Universal vaccine administration: new regulation

Arias - On November 15 of this year, the new Vaccination Law was approved through Decree Number 25-2024 by the Congress of the Republic of Guatemala. This regulation aims to strengthen the immunization system and ensure access to safe and effective vaccines for the entire population.

Below, the most relevant aspects of the law.

The law aims to ensure protection against vaccine preventable diseases through the universal administration of high quality, safe, and effective vaccines. To achieve this, it establishes the principles of equity, equality, availability, voluntariness, gratuity, and universality.

The Immunization Program is established as the technical regulatory body responsible for advising the Ministry of Public Health and Social Assistance (MSPAS) on guidelines related to the receipt, cold chain management, proper storage, coordination, and monitoring of compliance with all processes and protocols necessary to ensure vaccination and the surveillance of vaccine-preventable diseases. Additionally, it will be responsible for implementing the National Vaccination Schedule, which must be published at the beginning of each year to guarantee access to vaccine supplies for everyone. This schedule will be reviewed annually by the National Immunization Practices Council (CONAPI) to incorporate vaccines deemed necessary and appropriate based on the country’s epidemiological profile.

Additionally, The National Immunization Practices Council (CONAPI) is established as the technical and scientific body responsible for advising the Ministry of Public Health and Social Assistance (MSPAS) on the use of vaccines, biological preparations of immunoglobulin, and specific antibodies for the effective prevention and control of vaccine preventable diseases in Guatemala. It will be composed of a group of medical and public health experts from various health sectors.

As previously mentioned, the Ministry of Public Health and Social Assistance (MSPAS), through the Immunization Program, must ensure the sufficient and timely availability of vaccines included in the National Vaccination Schedule, as well as other necessary supplies. Therefore, the Ministry must strengthen healthcare services by enhancing human resources, cold chain systems, and transportation to implement vaccination strategies, prioritizing healthcare services that cater to underserved and vulnerable populations.

To ensure safe and effective vaccination, vaccines must be administered by healthcare professionals or individuals who have been trained and certified with the corresponding authorization issued by the Ministry of Public Health and Social Assistance (MSPAS). In the case of minors and individuals under legal guardianship, vaccinations must be carried out in the presence of or with the express authorization of one or both parents, guardians, or legal representatives responsible for their care.

In this regard, the establishment of a Unified Vaccination Registry within the health sector is mandated as a tool for recording the age and date of administration of each dose. The information contained in the registry will be exclusively accessible to the health sector.

Finally, the new Vaccination Law regulates that in situations that pose a risk to the population and that can be prevented through vaccination, the Ministry of Public Health and Social Assistance will develop and implement vaccination strategies and programs to address and control the emergency. In these cases, the State’s acquisition can be made without the need for prior registration in the country, under the conditions established by the Department of Regulation and Control of Pharmaceutical and Related Products of the Ministry of Public Health and Social Assistance.

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