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After the approval of the European Medicines Agency (Ema) and the Italian (Aifa), the first vaccines against the coronavirus also began on Sunday in Ravenna. To clarify doubts and answer questions, the Istituto Superiore di Sanità (Iss), the Government and the Italian Medicines Agency have drawn up a list of frequently asked questions, that is, the answers to the most frequent questions that citizens ask about the vaccine .
What are the objectives of the vaccination campaign against Covid-19?
The objective of the population vaccination campaign is to achieve herd immunity for Covid as soon as possible. The campaign begins on December 27, with the approval by the EMA of the first vaccine against Covid-19. After an initial phase, which will have to be limited by the number of doses administered, it will develop in continuous growth. Vaccines will be offered to the entire population, according to an order of priority that takes into account the risk of disease, the types of vaccines and their availability.
What is the vaccine and what is it used for?
The Covid-19 mRNA BNT162b2 vaccine (Comirnaty) is a vaccine intended to prevent coronavirus disease 2019 in people over 16 years of age. It contains a molecule called messenger RNA (mRNA) with instructions for making a protein found in SARS-CoV-2, the virus responsible for Covid-19. The vaccine does not contain the virus and cannot cause disease.
How effective is the vaccine?
The results of these studies have shown that two doses of the vaccine administered 21 days apart can prevent 95% of adults 16 years and older from developing Covid-19 disease with substantially homogeneous results for age classes, gender and ethnicity. The 95% reduction refers to the difference between the 162 cases that occurred in the group of more than 18,000 who received the placebo and the only 8 cases that occurred in the more than 18,000 who received the vaccine.
Is protection effective immediately after injection?
No, efficacy was demonstrated one week after the second dose.
Are vaccines safe?
Vaccines are only licensed after careful evaluation of the safety profile based on studies carried out in the research phase. In any case, the security profile will be continuously monitored even after authorization.
Will vaccination be mandatory?
At the moment, the Government does not intend to make vaccination mandatory. During the campaign, the citizen participation rate will be evaluated.
What are the priority categories in the early stages?
– Health and social health workers. “Frontline” healthcare and social health workers, both public and private accredited, are at increased risk of being exposed to Covid-19 infection and of transmitting it to susceptible and vulnerable patients in healthcare and social settings. In addition, it is recognized that vaccination of frontline health and social health workers will help maintain the resilience of the health service;
– Residents and staff of residential care centers for the elderly. A high percentage of nursing homes have been severely affected by Covid-19. Residents of these facilities are at high risk for serious illnesses, due to their advanced age, the presence of multiple comorbidities, and the need for help with eating and other daily activities;
– Elderly people. An age-based vaccination schedule is generally easier to implement and allows for greater vaccination coverage. It is also clear that an age-based program increases coverage even in people with clinical risk factors, since the prevalence of comorbidities increases with age. Therefore, given the high probability of developing a serious disease and the consequent recourse to admission to intensive or sub-intensive care, this population group represents a priority for vaccination.
I fall into the categories to get vaccinated in the first phase, what should I do to access the vaccination?
In the first phase, vaccination will be reserved for health professionals, health and socio-health personnel of hospitals and local services, as well as for guests and staff of residential facilities for the elderly. These categories will be contacted with an active call.
I do not belong to the categories of people who are entitled to receive the vaccine in the first phase, when can I also receive the vaccine?
The vaccination campaign will continue in phases that will depend on the number of vaccines available, the indications of the EMA authorizations for each new vaccine and, in any case, will affect the population classes indicated in the Strategic Plan for Anti-Vaccination. Covid-19. The indications can be updated based on the evolution of the pandemic and the knowledge derived from scientific research and the availability of vaccines. At the moment these are the categories identified:
– health and social health personnel
– guests and staff of residential facilities for the elderly
– people over 80 years old
– people from 60 to 79 years old
– people of all ages who suffer from more than one chronic disease, immunodeficiency and / or previous disability.
Will children be vaccinated?
Comirnaty (Pfizer / Bionthec), the first vaccine approved by Ema, is currently not recommended for children under 16 years of age. The European Agency, as well as other international agencies, await further studies to authorize vaccination in the pediatric population.
Will immunosuppressed people get vaccinated?
Limited data are available in people with immunodeficiency or on immunomodulatory drugs. While these people may not respond as well to the vaccine, there are no particular safety concerns. According to the Strategic Plan, people with immunodeficiency or on treatment with immunomodulatory drugs should be vaccinated in the early stages, as they are more likely to get sick with Covid-19.
Will people who have already received Covid-19 get vaccinated?
Yes, those who have had Covid-19 can get vaccinated.
For the first time, “RNA” vaccines will be used. What does that mean?
Usually the “weakened” virus (or bacteria), or part of it, is injected into the vaccine. The immune system recognizes the “intruder” and produces the antibodies that it will use when it encounters the “real one.” In the case of RNA vaccines, instead, the ‘instruction’ is injected to produce a particular protein, called a ‘spike’ protein, which is what the virus uses to ‘stick’ to cells. The cell then produces itself the “foreign” protein, which once recognized activates the production of antibodies.
Is this technology dangerous? Am I at risk of changes in my DNA?
In addition to not having the ‘instructions’ to modify DNA, messenger RNA never enters the cell nucleus, which is the part that contains the genome, so it cannot alter it in any way. Also, messenger RNA degrades after a few days, once its “job” has been done.
What adverse reactions have been observed?
The most frequently observed adverse reactions (more than 1 in 10 people) in the Covid-19 BNT162b2 mRNA vaccine study (Comirnaty) were generally mild or moderate in severity and resolved within a few days of vaccination. These included pain and swelling at the injection site, fatigue, headache, muscle and joint pain, chills, and fever. Fewer than 1 in 10 people experienced redness and nausea at the injection site. Injection site itching, pain in the extremities, swollen lymph nodes, difficulty falling asleep, and nausea were uncommon, affecting less than 1 in 100 people Weak muscles in one side of the face (acute peripheral facial paralysis) occurs rarely, in less than 1 in 1000 people.
Who controls adverse reactions? Who should they contact? And who evaluates them?
The Italian Medicines Agency, in addition to the pharmacovigilance activities normally carried out for medicines and vaccines (based on spontaneous reports and on the pharmacovigilance networks already present), will promote the launch of some independent post-authorization studies of Covid vaccines -19. The supervision activities will refer both to the collection and evaluation of spontaneous reports of suspected adverse reactions (passive pharmacovigilance) and to proactive actions, through pharmacoepidemiology studies / projects (active pharmacovigilance). Aifa has a Scientific Committee, which, throughout the period of the vaccination campaign, will have the function of supporting the Agency and the scientific managers of the individual studies in the start-up phase of the activities, in the global analysis of the data that will be collected and in the identification of possible interventions. The objective is to have, also through an international collaborative network, the ability to highlight possible signs of risk and, at the same time, to compare the safety profiles of the different vaccines that will be available, to give recommendations.
How is the absence of contraindications detected?
Before vaccination, health personnel ask the person to vaccinate a series of precise and simple questions, using a standardized form. If the healthcare worker detects meaningful answers to the questions, consider whether the vaccination can be given or postponed. In addition, the operator checks the presence of contraindications or special precautions, as also reported in the vaccine data sheet.
A new variant of the Covid-19 virus has been reported: will the vaccine also be effective against this new variant?
RNA viruses like Covid-19 are subject to frequent mutations, most of which do not significantly alter the structure and components of the virus. Many variants of Coronavirus have been reported in 2020, but so far these variants have not altered the natural behavior of the virus. The variant reported in England is the result of a series of protein mutations on the surface of the virus and the effects that these may have on the progress of the epidemic are being evaluated, while a negative effect on vaccination seems unlikely.
What vaccines will arrive in Italy and when?
Times and figures may be subject to variation depending on the authorization and dose allocation processes. Italy, based on the signed agreements, will be able to count on the availability of the following doses:
How many doses do you need to get vaccinated?
For almost all vaccines close to authorization at this time, two doses are scheduled a few weeks apart, depending on the type of vaccine.
How long does the protection last? Can I come back to life before the pandemic once I have the vaccine?
Observations in trials so far have shown that protection lasts for a few months, while it will be necessary to wait for longer observation periods to know whether a vaccination will be sufficient for several years or will need to be repeated. It is not yet clear, but studies are underway on whether the vaccine only protects against disease or also prevents infection. At least initially, even those who are vaccinated must maintain some protective measures.
Is there a provision for an international vaccination certificate?
Certainly, a normal vaccination certificate will be issued. International institutions such as the European Commission and the WHO are evaluating a proposal for an international digital certificate.
