Quite the contrary, this BLA review is underway and is one of the top priorities of government agencies, which will complete the review long before the PDUFA target date.
— Dr. Janet Woodcock (@DrWoodcockFDA) July 16, 2021
The US Food and Drug Administration (FDA) said,Priority reviewIs a Pfizer-BioNTech COVID-19 vaccine to determine full approval by January 2022.
According to the FDA Commissioner Dr. Janet WoodcockAction may come much sooner, as regulators are considering reviews “among government agencies’ top priorities.”
Confidential FDA sources said CNN The agency will probably be decided within the next two months.
The FDA has not yet fully approved any of the three COVID-19 vaccines approved for emergency use in the United States (Pfizer-BioNTech, Moderna, Johnson & Johnson).
Pfizer-BioNTech Data submission to FDA started in May To support Biopharmacy Approval Application (BLA), including the latest results of clinical trials that followed participants 16 years and older for 6 months after the second vaccination.
Both companies expect to seek full approval for use in people between the ages of 12 and 15 once the data is available. The FDA expanded its emergency use authorization for vaccines in May Youth..
Modana In addition, we have begun submitting data for full approval of the double-dose vaccine, and Johnson & Johnson will begin the process shortly.
Moderna is also granted Priority review For applications that provide a 6-month timeline for the approval process instead of the standard 10-month
BLA will allow businesses to distribute and sell vaccines even after the end of a formal public health emergency.
FDA approval may also help shape future vaccine obligations and form prompt requirements from employers, schools and other institutions.
Public health experts believe that such requirements will help upset people skeptical about vaccines and give them injections.
US Surgeon President Vivek Murthy said Washington post On Friday, “For some people, the FDA approval process may make a difference, but I think we now have a fair amount of experience, a tremendous amount of experience. Also demonstrates the benefits of this vaccine. It far outweighs the risks. ”
More than 160 million people, according to the US Centers for Disease Control and Prevention (CDC) — 48.4% of the US population — Fully vaccinated as of Saturday.
June survey from Kaiser Family Foundation We found that 31% of unvaccinated adults said they were more likely to be vaccinated if one of the shots currently allowed for emergency use was fully approved by the FDA.
Source: Equity news