Home Health Kids and COVID Vaccines: The FDA Timeline, Booster Recommendations and More Info – CNET

Kids and COVID Vaccines: The FDA Timeline, Booster Recommendations and More Info – CNET

23 min read

The COVID vaccine for kids under 5 is still in review while many schools drop mask mandates. Here’s what to know about shots for kids and teens.
Jessica Rendall

Jessica is a Wellness News Writer who wants to help people stay informed about their health. She’s from the Midwest, studied investigative reporting at the Missouri School of Journalism and is now based in NYC.
Dan Avery
Dan is a writer on CNET’s How-To team. His byline has appeared in Newsweek, NBC News, The New York Times, Architectural Digest, The Daily Mail and elsewhere. He is a crossword junkie and is interested in the intersection of tech and marginalized communities.
As school mask mandates start lifting, some parents are still waiting for the day their child can get vaccinated against COVID-19.
Pfizer and BioNTech announced last month that the companies are extending their “rolling submission” process for the vaccine for kids 6 months through 4 years and are waiting for more data on all three doses before asking the US Food and Drug Administration to authorize the first two shots. Just two doses of the vaccine weren’t effective for the whole age group.
“The extension allows the FDA time to receive updated data on the two- and three-dose regimen, conduct a thorough evaluation of it, and facilitate a robust, public discussion,” Pfizer and BioNTech said in the announcement. The companies expect to have three-dose protection data by early April, they said.
In December, Pfizer announced that while two doses of the vaccine — one-tenth the adult size — were effective in children ages 6 months to 2 years, two shots failed to promote a strong enough immune response in children ages 2 through 4 years. This prompted the company to start testing a three-dose version of the vaccine for children under 5.
One preprint study from last month suggested that the vaccine for kids 5 to 11 — which is one-third the strength of the adult vaccine — is less effective at preventing COVID-19 infection than it is for kids 12 and up, raising questions about the dosing of COVID-19 vaccines for kids. (The vaccine for babies and children under 5 is even smaller.)
Importantly, however, the vaccine for kids 5 and up remains effective at preventing severe COVID-19 and hospitalization. Booster shots are also thought to be necessary to restore infection protection against COVID-19, even while just two doses maintain good protection against severe disease. 
Here’s what we know about COVID-19 vaccines for kids and teens.
In a statement, the FDA said: “Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.” 
The vaccine for children under 5 covers kids 6 months through 4 years of age. While two shots of the smaller-dose vaccine were effective in babies and toddlers 6 months to 2 years, receiving only two doses failed to promote a strong immune response in children 2 to 4 years. Studies on a third dose are ongoing, but expected to complete the series for kids under 5. 
“Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” the companies said.
The extension of the rolling submission process for the vaccine for kids under 5 comes as a disappointment for many parents wanting to protect their younger children against COVID-19, but it’s more in line with earlier estimates from public health officials on when a COVID-19 vaccine might be available for the age group. 
Once Pfizer and BioNTech submit additional information to the FDA, a committee of experts that gathers to discuss safety and effectiveness data and vote on whether or not the FDA should authorize a vaccine will meet. The agency will provide an update on timing for the meeting on the vaccine for kids under 5 once they receive more data, FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said in a statement.
“This will give the agency time to consider the additional data, allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines,” the doctors said. 
The advisory committee’s meetings are open to the public.
If the FDA does authorize Pfizer’s vaccine for children as young as 6 months old, the CDC typically goes through the same process: An outside panel of health experts will discuss the benefits and risks of recommending the vaccine to children under 5 years old. If they vote to recommend Pfizer’s vaccine for the younger age group, the CDC’s director will likely accept the panel’s decision and the small doses of Pfizer’s COVID-19 vaccine for kids will become available in pediatricians’ offices or other clinics. 
Pfizer and BioNTech’s COVID-19 vaccine is not the only one being studied in kids under 5, however. Moderna said in January that it expects to report vaccine data on children 2 to 5 years in March. In a few countries outside the US, including Canada, Moderna’s vaccine has received regulatory authorizations for adolescents 12 and up. 
Pfizer and BioNTech’s vaccine for children 6 months through 4 years comes in two doses that are one-tenth the volume of the vaccine for people age 12 and up. A third 3-microgram dose is being researched right now is expected to complete the series. 
The vaccine for kids 5 to 11 is one-third the dose given to everyone 12 and up, and it’s delivered in two doses. Pfizer’s vaccine for kids can also be stored for up to 10 weeks in a fridge, making it easier to administer, and the cap on the vial is orange instead of purple and gray to avoid mix-ups. 
And if it helps to put your kids at ease, the needle used to administer the child’s dose of vaccine is also smaller. 
For more information about Pfizer’s vaccine for children ages 5 to 11, check out this fact sheet from the FDA
Children as young as 12 can now get a booster dose of Pfizer’s COVID-19 vaccine, given at least five months after their primary vaccination series.
Most kids younger than 12 can’t get a booster, although the CDC recommends a third dose of the Pfizer vaccine for children 5 and up who are immunocompromised. They’re eligible for a third shot 28 days after their second dose. 
Since Pfizer’s COVID-19 vaccine is the lone vaccine approved for people under 18, it’s generally only available in doctor’s offices and public health clinics, not pharmacies and other mass vaccination sites.
Call your pediatrician or local health clinic for a recommendation on where to go. Parents may also text their ZIP code to 438829 or use this vaccine finder link to find a clinic near them that has the child vaccine available. 
According to a report from the American Academy of Pediatrics, children made up 25% of reported COVID-19 cases for the week ending Feb. 3. (The AAP says the definition of “child” varies by the states reporting.) While pediatric cases were lower than in January, child COVID-19 were “double the peak level of the delta surge in 2021,” the AAP reported.
Children are much less likely to get severely sick from the virus than adults, but some children have died or been hospitalized with COVID-19. An infection, even a mild case, can disrupt a child’s ability to attend school or socialize, and they can pass the infection to more vulnerable family or community members. Kids can also experience dangerous complications from COVID-19, including long COVID and MIS-C
There are also racial disparities in the severity of how sick children get from COVID-19: Kids ages 5 to 11 who are Black, Native American or Hispanic are three times more likely to be hospitalized with COVID-19 than white children, according to an FDA advisory panel presentation. Of that group, about 1 in 3 will require admission to an intensive care unit.
In a statement following its authorization of booster doses for kids 12 to 15, the FDA said it reviewed real-world data from more than 6,300 children in Israel, ages 12 to 15, who received a booster shot at least five months after their second dose of Pfizer.
No additional safety concerns were reported to date in those individuals, according to the FDA. 
“These additional data enabled the FDA to reassess the benefits and risks of the use of a booster in the younger adolescent population in the setting of the current surge in COVID-19 cases,” the agency said. “The data shows there are no new safety concerns following a booster in this population.”
Vaccine side effects in kids ages 5 to 11 are mostly mild and similar to those adults may experience, according to the CDC, including soreness at the injection site, fever, muscle soreness, nausea and fatigue. In a Dec. 13 report from the agency, the CDC reviewed reports from safety monitoring systems on more than 8 million doses of Pfizer’s vaccine given to kids ages 5 to 11, confirming that children’s immune systems respond well to the vaccine with common mild side effects, and that serious adverse events are rarely reported. 
Inflammation of the heart muscle, known as myocarditis, and of the muscle’s outer lining, called pericarditis, are rare and typically mild side effects linked to the Moderna and Pfizer vaccines, mostly in adolescent males and young men ages 12 to 29. (Myocarditis can also occur after infection with COVID-19.)
In one study, the CDC said that 54 recipients out of a million males ages 12 to 17 experienced myocarditis following the second dose of Pfizer-BioNTech’s Comirnaty vaccine. In contrast, kids ages 5 to 11 who catch COVID-19 have a higher risk of multisystem inflammatory syndrome, or MIS-C, a potentially serious complication involving inflammation of the heart, lungs, kidneys, brain, skin, eyes or other organs. 
“The bottom line is that getting COVID is much riskier to the heart than anything in this vaccine, no matter what age or sex you are,” Dr. Matthew Oster, a pediatric cardiologist at Children’s Healthcare of Atlanta, told the CDC in November as reported by ABC News.
Yes, parents generally need to consent to their children receiving medical care, including Pfizer’s COVID-19 vaccine. This is especially true for younger children. 
However, depending on which state you live in, there may be a legal precedent for teens and other kids to request the vaccine without parental permission: Tennessee’s vaccine director, Michelle Fiscus, was fired in August allegedly in part for sending out a memo detailing Tennessee’s “mature minor doctrine,” which explains how minors may seek medical care without the consent of their parents. 
The CDC recommended a third dose for children as young as 5 who are “moderately to severely” immunocompromised, 28 days after their second shot. This guidance for immunocompromised children (including kids who’ve had an organ transplant or are taking medications that suppress the immune system) is in line with guidance for adults whose bodies don’t mount a good immune response to the COVID-19 vaccines.
Yes, though you might be asked to stick around the waiting room so health care providers can monitor them for (extremely rare) allergic reactions that can occur after any vaccination. 
“If the child has a history of anaphylaxis or other severe allergies, then the observation time after the injection may be 30 minutes instead of 15,” said Dr. Anne Liu, an infectious disease specialist with Stanford Hospital and Clinics and the Lucile Packard Children’s Hospital. Children who have been prescribed an EpiPen for any reason should bring it to their vaccine appointment, Liu added. 
As with adults, children with an allergy to an ingredient in Pfizer’s COVID-19 shouldn’t take it. You can find a list of ingredients in Pfizer’s vaccine for kids ages 5 to 11 on the FDA’s fact sheet
According to the CDC, your child may get other vaccines when they go in for their COVID shot without waiting 14 days between appointments. Flu shots can be given to children ages 6 months and older.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.


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