Considering the world health crisis, the Colombian Government in search of overcoming the pandemic through a general immunization, issued Resolution 507 of 2021 which authorizes privates to import vaccines against COVID-19 as long as the following requirements are met:
a. Request the modification of the Sanitary Authorization for Emergency Use- ASUE - before the INVIMA to be included as importers, different from the holder of the Authorization.
The ASUE is a temporary and conditioned authorization different from the sanitary registration for biological and chemical synthesis medicines destined for the diagnosis, prevention, and treatment of COVID-19; these products must have a clinical study that supports the generation of evidence of efficacy and safety of the product. The holder of the ASUE must authorize the inclusion, of the interested party, as importers in the resolution that granted the same; assimilating it to a standard procedure of addition of importer of a Biological product and not by request of the interested party or by INVIMA’S own motion.
b. Guaranteeing the storage conditions established by the manufacturer of the vaccines.
c. Complying with the regulations regarding traceability and final disposal of biological waste.
d. Assuming the costs of the vaccines and their importation.
e. Complying with the norms regarding labels, packaging, and inserts.
f. Assuming the conditions negotiated for importation.
Under this scheme, vaccines may only be imported if they have the Sanitary Authorization for Emergency Use duly granted by INVIMA. Currently, the vaccines that have this Authorization are:
- Janssen owned by Jassen Cilag S.A;
- Pfizer -Biontech Covid 19 owned by Pfizer INC, and
- ChadOx1-S of the AstraZeneca laboratory.
In the case of the CoronaVac vaccine developed by the pharmaceutical company Sinovac Life Sciences Co. Ltd, INVIMA approved the importation of the vaccine by means of an exception mechanism established in Decree 822 of 2003, which excludes the application of this Authorization for privates. Due to the application submitted, this vaccine has a restriction as to the amount that may enter the country, up to 2.5 million doses of the vaccine.
An additional requirement to those already mentioned, is that the vaccines to be imported have the tariff code 3002.20.90.10, which the Ministry of Commerce and Tourism created throughout Decree 373 of 2021 by unfolding 3002.20.90 tariff heading to facilitate COVID-19 vaccines identification and import. This decision was based on the need to distinguish this vaccines from others and to generate statistics for the competent control entities and the Government.
What is of concern now for privates who want to import such vaccines?
What is worrying now is that despite complying with the requirements described above after the Ministry of Health issued Resolution 507 of 2021, the manufacturers of the vaccines (AstraZeneca, Pfizer - Biontech and Janssen) - the only vaccines authorized so far by INVIMA - openly refused to negotiate with legal entities the distribution of their biological products.
The main reasons for not selling vaccines to privates is because they prioritize the global supply commitments of COVID-19 vaccines signed with national governments worldwide and the agreements signed with international organizations such as the COVAX mechanism, which is of extreme priority according to these pharmaceutical companies.
Despite the above, Pfizer gave some hope at the end of the statement clarifying that although they do not plan to sell their vaccines to private firms or individuals they will study and notify once they consider that the required conditions are in place to be able to expand their sales options.
This means that at this time, it will not be possible for private individuals or organizations to import these vaccines until a new vaccine counts with the Health Authorization for Emergency Use and the parent company or the authorized distributor accepts the sale of the biologicals.