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Julio César Aldana, director of the National Institute for Food and Drug Surveillance (Invima), revealed that the health authority on Tuesday gave an authorization for emergency use in Colombia of the Pfizer / BioNTech vaccine, which enables it to begin to be applied in the country within the framework of the National Vaccination Plan.
It is the first time that a license of this type has been granted, called the Sanitary Authorization for Emergency Use (ASUE). This approval was given in two business days, since on Thursday, December 31, the pharmaceutical companies had submitted the necessary documentation to the health authority, in accordance with the requirements of Decree 1787, which has just been issued to grant this type of permits for the first time. for vaccines and drugs in advanced stages of experimentation.
As explained by Invima, this decision was based onn the safety and efficacy information supported by the results of the best evidence available to date On the behavior of this biological medicine to combat the Sars-CoV-2 virus and for the effect, the criteria of safety, efficacy, quality and the pharmacovigilance plans presented by the pharmaceutical company were fundamental.
(Also: They ask to respect times for the second dose of Pfizer’s covid-19 vaccine)
Among the documents that the Invima specialized medicine room analyzed are the results of the phase III study of the vaccine that Pfizer developed together with BioNTech, which demonstrate an efficacy of 95 percent when applying two doses and high safety in its use.
In addition to the supports that for the effect have allowed other regulatory agencies to have made the decision in the same sense.
(Also read: 10 things to know about Pfizer’s vaccine against covid-19)
In that way Pfizer’s is the first vaccine approved in Colombia to combat the pandemic and the Invima decision is a fundamental step to start the National Vaccination Plan against covid-19 in February, as announced by the Ministry of Health.
It should be remembered that in mid-December the Government reported the purchase of 10 million of these doses through a bilateral negotiation with the pharmaceutical company that will serve to immunize five million Colombians.
In total, the country has secured 49 million doses: another 10 million from the Oxford / AstraZeneca vaccine, 9 million from Johnson & Johnson and 20 million through the COVAX mechanism.
(Extend: Colombia buys 9 million Johnson & Johnson vaccines)
More details of the vaccination plan
This Tuesday the Ministry of Health also released a document that compiles part of the details of the National Vaccination Plan and includes, for example, the route and the specific process to achieve the immunization of about 34 million citizens that the Government projects.
In practical terms, the Ministry of Health and Social Protection prioritized the target population to be vaccinated in different phases and stages for vaccination, starting with people with the highest risk of developing serious forms of the disease (over 80 years old) and health personnel who are in the first line of care in hospitals.
According to the document, the Ministry will deliver detailed information on the prioritized population by groups to be vaccinated to the EPS and other Benefit Plan Administration Companies (EAPB), as well as to the territorial entities, which must assign the population to be vaccinated to the Health Provider Institutions (IPS) authorized according to the municipality of residence and close to the place of residence.
(You may be interested: WHO warns of the danger of future pandemics ‘worse’ than covid-19)
The IPS (clinics and hospitals) must schedule the vaccination appointment (date and time) and inform the user and to the EPS and the EAPB, which will update the database of the vaccinated population and upload it to the “My covid-19 Vaccine” platform. In this platform, the user will be able to consult the information of his vaccination history.
“During the entire process of vaccination care, hygienic-sanitary measures must be maintained. The vaccination procedure must be explained to the user beforehand, as well as the informed consent completed and signed. After the injection, the vaccination card will be delivered with the date of the next appointment for the second dose of the vaccine (if required) ”.
HEALTH UNIT
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