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Vacciineees!!!

We don't have to say again what we've already said countless (too many) times about all that this year has meant to us, our families, and all aspects of our lives.

And despite the fact that this year has seemed endless, and that the vaccines that could return us to our old normality have been delayed for what seems like an eternity, we already have vaccines.

Under normal conditions, after a vaccine is ready to use (development that would not normally take less than 5 years of research and testing), the next step would be to apply for an application before our health authority, INVIMA, to carry out an evaluation of the technical and legal documentation for the product.

According to Colombian health regulations, vaccines are classified as drugs and must therefore comply with all regulations that these products must comply with.

In general, any pharma product to be used in our country must exhibit evidence related to two main points: Safety and Efficacy. The safety of the products must be demonstrated, that is, that the risks that their use may involve are reasonable and the risk / benefit ratio is favorable, and with respect to efficacy, it must be clearly demonstrated, to put it simply, that the product works for its intended use.

For the applicant to be able to show this, preclinical and clinical data must be presented for the product in general, to approve the use of the active principle in Colombia. Afterwards legal and technical information on the product, namely documentation on where and by whom is manufactured, its design, its shelf life, indications and risks involved in its use, among many other items must be produced.

A large number of products for human use, including medicines and vaccines, require for their commercialization in our country for a market approval process carried out before INVIMA, generally called "health registration."

Depending on the type of product, and the intrinsic health risk derived from its use, the health controls and the procedures that must be carried out to obtain approval change a lot. Different types of products are processed with INVIMA with very different risks of use. A cosmetic and a biomedical equipment with controlled technology have different risks associated with their use, which is why the control exercised over them is different.

Logically, the control that is carried out on vaccines to issue them a health registration is one of the strictest of all and it is a procedure that can take more than a year to complete.

Due to the urgency and importance of the situation in which we find ourselves, the authorities in charge of public health issues, the Ministry of Health as designer and responsible for policies and INVIMA as enforcer, are developing the use of a new procedure called "Emergency use". This figure would be established in a decree that would be issued in the coming days.

It would be an authorization limited in its scope and temporality to handle the current health crisis. INVIMA has already announced that it would be authorized in record time, even in a matter of hours.

The interested party should submit the scientific information that shows all the development of clinical trials. The main focus of the control and surveillance of the market would be in this case in monitoring the use of the product to be very attentive to adverse events or risk situations.

In other words, thanks to special and extraordinary circumstances, our health surveillance system would focus on the risks of usage of the product in the market, and not on a large pre-market control, as is usually done in our health system.

Authors

Luz Helena Vargas
Luz Helena Vargas
Associate Director
Bogotá