Mandatory vaccines: what they are for and how they are regulated

  • July 21, 2025

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For the past few years much discussion has been going on regarding vaccinations: there are those who strongly support the need to carry them out and those, on the other hand, who even demonize them; often debates on the subject have turned into fierce clashes or political instrumentalization. Even through social networks or through the Internet, all kinds of theories and statements have passed, as well as through ministerial, regional, and municipal circulars. In this chaotic succession of rumors, interviews, communications and stances, we risk losing sight of the foundational aspect: ensuring effective and scientifically valid protection for the individual and the community.

Let us then take stock of today's vaccine situation objectively and with the support of clinical evidence on the subject. One statistically significant and scientifically proven fact, for example, is the following: today serious diseases identified until a few years ago as "rare" or "eradicated" have resumed spreading threateningly in Italy .

The law

The law on compulsory vaccinations (Legislative Decree No. 73 of June 7, 2017, converted by Law No. 119 of July 31, 2017, as amended, www.salute.gov.it/vaccini) has been in effect for some time now. The Ministry of Health, through a circular on the new provisions on vaccinations, explains why it was chosen to introduce mandatory certain specific vaccines: since 2013, there has been a gradual decline in the use of vaccinations, both mandatory and recommended. This has meant that, for some diseases, vaccination coverage has fallen below that 95 percent of the citizenry indicated by the World Health Organization as the minimum threshold for so-called "population immunity. " Only above this threshold, for certain infectious diseases, is it guaranteed that the responsible microorganism actually stops spreading, protecting even those who cannot be subjected to direct prophylaxis or do not respond to vaccination.

Particularly worrisome are the figures for measles and rubella vaccinations, which lost as much as 5 percentage points from 2013 to 2015, from 90.4 percent to 85.3 percent, also undermining our country's international credibility, which threatens to derail WHO's "Global Plan for Elimination," in which we have been engaged since 2003, as the prerequisite for declaring the elimination of an infectious disease from a WHO region is that all member countries be declared "free."

Mandatory vaccinations

There are 10mandatory vaccinations, in the pediatric range from zero to 16 years; the obligation covers both first doses and booster shots and also affects unaccompanied foreign minors.

The 10 mandatory vaccines are as follows:

Dati vaccinazioni

Those born from 2017 onwards will have to take them all, according to the schedule set out in the National Vaccine Prevention Plan 2017-2019. Those born from 2001 to 2016, on the other hand, are exempt from the varicella vaccine, because at the time they should have been vaccinated, the obligation in this regard was not included in the calendar then in force.

For the measles, mumps, rubella, and varicella vaccines, the law stipulates that the obligation provision should be reviewed every three years: in fact, consistent with data on the spread of diseases and vaccination coverage, the obligation could be lifted.

What happens if mandatory vaccines are not taken

If a child or adolescent is not in compliance with the vaccinations required by law, and if his or her parents refuse to bring him or her into compliance even after being summoned by the ASL for the information interview, first there is a fine: from 100 to 500 euros.

In the case of grouped vaccinations, the fine is a single one; for example, parents who should subject their three-month-old baby to the six vaccinations on the calendar (against polio, diphtheria, tetanus, whooping cough, Haemophilus and hepatitis) if they do not comply with the relevant obligation will be fined only one fine, not six; following payment, the obligation towards those vaccinations is considered extinguished. The same family, however, may face a new fine if they fail to subject their child to subsequent vaccinations (measles, mumps, rubella and chickenpox, at 13-15 months).

Regardless of the fine payments, a child who has not undergone the mandatory vaccinations will not be allowed to enter kindergartens and preschools. He or she will be able to access compulsory schooling instead.

Recommended vaccines

The circular also reports that, by law, the following vaccinations must be offered free of charge to parents of newborns:

  • antimeningococcal B;
  • antimeningococcal C (in the first years of life), or tetravalent antimeningococcal ACWY in adolescence;
  • antipneumococcal;
  • antirotavirus;

In addition, there is HPV (papilloma virus) vaccination in adolescence for both males and females.

These vaccines are optional because they prevent diseases that are less common in our country, or not particularly contagious, but are strongly recommended by all Scientific Societies.

Exemptions

Vaccination can be waived in three cases:

If the child has already contracted the disease against which he or she was to be vaccinated; this condition must be certified through a notification from the treating physician, to which a blood test attesting to the presence of protective antibodies must be attached; The test is not free, but charged to the person requesting it; instead, the law provides that it is free for the family to receive the certificate from the treating pediatrician.

If the vaccine against the disease already contracted is contained within multicomponent formulations; the family may request that the child be vaccinated only for the other diseases, with single-component vaccines or combined vaccines, but without the antigen in question.

It should be pointed out, however, that it is not certain that these vaccines will be available. At present, for example, no single-component vaccines against diphtheria, pertussis, measles, rubella, and mumps are licensed in Italy . And even if they were, it is not necessarily always possible to obtain them.

The circular specifies, therefore, that if "special" formulations are not available, prophylaxis should be completed with existing combination vaccines, stressing that there is no contraindication to vaccinating those who have already had the disease. For that matter, combined vaccines should not be of much concern, both because the child's immune system is perfectly capable of receiving several "active ingredients" at the same time, and because such vaccines also contain fewer excipients than the sum of monovalent ones; moreover, as Prof. Pier Luigi Lopalco points out, "they reduce the number of adverse events, such as febrile convulsions or severe allergic events, which is related to the number of administrations."

The other possibility of exemption occurs when the vaccine itself poses a health hazard to the child. In cases where the individual has had a severe allergic reaction to a dose of a vaccine, or to a component of it, further vaccination is absolutely contraindicated. In contrast, the presence of a severe or moderate illness, with or without fever, is not in itself an absolute contraindication: the risk-benefit ratio should be evaluated on a case-by-case basis to decide whether or not to vaccinate.

The following are contraindications (Italian Society of Pediatrics, Italian Federation of Pediatricians, Italian Federation of General Practitioners, Italian Society of Hygiene, Ministry of Health)

True

False
  • current acute illnesses
  • Neuropsychiatric diseases
  • The primary/secondary immune defenses deficits
  • HIV infection
  • Major and product-specific allergies
  • Therapies with immunodepressant drugs
  • Treatments with corticosteroids
  • Minor afflictions, even repeated ones
  • Allergies to individual components
  • Atopic dermatitis with eczematous manifestations or localized skin infections
  • Therapy with both oral and injection antibiotics or cortisone drugs for local use
  • Insulin-dependent diabetes
  • Chronic diseases of the heart, lung, liver, and kidneys
  • Febrile and nonfebrile seizures, both familial and personal
  • Nondevelopmental neurological diseases
  • Prematurity and immaturity
  • Nutritional disorders

What is the vaccine

By definition, a vaccine is a preparation aimed at the production of protective antibodies by the body, conferring specific resistance against a given infectious disease. It consists of the antigen (viruses or bacteria or their parts or products or attenuated or inactivated synthetic substances), the suspending liquid (often sterile distilled water or sterile saline) and preservatives (Aluminum salts, also used as adjuvants). It should be mentioned that mercury-based preservatives have been abandoned since 2002 due to the disappearance of the multi-dose packages for which it was used, as well as the media attention that exploded at that time.

Vaccines are, therefore, pharmaceutical products consisting of very small amounts of killed or attenuated microorganisms (viruses or bacteria) capable of causing an infectious disease. Vaccines are designed so that the microorganisms lose their infectiouscapacity (i.e., to generate disease) but not their immunogenic capacity (i.e., the ability to trigger the immune defense reaction ).

Vaccines use our body's natural defense mechanism to build specific resistance to infection. This immune defense, similar to that which is triggered by disease, protects against attack by microorganisms in the environment and people in our community without developing the symptoms and complications of disease.

By using this strategy, viruses are weakened so that they reproduce with great difficulty within the body. Vaccines against measles, mumps, rubella and chickenpox are made in this way.

Natural viruses cause disease by multiplying thousands of times in the body; attenuated viruses in vaccines, on the other hand, usually replicate no more than 20 times, and for this reason are unable to cause disease.

The advantage of live "attenuated" viruses is that one or two doses of vaccine result in lifelong immunity.

The limitation of these vaccines is that they generally cannot be given to people with immune system defects.

Viruses that are completely inactivated (or killed) by chemical systems, on the other hand, cannot multiply. The advantage of this approach is that the vaccine cannot cause, even in a mild form, the disease it prevents and can also be given to people with compromised immune systems.

The limitation is that multiple doses of vaccine must be given to ensure immunization.

In conclusion.

In view of the objective data reported and what has been highlighted so far, we recommend that every parent should constantly pay the utmost attention to the welfare and health of their children, with special reference to those with fragile conditions or pathological states.

We also recall that, for the good of the individual and the community, it is imperative to adhere to current health regulations, such as those relating to vaccinations: safeguarding health is a right but also a duty of every citizen. It is also most important to seek the advice of experts and to document ourselves in order to properly understand and investigate the psycho-physical state of minors; in this way, in compliance with the common rules, we will be able to consciously make the correct choices for prevention, care and health protection.

SOURCES:

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