- The Pfizer/BioNTech COVID-19 vaccine appears to be safe and effective for children between the ages of 5 and 11, according to data released by the company.
- Children under 12 are not currently able to get any COVID-19 vaccine.
- For younger children, the drugmaker tested a dose that’s only a third of the amount that’s in the shots given now.
- Side effects appeared to be more mild for children.
Pfizer announced Monday that clinical trials of the company’s COVID-19 vaccine for children ages 5 to 11 showed promising results.
According to a press release from the drugmaker, results showed that the vaccine is safe for children and establishes a strong antibody response against the virus.
“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination,” Albert Bourla, chairman and chief executive officer of Pfizer, said in the statement on Sep. 20.
“These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” Bourla said.
According to Pfizer, for younger children, the drugmaker tested a dose that was only a third of the amount that’s in the shots given now.
Yet after a second dose, children ages 5 to 11 developed protective antibody levels as strong as what’s seen in teenagers and young adults receiving the regular-strength shots.
For the clinical trial, over 2,200 children between 5 and 11 years old were given a two-dose regimen of 10 micrograms (μg) administered 21 days apart.
According to Pfizer, side effects were “generally comparable” to those experienced by people between ages 16 and 25 who received the vaccine.
“Side effects were milder in this age group than with adults and older children. Low grade fever [and] injection site pain were the most common side effects,” Dr. Eric Cioe-Peña, director of Global Health for Northwell Health in New York, told Healthline.
However, despite the encouraging results, we’ll have to wait before we see an official rollout of vaccines for children ages 5 to 11.
After analysis of the trial data is completed, Pfizer said they will submit the results “in the near term” to the Food and Drug Administration (FDA) for review and possible emergency use authorization (EUA).
According to Cioe-Peña, vaccinating this age group is essential not only to control disease spread, but to help stop the cycle of shut downs that new cases bring — and help us get back to normal.
“Kids being in schools is important for their academic and social development, and for the economy,” he said.
Cioe-Peña emphasized not only is this age group, in particular, at risk because remote schooling is not as effective for them, but parents also need the ability to work.
“With an unvaccinated population, the threat to schools closing with COVID cases will paralyze the economy and prevent us from moving past this pandemic,” he said.
The Delta variant has caused a significant uptick in new cases, especially among children, reports the American Academy of Pediatrics (AAP).
Cioe-Peña confirmed that the pediatric age group is especially affected.
“Yes, the Delta variant is very infectious in kids,” he said. “Much more so than when compared to Alpha.”
“It’s resulting in more widespread infections and more sick kids,” he continued. “Not because it’s more serious symptoms, but because the same small percentage of children that get very sick is a much bigger number with so many infections in the pediatric age group.”
Instead of testing whether the vaccine prevented COVID-19 illness for this age group, as was done for adults, Pfizer looked at antibody levels generated by the vaccine.
The FDA approved this approach to speed the study of the vaccine for children who are beginning their new school year in most of the United States.
Cioe-Peña said parents shouldn’t hesitate to have their children vaccinated as soon as they’re eligible.
“Know that this vaccine has been extensively tested, that children do better with vaccination than adults,” he said. “I have two children, 4 and 6 years old, who will both get vaccinated as soon as they’re eligible because I know that that decision is in their best interest.”
Pfizer recently announced encouraging results from a clinical trial of children ages 5 to 11. The drugmaker gave children a dose one-third of the adult one to find they developed a robust antibody response.
Experts say the side effects are milder for younger children than seen in adults, and that vaccinating children is in their best interest.
They also say that having elementary school-aged children vaccinated against COVID-19 will relieve the threat of schools closing due to new cases, and allow parents to get back to work — and help all of us to move past the pandemic.