The Romanian government has published a series of questions and answers that are offered in an attempt to help Romanians to clarify about this procedure, but also about the benefits that the vaccine brings, separate from the obvious one regarding protection against infection.
Why should I get vaccinated against COVID-19?
Vaccination against COVID-19 is important because it reduces the risk of getting sick and the risk of developing a severe form of the disease. Vaccination is an important tool to stop the spread of the pandemic, reduce the overload of health facilities, thus allowing the reopening of health facilities for non-COVID patients. Thus, the conditions will be created for the reopening of socio-economic activities and the facilitation of free movement.
How is personal data protected regarding the vaccination against COVID-19?
The monitoring of the level of vaccination coverage, the safety and effectiveness of vaccines against COVID-19 is carried out with the help of electronic platforms, respecting the legislation on the protection of personal data. According to the strategy regarding vaccination against COVID-19 in Romania, a module dedicated to vaccination against COVID-19 will be developed within the National Electronic Register of Vaccination (RENV), which will constitute the electronic database related to vaccination, in compliance with the legal provisions on data protection personal.
What document will be issued at the time of vaccination?
Each person who will be vaccinated will receive a proof of vaccination certificate which will include the following information: name and surname of the vaccinated person, date of birth, age, county of residence, CI number and series, data about the vaccine: dose 1 (type of vaccine, product , series/batch, expiry date), dose 2 (type of vaccine, product, series/batch, expiry date), data about the vaccination center (vaccination center name, county, coordinating doctor/vaccinator), electronic signature of the National Electronic Register of Vaccinations.
The proof of vaccination is made available to the vaccinated person either electronically or on paper to allow him to keep track of himself between the two visits to the vaccination center (initial dose and booster) and to provide him with essential information about the characteristics of the vaccine administered . We specify that the vaccination is free, voluntary/non-mandatory, and the proof certificate is not issued with the aim of conditioning or restricting the rights of the vaccinated persons.
If I have been infected with SARS-CoV-2, is vaccination still necessary?
In clinical trials, the vaccine was also administered to people who had a detectable level of antibodies against SARS-CoV-2 and no adverse effects were detected, only an increase in the level of immune response. Vaccination is available, based on consent, whether or not there has been infection.
Where can I find out about vaccine candidates?
At the level of the European Union, the vaccines that will be used in the vaccination campaigns against COVID-19 are those that have received approval from the European Medicines Agency. All details regarding the evaluation and approval process are available and constantly updated on the website of the European Medicines Agency.
Who do I contact if I want to get vaccinated?
According to the Strategy for vaccination against COVID-19 in Romania, vaccination will be carried out in stages, respecting the population groups. For stage I, vaccination will be organized at the workplace and through fixed and mobile vaccination centers, and for stages II and III vaccination will be organized through fixed and mobile vaccination centers, mobile teams, the family medicine network, drive centers - through.
Can I refuse to be vaccinated?
Yes, according to the strategy for vaccination against COVID-19 in Romania, vaccination is voluntary and non-mandatory.
Is vaccination free?
Yes, according to the strategy for vaccination against COVID-19 in Romania, vaccination is free.
If I am vaccinated, do I still need to comply with the other hygiene measures?
The administration of a vaccine against COVID-19 is one of the critical tools for limiting the effects of the pandemic, along with the other tools: compliance with restrictions and hygiene measures (wearing a mask, washing hands and physical distancing).
Are people with pre-existing medical conditions eligible for vaccination?
According to the national vaccination strategy against COVID-19, people with chronic diseases, regardless of age, are prioritized for vaccination, taking into account the indications and contraindications of the vaccines used.
Can a person who has been infected with SARS-CoV-2 get vaccinated?
Yes, a person who has been infected with SARS-CoV-2 can be vaccinated voluntarily, when they meet the criteria related to prioritization. Exclusion from vaccination of persons with known previous infection, nor testing of persons prior to vaccination, is not contemplated.
At the moment it is not known how long after infection we are protected, nor the level of antibodies needed to be protected. Recent studies show that in most people, neutralizing antibodies (those that can block infection of cells) persist for at least several months after the initial infection. Also, studies show that the immune response following natural infection can vary greatly depending on the individual and the severity of the disease.
Regulatory authorities do not recommend excluding participants from Phase 3 clinical trials based on evidence of a previous infection, so most manufacturers have already vaccinated people who have had the disease without severe adverse reactions being reported.
What are drive-through vaccination centers?
Drive-through vaccination centers are fixed vaccination centers specially set up for stage III of the vaccination process that is addressed to the general population. According to the recommendations of the World Health Organization, the organization and arrangement of these centers will be done in large urban agglomerations, in areas that allow access to people with their own vehicles. The organization and setting up of drive-through vaccination centers will be done in compliance with all safety and sanitary rules, in order to facilitate people's access to vaccination, to make the vaccination process more efficient, to avoid overcrowding or sacrificing vaccine doses. The organization of such drive-through centers is proposed by the strategy of the World Health Organization.
What are mobile vaccination centers?
Mobile vaccination centers are mobile vaccination centers/caravans organized at different stages of the vaccination process. The organization and arrangement of these mobile vaccination centers will be done, when necessary, to facilitate access to vaccination for people who serve essential activities, for people in residential and medico-social centers and, as the case may be, for people from among the population general conditions for which access to vaccination is limited. The organization and setting up of mobile vaccination centers will be done in compliance with all safety and sanitary rules, in order to facilitate people's access to vaccination, to make the vaccination process more efficient, to avoid overcrowding or sacrificing vaccine doses.
What is a Conditional Marketing Authorization (CMA)?
Within the European Union, a conditional marketing authorization allows the authorization of medicines that address an unmet need, based on less complete data than those normally required. This happens in public health emergencies like the Covid-19 pandemic only if the benefits far outweigh the possible risks created by not having all the data yet. Conditional authorizations are used in the case of the Covid-19 pandemic to respond to a public health emergency. Even so, the data provided must clearly indicate that the benefits of the drug or vaccine outweigh the possible risks. The requirement that the benefits be much greater in relation to the possible risks is all the more explicit in the case of vaccines that will be administered to healthy people. Once such a conditional authorization has been issued, companies must provide more data, from ongoing or new studies, at pre-set deadlines to further demonstrate that the benefits outweigh the risks.
What happens after a company applies for marketing authorization for a vaccine?
If the European Medicines Agency concludes that the benefits of the vaccine outweigh the risks, it will recommend to the European Commission that it be granted conditional marketing authorization. The Commission will then speed up the decision-making procedures and, within days, the authorization could be adopted at the level of EU Member States and EEA States.
As with other medicines, EU regulatory authorities will continue to gather and assess new information after it has been placed on the market and take action if and when needed. In line with the European plan for monitoring the safety of vaccines against COVID-19, monitoring will be more frequent and will include specific activities for these vaccines. For example, in addition to the periodic updates required by law, companies will provide monthly reports that monitor safety and conduct studies to monitor the safety and effectiveness of COVID-10 vaccines, even after they are licensed. These measures will allow regulatory authorities to evaluate data coming from different sources and take the necessary measures to protect public health, if necessary.
How do vaccines for which marketing authorization applications have been submitted work? (BNT162b2 and RNA1273)
Vaccines will prepare the human body to defend itself against COVID-19. To enter the body and cause disease, the SARS-CoV-2 virus uses a protein on its coat, a protein called protein S (spike). Vaccines contain the genetic instructions (messenger RNA) needed to generate protein S. When a person is vaccinated, their cells will "read" the genetic instructions in the messenger RNA and synthesize protein S. The person's immune system will recognize this protein as foreign and will trigger immune defense mechanisms, producing antibodies and specific T cells. If the vaccinated person later comes into contact with the SARS-CoV-2 virus, his immune system will recognize the virus and, by means of antibodies and specific T cells, will neutralize the virus, thus preventing it from entering the body's healthy cells and destroying any infected cells. Thus, protection against COVID-19 will be ensured.
