(NEW YORK) — COVID-19 vaccine eligibility for teens and even younger children appears to be on the horizon.
The U.S. Food and Drug Administration may grant emergency use authorization to Pfizer-BioNTech’s coronavirus vaccine for teens and children ages 12 to 15 any day now.
All people in America 16 years and older are already eligible to receive the Pfizer a vaccine and anyone 18 years and older is eligible for Moderna or Johnson & Johnson.
Pfizer, which is currently conducting clinical trials with children as young as 6 months old, has said it will likely seek an emergency use authorization for its vaccine for children ages 2 to 11 in September.
Moderna — which, like Pfizer, received emergency use authorization for its COVID-19 vaccine from the FDA in December — and Johnson & Johnson — which received emergency use authorization from the FDA for its vaccine in February — are also both currently conducting clinical trials with children.
The rapid pace of progress has left parents searching for answers as quickly as the science develops.
Here is what parents may want to know about the COVID-19 vaccines and kids to help them make decisions:
1. What is the science behind the COVID-19 vaccine?
Both the Pfizer and Moderna vaccines use mRNA technology, which does not enter the nucleus of the cells and doesn’t alter human DNA. Instead, it sends a genetic “instruction manual” that prompts cells to create proteins that look like the virus — a way for the body to learn and develop defenses against future infection.
The Johnson & Johnson vaccine uses an inactivated adenovirus vector, Ad26, that cannot replicate. The Ad26 vector carries a piece of DNA with instructions to make the SARS-CoV-2 spike protein that triggers an immune response.
This same type of vaccine has been authorized for Ebola, and has been studied extensively for other illnesses — and for how it affects women who are pregnant or breastfeeding.
Neither of these vaccine platforms can cause COVID-19.
2. Why do kids need to be vaccinated against COVID-19?
While have not been as many deaths from COVID-19 among children as adults, particularly adults in high-risk categories, kids can still get the virus and just as importantly, they can transmit the virus to adults.
The American Academy of Pediatrics reported this week that children now make up 22.4% of all new weekly cases, and over 3.7 million children have been diagnosed during the pandemic.
“There are really two big reasons why kids need to get the vaccine,” explained Dr. Jennifer Ashton, ABC News chief medical correspondent.
“One of them is that it is possible that they could be infected and then unknowingly pass COVID-19 to someone with a serious or underlying, pre-existing medical condition,” she said. “And also, though it’s very uncommon and unlikely, it is still possible that children infected with COVID-19 could become seriously ill or worse. We have seen that.”
“It’s important to think in ripple effects, outside the box,” Ashton added. “It’s not just your home environment that you need to worry about.”
3. Will kids experience the same vaccine side effects as adults?
Initial reports from the clinical trials say the vaccines were well tolerated, with side effects generally consistent with those observed in older participants. Once the vaccine is authorized more specific data on possible side effects will be made publicly available.
Moderna announced Thursday that an initial analysis of its COVID-19 study with teens ages 12 to 17 found the majority of side effects were mild or moderate in severity, and said no serious safety concerns had been identified.
4. Will kids get the same dose of the vaccines as adults?
Pfizer is asking for the same dosing for 12- to 15-year-olds as adults in its current request.
Moderna and Pfizer are currently undergoing what’s referred to as “dosing” trials, where researchers work to figure out how much of the vaccine kids can tolerate, and how much they need to be protected.
After researchers find an appropriate dose with the younger children, they’ll move onto the second part of the trial, which includes splitting children into a placebo and a treatment group.
“We’re looking to identify the optimal dose in the first set of kids, and then we’ll substantially expand the number of kids involved in that study,” Stephen Hoge, president of Moderna, said in an interview that aired Wednesday on ABC News’ World News Tonight. “We hope to have that data in the fall of this year, and obviously we’ll submit it with regulatory regulators and hope to be able to start vaccinating younger children, by the very end of this year, if not early next year.”
5. Could COVID-19 vaccines impact puberty, menstruation?
There is currently no clinical evidence to suggest the vaccines can have long-term effects on puberty or fertility, according to Ashton, a practicing, board-certified OBGYN.
Ashton noted that while there has been anecdotal discussion of the emotional event of finally receiving the vaccine temporarily impacting menstruation for adult women, the idea of the cause being from the vaccine itself “defies science and biology.”
“It is really important to understand basic biology here,” Ashton said. “Women can have changes in their menstrual cycle and also have gotten the vaccine, that does not mean that one caused the other.”
“Right now there is no puberty concern. There is no fertility concern,” she added.
6. Will the Johnson & Johnson COVID-19 vaccine be available for kids?
Johnson & Johnson announced in April that it had begun vaccinating a “small number of adolescents aged 16-17 years” in a Phase 2a clinical trial.
As of April, the trial was enrolling participants only in Spain and the United Kingdom, with plans to expand enrollment to the U.S., the Netherlands and Canada, followed by Brazil and Argentina.
7. What are health groups saying about COVID-19 vaccines and kids?
The American Academy of Pediatrics has called on all adults and teens who are eligible to receive a COVID-19 vaccine to do so, while also pushing for clinical trials for younger teens and children.
“Research has shown the new vaccines to be remarkably effective,” AAP President Dr. Lee Savio Beers said in a statement. “The vaccine is a powerful tool that — in conjunction with other safety measures like face masks, good hygiene and physical distancing — can help us end the suffering and death caused by COVID-19. Pediatricians can play a key role in making that happen.”
8. Are other countries giving COVID-19 vaccines to children?
Yes. Canada’s health department authorized the use of the Pfizer-BioNTech COVID-19 vaccine in children 12 to 15 years of age on May 5.
9. Will COVID-19 vaccines be required by schools?
It will be up to each state’s government to decide whether a COVID-19 vaccine is required for school entry. Many colleges and universities in the U.S. have announced they will require students to be vaccinated from COVID-19.
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