Starting tomorrow, October 20, states and other jurisdictions will be able to preorder doses of the Pfizer-BioNTech COVID-19 vaccine formulated for children ages 5 to 11, according to a federal planning document. The orders are in anticipation of a rollout that could begin as early as November 3.
The vaccine is not yet authorized by the Food and Drug Administration, and the Centers for Disease Control and Prevention has not yet given the green light for its administration. But US officials are wasting no time in preparing to vaccinate as many children as possible as quickly as possible. There are an estimated 28 million children in the US between the ages of 5 to 11, and the US government says it has enough vaccine doses for all of them. Vaccine doses are planned to roll out at pediatricians’ offices, pharmacies, health centers, and rural clinics when the time comes.
The Pfizer-BioNTech vaccine is currently available for people ages 12 and up. In late September, Pfizer and BioNTech submitted data to the FDA indicating that small doses of their vaccine—a third of the dose used for adults—could safely and robustly protect children ages 5 to 11 from COVID-19. On October 7, the companies formally requested that the FDA grant an Emergency Use Authorization (EUA) for the use of their vaccine in those youngsters.
Now, the FDA’s committee of independent vaccine experts—the Vaccines and Related Biological Products Advisory Committee (VRBPAC)—is scheduled to meet to discuss the EUA on Tuesday, October 26. In the meeting, the advisers will review the companies’ data and the FDA’s own assessment, then vote on whether the FDA should grant the EUA. If they vote in favor, the FDA will likely sign off on the EUA within days. Once an EUA is issued, the federal government can begin shipping the preordered doses to states and jurisdictions.
Next, the CDC will convene its committee of independent vaccine experts to set official recommendations for the vaccine’s use. Vaccine providers are required to follow official CDC guidance on vaccine administration because all of the COVID-19 vaccines are purchased and distributed through the US government—with provider agreements attached. The CDC’s Advisory Committee on Immunization Practices (ACIP) is expected to discuss the pediatric vaccines in a meeting scheduled for November 2 and 3. If the ACIP votes to recommend the vaccine’s use, CDC Director Rochelle Walensky will likely sign off on the committee’s recommendation quickly. Once that happens, vaccine doses that have been shipped out to states can then be administered to children. So if all of that goes smoothly, doses could start going into little arms as early as November 3.
Although it’s widely anticipated that children will get the green light to get vaccinated, VRBPAC and ACIP will carefully weigh the risks and benefits for children and the people around them. Data submitted by Pfizer and BioNTech suggest that the smaller doses for 5- to 11-year-olds led to similar side effects—like injection-site pain and fatigue—as those seen in teens and young adults already cleared to get the vaccines.
But young males are at higher risk of developing myocarditis (inflammation of the heart), a concerning complication linked to the vaccines. Based on extensive vaccine safety monitoring data, the condition appears to be rare, mild, and resolve on its own, though it’s unclear if there are long-term effects. Males between the ages of 12 to 17 seem to have the highest risk. Some estimates suggest there will be seven cases or so from 100,000 vaccine doses administered to males ages 12 to 17. Such a rate is too small to show up in modestly sized trials, so VRBPAC and ACIP members will have little data to go on in assessing the risk in children 5 to 11.
Risks, benefits, and urgency
That said, the risk of myocarditis is clearly highest in those who become infected with COVID-19, not in those who are vaccinated. In a study involving more than 880,000 people ages 16 and up, researchers found that getting the Pfizer-BioNTech vaccine led to 2.7 more myocarditis cases in 100,000 people than if they had not been vaccinated. But cases of COVID-19 led to an extra 11 cases of myocarditis. The study was published in the New England Journal of Medicine last month.
According to data updated on October 18 by the American Academy of Pediatrics, roughly 6.2 million children in the US have reported cases of COVID-19 so far in the pandemic. And children are making up a larger and larger share of cases. In the week ending on October 14, children represented 25.5 percent of all COVID-19 cases reported, even though they make up just 22.2 percent of the US population.
VRBPAC and ACIP will review such data and more as they decide if the benefits of the vaccines outweigh the risks for younger children. Typically, the FDA and CDC follow the advice of their advisers. But the agencies do have the ability to overrule them. Just last month, CDC Director Walensky overruled the ACIP’s recommendations on Pfizer-BioNTech booster doses. Walensky opened boosters up to people with occupational or institutional exposures, such as health workers and teachers. That’s despite the fact that ACIP members had voted nine to six against offering boosters to that group.
In general, the Biden administration has been anxious to get as many people vaccinated as possible to try to bring the pandemic to an end. The preparation for a rollout to children has the same sense of urgency. While preordering will begin tomorrow for pediatric doses, it is just one of three waves of preordering. States and jurisdictions will have 48-hour windows to put in capped orders on October 20, October 22, and October 24. After that, the government will ready orders for shipping following VRBPAC’s meeting on October 26, according to the federal planning document. In addition, to support the massive effort of getting millions of children vaccinated, the government will suspend the distribution of adult Pfizer-BioNTech vaccines for a few days so that it can put all of its efforts into pushing out the pediatric doses.