By: Olga Torres, Ruth Olivares and Adriana Pérez
On July 27, 2021, it was published in the Diario de Centro América, the PROVISIONS FOR THE OPERATION OF THE COMMITTEE FOR THE EVALUATION OF SERIOUS ADVERSE REACTIONS TO VACCINES, Ministerial Agreement 149-2021, of the Ministry of Public Health and Social Assistance. The goals of this committee are to serve as technical advisor and assistant in the evaluation of events attributable to vaccination against COVID-19. Likewise, it will function as support in the investigation, analysis, and ruling of an adverse reaction to immunization.
Such Provisions are effective upon publication on July 27, 2021, and repeal the Exception Rule for Liability and Compensation for Adverse Reactions Attributable to COVID-19 Vaccines, Ministerial Agreement 40-2021 of February 17, 2021.
Along with the provisions, the REGULATION OF THE COMPENSATION MECHANISM FOR THE USE OF VACCINES AGAINST COVID-19 WITH EMERGENCY USE AUTHORIZATION FOR THE SARS VIRUS PANDEMIC COV-19, Ministerial Agreement Number 150-2021, of the Ministry of Public Health and Social Assistance, was also published. It establishes the conditions, procedure, and deadlines to be verified by the Committee for the Evaluation of Adverse Reactions, derived from events attributable to vaccination (ESAVI).
Such Regulation indicates that there will be epidemiological surveillance in the vaccination posts for the notification of ESAVI, it also indicates that in the website of the Ministry of Public Health and Social Assistance of Guatemala an ESAVI notification form will be available, which will be sent to the Health Area Director or to the Delegate of the Pharmacovigilance Committee, to follow up the case and issue an opinion.
The affected person, his/her legal representative, or his/her relatives within the degrees of the law, will be able to make the claim for compensation only if the issued opinion classifies the adverse reaction as a consequence of the COVID-19 vaccine.
This regulation became effective on July 28, 2021.