Enlarge /. Pfizer headquarters in Manhattan, New York City, USA on November 19, 2020.
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Today, the US Food and Drug Administration will for the first time submit a vaccine candidate to fight the pandemic coronavirus.
Pharmaceutical company Pfizer and German biotech company BioNTech announced this morning that they were filing a formal application for an Emergency Use Authorization (EUA) for the company's BNT162b2 mRNA vaccine.
The filing follows the acclaimed news Wednesday that the companies had completed their Phase III study and found the vaccine to be 95 percent effective against symptomatic COVID-19, the disease caused by the coronavirus SARS-CoV-2.
Although full data on the study has not yet been released, the companies said in a press release that the vaccine was consistently effective across racial and ethnic backgrounds, and 94 percent effective in people over 65 years of age – an age group at highest risk for heavy diseases. Study data also showed that the vaccine protected against both serious illnesses and mild cases.
The study reached an endpoint when 170 cases occurred among the 43,661 participants enrolled at one of 150 trial sites in the United States, Germany, Turkey, South Africa, Brazil, and Argentina. Of the 170 cases, 162 were in the placebo group and only eight were in the group that received the experimental two-dose vaccine. Of all cases, 10 were serious, nine of which were in the placebo group.
In addition to the impressive efficacy numbers, the companies will provide the FDA with detailed safety reports on 8,000 randomly selected adult participants and data on approximately 38,000 adult participants who were passively monitored for a median of two months after the second dose of vaccine. The companies also have safety data on 100 children between the ages of 12 and 15. The companies reported no serious reactions to the vaccine, with the most bothersome side effects such as severe headache and fatigue.
It is unclear how long it will take the FDA to consider the EUA application. However, the FDA has repeatedly stated that it is committed to swift action to tackle the dire health crisis that is getting worse by the day.
In announcing the filing, Pfizer Chairman and CEO Dr. Albert Bourla:
Our work to provide a safe and effective vaccine has never been more urgent as the number of COVID-19 cases continues to rise at an alarming rate around the world. 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.
The companies said they are also preparing for filing with other regulatory agencies around the world, including ongoing filing with the European Medicines Agency.
Pfizer and BioNTech "will be ready to distribute the vaccine candidate within hours of approval," the announcement said.
The couple has the manufacturing capacity to produce up to 50 million vaccine doses globally by 2020 and up to 1.3 billion doses by the end of 2021. The companies have signed a deal with the US government to dispense 100 million doses – enough to vaccinate 50 million people – with the option for the US to buy an additional 500 million.