ATTENTION COVID-19. Global alert for those vaccinated. This will happen to you… See more
GLOBAL ALERT!: MANDATORY CORONAVIRUS VACCINATION APPROVED IN EUROPE
In a decisive turn in the fight against the pandemic, several European countries have approved mandatory COVID-19 vaccination, generating a wave of reactions worldwide. This measure has been driven by the increase in infections in certain regions and the emergence of new variants of the virus.
The decision was made as part of a broader strategy to protect vulnerable populations, prevent the collapse of healthcare systems, and ensure a sustained recovery from the economic and social impacts caused by the pandemic.
Which countries have approved the measure?
Among the countries that have adopted mandatory vaccination are Austria, Greece, Italy, and Germany, although the conditions vary in each case. For example:
Austria was one of the first countries to announce mandatory vaccination for all adults, with financial penalties for those who do not comply.
Greece has made vaccination mandatory for those over 60, applying monthly fines to those who do not get vaccinated.
Italy has required it for certain occupational groups, such as healthcare and education workers.
Germany has debated this measure in depth in its parliament, considering it a progressive approach.
Citizen Reactions
The implementation of this measure has generated both support and opposition. Many citizens consider mandatory vaccination an essential tool to finally emerge from the pandemic. Others, however, argue that it violates individual freedoms and the right to decide about one’s own body.
Demonstrations have been held in various European cities both for and against this policy. Governments, for their part, have called for collective responsibility and dialogue to overcome this critical phase.
The European Union’s Position
The European Commission has left the decision to implement mandatory vaccination up to each member country, but has expressed its support for strategies to increase vaccination coverage. It has also reiterated the importance of maintaining complementary measures such as mask-wearing, social distancing, and regular testing.
Conclusion
The approval of mandatory COVID-19 vaccination in Europe marks a key point in the management of the global health crisis. Although the measure is controversial, it reflects the urgency with which we seek to protect public health and prevent future waves of infection. The debate remains open, and what is clear is that the world remains attentive to every step the European continent takes in this matter.
Frequently Asked Questions about the COVID-19 Vaccine
In order to maintain the gains in controlling and eliminating vaccine-preventable diseases, it is a priority that you visit the nearest vaccination center to start and/or complete your vaccination schedule.
Our National Vaccination Schedule includes vaccines for all life stages, special situations, or for specific groups. They are safe, free, and are administered in health centers without a doctor’s order.
COVID-19 vaccines are part of the vaccination strategy with the primary goal of minimizing hospitalization, complications, and fatal outcomes. They can be co-administered with any other vaccine, and can be administered on the same day or on different days, with no gap between doses.
Production and Development of Candidate Vaccines 1. What COVID-19 vaccine platforms are being used?
A platform is the mechanism through which the body’s immune system is presented with the virus (or the part of it) whose action is intended to be blocked.
The 4 main platforms are:
Inactivated virus vaccines: These use the previously inactivated SARS-CoV-2 virus, so it does not cause disease but does generate an immune response. Protein-based vaccines: These use harmless protein fragments or protein structures that mimic the virus that causes COVID-19, in order to generate an immune response. Viral vector vaccines: These use a genetically modified virus other than SARS-CoV-2 (e.g., adenovirus) that cannot cause disease but can produce SARS-CoV-2 proteins to generate a safe immune response. RNA and DNA vaccines: This is a novel approach that uses genetically modified RNA or DNA to generate a protein that alone triggers an immune response against SARS-CoV-2.
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2. Are vaccines produced under similar platforms used in our National Immunization Schedule or worldwide?
There is extensive experience with live attenuated or inactivated virus platforms, and with those based on proteins or protein subunits. These have been used for years in vaccines included in our National Immunization Schedule, as well as in all countries around the world (e.g., measles, chickenpox, polio, hepatitis A, HPV, among others).
Viral vector platforms are used in vaccines against Ebola, MERS, and gene therapies.
Nucleic acid platforms (mRNA and DNA) are innovative and recently developed, and currently only recently licensed vaccines are available.
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3. What platforms does each of the vaccines used in Argentina use?
The British-made ChAdOx1-S vaccine (Oxford/AstraZeneca) and the homologous Covishield vaccine from the Serum Institute of India use a non-replicating viral vector platform (using chimpanzee adenovirus).
The Russian-made vaccine (Sputnik V from the Gamaleya Institute) uses a non-replicating viral vector (it uses 2 human adenoviruses: 26 and 5).
The Chinese-made Sinopharm vaccine is an inactivated virus platform.
Moderna’s vaccines use a nucleic acid platform: mRNA.
The Convidecia or Ad5-nCoV vaccine is a recombinant vaccine that uses a non-replicating adenovirus type 5 viral vector expressing the SARS-CoV-2 Spike (S) glycoprotein. It is produced by the Beijing Institute of Biotechnology (Beijing, China) and CanSino Biologics Inc.
The Comirnaty vaccine is a vaccine that uses a nucleic acid platform: mRNA, produced by Pfizer-BioNTech.
The Sputnik Light vaccine produced by the Gamaleya Institute uses a non-replicating viral vector platform (human adenovirus 26).
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Regulatory Aspects 4. What are the legal regulations governing COVID-19 vaccination?
The following legal regulations are in place:
Law 27,573 on vaccines intended to generate acquired immunity against COVID-19.
Resolution 2883/2020 of the National Ministry of Health, approving the Strategic Plan for COVID-19 vaccination in the Argentine Republic.
Provincial resolutions for the implementation of actions and use of funds.
Provincial resolutions for the incorporation of temporary vaccinators.
Authorization by ANMAT for emergency use of COVID-19 vaccines.
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5. What are the regulatory and pharmacovigilance aspects of COVID-19 vaccines in Argentina?
The emergency use authorization for COVID-19 vaccines falls within the framework of Law 27,573, and the Ministry of Health of Argentina issues the corresponding resolution establishing their use, following the intervention of the competent agencies. Articles 8 and 9 establish which agencies must participate in the process and how it should be carried out.
In this case, the National Administration of Drugs, Food, and Medical Technology (ANMAT), as the competent agency, requests from purchasers the necessary information to support the scientific evidence necessary to verify its safety and efficacy and evaluates the conditions for the availability of this vaccine within the framework of the strategy established by our country.
Another procedure, for public or private pharmaceutical companies with representation in the country (registrants regulated by ANMAT), is the application for vaccine registration—whether emergency or permanent—under ANMAT Regulation No. 705/05. The aforementioned regulation establishes the requirements that must be met for registration in the Registry of Medicinal Specialties (REM), including information on development, production, and quality control, as well as clinical studies that support the quality, safety, and efficacy required for use in humans.
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6. Which COVID-19 vaccines are currently authorized for use in our country?
On December 22, 2020, ANMAT reported that, through Provision 9210/20, it authorized the registration in the Registry of Medicinal Specialties (REM) of the product “COMIRNATY/BNT162b2,” a SARS-CoV-2 vaccine from PFIZER S.R.L.
On December 23, 2020, through Ministerial Resolution 2020-2784-APN-MS, it authorized on an emergency basis the Gam-COVID-Vac vaccine, known as Sputnik-V, developed by the Gamaleya National Center for Epidemiology and Microbiology of Russia, pursuant to Articles 8 and 9 of Law 27,573 and in accordance with ANMAT recommendations.
On December 30, 2020, through Provision 9271/20, ANMAT authorized the registration in the Registry of Medicinal Specialties (REM) of the COVID-19 Vaccine product.
AstraZeneca and generic name COVID-19 VACCINE ChAdOx1-S recombinant, from AstraZeneca S.A.
On January 19, 2021, ANMAT, after analyzing the new information provided on the Gam-COVID-vac (Sputnik-V) vaccine, established through the expansion report that it meets an acceptable margin of safety, immunogenicity, and efficacy for the age group over 60 years of age. Therefore, it recommended that the Ministry of Health use the Gam-COVID-Vac vaccine in this age group.
On February 21, 2021, the inactivated SARS-CoV-2 vaccine (vero cells), developed by the Beijing Institute of Biological Products laboratory in the People’s Republic of China, was authorized on an emergency basis through Ministerial Resolution 688/2021, following recommendations made by ANMAT.
On June 10, 2021, through Ministerial Resolution No. 1671/2021, the CONVIDECIA vaccine (Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) from Cansino Biologics Inc. (Beijing Institute of Biotechnology) was authorized on an emergency basis.
On July 23, 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended extending the authorization for the Moderna vaccine for the prevention of COVID-19 in adolescents aged 12-17 years.
On October 1, 2021, ANMAT, after analyzing the new information provided on the inactivated SARS-CoV-2 Vaccine (Vero cells) – SINOPHARM, from the Beijing Institute of Biological Products Laboratory, established through the extension report that it is within an acceptable margin of safety and immunogenicity from the 3 years, and therefore recommended that the Ministry of Health of the Nation grant emergency use authorization for the SINOPHARM vaccine in the age group evaluated.
That same day, ANMAT (National Agency for the Prevention and Control of Coronavirus) issued Resolution 7502/2021 to register the COVID-19 Vaccine Ad26.COV2-S (recombinant), trade name COVID-19 Vaccine Janssen, for emergency use.
On December 3, 2021, ANMAT (National Agency for the Prevention and Control of Coronavirus) issued Resolution 3451/2021 to register the Sputnik Light vaccine, produced by the Gamaleya National Research Center for Epidemiology and Microbiology, Ministry of Health of the Russian Federation, for emergency use.
On January 13, 2022, through regulation DI-2022-450-APN-ANMAT#MS, the National Agency for the Prevention and Control of Infections (ANMAT) approved the new formulation of the Pfizer-Biontech COMIRNATY vaccine for use in the 5- to 11-year-old age group. On March 12, 2022, the National Agency for the Prevention and Control of Infections (ANMAT) recommended (according to report IF-2022-22630342-APN-DERM#ANMAT) the incorporation of the Moderna mRNA vaccine against SARS-CoV-2 in the 6- to 11-year-old age group.
On June 17, 2022, the U.S. Food and Drug Administration (FDA) approved the new formulation of the Pfizer-Biontech COMIRNATY vaccine for use in the 5- to 11-year-old age group. (FDA) authorized the emergency use of the Moderna vaccine for the prevention of COVID-19 in children 6 months of age and older. In January 2023, Argentina incorporated the COMIRNATY BIVARIANTE vaccine, Original/Omicron BA.4-5, as a booster dose for people 12 years of age and older.
In February 2023, Argentina will incorporate the SPIKEVAX BIVARIANT Original/Omicron BA.4-5 vaccine as a booster dose for people 6 years of age and older. On July 27, 2023, ANMAT (National Agency for the Prevention and Control of Malaria) (ANMAT), under regulation “DI-2023-5817-APN-ANMAT#MS,” extended the use of the Spikevax® bivalent Original/Omicron BA.4/BA.5 vaccine to people 6 months of age and older for both the initial schedule and booster doses.
On April 8, 2024, ANMAT (National Agency for the Prevention and Control of Malaria) (ANMAT), under regulation “DI-2024-3229-APN-ANMAT#MS,” established the use of the Spikevax® monovariant XBB.1.5 vaccine for people 6 months of age and older for both the initial schedule and booster doses.
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7. What vaccines are currently available in Argentina?
Currently available vaccines are Spikevax® monovariant XBB.1.5 (Moderna) for initial vaccination and boosters starting at 6 months of age, and Comirnaty® bivariate Original/Omicron BA.4/BA.5 (Pfizer-BioNTech), indicated for boosters starting at 12 years of age.
Bivariant COVID-19 vaccines are vaccines that have two mRNA components: one corresponding to the original strain of the virus and the other to the BA.4 and BA.5 lineages of the omicron variant. They are just as safe and effective as monovariant vaccines.
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Guidelines and phasing 8. What is the purpose and objective of COVID-19 vaccination in Argentina?
The purpose of vaccination is to reduce morbidity and mortality caused by COVID-19 in Argentina. Currently, the target population for vaccination includes people 6 months of age and older.
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Technical Guidelines and Vaccination Manual 9. What are the current recommendations for COVID-19 vaccination?
As of May 2023, the current recommendations for administering booster doses stratified by risk will apply:
High risk of severe COVID-19 (people with immunocompromised conditions from 6 months of age, pregnant women, people 50 years of age and older) – booster dose 6 months after the last dose; continue with the same frequency. Intermediate risk of severe COVID-19 or high occupational exposure to SARS-CoV-2 infection (people under 50 years of age with non-immunosuppressive comorbidities (chronic diseases or obesity), healthcare personnel, and strategic personnel) – booster dose 6 months after the last dose; continue with annual doses. Low risk of severe COVID-19 (between 6 months and 49 years of age inclusive without comorbidities) – booster dose 12 months after the last dose; continue with this frequency.
The population considered at highest risk of the disease:
Healthcare personnel. Strategic personnel. People over 50 years of age. Pregnant women in any trimester of pregnancy. People under 50 years of age who have any of the following conditions. Type 1 or 2 diabetes (insulin-dependent and non-insulin-dependent). Obesity. Severe malnutrition. Chronic cardiovascular disease: heart failure, coronary artery disease, valvular heart disease, cardiomyopathies, pulmonary hypertension. Chronic kidney disease (including patients on chronic dialysis). Nephrotic syndrome. Chronic respiratory disease: chronic obstructive pulmonary disease [COPD], cystic fibrosis, interstitial lung disease, severe asthma. Cirrhosis. HIV regardless of CD4 count and viral load levels. Waiting list for solid organ transplants and solid organ transplant recipients. Intellectual and developmental disabilities. Newly diagnosed oncological and/or oncohematological disease or “ACTIVE” disease. Active tuberculosis. Down syndrome. Chronic autoimmune inflammatory rheumatic diseases (CRIAD) and people receiving immunosuppressive treatments. Primary immunodeficiencies.
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Indications and phasing 10. Is COVID-19 vaccination mandatory in Argentina?
No, COVID-19 vaccination is not mandatory. The National Ministry of Health and the Expanded Program on Immunization advocate for building and fostering acceptance and trust in vaccination as a supportive, equitable, and beneficial public health strategy for the well-being and health of individuals and the population. This strategy is based on compelling scientific evidence and has saved millions of lives worldwide as a primary preventive measure. Thus, in Argentina, the majority of the population understands the individual and collective benefits of vaccination and accepts it voluntarily.
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11. Is the COVID-19 vaccine free?
The COVID-19 vaccination campaign is being implemented by the public sector, guaranteeing free access to the vaccine for the population 6 months and older.
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12. How are the doses administered recorded?
According to the Strategic Plan approved by Royal Decree 2883/2020, all doses of COVID-19 vaccines administered in Argentina must be recorded in the Nominal Vaccination Registry (NOMIVAC), which is mandatory. The registry includes data on the vaccination date, vaccine received, batch, number of doses, among other things, to provide the real-time information necessary for proper monitoring of vaccinated individuals.
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13. Is it possible to know how the vaccination campaign is progressing in the country?