Pfizer requests authorization from the FDA to supply its vaccine

The pharmaceutical Pfizer and his german partner BioNTech requested this Friday emergency authorization from the United States drug regulator (FDA) to be able to begin distributing their covid-19 vaccine, which has been shown to be up to 95% effective in preliminary clinical trials, and which could be supplied to the population at risk as of December.

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

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

Pfizer CEO Albert Bourla today recalled that there is no time to lose after the United States has passed the quarter of a million deaths from the pandemic and 200,000 infections and 2,000 deaths a day, a level that some experts already call a “humanitarian crisis” in the world’s richest 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 indicated that they work in parallel to advance the processes of approval of the vaccine with regulators in Australia, Canada, Japan, United Kingdom Y 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, which provides its messenger RNA technology that uses the vaccine.

Promising data

Data from phase 3 clinical trials were obtained from a group of 43,661 volunteers, 41,135 of which they received the two doses of which the vaccine consists in test centers in the United States, Germany, Turkey, South Africa, Brazil and Argentina.

The efficiency rate is 95% overall and 94% among those over 65 years (risk population), and therefore is much higher than the 50% required by the FDA to approve candidates for vaccines against covid-19.

Efficacy checks were made after 170 volunteers were infected with COVID-19, while safety and side-effect data are based on results collected from 8,000 random participants and for the follow-up given to the majority of those who have received two doses of the so-called BTN162b2.

Safety data, critical to societal acceptance of the vaccine, includes response in 100 children between 12 and 15 years of age, and more than 40% of people of diverse ethnic and racial origins, as well as 41% aged between 56 and 85 years.

America depends on the vaccine

The sad image of the vice president, Mike Pence, ending on Thursday his first press conference in months on the fight against pandemic, without accepting questions and involved in the shouts of journalists, and the criticism today by Donald Trump’s adviser, Peter Navarro, of the confinement measures decreed by some states in the face of the increase in cases confirm what was already evident for a long time: the the only hope for the US is the vaccine.

Navarro assured that the mobilization of funds and federal agencies to accelerate the obtaining of the vaccine as part of “Operation Warp Speed” will be one of the “greatest legacies” of the Trump presidency, which with the investment of several billions tries to procure 300 million doses of the vaccine in record time by January.

However, Pfizer has not used these funds for the development of the vaccine, which it has financed out of pocket, although it has reached an agreement with Washington worth almost $ 1.95 billion to provide them with 100 million doses.

For its part, Moderna, which has also presented preliminary results similar to those of Pfizer And it could apply for emergency authorization shortly, if it owes the injection of funds from the US government part of its success in the historically rapid vaccine development process.

According to Pfizer, its “cold” infrastructure and supply chain has the potential to manufacture 50 million doses worldwide in the remainder of the year and 1.3 billion doses more in all of 2021.

Precisely, the need to stay at temperatures below 70 degrees below zero is one of the weak points that Moderna or other competitors who are immersed in the last phase of tests such as AstraZenaca / University of Oxford do not have.