FDA Advisers Vote To OK Low-Dose Pfizer Vaccine For Kids Ages 5 To 11
Determining that the benefits outweigh the risks, the Food and Drug Administration's vaccine advisory panel voted 17-0, with one abstention, to recommend that Pfizer's covid shot be allowed for younger children.
Stat:
FDA Advisers Recommend Pfizer Covid Vaccine Be Authorized For Children
An advisory panel to the Food and Drug Administration voted in favor of authorizing the Covid-19 vaccine made by Pfizer and BioNTech for children ages 5 to 11. After sometimes tense deliberations that weighed the benefits of vaccination against potential risks, the Vaccines and Related Biological Products Advisory Committee voted 17-to-0 with one abstention on Tuesday that two 10-microgram doses of the vaccine should be granted emergency use authorization, a clearance that will remain in effect only as long as the pandemic is considered a public health emergency. (Herper and Branswell, 10/26)
NBC News:
FDA Advisory Panel OKs Pfizer Vaccine For Kids 5 To 11
Despite the vote in favor, deciding whether the benefits of vaccination for young kids outweigh potential risks appeared to weigh heavily on the advisers. "This is a much tougher one, I think, than we had expected coming into it," said committee member Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine. "The data show that the vaccine works and it’s pretty safe ... we’re worried about a side effect that we can’t measure yet," he said, referring to a heart condition called myocarditis. (Miller, 10/26)
USA Today:
FDA Committee Moves Pfizer-BioNTech COVID-19 Vaccine Closer To Use For Children Ages 5-11
Children are far less likely than adults to be hospitalized with COVID-19 or suffer long-term consequences from the disease – putting a higher burden on the vaccine to prove safe and effective to justify its risk. The committee of vaccine experts and pediatricians said that although they are concerned about the unknowns, they felt the data is sufficient to support using Pfizer-BioNTech's vaccine in that age group because it is likely to benefit far more children than it will harm. (Weintraub and Weise, 10/26)
How big will the doses be? —
Bloomberg:
Pfizer Vaccine For Small Kids Could Also Work For Big Kids, Company Says
Pfizer Inc.’s lower-dose Covid-19 vaccine for kids under 12 appears to offer protection across the board, company officials said, and the drug giant may look into offering lower doses for teens who now get the adult dose. A scientific advisory panel to the Food and Drug Administration is deliberating Tuesday on whether to recommend the vaccine, which Pfizer makes with partner BioNTech SE, for 5- to 11-year-olds. If cleared by regulators, it would make a Covid-19 vaccine available to all school-age children for the first time. (Baumann, 10/26)
The New York Times:
When Vaccinating Kids, Does Weight Matter? Should an 11-Year-Old Wait to Turn 12 to Get a Bigger Dose?
Children ages 5 to 11 may be eligible for the Pfizer-BioNTech Covid vaccine by early next month: two shots spaced three weeks apart. But unlike kids 12 and older, who get the same dosage as adults, the kids in the younger age group will receive 10 micrograms of vaccine per dose, or one-third the amount that a 12-year-old would get. This has created some confusion for parents of 11-year-olds on the cusp of turning 12. Is it best to hold out for the larger dose? Or is it better to get the smaller dose right away? Does the weight or height of the child make any difference? (Caron, 10/26)
CNN:
What Will A Covid-19 Vaccine For Younger Kids Mean? An Expert Weighs In
A US Food and Drug Administration advisory committee recommended Tuesday that the agency grant emergency use authorization for the Pfizer-BioNTech Covid-19 vaccine for children ages 5 to 11. Next, the FDA decides whether to authorize the vaccine, and then the US Centers for Disease Control and Prevention's vaccine advisory committee will meet to consider whether it should be recommended for that age group. If CDC Director Dr. Rochelle Walensky signs off on that recommendation, younger children could be getting vaccinated next week. (Hetter, 10/27)
In related news about vaccines for children —
Atlanta Journal-Constitution:
COVID Vaccine For Younger Children Won’t Be Required In Georgia Schools For Now
The imminent arrival of a COVID-19 vaccine for younger children promises to suppress the spread of the virus, making schools safer and offering a glimmer of hope for parents looking to restore some normalcy into their children’s lives. It remains to be seen, though, how many Georgia parents will get their children vaccinated, a decision they will make without requirements from their schools. While vaccination against diseases such as measles, mumps and rubella have been mandatory in public schools for years, the state has no immediate plans to add a COVID-19 vaccine to the list. (Tagami, 10/26)
New Orleans Times-Picayune:
Louisiana Orders 148K COVID Vaccines For Kids Ages 5 To 11; Pediatricians Prepare To Receive It
A long-awaited moment for some Louisiana families may soon arrive: The authorization for a COVID-19 vaccine for children ages 5 to 11 is a step closer after an advisory committee to the Food & Drug Administration voted to recommend it for that age group on Tuesday. "We could be offering vaccine to children within one to two weeks," Dr. Joe Kanter, Louisiana's state health officer, said at a Tuesday press conference. "That's very, very exciting." Louisiana has ordered 148,000 initial doses for the 421,000 kids in that age group in the state, Kanter said. (Woodruff, 10/26)
AP:
Emails Reveal Dismay, Anger Over Vaccine Chief's Firing
The firing of Tennessee's former vaccination director caught the state's top health leaders off guard and sent them scrambling for answers as the health commissioner fumed over the praise coworkers heaped on the ousted employee, documents show. Earlier this year, Tennessee's Department of Health sparked national attention after Dr. Michelle “Shelley” Fiscus was fired under pressure from Republican legislators incensed over the department's efforts to get children vaccinated against COVID-19. Fiscus accused Health Commissioner Lisa Piercey of terminating her “to appease a handful of outraged and uninformed legislators.” (Kruesi and Mattise, 10/26)