Pfizer and BioNTech today announced that they are filing with the U.S. Food and Drug Administration (FDA) for approval to use their emergency coronavirus vaccine candidate.
Less than two weeks ago Pfizer had announced that the vaccine with which it is developed BioNTech SE to fight the novel coronavirus "It has been found to be over 90% effective in prevention COVID-19 in participants with no previous SARS-CoV-2 infection in the first preliminary efficacy analysis. ”
If the vaccine is approved by the FDA, it may be able to be distributed to high-risk populations in the US by mid to late December 2020.
“Our work to provide a safe and effective vaccine has never been more urgent as the number of COVID-19 cases worldwide continues to rise at an alarming rate. The filing in the US is a critical milestone on our journey to deliver a COVID-19 vaccine worldwide. We now have a more complete picture of the effectiveness and safety profile of our vaccine and we are confident in its potential, ”said Dr. Albert Bourla, Pfizer Chairman and CEO, in a written statement.
"We look forward to the upcoming discussion by the Advisory Committee on Vaccines and Related Biological Products and continue to work closely with the FDA and regulatory agencies around the world to ensure our vaccine candidate is approved as soon as possible."
"Submitting an emergency permit in the US is a critical step in making our vaccine candidate available to the global population as quickly as possible," said Ugur Sahin, M.D., CEO and co-founder of BioNTech.
“We intend to continue working with regulators around the world to enable the rapid spread of our vaccine worldwide. As a company based in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us, and we have continuously provided them with data as part of our ongoing review process. "
The phase 3 clinical trial of the vaccine, based on mRNA technology developed by BioNTech, began on July 27 and enrolled 43,661 participants, of whom 41,135 received a second dose of the vaccine candidate as of November 13. Those who have participated will be monitored for long-term protection and safety for two years after their second dose.