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The World Health Organization gave the first authorization for the emergency use of a vaccine: the one developed by Pfizer, which on December 31 also filed the request for approval in Colombia.
2020 closes with another momentous news: the World Health Organization announced today, December 31, its first authorization for emergency use of a vaccine against COVID-19: the one developed by the pharmaceutical companies Pfizer and BioNTech. (Read This is what you should know about the world of vaccines)
The approval “opens the door for countries to accelerate their own regulatory approval processes to import and administer the vaccine,” warns the WHO in a statement.
The WHO also noted that the authorization will allow the use of the vaccine to agencies such as the Pan American Health Organization or the United Nations Children’s Fund (Unicef).
“This is a very positive step to ensure global access to COVID-19 vaccines. But I want to emphasize the need for an even greater global effort to achieve a vaccine supply sufficient to meet the needs of priority populations everywhere, “said Dr. Mariângela Simão, WHO Assistant Director-General for Access to Medicines and Products Sanitary.
According to the organization, both the experts convened by the WHO and the entity’s team reviewed the data on the safety, efficacy and quality of the Pfizer / BioNTech vaccine. The conclusion is that “the vaccine met the essential safety and efficacy criteria established by the WHO.”
In fact, today Pfizer, as Julio Aldana, Invima director explained, formally filed the request for this vaccine to be approved in Colombia. “With this request, Invima has 10 working days for the Specialized Chamber of Medicines to evaluate the information and to issue a decision on the merits,” he explained on Twitter.
The use of emergency explains in the statement the WHO, assesses the suitability of new medical devices with the aim that “drugs, vaccines and diagnoses are available as quickly as possible to address the emergency, respecting strict criteria of safety, efficacy and quality ”.
Pfizer and BionTech, for their part, agree to continue to generate data to allow full licensing and prequalification of the biological.