QCOSTARICA – Any vaccine against Covid-19 that has authorization from a regulatory agency recognized by the World Health Organization (WHO) could be sold in Costa Rica.
In other words, beyond the vaccines developed by Pfizer/BioNTech or AstraZeneca, which are the ones that the Government has bought (directly and through the COVAX in the case of AstraZeneca), private pharmacies in the country will be able to purchase others, as long as they comply with the requirement.
There are about ten such regulatory agencies in the world (such as the FDA or the European Medicines Agency); which are in charge of reviewing the trials of these vaccines and are the ones that guarantee that they have the minimum level of safety and efficacy, explained Daniel Salas, Minister of Health.
Some examples of strict regulatory agencies are the authorities of Australia, Canada, the United States, Iceland, Japan, Liechtenstein, Norway, the United Kingdom, Switzerland and the European Union, detailed the Ministry of Health press office.
For now, it is important to remember that the companies that develop vaccines against Covid-19 keep their production focused on administering doses to governments.
“I cannot rule out that this will change in the following months, in the second semester it is possible that there will be an eventual sale in private pharmacies,” Salas clarified.
But once the developers leave this priority there will be no obstacles, promises the Minister.
“As soon as the vaccine is available to be purchased in the private sector by legal mechanisms, which are fully regularized, we will expedite everything possible, provided that the sanitary conditions and registration at the sanitary level are met,” said Salas.
At the end of March, there was still no formal request to market any of the Covid-19 vaccines that have the authorization of the agencies.
In the country, some 1,200 pharmacies are interested in supporting the government vaccination campaign and also in marketing the vaccine.
Another important point clarified by the WHO is that the emergency use list procedure involves a rigorous evaluation of the most recent data from phase II and III clinical trials, as well as substantial additional data on safety, efficacy, quality and of the risk management plan.
Data that is reviewed by independent experts and WHO teams, which consider the current body of evidence on the vaccine in question, plans to monitor its use, and plans for further studies.
In addition, as part of the emergency use list process, the company producing the vaccine must commit to continuing to generate data that will allow full authorization and prequalification of the vaccine by WHO.
The vaccines that Costa Rica purchased have already gone through the review process and were endorsed for use by the Ministry of Health on the following dates:
- Pfizer / BioNTech: December 15, 2020
- AstraZeneca and Oxford: February 2, 2021