ATLANTA - The FDA's decision late Friday to authorize Pfizer-BioNTech's pediatric vaccine for children ages 5 through 11 set in motion a massive campaign to vaccinate 28 million American children.
White House Coronavirus Response Coordinator Jeff Zients told reporters the rollout began within minutes of the FDA's announcement.
"We began the process of moving 15 million doses from Pfizer's freezers and facilities to distribution centers," Zients says. "There, millions of doses are being packed with dry ice and tracking labels before they're loaded into small, specialized shipping containers."
The vaccines will be shipped by ground and air to about 20,000 pediatric providers across the US, he says.
Children's Medical Group in Atlanta received its first shipment of vaccine supplies but not the actual vaccine, which is a third the dose of the vaccine for teens and adults 12 and older.
The Georgia Department of Public Health had ordered about 145,000 doses as of Friday, gearing up to vaccinate nearly a million children ages 5 through 11.
So far, the state has signed up 1,760 pediatric vaccine providers.
"Over the next couple of days several million doses will start arriving at local pediatricians and family doctors' offices, pharmacies, children's hospitals, community health centers, rural health centers, and other locations," Zients says.
Because the Pfizer pediatric vaccine is specifically formulated for younger children, none of the available vaccines teens and adults are receiving can be used to vaccinate kids 5 through 11.
Providers cannot start giving shots until the CDC makes its final recommendations, which could come Tuesday or Wednesday.
CDC Director Dr. Rochelle Walensky says the children's vaccine efficacy proved nearly 91 percent effective in preventing the COVID-19 vaccine in the pediatric vaccine trial.
"There were only 3 cases of COVID-19 in the over 1,300 children who received the vaccine and 16 cases in the 660 children who received placebo," Dr. Walensky says.
The FDA Advisory Committee also reviewed safety data from an additional 2,000 children, Walensky says, and found no severe adverse events.
The most common reported post-vaccine side effects included soreness at the injection site, headaches, muscle aches, and low-grade fevers, all similar to side effects experienced by adults who were vaccinated.
"We know the possibility of vaccines for children will be a welcome relief for many families, and we also know parents will have a lot of questions," Dr. Walensky says. "I would encourage parents to ask questions as they consider the benefits of vaccinating their children."
Once the CDC makes its recommendations, parents and guardians will be able to go to www.vaccines.gov, type in their zip code and search for pediatric vaccine providers in their area.
White House officials say it will take a few days to ramp up the rollout, but millions of doses should be available by early next week.
"Bottom line: we've been planning and preparing for this moment," Zients says. "We are ready to execute, pending the CDC's decision. And starting the week of November 8th, our vaccination program for kids ages 5 through 11 will be running at full strength."