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The U.S. Food and Drug Administration on Friday authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine on children ages 5-11, marking a long-awaited milestone in the nearly two-year fight against the deadly virus that experts say has likely already infected nearly half the population in that age group.
In Texas, that could mean up to 2.9 million children are eligible for the vaccine.
The federal regulatory agency said the vaccine is safe and effective for children in that age group. The Pfizer test results shared with the FDA show that its vaccine prevents symptoms in most children and causes no side effects more serious than those already seen in older age groups. FDA panelists decided that the benefits of the vaccine for children ages 5-11 — many of whom have suffered isolation, depression and learning loss throughout the course of the pandemic — outweigh the risks associated with the Pfizer shot.
“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,” said Dr. Janet Woodcock, acting FDA commissioner. “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.”
Still uncertain, however, is whether the U.S. Centers for Disease Control and Prevention will limit the shots to only children with preconditions that put them at high risk of serious disease from COVID-19 — a decision expected next week.
The FDA’s announcement, which follows a recommendation by its vaccine advisory panel earlier this week, triggers an initial federal allocation of more than a million doses destined for children ages 5-11 to providers in nearly half of Texas counties. Those will start landing in Texas pharmacies, pediatrics offices, health clinics and hospitals within a few days, state health officials said.
After the first federal shipment, others will continue on a weekly basis. The amounts will vary based on providers’ requests, officials said.
As with other age groups authorized to receive the vaccine, the shots will be free and require two doses to be fully effective.
The vaccines cannot be given to kids, however, until the U.S. Centers for Disease Control and Prevention releases the rules for administering the shot: who qualifies for it, what information must be disclosed to parents at the time it’s given and other safety parameters not outlined in the FDA’s decision.
CDC advisers are expected to meet next week, with an announcement by the agency to follow shortly after. The agency could decide that the vaccine is appropriate for all or most children, limit its use to only those determined to be at a high risk for death or hospitalization from COVID-19, or impose other limitations or guidelines.
Data from the CDC presented during the FDA panel meeting suggested that as many as 40% of the nation’s 28 million children ages 5-11 had already caught the virus and that about one-third of those hospitalized from it had no prior medical history that would have flagged them as high risk.
Only the Pfizer-BioNTech vaccine has been recommended for use in minors, including the 5-11 age group. The Moderna and Johnson & Johnson vaccines are still authorized for use only in adults.
FDA: Safe and effective
This version of the Pfizer vaccine contains one-third of the dosage given to people ages 12 and up. But Pfizer officials say it still offers the same level of antibody response triggered in 18- to 24-year-olds. The Pfizer trial involved some 4,600 children over three phases, with about 3,100 receiving the vaccine instead of a placebo.
Pfizer told panel members both in remarks Tuesday and in briefing documents that its vaccine is 91% effective in preventing symptomatic transmission in kids. The test group showed no new side effects — nothing worse than had been seen in older groups — and no incidents of myocarditis, a rare heart inflammation that has occurred in some male adolescents and young adults after taking one of the mRNA vaccines.
There have been no reported deaths from vaccine-induced myocarditis, FDA experts said this week.
Any side effects were described by Pfizer as “mild to moderate” and typical of those experienced by children after receiving common childhood vaccines. If symptoms appeared, they arose in the first two days and went away quickly, the trials showed. Most common among them was pain around the injection area, while other reactions sometimes included fatigue, headache, muscle pain and chills.
Providers will be strictly prohibited from administering diluted adult-sized doses to children. Providers who violate these instructions could have their COVID-19 vaccine provider authorization pulled.
The kid doses are being packaged with smaller needles and orange packaging to differentiate them from purple-topped adult doses.
Moderna and Johnson & Johnson are conducting their trials for the same age group but have not yet released their test data. Pfizer is already doing trials for two younger age groups: 6 months to 2 years, and 2-5 years. The pharmaceutical company’s data on the older segment is expected early next year.
No school mandates in Texas
The FDA ruling did not address whether the vaccine should be mandated for school attendance or other activities, and the CDC’s decision next week will not address that either. Leaders of both of those agencies have said it is not their responsibility to make those decisions.
In Texas, there is no indication that Republican lawmakers and state leaders, who have adamantly opposed all COVID-19 vaccine mandates, will require children to receive the COVID-19 vaccine to attend school in the state.
Since the vaccine was approved for children 12-15 earlier this year, there have been no moves to require it at middle or high schools.
Texas already requires some vaccines — such as hepatitis C, polio and measles — for children attending school but has many exceptions for parents who wish to opt out.
School districts across the state are already making plans to administer the vaccine. The Austin Independent School District will host vaccine clinics just as it did when COVID-19 vaccines were first approved for children over the age of 12 at the beginning of summer. Since then, these clinics have vaccinated more than 9,000 children in the Austin area.
In Big Spring Independent School District, which has about 3,700 students, Superintendent Jay McWilliams said a section of the district’s high school will be used as a vaccine clinic.
Cassidy McBrayer, superintendent for the Hawley Independent School District, north of Abilene, said there won’t be a big push in her district to set up any clinics because they're not sure if there will be a demand for them.
In Texas, the Legislature determines which vaccines are mandatory for school, not the state’s health agency.
Young children and COVID-19
Federal health experts said this week that children ages 5-11 are “at least as likely” as adults to catch the virus, contradicting some early theories that they were less susceptible to transmission.
Nationally, 8,300 children ages 5-11 have been hospitalized with COVID-19 to date, Dr. Fiona Havers, a viral disease specialist at the CDC, told FDA panelists.
Native American, Hispanic and Black children were three times more likely than white children to be hospitalized, she said.
While the Texas Department of State Health Services maintains unreliable information on age breakdowns of positive COVID-19 cases, schools have regularly reported infections on campuses and can offer an idea of the spread among minors.
Three months into this school year, the number of total COVID-19 cases reported among students surpassed the total from the entire 2020-21 school year. As of Oct. 17, Texas schools had reported around 200,000 total student cases, or roughly 4% of students, since the beginning of this semester.
Some 272 school districts nationwide have had unplanned closures this school year due to COVID-19, with more than 2,000 schools and 1 million students affected, Havers said. That includes at least 45 small districts in Texas that shut down in the first few weeks of this school year.
After reaching their highest hospitalization numbers of the entire pandemic earlier this summer, Texas hospitals have reported that the number of kids showing up with COVID-19 is starting to decrease.
As of Oct. 22, DSHS data shows that 31 out of nearly 69,000 COVID-19 deaths reported in Texas were children younger than 10, a very small fraction of the statewide death toll.
According to the Pfizer brief filed with the FDA, there was a 419% increase in COVID-19 cases among children younger than 18 in the United States in August and September compared to June and July. COVID-19 was among the top 10 leading causes of death for children 5-14 years of age nationwide between January and May, according to the CDC, although the mortality rate from COVID-19 for that age group remains small.
Among children 5-11 years old nationally, there have been nearly 2 million confirmed and reported cases of COVID-19 and at least 143 deaths.
FDA officials said Friday they hope parents will get their children vaccinated quickly, and that they believe hesitant parents would likely be encouraged to do so as more and more kids get vaccinated and return to normal pre-pandemic activities that have been absent in their lives for nearly two years.
"As we accumulate more experience with the vaccine, more comfort with the safety will occur,” Woodcock said. “We’re watching the safety all the time. ... I would get them vaccinated now. I would not want to take the risk that they would be one of the ones who would develop long COVID, or develop multi-system inflammatory syndrome, or have to be hospitalized from the virus."
Mandi Cai and Brian Lopez contributed to this report.