Pfizer vaccine authorized for kids ages 12 to 15: What parents should know
(NEW YORK) — COVID-19 vaccine eligibility has now been widened for children ages 12 and up.
The U.S. Food and Drug Administration (FDA) on Monday authorized the Pfizer vaccine for children ages 12 to 15, bolstering chances for a safe return to full-time school in the fall. Vaccinations for 12-15-year-olds may start later this week after the director of the U.S. Centers for Disease Control and Prevention (CDC) endorses recommendations on distribution plans.
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 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.”
The AAP also cheered the FDA’s decision to authorize the Pfizer vaccine for children ages 12 and up, calling it a “critically important step.”
“Our youngest generations have shouldered heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development,” Savio Beers said in a statement, in part. “We look forward to the discussion by the Advisory Committee on Immunization Practices of the CDC, which will make recommendations about the use of this vaccine in adolescents. Meanwhile, pediatricians stand ready to assist in efforts to administer this and other COVID-19 vaccines.”
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.
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