The FDA’s Vaccines and Related Biological Products Advisory Committee voted 17-4 to give green light to a COVID vaccine developed by Pfizer in association with BioNTech for Emergency Use Authorization (EUA) in people aged 16 and above.
On Thursday afternoon, the committee discussed the clinical and safety data of the vaccine for hours. The committee members analyzed the Phase 3 clinical trial data submitted by the companies, which showed their vaccine to be 95% effective at preventing COVID.
Once the FDA’s EUA is granted, officials from Operation Warp Speed (OWS) said millions of doses will begin to be administered to long-term care residents, frontline health workers, and older adults who are more vulnerable to the virus.
Pfizer and BioNTech submitted their application for EUA on November 20 of their mRNA-based vaccine. Once injected, the vaccine helps bodily cells to churn out the viral spike protein, triggering the system to recognize the virus.
Moderna has also submitted its EUA, with the FDA’s advisory committee meeting scheduled for December 17.
Last week, the United Kingdom became the first nation to deliver, distribute, and administer the Pfizer/BioNTech coronavirus vaccine. Recently, Bahrain became the second nation and Canada the third to approve the vaccine.
However, two UK patients who received the vaccine reported severe anaphylactic reactions. The patients have been treated and recovered. The UK health officials have indicated that people with a history of anaphylaxis to a vaccine should not get the vaccine.
OWS plans to begin the first vaccine distribution within 24 hours of receiving approval from the FDA. The Pfizer/BioNTech vaccine is developed at two vaccine factories – one in Michigan and the other in Belgium. The US Department of Health and Human Services (HHS) has confirmed that the shipments were coming from Belgium.
HHS said, “Operation Warp Speed leaders are aware of and facilitating vaccine shipments coming to the U.S. from Belgium. In an effort to minimize the potential risk to delivery and distribution, we are unable to provide specific details regarding where vaccines are produced and stored.”
Meanwhile, the Wall Street Journal reported that United Airlines charter flights have been prepared for quick distribution once the FDA announces the approval.
The Federal Aviation Administration (FAA) said, “The FAA is ensuring around-the-clock air traffic services to keep air cargo moving and prioritizing flights carrying cargo, such as vaccines, and personnel critical to the nation’s response to and recovery from COVID-19.”
“The FAA is working with manufacturers, air carriers, and airport authorities to provide guidance on implementing current regulatory requirements for safely transporting large quantities of dry ice in air cargo,” the federal transportation agency added. The article appeared on BioSpace.
