Pfizer Boosters For Older Teens Advances In FDA Review Process
The Food and Drug Administration determined that additional study by an advisory committee would not be required in reviewing a third Pfizer covid shot for those aged 16 and 17. News outlets report on other developments related to youth vaccines.
Pfizer Booster for More Teens Moves Closer to FDA Clearance
Food and Drug Administration authorization of Pfizer Inc. booster vaccines for more teens took a step forward when the agency said further study by an advisory committee wasn’t necessary. Third doses for those age 16 and 17 do “not raise questions that would benefit from additional discussion by the members of the committee,” the FDA said in an email. The development on Wednesday signals the FDA has no particular safety concerns for the age bracket. (Rutherford, 12/8)
Some Teens May Get A Covid-19 Vaccine Booster Soon, But Younger Kids Might Not Get One At All
As more young children are getting their second doses of Covid-19 vaccine, another question is popping up: When will kids and younger teens need a booster shot? ... While adults have been eligible for Covid-19 vaccines since last year, younger kids got a later start. The emergency use authorization of the Pfizer vaccine wasn't expanded to include children 12 through 15 years of age until May 10. For children 5 to 11, it was October 29. That means the research on the kids is running behind the adults. "Most people really aren't talking about this yet because we don't know how long kids respond to the vaccine," said Dr. Claudia Hoyen, director pediatric infection control at UH Rainbow Babies and Children's Hospital in Cleveland. (Christensen, 12/7)
Will Children Need Covid-19 Booster Shots?
During an appearance on CNN last month, Dr. Anthony Fauci, the government's top infectious disease expert, said it is possible that children ages 12 to 15 will need a booster shot, but he suggested it may not be necessary. Children in that age group have robust immune systems, Fauci said, adding that "healthy, strapping teenagers have a much better and stronger immune response" than older adults do. He said he would not be surprised if their vaccine protection lasts longer than six months. (Griffith, 12/8)
And more on the Pfizer vaccine —
Pfizer Boosters Dominate The U.S. See A State-By-State Breakdown
The Pfizer-BioNTech Covid vaccine booster, which the companies say offers better protection against the new variant than an initial one or two-dose series, accounts for about 55 percent of all booster shots in the U.S., according to an NBC News analysis of vaccine data from the Centers for Disease Control and Prevention. Several states have exceeded the national average. In Hawaii, 70 percent of boosters were from Pfizer, and Pfizer shots accounted for about 60 percent of boosters in states such as Utah, Missouri and Indiana. Just under 25 percent of people in the U.S. have received a booster, the CDC says. (Ramos, 12/8)
Pfizer’s Vaccine Chief On Omicron, Boosters, And Preparing For The Unknown
Pfizer and partner BioNTech announced Wednesday that new data show that antibodies generated by their Covid vaccine appear less effective against the Omicron variant than other variants, but that a third booster dose likely provides sufficient antibody protection. Those data are very preliminary. But STAT took the opportunity to catch up with Pfizer’s head of vaccine research, Kathrin Jansen, who has been one of the main architects of the development program that has helped make the Pfizer-BioNTech vaccine the most widely used of the Covid shots. Jansen emphasized that Pfizer is developing an Omicron-specific vaccine, but that she does not know exactly what strategy the world should or will take over the coming months. Instead, she is focused on being prepared for anything. (Herper, 12/8)