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The American pharmaceutical Pfizer filed this Thursday, December 31, before the National Institute for Food and Drug Surveillance (Invima) the application for a license for emergency use of the vaccine against covid-19 which he developed together with the German BioNTech.
This was confirmed by EL TIEMPO, which also established that the study of this request by the health authority could be ready in a matter of days.
Pfizer submitted the documents required by Decree 1787, including the results of your phase III study, which demonstrate an efficacy of 95 percent when applying two doses and high safety in use.
(Also read: Colombia buys 9 million Johnson & Johnson vaccines)
This decree has just been issued to grant for the first time this type of permits for vaccines and drugs in advanced stages of experimentation.
With this request, the Invima specialized medicine room can evaluate the information collected on the safety and efficacy of the vaccine to grant emergency authorization. According to the decree, he would have a maximum of 10 business days to provide a statement on the merits.
To be positive, Pfizer’s could be the first vaccine approved in Colombia to combat the pandemic and it would be a fundamental step to start the National Vaccination Plan against covid-19 in February, as announced by the Ministry of Health.
(In context: 1.7 million doses of Pfizer start vaccination in February)
It should be remembered that Pfizer’s vaccine was the first to be approved and used in most of the 50 countries in the world that are already immunizing their citizens.
Colombia last week reported the purchase of 10 million of these doses through bilateral negotiations 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.
For his part, Julio Aldana, director of Invima, reported that the entity has 10 business days for the Specialized Medicines Chamber to evaluate the information and can issue a substantive statement about the Health Authorization for Emergency Use of the vaccine from Pfizer.
“However, the Institute will make every effort to provide an agile response, without subordinating the sanitary rigor that safeguards public health in the country,” said Aldana.
HEALTH UNIT
