COVID-19 vaccine eligibility has now been widened for children ages 12 and up.
An independent panel of advisers to the U.S. Centers for Disease Control and Prevention (CDC) voted Wednesday to recommend the Pfizer vaccine for use in children ages 12 to 15.
The U.S. Food and Drug Administration (FDA) authorized the Pfizer vaccine for this age group Monday.
As soon as CDC Director Rochelle Walensky signs off, vaccinating children as young as 12 becomes the official recommendation by the nation’s top public health experts.
All people in America 16 years and older are already eligible to receive the Pfizer 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?
Adolescents experienced a similar range of side effects as seen in older teens and young adults — generally seen as cold-like symptoms in the two to three days after the second dose — and had an “excellent safety profile,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at a press briefing announcing Pfizer’s authorization.
“Based on all this available information, the FDA determined the Pfizer-BioNTech vaccine has met all of the criteria required to amend the EUA, which concluded that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the vaccines known and potential risks,” Marks said.
Marks encouraged parents who were hesitant to vaccinate their children to speak with their pediatricians, urging confidence in the trial and data.
Moderna has said 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. The FDA will scrutinize Moderna’s clinical data before authorizing the use in anyone under 18.
4. How effective is the Pfizer vaccine in children?
Pfizer announced in late March that its clinical trials showed the vaccine was safe and 100% effective in children ages 12-15, similar to the 95% efficacy among adult clinical trial participants.
Marks confirmed on May 10 that after a trial with over 2,000 children, Pfizer found no cases of infection among the children who had been given the vaccine and 16 cases of infection among the children who received a placebo.
No cases of COVID occurred in the 1,005 adolescents that received the vaccine, while there were 16 cases of COVID among the 978 kids who received the placebo, “thus indicating the vaccine was 100% effective in preventing COVID-19 In this trial,” said Marks.
5. Will kids get the same dose of the vaccines as adults?
The FDA has authorized the same dosing for 12- to 15-year-olds as adults with the Pfizer two-dose vaccine.
6. What will fully vaccinated kids be able to do?
Children who are fully vaccinated will be able to follow the updated guidance for vaccinated people from the CDC.
That means not wearing a mask while outdoors, except in crowds, and not having to quarantine after known or suspected exposure to COVID-19, according to the CDC.
Kids who are fully vaccinated may also attend small outdoor gatherings with fully vaccinated family, friends, or those who are unvaccinated, and dine at outdoor restaurants with friends from multiple households, according to the CDC.
Being fully vaccinated — a milestone achieved two weeks after a person’s final vaccine shot — will also make it easier for children to travel internationally and gain entry into concerts or sporting events.
7. 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.
8. 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.
9. Where will children access COVID-19 vaccines?
As with the distribution of vaccines to adults, the process of distributing COVID-19 vaccines to children will differ by state.
The vaccines will likely be available to kids through a combination of pharmacies, pediatricians, medical centers and larger vaccine events
Pfizer has announced they are going to ship their vaccine in smaller shipments of 450 doses per box instead of over 1000 doses, which means it can be kept in places like pediatricians’ offices.
10. What are health groups saying about COVID-19 vaccines and kids?
The American Academy of Pediatrics (AAP) has recommended that “all eligible children, teens, family and household members be vaccinated as soon as possible.”
“This is truly an exciting development that allows us to protect a large population of children and help them regain their lives after a really rough year,” AAP President Lee Savio Beers, MD, said in a May 12 statement. “As a pediatrician and a parent, I have looked forward to getting my own children and patients vaccinated, and I am thrilled that those ages 12 and older can now be protected. The data continue to show that this vaccine is safe and effective. I urge all parents to call their pediatrician to learn more about how to get their children and teens vaccinated.”
“We’ve seen the harm done to children’s mental and emotional health as they’ve missed out on so many experiences during the pandemic,” Beers said. “Vaccinating children will protect them and allow them to fully engage in all of the activities—school, sports, socializing with friends and family— that are so important to their health and development.”
11. 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.
12. 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.
Jade A. Cobern, MD, a member of the ABC News Medical Unit contributed to this report.
