The data refers to the FDA’s decision to license what is now known as the Comirnaty vaccine against Covid-19, produced by Pfizer in collaboration with BioNTech. Back in November of 2020, when considering Pfizer-BioNTech’s request for emergency use authorization (EUA) of its product, the ...
Pfizer and Moderna presented early data on shots targeted at KP.2 as well as JN.1 to a panel of the FDA's outside vaccine advisers in June, as the companies prepared to ramp up production. While the FDA's advisers called for the agency to target JN.1, the agency cited the "recent...
The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021. “This milestone follows a year of incredible work by our dedicated tea...
In this section, we introduce the components and the trial efficacies of the vaccines. It should be noted that efficacy refers to vaccine performance in controlled trials, whereas effectiveness is drawn from real-world observations. Vaccine efficacies cannot be readily compared because the efficacy can...
FDA The U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and ...
Two days before the meeting, the FDA is expected to release a roughly 100-page document evaluating the companies' clinical trial data, said Dr. Paul Offit, a voting member of the advisory committee, offering a glimpse into the agency's view of the vaccine. ...
In addition to Pfizer releasing its data, Moderna announced on Monday its Covid-19 vaccine was almost 95% effective in preventing the disease, based on preliminary results. The Massachusetts-based biotech firm said it would apply for emergency use authorization with the FDA in the coming weeks...
The FDA EUA permits use of the COVID-19 vaccine (Novavax) for prevention of COVID-19 in adolescents 12 through 17 years of age† [off-label] based on safety and effectiveness data in this age group in addition to data from the adult population....
“The U.S. now has access to the Novavax COVID-19 Vaccine, adjuvanted, the first protein-based option, as a booster,” Novavax President and CEO Stanley Erck said in a news release. “According to CDC data, almost 50 percent of adults who received their primary series have yet to re...
In its analysis of Pfizer's data, the FDA said that rates of hospitalization and death due to COVID-19 among children under 5 were higher than among those aged 5 to 17, "underscoring the benefit of an effective COVID-19 vaccine in this age group." ...