WASHINGTON — Pfizer and BioNTech on Friday announced that the U.S. Food and Drug Administration has granted priority review for their two-dose mRNA coronavirus vaccine for individuals 16 and over.
The priority review shortens the approval process from 10 months to only six.
In May, the companies submitted a biologics license application with the clinical data from its Phase 3 trial of the vaccine. The companies also submitted an application with the FDA in May for full approval of the vaccine for children ages 12 through 15.
At this point, it's unknown if the FDA will approve a priority review for the vaccine application for younger children.
Currently, Pfizer and BioNTech's vaccine is approved through an Emergency Use Authorization (EAU) in the United States for individuals 12 and older. The EAU of the product is only authorized for the duration of a declared emergency.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer said in a statement back in May. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”
On Friday, The director of the Centers for Disease Control and Prevention warned that the COVID-19 outbreak in the U.S. is becoming “a pandemic of the unvaccinated.”
Dr. Rochelle Walensky says cases in the U.S. are up about 70% over the last week, hospital admissions are up 36% and deaths rose by 26%. Nearly all hospital admissions and deaths, she says, are among the unvaccinated.
White House COVID-19 coordinator Jeff Zients echoed the pandemic is “one that predominantly threatens unvaccinated people.”
For most people, the coronavirus causes mild or moderate symptoms. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia and death.
The United States has more than 33 million confirmed cases of COVID-19, according to data from Johns Hopkins University.
As of Friday, the U.S. had more than 608,000 deaths from the virus. Worldwide, there are more than 189 million confirmed cases with more than 4 million deaths.
The Associated Press contributed to this report.