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Pfizer requests authorization to begin distribution of its vaccine

The pharmaceutical company Pfizer and its German partner BioNTech requested this Friday emergency authorization from the United States drug regulator (FDA) to begin distributing its vaccine against covid-19, which has shown up to 95% efficacy in preliminary clinical trials, , and that it could be supplied to the infected from December.

The Food and Drug Administration (FDA) will need to review at least two months of volunteer response data to the vaccine, as well as certify its safety in children, the elderly and racially diverse, but due to the urgency of the process could take weeks for the first American vaccine against COVID-19 to be available.

The application was formalized with the FDA this afternoon and approval is expected to be prioritized and confirmed in December, with the first of the two required doses of the vaccine available between the middle and the end of that month.

Pfizer CEO Albert Bourla reminded today that there is no time to lose after the United States has exceeded a quarter of a million deaths from the pandemic, 200,000 infections and 2,000 deaths a day, a level that some experts already describe as “humanitarian crisis” in the country. 

“Our work to deliver a safe and effective vaccine could not be more urgent as we continue to see alarming increases in the number of COVID-19 cases worldwide. The application in the US represents a critical milestone in our trip to deliver a covid-19 vaccine to the world,” Bourla said.

Pfizer and Germany’s BioNTech said they are working in parallel to advance the vaccine approval processes with regulators in Australia, Canada, Japan, the United Kingdom and the European Union, where the increase in cases may have already reached its highest peak.

“As a company located in Germany, in the heart of Europe, our interactions with the European Medicines Agency (EMA) are particularly important and we continue to provide them with data as part of the ongoing review process,” said Ugur Sahin, CEO of BioNTech. 

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