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 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 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...
"We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine," Moderna CEO Stephane Bancel said in a press release. "We look forward to working with the FDA and will continue to submit data from our Pha...
Johnson & Johnson and the FDA on Wednesday released respective detailed analysis on the one-shot COVID-19 vaccine, with the FDA announcing the company's data meets the requirements for the emergency use authorization review process. FDA scientists found that the Johnson & Johnson vaccine was...
The COVID-19 vaccine (Novavax) is not authorized for use in individuals <12 years of age.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 ...
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. ...
Johnson vaccine will now be limited to people ages 18 and older for whom other authorized or approved COVID-19 vaccines are not "accessible or clinically appropriate," and to adults who choose to receive the vaccine or else they would not get vaccinated, the FDA wrote in a press release. ...
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." ...