Most school systems across American have opened, but a COVID vaccine for children under 12 has yet to be approved. For those parents who want to vaccinate their children, it’s an anxious time. The delta variant of the coronavirus is infecting more children, although there’s no evidence that there are large increases in hospitalizations and deaths.
But children with some of the same risk factors as adults are still vulnerable to the disease. And while the efficacy of the vaccines is debated, it’s vaccine safety that most concerns parents.
To that end, the FDA is moving slowly in approving a vaccine for kids under 12. Drug manufacturer Pfizer has had a vaccine in clinical trials, but the process to approve a vaccine for use in children is more detailed and laborious than it is for vaccines approved for adults.
The manufacturer believes it will be late fall or winter before emergency use of a vaccine is approved, according to Dr. Scott Gottlieb of the Pfizer board.
“The application probably isn’t going to be submitted until some point in October,” said Gottlieb, who led the FDA from 2017 to 2019 during the Trump administration.
“If the FDA sticks to its normal timeline, in terms of how it reviews these applications, you would expect that review to be a four-to-six week review for a potentially emergency use authorization, so that puts you on a timeline where you’re late fall, early winter,” Gottlieb added in a “Squawk Box” interview.
Gottlieb’s expectations are in line with recent remarks from White House chief medical advisor Dr. Anthony Fauci on NBC’s “Today” show.
While the Pfizer-BioNTech Covid-19 vaccine has gotten conditional approval for use in adults over 18, the regulatory hoops that manufacturers have to jump through for FDA approval for emergency use in children are daunting. Dr. Gottlieb says that the timeline of late fall or winter for emergency use of a children’s vaccine is an “optimized scenario if everything goes right and this is an accelerated review like the other applications have been.”
Otherwise, it could be many months longer.
The former FDA chief left open the possibility the timeline could change. It’s possible it could be delayed if the drug regulator decides it wants a “three-to-six month median follow up of the kids in the clinical trials,” Gottlieb said, which would offer “a longer-term view of how they perform over time.”
On the other hand, Gottlieb said the highly transmissible delta variant, which has sparked a resurgence in coronavirus cases, hospitalizations and deaths among Americans, could impact the vaccine review process the younger kids.
“If we continue to see these accelerating rates of infections in kids, particularly as the delta variant moves to the Northeast, I think there could be more pressure to try and make an earlier authorization for a vaccine,” Gottlieb said.
Many doctors disagree with the idea that vaccinating children is key to ending the pandemic. They point to the wide differences in the immune systems for children vs. adults and that developing a safe, effective vaccine for kids of all ages is very difficult.
“Children’s immune systems are growing up just as they are,” explains Dr. Esper. “We often split kids up by age groups and stages. We can’t just say all kid’s immune systems are the same at any given age.”
For adults, we’re often lumped together from age 18 to 65 and then 65 and over. With children, there is a much wider range in terms of stages and ages because they are still growing and developing. All of this has to be taken into consideration with a vaccine since kids at varying ages will likely respond differently.
Still, parents should be given the option of whether or not to vaccinate their children. For some kids with conditions like asthma or an immuno-deficiency disease, a vaccine could be a lifesaver.
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But that should be up to the parents and not health or education bureaucrats.