A White House official on the COVID-19 task force said parents should be patient before getting their children vaccinated as the logistics of getting the specialized doses rolls out.
"We're talking about a specialized vaccine for children," said Jeff Zients, the White House's COVID-19 response coordinator, in an exclusive interview with NPR.
"We are hard at work, planning the logistics and making sure that vaccines will be available at tens of thousands of sites that parents, and kids know and trust. We urge parents to get ready and make a plan, and the program will be fully up and running the week of Nov. 8."
The Food and Drug Administration on Friday paved the way for children ages 5 to 11 to get Pfizer’s COVID-19 vaccine.
The FDA cleared kid-size doses — just a third of the amount given to teens and adults — for emergency use, and up to 28 million more American children could be eligible for vaccinations as early as next week.
The Pfizer authorization for children was based on its "thorough and transparent evaluation" of the data from an independent advisory committee that "overwhelmingly" voted to make the vaccine available to children in this age group.
"As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy," Acting FDA Commissioner Janet Woodcock, M.D. said in an FDA release.
"Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards."
According to the agency, the data from its testing showed that the vaccine was 90.7 percent effective in children ages 5-11, and had similar immune responses to individuals 16-25, and had no serious side effects in an ongoing study of 3,500 children in that age group.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is expected to meet this week to recommend the vaccination for the children.
Like its adult counterpart, the lower dose Pfizer vaccine for children is administered in two shots three weeks apart.
According to the FDA, the vaccine administers 10 micrograms of the vaccine compared to 30 micrograms for people ages 16 and older.
"The FDA is committed to making decisions that are guided by science that the public and healthcare community can trust. We are confident in the safety, effectiveness and manufacturing data behind this authorization," Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research said in the release.
"As part of our commitment to transparency around our decision-making, which included our public advisory committee meeting earlier this week, we have posted documents today supporting our decision and additional information detailing our evaluation of the data will be posted soon. We hope this information helps build confidence of parents who are deciding whether to have their children vaccinated."
According to the NPR report, Zients said 15 million child vaccine doses are being prepared and will be shipped to 20,000 locations around the nation, pending the CDC’s decision next week, and there are enough vaccinations ordered for the country’s estimated 28 million children in that age group.
"While we hope to see the first set of kids start to get vaccinated at the end of next week, the bulk of vaccines will be in their locations by the week of Nov. 8," Zients told NPR. "Between now and then, the program will be ramping up to its full strength."
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