Parents wait as FDA analyzes COVID-19 vaccine for children
CHICAGO – Many parents and children are eagerly awaiting news from vaccine manufacturers and the Food and Drug Administration on progress toward authorizing vaccines for children younger than 12.
Though children are generally less affected by COVID-19, they can still be vectors to transmit the virus in the community. They are key for communities to reach high rates of inoculation, especially as vaccine hesitancy among adults proliferates. Small numbers of children have also become sick with multisystem inflammatory syndrome.
Now that schools are open, the virus could be more likely to spread. Chicago Public Schools reported nearly 500 cases of the COVID-19 virus in the first three weeks of school. And the incoming cooler weather has some parents and children looking ahead with trepidation to another pent-up winter.
“My daughter asked me if I could bring her home a shot the other day,” said Dr. Taylor Heald-Sargent, assistant professor in pediatric infectious diseases at Northwestern University and physician at Lurie Children’s Hospital.
Though 6 and wary of needles, her daughter is ready for a return to normal, Heald-Sargent said.
Here’s what you need to know about the current status of vaccines for children:
When might the vaccine be approved for children 5 to 11?
Pfizer has said it plans to present its trial data for children 5 to 11 to the FDA by the end of the month. As it has for the older age groups, the drug company will ask the agency for emergency use authorization.
After that, the FDA will review the material and make a decision about authorization. Based on the timelines for authorization for other age groups, experts say, it could take about a month for the FDA to make a decision, meaning kids could be authorized by the end of October or early November.
“If they are happy with the data, a month is probably the amount of time it takes,” said Dr. Bessey Geevarghese, a pediatric infectious diseases specialist at Northwestern Medicine Central DuPage Hospital.
Still, doctors cautioned that the timeline is speculative. Geevarghese said the FDA could ask for more data or larger trials if they have concerns. Heald-Sargent noted that two key FDA regulators are leaving the agency, which could affect the workflow.
“There is enough pressure that I hope they will expedite this, not in … cutting corners, but putting it on a high enough priority list,” Heald-Sargent said.
What about children under 5?
Parents with young children will have a longer wait for authorization. Moderna and Pfizer are still studying children under 5.
Geevarghese estimated that the earliest children between about 2 and 5 would be authorized would be early next year.
Vaccine authorization for babies and toddlers under 2 would come even later.
How effective is the vaccine in children?
Doctors don’t yet know how younger children responded in vaccine trials because the data has not yet been made publicly available.
But Pfizer and BioNTech say the trials showed the vaccine was safe and effective in younger children.
On Monday, the companies announced in a news release that children under 12 that participated in trials had a strong immune response to the vaccine. The companies also said that the vaccine showed a “favorable safety profile.”
The children were given a smaller dose than people 12 and older, but showed “robust neutralizing antibody responses,” the news release said.
Doctors noted that the data has not yet been reviewed by people outside of Pfizer.
What should parents do in the meantime?
While waiting for the vaccine, doctors urge parents to ensure the adults and teens around the children – such as friends, aunts, uncles and cousins – are inoculated against COVID-19.
“Getting everybody in the close circle vaccinated is definitely going to help younger kids,” Geevarghese said.
And in cases where adults don’t know the vaccination status of those around them, particularly indoors, then children should continue to wear masks, Geevarghese said.
Doctors also urged parents to have their children get the flu shot, to at least eliminate one source of potential illness.
And if the FDA determines the COVID-19 is safe, doctors say parents should go out and vaccinate their children.
“If the data is there and the safety is validated by the FDA, I definitely recommend younger kids get vaccinated when they are approved to do so,” Geevarghese said.