Bogotá DC, December 12, 2023. Given the information circulating regarding delays in the process of disposing of Bivalent biologicals against COVID-19, the Ministry of Health and Social Protection reports that the time elapsed between the arrival of the biologicals and their availability to the target population in throughout the national territory, corresponds to the development of procedures and procedures that ensure compliance with the quality standards defined by the manufacturer, international organizations and national regulatory entities to achieve safe vaccination.
The Expanded Immunization Program (PAI) and the National Vaccination Plan (PNV) against COVID-19 are responsible for ensuring that all components of the Safe Vaccination System are fully complied with; strategy of the Pan American Health Organization that is implemented in the Region of the Americas, to improve acceptance and confidence in vaccination and strengthen its impact on public health.
There are multiple processes that guarantee safe vaccination in Colombian territory: vaccine control by the National Regulatory Authority, guarantee of the cold chain, definition of vaccination tactics and strategies, definition of waste management and communication. Compliance with all requirements is an obligation.
The Ministry of Health and Social Protection acquired 757,400 doses of Moderna Bivalent vaccine (BA.4/5), which arrived in the country on September 28 and October 2, 2023. This administration carried out the required procedures to legalize the biological and initiate with the distribution for your application; In accordance with the National Vaccination Plan (PNV), the vaccine from the MODERNA Bivalente laboratory was acquired and imported by the National Unit for Disaster Management (UNGRD), which was delivered to the Ministry of Health and Social Protection.
It is worth clarifying that the nationalization, legalization and release of the amount documents, a procedure specific to the importer (UNGRD), took more than 30 days to begin the distribution of the vaccine to the territorial entities of the departmental and district order.
Simultaneously, this portfolio carried out the regulatory management for the modification of the guidelines of the National Vaccination Plan against COVID-19 with the inclusion of the Moderna Bivalent vaccine. Likewise, planning and technical tests were carried out to guarantee the cold chain and transportation of the biological with the objective of optimizing the useful life of the vaccines and allowing territorial entities to micro-plan for the management of the vaccine.
Likewise, programming began for the allocation of this vaccine in the national territory and communications strategies were designed to reach the beneficiary population of the vaccine.
For the Moderna Bivalent vaccine, the National Institute for Food and Drug Surveillance (INVIMA), through Resolution 2023029356 of June 30, 2023, resolved to GRANT THE HEALTH AUTHORIZATION FOR EMERGENCY USE — ASUE, indicated for active immunization to prevent COVID-19, caused by the SARS-CoV-2 virus, in population groups at high risk of complications, aged 18 years or older, who have previously received at least the first vaccination against COVID-19.
The Government carried out the assignment and distribution of the Moderna Bivalent vaccine to the 38 territorial entities under the regulatory act Res. 1913 of 2023; The modern bivalent vaccine, Spikevax bivalent Original/ómicron 8A.4-5, is indicated for active immunization to prevent COVID-19, caused by the SARS-CoV-2 virus, in population groups at high risk of complications aged 18 years and older. older people who have previously received at least the first vaccination.
Taking into account the ASUE, the Moderna Bivalent vaccine has a shelf life extension of 12 months after the date of manufacture; Thus, the lots that entered the country have an expiration date between the months of March and April 2024. This information was shared under Files No.202321112265981 of 10/27/2023 and 202321112582191 of 12/01/2023; However, Congressman Andrés Forero omitted these data in his statements, generating a high negative impact on the acceptance of biologicals.
In order to offer and guarantee access to the Moderna Bivalent vaccine as an additional dose to the population over 18 years of age, belonging to the prioritized groups according to what is indicated by the ASUE, this administration carried out programming and training for the 38 territorial entities. in the management of the biological, cold chain, dosage, prioritized groups and the different activities and strategies to achieve vaccination. Thus, the Modern Bivalent Vaccine Action Plan was socialized and each territorial entity of the departmental and district order, in coordination with the insurers, was requested to prepare the action plan with the specific strategies for each prioritized group with the objective of achieving vaccination.
The Ministry of Health and Social Protection confirms that all the processes implemented were carried out within the framework of safe vaccination and have allowed progress in public health results, not only against COVID-19, but against 29 more preventable diseases. for vaccines. However, it is worth highlighting the current situation, in which the population is not demanding the application of the biological against COVID-19, a situation that is due to the low perception of risk and the declaration of end of the health emergency.
2023-12-12 19:02:54
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