[ad_1]
The WHO (World Health Organization) today approved the emergency use of the vaccine developed by the American pharmaceutical company Pfizer, in association with BionTech. The immunizer is the first with the seal of the specialized health agency and subordinate to the UN (United Nations).
The pharmaceutical company has already stated, according to data from the third phase of tests, that the vaccine is safe and is 95% effective. In recent weeks, both the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) approved the emergency use of the immunizer. Pfizer said yesterday that, in Brazil, it is considering requesting an emergency use after meeting with the National Sanitary Surveillance Agency (Anvisa).
The WHO Emergency Use List (EUL) opens the door for countries to accelerate their own regulatory approval processes to import and administer the vaccine, the agency said. According to the WHO, the approval also allows UNICEF and the Pan American Health Organization to purchase the vaccine for distribution to countries that need it.
Health regulation experts from around the world and WHO teams have reviewed data on safety, efficacy and quality of the Pfizer vaccine, as part of a risk-benefit analysis, the organization said in a statement posted on the website.
The review concluded that the vaccine met mandatory criteria for safety and efficacy established by WHO, and that the “benefits of using the vaccine to treat COVID-19 outweigh the potential risks.”
“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 obtain enough vaccines to meet the needs of priority populations everywhere,” said Dr. Mariângela Simão, WHO Deputy Director General for Access to Medicines and Health Products, in a note.
“WHO and our partners are working around the clock to evaluate other vaccines that have met safety and efficacy standards. We encourage more developers to participate in our review and evaluation. It is vitally important to ensure the critical supply necessary to meet all countries of the world and contain the pandemic. “
The WHO Strategic Group of Experts on Immunization (SAGE) will release, on January 5, 2021, specific vaccine policies and recommendations for the use of Pfizer in populations of different countries, based on SAGE’s population prioritization recommendations. for covid-19 vaccines in general, launched in September 2020.
Still in the statement, the agency explained that the EUL evaluates the “suitability of new medical devices during public health emergencies” – the main objective is that medicines, vaccines and diagnostics are available as soon as possible to attend the emergency “, respecting strict criteria of safety, efficacy and quality “.
The assessment weighs the threat posed by the emergency, as well as the benefit to be gained from using the product against any potential risks.
No brazil
Yesterday, Pfizer said, after a new meeting with Anvisa, that it again considered the request for the emergency use of its vaccine against covid-19 in Brazil. The company had said last Monday (28) that it would send the immunizer only for the so-called continuous presentation.
Pfizer’s argument earlier this week was that it had “had difficulties” in the Presentation Guide for Emergency Use, prepared by the Brazilian agency itself.
However, today, with new clarifications from Anvisa, the laboratory declared that there is the possibility that the agency “modulate” specific points in the presentation guide, allowing greater agility in the presentation of this type of process.
“A new technical meeting will be held and, based on this additional discussion and the progress of the negotiations with the Brazilian government, Pfizer will evaluate the possibility of requesting an emergency use,” the company said in a statement.
“In parallel, the company will continue with the process of continuous submission to the Agency, in search of a rapid approval of the registration of its vaccine,” he added.
