Pfizer and BioNTech asked the FDA for emergency authorization to begin distributing their COVID-19 vaccine, which has been shown to be up to 95 percent effective.
The pharmaceutical Pfizer and his german partner BioNTech requested this Friday emergency authorization from the drug regulator of United States (FDA) in order to begin distributing your vaccine against COVID-19, which has been shown to be up to 95 percent effective in preliminary clinical trials, and which could be supplied to the population at risk from December.
The Food and Drug Administration (FDAmust review at least two months of volunteer response data to the vaccine, as well as certify its safety in children, old people Y racially diverseBut given the urgency of the process, it could take weeks for the first US vaccine against COVID-19 to be available.
The request was formalized before 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.
The CEO of Pfizer, Albert bourla, reminded today that there is no time to lose after United States has exceeded a quarter of a million deaths from the pandemic and 200,000 infections and 2,000 deaths a day, a level that some experts already describe as a “humanitarian crisis” in the richest country in the world.
“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 around the world. The application in the United States represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world, “he said. Bourla.
Pfizer and the german BioNTech indicated that they work in parallel to advance the vaccine approval processes with the regulators of Australia, Canada, Japan, United Kingdom and the European Union, where the increase in cases may have already reached its highest peak.
“As a company located in German, 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, ”he said in a statement. Ugur Sahin, CEO of BioNTech, which provides its technology Messenger RNA used by the vaccine.
Data from phase 3 of clinical trials were obtained in a group of 43,661 volunteers, 41,135 of whom received the two doses of the vaccine in test centers in United States, Germany, Turkey, South Africa, Brazil Y Argentina.
The efficiency index is 95 percent overall and from 94 percent between older than 65 years (risk population), and therefore it is much higher than the 50 percent required by the FDA to approve candidates for vaccines against COVID-19.
Efficacy checks have been achieved after contagion with COVID-19 from 170 volunteers, while the safety data and side effects are based on results collected from 8,000 randomized participants and by follow-up given to the majority of those who have received two doses of the so-called BTN162b2.
The safety data, critical to the acceptance of the vaccine by society, includes the response in 100 children between 12 and 15 years old, and more than 40 percent of people of diverse ethnic and racial origins, as well as 41 percent of ages between 56 and 85 years.
America depends on the vaccine
The sad image of the vice president, Mike pence, ending this Thursday its first Press conference in months on the fight against the pandemic, without accepting questions and involved in the shouts of journalists, and the criticism today of the advisor of Donald trump, Peter navarro, to 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 only hope for America is the vaccine.
Navarrese assured that the mobilization of funds and federal agencies to accelerate the obtaining of the vaccine as part of the “Operation Warp Speed” will be one of the “Greatest legacies” of the presidency of Trump, which with the investment of several billions tries to procure in record time 300 million doses of the vaccine by January.
However, Pfizer He has not used these funds for the development of the vaccine, which he has financed out of pocket, although he has reached an agreement with Washington worth almost 1,950 million dollars to provide them with 100 million doses.
For its part, Modern, which has also presented preliminary results similar to those of Pfizer and could request emergency authorization shortly, it does owe to the injection of funds from the government American part of its success in the historically rapid vaccine development process.
According Pfizer, its infrastructure and supply chain “cold” has the potential to manufacture 50 million doses around the world 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 that are immersed in the last phase of tests such as AstraZeneca / University of Oxford.
With information from .