In the framework of the pandemic generated by COVID-19, great interest has been generated at the national level about the regulation and phases that a vaccine must provide for it to be approved in Colombia and to allow its use and commercialization.
Taking into account that the development of a vaccine is a long, complex and technical process that takes years, and that it is not exactly the same for every vaccine and disease that is to be prevented, below are the main stages when it comes to approval and marketing of a vaccine. This, with the incentive that in the framework of the global health emergency caused by COVID-19, these processes are speeded up and shortened due to the latent need for a vaccine.
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- Exploration stage – Phase I: the exploration stage lasts for 2 to 4 years of research where advances reach a preclinical stage in which culture or tissue or cell systems and animal tests are used to evaluate the safety of a candidate vaccine and its ability to elicit an immune response.
- Testing – Phase II: This stage involves testing groups of people who are at risk of contracting the disease. Some of the vaccination initiatives against the Coronavirus COVID-19 are currently at this stage, such as the vaccine that is being developed by the University of Oxford i . With these tests in humans, the aim is to carry out a study of the candidate vaccine in terms of its safety, immunogenic capacity, proposed doses, vaccination program and method of application.
- Testing – Phase III: During phase III of the study of the possible candidate vaccine, random tests are carried out where the origin of the vaccine and its effectiveness are determined, including factors regarding whether it prevents the disease, the infection of the pathogen and leads to the production of antibodies related to the pathogen ii .
If this process is successful, the creator of the vaccine must send an official authorization request for biological products and will be monitored in its production. This surveillance, inspection and control is in charge of the Ministry of Health and Social Protection and INVIMA.
A vaccine, therefore, is a biological medicine, which means that they are complex molecules that cannot be defined chemically and that, having an inherent variability in biological systems, each production batch is considered unique, hence they have a special regulation and monitoring of their production, starting from the same plants where iii are manufactured.
Finally, from a normative perspective, vaccines in Colombia are initially regulated in Law 9 of 1979, which by means of its articles 478 to 490 established the parameters of surveillance and control that these drugs have before the Ministry of Health and Social Protection in the country.
Subsequently, through Resolution 1606 of 2014 of the Ministry of Health and Social Protection, technical guidelines were established for the presentation of information on the control of vaccines, by which those interested in manufacturing or importing vaccines in the national territory must Present information to INVIMA following these and the guidelines established in Decree 677 of 1995, which partially regulates the Regime of Registries and Licenses, Quality Control, as well as the Regime of Sanitary Surveillance of Medicines.
To conclude, and taking into consideration the category of biological medicine with which vaccines are recognized today in Colombia, it is of vital importance to refer within this regulatory organization to Resolution 2010022392 of 2010 of INVIMA, which establishes that every holder of the Sanitary registry, producer or importer of vaccines that are imported or produced in the country must present to INVIMA, before their circulation and / or commercialization, the samples and supporting documentation of the batch to be released, in order for it to be evaluated by the Laboratory of Biological Products of INVIMA.
By Manuel Londoño, Legal Assistant of Gómez-Pinzón Abogados.
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[i] For more information, consult https://www.bbc.com/mundo/noticias-53504034
[ii] These phases are reproduced on the page of the Ministry of Health with statements by Ph.D. Claudia Cuellar. For more information, consult https: / /www.minsalud.gov.co/Paginas/Como-se-desarrolla-una-vacuna.aspx
[iii] For more information consult https://www.invima.gov.co/es/web/guest/biologicos-y-de-sintesis-quimica