Pfizer-BioNTech has cleared its first hurdle for getting their vaccine approved for children ages 5-11 from the FDA. On Tuesday, an advisory panel voted to approve the vaccine for emergency use in this age group. It’s the next big step in getting shots into the arms of kids, as parents patiently wait for their children to get vaccinated against COVID-19.
The FDA is expected to make its final ruling in the coming days. If approved, children in this age group could become eligible for shots the first week of November.
Deciding whether to approve has weighed heavily on FDA advisors who must consider whether the vaccine is necessary in children, who have been less susceptible to COVID, and whether the risks of side effects outweigh the protection of vaccination.
While the vaccine is a smaller dose of the adult version, it’s unknown what the long term side effects will be, in particular regarding the heart condition myocarditis.
If approved, this would be the first vaccine available to kids under age 12 and could potentially protect over 28 million people, according to The New York Times. Pfizer tested its COVID vaccine on 4,500 children worldwide, with 2,268 participants enrolled in the 5-11 age group. The children in the study showed a strong immune response one month after the second dose, said Pfizer.
Dr. Maya Ramagopal, associate professor at the Rutgers Robert Wood Johnson Medical School, told New Jersey Family that the FDA is expected to approve Pfizer’s request after looking closely at all the data that has been collected from the trials. Ramagopal said that the vaccine for kids 5-11 is one-third of the dose given to adults.
In the meantime, she said that parents should continue to follow all of the COVID safety measures that have been put in place.
“The Delta variant is more contagious,” she said. “We are still telling children to use masks indoors and in school and when they cannot be sure whether the people around them are vaccinated. They should also continue with social distancing.”
She says she understands the predicament many parents who are vaccinated and may have older children who are vaccinated are in.
“We are telling parents to continue to use their best judgment,” she said, acknowledging that parents cannot be watching their kids constantly.
“Without going completely overboard, have the children mask up and stay away from someone who seems sick,” she advised.
She also noted that now that fall is here, we are seeing other respiratory viruses which may be confused for COVID. The incidence of these cold viruses is up since last year, when everyone was staying indoors.
“We completely empathize with parents who are confused,” she said. “But right now, nothing has changed regarding our recommendations. Use common sense as much as possible,” she advised.
And when the vaccine becomes available, she hopes that parents will get it for their children.
“The study has been done very diligently,” she said. “People think it’s rushed but it’s not. This is a safe vaccine, it’s not a live vaccine and you’re not going to get COVID from it.”
She also addressed fears that the vaccine won’t be safe long-term.
“We have not had a COVID-19 vaccine, but the mRNA technology has been used for other vaccines such as Zika and HIV so the modality is tested and it is a safe one,” she said. “What we’re seeing now, it’s minor side effects like pain at the site, low-grade fever. Actually getting COVID is going to be far worse than some minor side effects. It’s not true that children are not getting very sick. Even after recovering people are having long-term fatigue, breathing problems and some are unable to do things before they got COVID.”
In the meantime, screening testing has ramped up at both public and private schools in the Garden State in an effort to get a better picture of how the virus is spreading.