (i.e., whose immune system is weakened). Although these people may not respond as well to the vaccine, no particular safety concern is present. Immunocompromised people can be vaccinated since they may be at high risk for COVID-19 infection.

Additional dose for organ transplant recipients and immunocompromised individuals

Solid organ transplant recipients and immunocompromised individuals show a reduced antibody response after a complete primary vaccination course (2 doses of Comirnaty, Spikevax, Vaxzevria and 1 dose of Jcovden, ex COVID-19 Vaccine Janssen). Therefore, they are considered at risk of severe COVID-19. In these people, an additional dose of mRNA vaccine can significantly improve the immune response and thus the protection against COVID-19. 

To complete the primary vaccination course, an additional dose of mRNA COVID-19 vaccine may be considered in adults and adolescents >12 years of age with clinically relevant immunocompromised conditions.
These include individuals who have received a solid organ transplant and those with comparable immunocompromised conditions based on clinical evaluation

In all cases, the additional dose is based on one of the two mRNA vaccines authorised in Italy (Comirnaty and Spikevax). This applies even in case an adenoviral vaccine (Vaxzevria and Jcovden, ex COVID-19 Vaccine Janssen) was used for the first vaccination. In addition, if the same mRNA vaccine used for the first two doses is not available, an additional “heterologous” dose with a different type of mRNA vaccine may be used.

Based on current knowledge, the recommended dosage for the additional dose is equal to the dosage authorised for each single dose of the primary vaccination course (i.e. 30 micrograms for Cominarty and 100 micrograms for Spikevax).

The additional dose may be administered after at least 28 days following the last dose of the primary vaccination course (second dose of Comirnaty, Spikevax, Vaxzevria and single dose of Jcovden (ex COVID-19 Vaccine Janssen).

Preliminary data on the tolerability of a third dose of a mRNA vaccine or of an additional dose after vaccination with Jcovden (ex COVID-19 Vaccine Janssen), from studies carried out on a limited number of subjects, and show a safety profile similar to that observed after the first or the second dose. This applies both in terms of type and frequency of local (injection site pain and redness) and systemic (tiredness, headache, chills, muscle and joint pain, fever) undesirable events.
In addition, pharmacovigilance in the COVID-19 vaccines post-authorisation phase provides for a system for collecting all suspected adverse reactions reports and continuous monitoring of adverse reactions in order to identify possible warning signals and implement appropriate risk minimisation measures.

Booster dose in the general population

In order to maintain an effective immune response after completing the primary vaccination course (two doses of Comirnaty, Spikevax, Vaxzevria and one dose of Jcovden (ex COVID-19 Vaccine Janssen), a booster dose may be administered to:

  • people aged 60 years and older;
  • staff and guests of residential centres for the elderly;
  • healthcare professionals and other professionals in the healthcare sector who carry out their activities in healthcare facilities, socio-healthcare and social welfare facilities, as currently indicated;
  • highly vulnerable people due to underlying/concurrent conditions, aged 18 years and older;

As of 1 December 2021, a booster dose is administered to all people aged 18 years and older. In addition, as of 5 January 2022, a booster dose of Comirnaty (30 micrograms) is recommended also for the 12-17 age group.
For the booster dose, an mRNA vaccine authorised in Italy (Comirnaty or Spikevax) can be used. This applies even in case an adenoviral vaccine (Vaxzevria or Jcovden, ex COVID-19 Vaccine Janssen) was used for the first vaccination course. In addition, if the same mRNA vaccine used for the first two doses is not available, a booster dose with a different mRNA vaccine may be used (“heterologous vaccination”). Compared to the doses used for the primary vaccination course, an equal dose of Comirnaty (30 micrograms) and half a dose of Spikevax (50 micrograms) is expected to be administered based on the studies conducted.
The administration of a booster dose is possible after a minimum interval of at least four months (120 days) after completion of the primary vaccination course, or after administration of the single/last dose or diagnosis of confirmed infection in case of people vaccinated before or after SARS-CoV-2 infection.

Individuals vaccinated abroad with COVID-19 vaccines not authorised by EMA and AIFA

There is currently no information available both on the level of vaccine effectiveness and on the progress of protection over time offered by COVID-19 vaccines currently in use in other countries, but not authorised in Europe. However, in order to ensure greater protection against severe forms of COVID-19, and at the same time reduce the circulation of the virus, such people are advised to have a booster dose administered with a mRNA vaccine from 28 days up to 6 months after completing the primary course. The dosages used will be those for the booster dose (Comirnaty 30 micrograms and Spikevax 50 micrograms).  

After the six-month period of the primary course, as well as if the primary course is not completed, consideration should be given to the possibility of starting a new vaccination course.  

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