Children under 12 years of age waiting for vaccine against convid-19 1:20
(CNN) -
Americans 12 and older can get vaccinated against COVID-19, but younger children are still waiting. Just weeks before the fall semester reopens in many U.S. schools, pharmaceutical companies Pfizer and Moderna continue to conduct clinical trials to see how coronavirus vaccines work in children under 12 years of age, if they are safe and what should be the appropriate dose.
Meanwhile, in all but four states, there is an increasing trend in cases, with doctors describing patients younger and sicker than those they saw in the winter.
The increase in cases makes many parents of children under 12 years old wonder when their little ones and not so young will be able to get vaccinated.
The answer is that there are still months, if not more.
It is not as simple as administering the doses available for adults to the very young.
"I understand parents' concern about wanting their children to be vaccinated, but we have to make sure that we are doing the best and safest thing for children," said Dr. Chip Walter, a Duke University pediatrician and researcher for the Pfizer trials.
When could we vaccinate children under 12 years of age
Pfizer's COVID-19 vaccine study has more than 4,600 participants in three age groups: children ages 5 to 11, children ages 2 to 5, and infants 6 months to 2 years.
Data for children ages 5 to 11 could come in sometime in September, and based on the results, the company told CNN it could ask the U.S. Food and Drug Administration (FDA, for its that authorizes the emergency use of the vaccine that same month.
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A pediatrician considered "essential that Pfizer vaccines arrive for children"
Data for 2- to 5-year-olds could come in shortly thereafter.
For younger children, Pfizer said it could get data in October or November, and soon after ask the FDA to authorize emergency use.
Emergency use considerations by the FDA can take several weeks, meaning that the vaccine for younger children probably won't be available until late fall or even next year.
Moderna's COVID-19 vaccine study has about 6,700 children between 6 months and 11 years old.
He declined to provide CNN with a deadline on when he might have the trial results.
"Companies have said that in the fall ... I would be surprised if they could move forward so quickly, although I suppose it is possible," said Dr. Peter Hotez, an immunologist and dean of the National School of Tropical Medicine at Baylor College of Medicine.
Moderna's covid-19 vaccine will be available for children from 5 years old
"I cannot imagine that we will be in a position to even consider how to use these vaccines until the very end of calendar year 2021, entering the first quarter of 2022," said Dr. Buddy Creech, a specialist in pediatric infectious diseases at the University of Vanderbilt and one of the principal investigators of Moderna's pediatric COVID-19 vaccine.
"I love that we are riding the success of how quickly we were able to get an adult vaccine, but we have to be patient."
"Children are not just little adults"
A year and a half after the pandemic started, parents might wonder why there is still no vaccine for younger children.
After all, some young children are as big as the older ones for whom the vaccine is licensed.
"It's something I've discussed with several parents," says Dr. William Schaffner, a professor in the Division of Infectious Diseases at Vanderbilt University and a vaccine advisor to the US Centers for Disease Control and Prevention. (CDC).
"It has nothing to do with size. It has everything to do with the maturity of the immune system, and that does not correlate one-to-one with the size of the child."
Young children may need different doses.
They may need a different number of doses.
They may not need as many doses.
We don't know in the case of young children, "Creech said." Children are not just little adults. "
And children are not all the same either.
"What you see in a 6-month-old child may differ from what you see in a 3-year-old versus an 8-year-old child, or versus a 13- or 14-year-old. Therefore, it is necessary to take each age separately and evaluate the vaccines, "said Walter.
The delta variant leaves children vulnerable to covid-19.
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Creech said that finding the ideal dosage for young children takes time.
If too low a dose is given, the child may not have a sufficient immune response to the coronavirus.
In that case, they will receive a vaccine that can have side effects with little or no benefit.
"We never like to do that. That is far from good," Creech said.
But if too much is given to children, the scale tips in the other direction.
"You get a good immune response, but things like fever, arm pain, fatigue and irritability are triggered unnecessarily," he said.
"If I get a vaccination and my arm hurts all day, my wife may tease me, but it's not that bad. I'll just complain a little. But if a two-year-old gets a shot in the thigh and she has such severe leg pain that she cannot crawl or walk, because now we have a different problem, and that produces much more anxiety. "
Monitoring of the effects on minors
For the little ones who may be close to being eligible, the reason they can't get the vaccine is also, in part, a bit arbitrary.
"Certainly some children are older than others. There may be a really large 10-year-old who is the size of a 12-year-old for whom the vaccine is indicated, but generally we work with recommendations for certain age groups and it's best to stick to that guidance, "said Walter.
Hotez and Creech agreed.
"Is there a drastic difference between an 11-year-old and a 12-year-old? Probably not. But you have to draw a line somewhere, and historically, the FDA has considered preteens to be different from teens in terms of normative, "Creech said.
"Why the decision was made to do it at 12 years old instead of 11 or 10 or 14, I don't know that. I suppose that indicator could have moved in any direction, probably," Hotez said.
Another reason the vaccine is slow moving: Companies want to make sure children who get COVID-19 don't get sicker, a scenario called immune boosting.
This builds on what happened in the 1960s with a vaccine that was supposed to defend against RSV, the respiratory syncytial virus infection, Hotez said.
"[The vaccine] triggered an immune-boosting phenomenon that actually made the disease worse, so I think that would be a consideration to take into account: make sure that doesn't happen," he said.
Hotez said the companies also want to make sure the vaccine doesn't worsen a rare but serious disease related to Covid-19 called multisystem inflammatory syndrome in children, or MIS-C.
In some cases, it has caused neurological abnormalities and deaths.
How is pediatric multisystemic inflammatory syndrome manifested?
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"You have to make sure the vaccine is not making that worse," Hotez said.
"That may take longer to convince both companies and regulators that these types of phenomena are not happening."
Another reason why a vaccine for young children is slow to arrive: In the case of COVID-19, it was clear that older people were more affected, so the vaccine trials began with them.
"Children were not considered to be at high risk of dying from this virus, which is true," said Dr. Paul Offit, director of the Center for Vaccine Education at Children's Hospital of Philadelphia and a vaccine advisor to the FDA.
"In the big picture of things, when you tried to do your best, as fast as you could, kids weren't a priority."
Testing vaccines in adults first is a very traditional way of evaluating them, Schaffner said.
"The first people to volunteer for these vaccines are older adults, then middle-aged adults, and then we go down the age scale," he said.
"Someone might ask, 'Wow, why aren't they done simultaneously? Well, there's not that much bandwidth. You just can't do too many rehearsals simultaneously."
Schaffner said the pacing should ultimately reassure parents.
"There are many parents who are very suspicious when giving these vaccines to children, and want to be sure that these vaccines are, as we say, safe and effective," he said.
"Do younger children need the same dose? Are they going to have a different spectrum of side effects than older adults? All of these things have to be handled very carefully, so that we can be transparent and honest when we talk to parents about to vaccinate, for example, a six-year-old child. "
The risk of minors in the face of covid-19
Although it is much rarer than in adults, children can suffer, be hospitalized and die from the coronavirus.
Also, this virus does something that other viruses that have vaccines, such as chickenpox and measles, do not;
it can cause long-term side effects: post-infection phenomena such as MIS-C and also long-term covid-19, where symptoms can last for months.
For now, while the world waits for a vaccine, unvaccinated young children remain vulnerable.
"Children are going to continue to be exposed. Children are going to continue to transmit, although it appears, at least based on our experience so far in the pandemic, that they may be less efficient at that than adults," Creech said.
This makes Offit worried about the next school year, in which young children will return to classrooms without vaccinations.
"If I had a 10- and 8-year-old, I would be very nervous if I sent them back to school," he said.
"Certainly, I would want them to wear a mask and physically distance themselves as much as possible, but I would also have to wait for the school to do it, for everyone at the school to do it, and that's a lot to ask. I think in many schools that doesn't. it will happen ".
The CDC last week updated its Covid-19 guidance for schools to emphasize that in-person schooling is a priority this fall, regardless of whether all mitigation measures may be applied.
Vaccination, he said, is a key safety measure, but other layers of protection, such as masks and physical distancing, may also be appropriate.
Hotez said parents' concerns can vary depending on where in the country their children attend.
"If you're in Vermont and Massachusetts, or in the Northeast or parts of the West Coast, there are so many people vaccinated, such a high percentage of adults and teens are vaccinated, that it will have the collateral benefit of stopping or slowing transmission so that even young children can go back to school, "he said.
But Hotez said that is not the case in other parts of the country, such as Tennessee, Alabama, Mississippi, Louisiana and Texas, where the delta variant is accelerating among adult populations that remain significantly under-vaccinated.
"There is going to be a lot of transmission in schools," he said.
"We know this can go wrong in the fall."
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Creech was more optimistic about the upcoming school year.
"We have some experience from last year, when the pandemic raged, and in some areas of our country schools were reopened. I think we can make face-to-face education very reasonable for children," he said.
"We know that there are some risk mitigation strategies that we can implement."
Right now, the best way to protect young children who cannot be vaccinated is to have everyone in a community vaccinated.
"I cannot think of a higher calling than to receive an injection to protect not only myself, but those around me, particularly the most vulnerable," Creech said.
"If we are unable to commit to protecting the vulnerable around us, and the children around us, then we have bigger problems than the pandemic."
covid-19 vaccine