FDA Expected to Approve Pfizer Vaccine for 12-15 Year Olds
Army Spc. Angel Laureano holds a vial of the COVID-19 vaccine, Walter Reed National Military Medical Center, Bethesda, Md., Dec. 14, 2020. (DoD photo by Lisa Ferdinando) [Public Domain] via Wikimedia Commons
The FDA will consider granting emergency use authorization for the Pfizer vaccine that is already in use for those 16 and up for children as young as 12.
The Food and Drug Administration is expected by next week to grant expanded emergency use authorization to allow children as young as 12 to receive the coronavirus vaccine developed by Pfizer and German firm BioNTech, according to three federal officials familiar with the situation.
The agency is still working on the authorization, said the officials, who spoke on the condition of anonymity to speak freely. Shortly after the FDA decision, a Centers for Disease Control and Prevention advisory committee is expected to meet to recommend how the vaccine should be used.
The New York Times first reported that the regulatory action was pending.
Families and pediatricians have been eager for a vaccine to become available for children, particularly in advance of the next school year.
Stephanie Caccomo, a spokeswoman for the FDA, declined to comment on the timeline.
“The FDA’s review of Pfizer’s request to amend its emergency use authorization (EUA) in order to expand the age range for its COVID-19 vaccine to include individuals 12-15 years of age is ongoing. We can assure the public that we are working to review this request as quickly and transparently as possible,” Caccomo said.
The FDA authorized the Pfizer-BioNTech vaccine for use in people 16 and older in December.
Pfizer announced at the end of March that it had submitted data from a trial of nearly 2,300 adolescents between 12 and 15 years old, half of whom had received the same two-shot regimen that has been shown effective and safe in adults.
The shot triggered stronger immune responses in the teens than those found in young adults. There were 18 cases of covid-19 in the trial, all of them among adolescents who received a placebo, suggesting the two-shot regimen offered similar protection to younger recipients as it does to adults.
Children are far less likely to suffer severe illness from covid-19, the infection caused by the virus. About 300 children have died in the United States, out of more than 576,000 total deaths.
Moderna is also expected to seek approval for their vaccine.
One expected effect, if approval for children young as 12 is granted, is increased debate about what will happen for schools. Vaccinations have long be required for school-aged children before attending, but the legalities of enforcing a vaccine that is only emergency approved would complicate efforts to enforce. School systems are going to want such enforcement, and there is bound to be some public pushback if they do, along with more debate about the very uneven application of Covid protocols, closings, and re-openings across school systems. Not to mention the small but loud chorus of bad faith, bad information, and flat-out misleading arguments against vaccines in general.
The complications are apparent in states like Florida, which is lifting restrictions, running vaccination programs on-campus at public schools, and at the same time legislating that it will not be allowed to force proof of Covid-19 vaccination.
Even as Covid the disease and human tragedy seems to — hopefully — be ebbing, the argument of Covid the crisis of governing is still to be resolved.
I was talking this over with my girlfriend last night. Her daughter just turned 14. She (my girlfriend) got vaccinated in January and struggled with the experience. She had some hesitancy about getting the shot and would have preferred more of a “wait-and-see” approach. But she was pressured by her employer (a private school) and ended up among the first of the general public fully vaccinated. I had no hesitations and got my doses shortly after her, owing to a separate scheduling conflict; otherwise, I’d have gone the same day as her.
She continues to have some hesitancy about getting it for her daughter. One thought she had was that she is past the point of having kids while her daughter will one day… could this vaccine possibly impact that*? And while I haven’t seen ANYTHING related to the vaccine and reproductive health, we’re not yet at the point where someone has gotten vaccinated and then had a child… such is the newness of all this. So we can’t exactly point to all the people who have had pregnancies completely unaffected by getting vaccinated.
She asked if I’d get my sons (ages 8 and 6) vaccinated. My feeling is that, if the testing/study for that age group is as thorough as it was for the adult age groups, I’d have no reluctance.
We then talked about who would be administering the shots. She’d prefer to goto her daughter’s pede… the relationship they have would offer some peace of mind. By and large, I think we need to make getting the shot the easiest thing people do and imagine we’ll see shifts in where you can get it, perhaps in your own doctor’s office. I could see that being a huge factor for parents.
Lastly, we discussed how this vaccine feels — and maybe is — different than the regular vaccine schedule most of us follow for our children without much thought. While those shots have an eye on herd immunity, they are primarily intended to protect the recipient from really awful diseases. The Covid vaccine seems differently because we’d be giving it to kids as much — if not more — to protect those around them than to protect them directly. I think that matters in a few interesting ways.
Current vaccine requirements are basically about saying to parents, “We think this thing is so good for your child, we’ll force you to do it on their behalf.”
A Covid vaccine requirement may be more like, “We don’t want the teachers or other adults around your child to get sick and this could go a long way towards further reducing their risk.”
That’s… different. More justifiable? Less? Hard to say.
Assuming the vaccine gets whatever approval isn’t Emergency Use, I anticipate schools moving towards requiring it just as they do so many others. Hell, it was just a couple years ago NYC (maybe New York state?) moved to requiring flu shots for kids.
Some of the devil details will depend on how easy it is to get an exemption to such requirements, which varies pretty wildly state-to-state, and whether Covid is treated differently than others.
This is a hugely positive step but not without a whole bunch of tripping points along the way.
*She had difficulties getting pregnant and had to use IVF and as a result only has the one daughter when she would have liked to have more, so this is an area of particular importance and concern for her.Report
The reproductive health thing must be used by the anti-vax forces because I’ve heard that a fair amount. A quick google search says there’s nothing to that. My expectation is the argument is an effort to raise the goal posts for acceptable evidence so high that they can’t be passed.Report
That may be so. I don’t think that’s the case w/r/t her initial fears; due to her own experiences, her daughter’s reproductive health is a pretty constant concern for her.
That said, her Googling the topic could certainly leave her vulnerable to bullspit anti-vax nonsense that preys on those very fears.
From what I’ve read, it seems about age 12 is the dividing line between “child” and “adult” as far as Covid is concerned. If puberty is somehow a factor in how the body responds, that all sort of fits. And thus it makes sense that the 12-16 trial group showed the same response as the next age cohort up.
Though now we’ve created this kind of weird group of 2-12 year olds, who must be masked, can’t get vaccinated, seem least impacted by the virus, yet remain among the most restricted. Go figure.Report
When my kids were little, their pediatrician pushed the chickenpox vaccine pretty hard. I always turned him down, with the knowledge that it wouldn’t kill them to get it. Sure enough, they caught it somewhere, though by that time (early 2000s) it was becoming increasingly rare due to the vaccine becoming popular. As it turned out, they both survived the experience, and as far as I know, didn’t pass it on to anyone.
I don’t have to face the choice about the COVID vaccine because my kids are now both fully vaccinated adults. But I like to think I’d realize my kids could be carriers even if getting it would have very little chance of affecting them, and there’s a very real chance they could pass it on to someone very vulnerable. It would be tough to live with that uncertainty.
When my doctor says to me, “This stuff’ll kill ya”, I tend to listen.Report
What was your reason for turning it down? Just not concerned enough about the disease itself?Report
Exactly. Chickenpox just isn’t that big a deal. In hindsight, I maybe should have done it, but that ship sailed 20 years ago.Report
Get the Shingles Vaccine if you are 50 or older.
People who had Chickenpox are much higher risk for shingles.Report
I’ve talked to my doctor, actually, about that. At my current age the risk is pretty minimal.Report