Children under the age of 12 could be eligible for a vaccine for COVID this fall: Gunshots
Chris O’Meara / AP
With the US under control of a terrifying spate of coronavirus cases, many parents are understandably excited to see when the COVID-19 vaccine will finally be available to children under the age of 12.
This age group accounts for approx. 50 million Americans and currently none of them qualify for a shot. However, scientists are trying to figure out how any of the COVID-19 vaccines currently available for adults could be given to this age group.
Pfizer and Moderna are both conducting large pediatric studies to evaluate the efficacy and safety of using their COVID-19 mRNA vaccines for children under the age of 12.
We can expect the following:
What do we know from the vaccination studies of children under 12?
Researchers have already shared some early findings on how a COVID-19 vaccine can be used in younger children.
In the clinical trial for the Pfizer vaccine, the data collected shows that a third of the adult dose is the optimal range for children under 12 and over 5, says Dr. Flor Muñoz at Texas Children’s Hospital and Baylor College of Medicine, who is leading the Pfizer study.
“‘Optimal’ means the dose that gives you a similar immune response that, as we’ve seen in adolescents, protects with minimal side effects,” she says.
Muñoz and her team have taken in children aged 6 months and up to 11 years. Your team is now in the next phase of the study, where they will randomly assign the children either a vaccine or a placebo. Comparing a vaccinated group to a placebo group allows researchers to be sure that any benefit or risk during the study is genuinely related to the vaccine.
The Pfizer study won’t test whether the vaccine actually prevents children from getting sick. Instead, their blood will be tested to see if they are making the types of antibodies that have been shown to prevent disease. Studies with the Pfizer COVID-19 vaccine in adults have already shown that such antibodies indicate that someone is well protected from becoming seriously ill with COVID-19. Children will be enrolled in the study for two years so researchers can determine how long the protection lasts, whether there are rare, long-term health problems, and whether a booster is needed.
Moderna carries out a similar pediatric study of his COVID-19 vaccine. Children enrolled in the Moderna trial now have a 3-in-1 chance of getting the vaccine as only 25% of the participants are in the placebo arm of the trial.
“We are testing different doses in different age groups because younger children may not need the same dose as adults, ”says Dr. Jacqueline Miller, Senior Vice President at Moderna.
When might recordings be available?
It depends on how quickly the studies collect the necessary data and what the Food and Drug Administration regulators ultimately decide when they review the results.
At the moment, it looks like the Pfizer vaccine will be the first vaccination for children under the age of 12. The vaccine manufacturer expects to have enough data by the end of September to establish a Emergency use authorization for his vaccine in children aged 5 to 11 years.
“We hope to get approval – depending on both results and of course some decisions – not too long after the start of the school year,” said Dr. Phil Dormitzer, Pfizer’s chief scientific officer for viral vaccines, recently told NPR.
The data for children under the age of 5 will be released shortly thereafter, a Pfizer spokesman told NPR.
Currently, the other US-approved mRNA COVID-19 vaccine – that of Moderna – can be given to people aged 18 and over. Moderna expects to have enough data by the end of the year to apply for approval for a syringe that can be given to children aged 6-11.
Moderna recently expanded the scope of its study to include 12,000 children to increase the likelihood of discovering rare but serious adverse events. The Pfizer study is currently planning to enroll up to 4,500 children, a company spokesperson told NPR.
“The safety profile so far has really been comparable to that of adults and so far there are no safety concerns,” says Miller, referring to the Moderna vaccine. Data for children under the age of 6 could be submitted to the FDA “early next year,” she says, “but that could be faster depending on the school enrollment rate.”
Do we have to give COVID-19 injections to children?
Even with the advent of new variants, the risk of serious illness from COVID-19 for younger children compared to the adult population remains quite low. But with so many infections every day in the US, large numbers of children are exposed to the virus and test positive.
“They have a milder illness and less chance of getting infected,” says Muñoz of Texas Children’s Hospital. “But they can get infected. They can have serious illnesses and they can transmit the virus.”
And with such a high number of infections nationally and with no protection from a vaccine if they become infected, there is a risk that more children will be among the few unhappy children who become seriously ill after infection or experience long-term symptoms – a common syndrome known as “long COVID. “
Dr. Paul Offit, a pediatric vaccine specialist at Children’s Hospital of Philadelphia, says a vaccine for younger children cannot come soon enough given the rise in cases.
To add to the urgency, hospitals in some parts of the country are accepting record numbers of children with COVID-19.
“We currently have more pediatric patients hospitalized with COVID than ever before in this pandemic,” says Dr. LouAnn Woodward, who oversees the University of Mississippi Medical Center. “We’re seeing a younger group of patients getting very sick from it.”
In one Letter sent earlier this month, the head of the AAP urged the FDA to “work aggressively to get safe and effective COVID-19 vaccines to children under the age of 12 approved as soon as possible.”
“Simply put, the Delta variant has created a new and urgent risk for children and adolescents across the country, as it has for unvaccinated adults,” wrote AAP president Dr. Lee Savio Beers.
Many parents do not want to put their children’s health at risk, especially at the start of the school year – a fact that is also reflected in the great interest of parents trying to enroll their children in clinical trials.
“I get several emails a day asking me, and unfortunately we have limited places,” says Baylor College of Medicine Dr. Erin Nicholsonwho is conducting a study of the Moderna vaccine in children under the age of 12.
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