Here’s what to know about how the Pfizer vaccine works in adolescents, and what to expect.
Giddy parents of 12-15-year-olds are still rejoicing at the news that their children are on track to get the COVID-19 vaccine after the US Food and Drug Administration (FDA) approved the use of the Pfizer vaccine in adolescents Monday.
Here’s what you need to know about the approval, the safety and effectiveness of the vaccine, and when parents can expect to get appointments for their children.
How do I know the vaccine is safe for my 12 year old?
They are very safe for the vast majority of people, producing only mild side effects.
Dr. Michael Smith, a pediatrician and the medical director of the Duke Children’s Health Center Infectious Diseases Clinic in Durham, helped conduct the Pfizer trials in this age group. The data, he said, shows the vaccine to be as safe in adolescents as it is in adults, and could even be more effective.
“The most common things that we are seeing were not surprising to anybody – it hurts; it can be a little bit red; your injection site can be a little bit swollen,” Smith said in a Zoom conference call with reporters on Tuesday. Headaches and low-grade fevers can also occur.
And though some of these common and mild side effects can be a little worse in this age range, he said, it is only because their immune systems are younger and stronger.
Just like with adults, a strong immune response to the vaccine is simply a sign that it’s working. The arm might be a little sorer, the headache a little stronger, he said, but the side effects go away within 24 hours. Though Pfizer has not released a detailed account of all its data, there were no reported instances of severe side effects.
“I have no doubt in my mind that this is a good idea, if you have a 12- to 15-year-old at home, to give them the vaccine,” Smith said. “At this point there is no reason not to.”
How effective will the vaccine be for adolescents?
“The important thing to note is that of the children in the trial who ultimately had a COVID infection, all of them were in the placebo group, and none were in the vaccine group,” Dr. Smith said. “So if you got the vaccine in this trial, you did not get COVID. That translates to a vaccine that has 100 percent efficacy.”
It’s a big exciting number, 100% protection.
But, as with all vaccines there is no such thing as true 100% protection. Once the pool is expanded, there are sure to be some children who contract the virus after getting the vaccine. This has happened in every vaccine ever made. But, just like with vaccinated adults, any vaccinated child who gets COVID will still have profound protection against the worst effects of the disease. Data on the vaccines in adults show far lower rates of hospitalizations and virtually no deaths.
When can I get my children their vaccine?
Soon, maybe even as early as Thursday, Smith said.
Now that the FDA has approved the use in children, the Centers for Disease Control and Prevention (CDC) must formally sign off. A group of CDC experts will vote Wednesday one way or another and then the CDC director will make her formal recommendation. Both the committee and the director are expected to give their seal of approval. Then the CDC will help decide how the vaccines will fit into the larger vaccine process. NC has followed CDC directives so far and is expected to in this case as well.
Because 12-15-year olds will be getting the same dosage, supply should not really be affected, at least in the short term.
But, there is a lot of demand out there, he said, and there could be some scheduling issues after the first few weeks.
Still, he said, it will be a “nice problem to have” if demand for the vaccine remains strong, and there is still plenty of vaccine out there.
Do children need parental permission to get the vaccine?
No. While parents or guardians can give permission for their children to get the vaccine, North Carolina law also allows minors to give consent to physicians for vaccines or other related treatments for some infectious diseases, which, according to the NC Department of Health and Human Services, applies to COVID.
NC General Statute 90-21.5 says that “[a]ny minor may give effective consent to a physician licensed to practice medicine in North Carolina for medical health services for the prevention, diagnosis and treatment of (i) venereal disease and other diseases.”
But it is not quite clear what happens if a parent says “no” but their dependent child says “yes.” That premise just hasn’t been widely tested, but so far 16- and 17-year-olds have not needed parental permission.
What about younger children?
While 12-15-year-olds will get the same dose as adults, younger children will likely need less. And how much less is what doctors and scientists are trying to figure out now.
Smith said Duke is among those conducting small-scale trials on children under 12 to see what dose is right. Once that is determined, he said, the trials will broaden to gauge effectiveness and safety. News reports have indicated that Pfizer expects to know those full results in September, and that a similar fast-track approval process for complete approval of the vaccine could come soon after.
Will children need a booster?
It’s too early to tell, though it is likely that emerging variants of the virus will indeed mean that we’ll need updates. Moderna is already working on a booster for some variants, and the best news so far is that all vaccines show at least some protection against the existing variants of concern.
“My best guess is, yes, we probably will need boosters,” Smith said.
But the logistics of such an undertaking won’t be cumbersome. The Pfizer and Moderna vaccines use what is called messenger RNA to train your immune system to spot the coronavirus’s unique spike proteins. Most of the mutations in the virus occur in this spike protein, which it uses to invade your cells, and mRNA vaccines act like spies and fight trainers all at once. The vaccine gives your immune system the intel on the spike protein and shows it how to immediately recognize the intruder and kill it. When the virus mutates in its spike protein, however, the difference can be enough to elude the body’s vaccine-trained defenses.
Boosters would be tuned directly to the specific proteins of whatever variants are most troublesome and it would be relatively easy to plug in the new data and make new vaccines. “The technology is there”, Smith said, and the process should be relatively seamless.
So … should I get my child vaccinated?
Yes, Smith said.
“Let’s be clear,” Smith said, “kids are affected by this.”
Vaccines will help children restore what was lost, he said.
“I think all of us—whether we are parents or grandparents or physicians—can clearly see the impact that this pandemic has had on kids. And anything we can do to reduce disease incidence and disease transmission in kids, to get society back open to the way it was pre-pandemic, I think is useful.”