More Places Likely To Require Shots As FDA Issues Full Approval For Pfizer Vaccine
The FDA announced full approval of the Pfizer/BioNTech covid vaccine. As one Ohio health official said, "It takes away from a certain number of people the argument it's not approved. That's been their argument of not getting it. Now we're eliminated that."
US Regulators Give Full Approval To Pfizer COVID-19 Vaccine
The U.S. gave full approval to Pfizer’s COVID-19 vaccine on Monday, a milestone that may help lift public confidence in the shots as the nation battles the most contagious coronavirus mutant yet. The vaccine made by Pfizer and its partner BioNTech now carries the strongest endorsement from the Food and Drug Administration, which has never before had so much evidence to judge a shot’s safety. More than 200 million Pfizer doses already have been administered in the U.S. — and hundreds of millions more worldwide — since emergency use began in December. (Neergaard and Perrone, 8/23)
FDA Grants Full Approval To Covid-19 Vaccine Developed By Pfizer
The vaccine is the first of the pandemic vaccines used in the United States to transition from emergency use status to full licensure, a major victory for a partnership that decided to forgo funding through the government’s Operation Warp Speed program on the belief that the development project could move faster without being part of the government fast-tracking program. The FDA said the vaccine was now approved for use in people ages 16 and up, the only group for which Pfizer now has the required six months of followup safety data. Study of the vaccine in 12- to 15-year-olds began later, and the six-month followup is still underway. Until it can be submitted to the FDA and an extension of the license can be issued, the vaccine will continue to be used in 12- to 15-year-olds under the emergency use authorization. (Branswell, 8/23)
FDA Grants Full Approval To Pfizer-BioNTech’s Covid Vaccine
Up until now, the mRNA vaccine, which will be marketed as Comirnaty, was on the U.S. market under an Emergency Use Authorization that was granted by the FDA in December. Since then, more than 204 million of the Pfizer shots have been administered, according to data compiled by the Centers for Disease Control and Prevention. Federal health officials had been under mounting pressure from the scientific community and advocacy groups to fully approve Pfizer and BioNTech’s vaccine ever since the drugmakers submitted their application to the agency in early May. The companies submitted a Biologics License Application, which secures full approval, to the FDA on May 7 for patients age 16 and up. (Lovelace Jr., 8/23)
Surgeon General: Vaccine Requirements At Business, Colleges 'A Very Reasonable Thing To Do'
Surgeon General Vivek Murthy on Sunday said vaccine requirements at businesses and colleges are “a very reasonable thing to do,” as the Food and Drug Administration (FDA) is reportedly set to fully approve the Pfizer-BioNTech COVID-19 vaccine as soon as this week. Murthy, when asked on CNN’s “State of the Union” if he would urge business and colleges to consider mandating the vaccine once it receives full approval, said such a requirement could “create a safe environment.” (Schnell, 8/22)
Full Covid-19 Vaccine Approval Won't Just Boost Confidence. It'll Likely Lead To New Business Requirements, Surgeon General Says
With the "imminent" full approval of the Pfizer/BioNTech vaccine expected, more businesses will likely issue vaccine mandates to help prevent the Delta variant from sending the country further backward in this pandemic, doctors say. "For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think that this move from the FDA ... will actually help them to move forward with those kinds of plans," US Surgeon General Dr. Vivek Murthy told CNN on Sunday. (Caldwell and Yan, 8/22)
As Covid-19 Hospitalizations Rise, Doctors Hope Vaccine Approval And Boosters Can Stave Off The Surge
As Americans face a daunting surge of Covid-19 hospitalizations -- with the rates for children and adults under 50 hitting their highest levels yet -- officials are hoping full approval of the vaccines could encourage more people to get vaccinated. Full approval from the US Food and Drug Administration (FDA) of the Pfizer/BioNTech vaccine is "imminent," a senior federal official told CNN last week. Once it happens, it could help allay concerns for those who are vaccine hesitant, as all three vaccines available in the US have so far been distributed under emergency use authorization. (Silverman, 8/23)
Health Officials Call Expected Full FDA Approval Of Pfizer Vaccine 'Game Changer'
Federal officials believe the Food and Drug Administration will give full approval to the Pfizer COVID-19 vaccine sometime this week. Local health officials said that would be a game-changer. COVID-19 vaccines are currently being administered under emergency use authorization. But that could change for the Pfizer vaccine in a matter of days. "Certainly it's going to have an impact that we're going to save people's lives first. Get people immunized so we can't pass it on. But more importantly, slow the mutation and passage of delta," said public health expert Dr. O'dell Owerns. (Lair, 8/23)
And on how the approval process works —
Voice of America:
How Does FDA Approve Vaccines?
Some experts say that this approval, which is a much longer and more complicated process, may encourage some skeptics to get vaccinated."We recognize that for some, the FDA approval of COVID-19 vaccines may bring additional confidence and encourage them to get vaccinated," Dr. Peter Marks, the director of the Center for Biologics Evaluation and Research at the FDA, told VOA via email. ... "The full approval process has less to do with getting additional scientific evidence and more to do with some of the logistics," said Dr. David Dowdy, an epidemiologist at the Bloomberg School of Public Health at Johns Hopkins University. He told VOA the process included steps such as specifying the labeling of the vaccine and the specific wording on packaging. (Sarai, 8/11)