The COVID vaccine for kids under 5 is almost here: Pfizer submits to the FDA for authorization

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The FDA could give approval for a COVID-19 vaccine for children under 5 as soon as late February.


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Pfizer and BioNTech asked the US Food and Drug Administration to authorize its COVID-19 vaccine for children 6 months through 4 years on Tuesday. While the vaccine for children under age 5 is expected to be a three-dose vaccine series (it’s one-10th the size of Pfizer’s vaccine for people 12 and up), Pfizer is asking the FDA to review data on the first two doses as part of a “rolling submission” process. 

The FDA said it scheduled a meeting with its advisory committee for Feb. 15 to discuss whether to authorize the vaccine for children as young as six months. Once given the green light from the FDA, a committee that advises the US Centers for Disease Control and Prevention typically meets to discuss whether to recommend a vaccine series. Then, if the CDC accepts the recommendation, parents of babies and preschoolers will be able to start the process of vaccinating their children against COVID-19.

“Having a safe and effective vaccine available for children in this age group is a priority for the agency and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent omicron surge,” Dr. Janet Woodcock, FDA commissioner, said in a statement Tuesday. 

In December, Pfizer announced that while two doses of the vaccine were effective in children 6 months to 2 years, two shots failed to promote a strong enough immune response in children ages 2 to 4 years. This prompted the company to start testing a three-dose version of the vaccine for children under age 5. In the coming months, that data will also be submitted to the FDA for authorization. 
 
In October, the FDA authorized a smaller dose of Pfizer-BioNTech’s mRNA vaccine for children ages 5 to 11. Pfizer’s vaccine has full FDA approval for people age 16 and up.

Earlier this month, Pfizer researcher Alexandra Gurtman said the company was also looking at a booster for children ages 5 to 11, given six months after their second dose. Right now, only kids 12 and older can get a Pfizer booster.

As the COVID-19 landscape continues to evolve, here’s what we know about COVID-19 vaccines for kids and teens. Plus, learn about the possibility of a fourth booster shot and how to find an at-home COVID-19 test

Can children 4 or younger get a COVID-19 vaccine?

Not quite yet. The FDA has a meeting with an independent panel of experts that reviews safety and effectiveness data scheduled ffor Feb. 15. If authorized by the FDA, and then recommended by the CDC and its own panel of experts, the first doses of the anticipated three-dose series can start rolling out to the younger age group. 

In December the FDA authorized Eli Lilly’s COVID-19 monoclonal antibody treatment for young children, even newborns, if they’re at high risk of severe COVID-19. Last week, though, the FDA halted the emergency-use authorization of the treatment because it’s no longer effective against the omicron variant, so it won’t be available in the US as long as omicron is responsible for most COVID-19 cases.

When can my child get a booster shot?

Children as young as 12 can get now get a third dose of Pfizer’s COVID-19 vaccine, given at least five months after their second shot.

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 booster 28 days after their second dose.  

Where can my kid get a booster shot?

Since only Pfizer’s COVID-19 vaccine is currently approved for anyone 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. 

Do kids really need a COVID-19 vaccine? 

According to recent CDC data, 1.5 million children ages 4 and under are currently infected with COVID-19. While it’s true children are much less likely to get severely sick from the virus than adults, Fauci said, “The risk is not zero.” 

The CDC reports 362 children ages 5 and under years have died from COVID-19; 230 kids ages 5 to 11; 266 kids ages 12 to 15; and 273 kids ages 16 to 17.

An infection, even a mild case, requires quarantining and potentially sending classmates out of the classroom and back to remote learning. And kids can experience dangerous complications from COVID-19, including long COVID and MIS-C

According to a report from the American Academy of Pediatrics, in January COVID-19 cases in children reached their highest case count since the beginning of the pandemic: Nearly 7.9 million children have tested positive for COVID-19 since the beginning of the pandemic, or one in 10 children, the AAP reported. (The AAP says the definition of “child” varies by the states reporting.) 

There are also racial disparities in 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. Of that group, about one in three will require admission to the ICU.

Are booster shots safe for children?

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.”

What side effects can kids get from a COVID-19 vaccine or booster? 

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, ABC News reported.

How is Pfizer’s child vaccine for kids under 12 different?

Though it’s still delivered in two shots given three weeks apart, Pfizer’s vaccine for kids 5 to 11 is one-third the dose given to everyone 12 and up. 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 younger children, check out this fact sheet by the FDA. 

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Do I need to give consent for my young child to get vaccinated? 

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 your 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. 

If my child has a serious health condition, can they get a third shot? 

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.

My child has allergies. Can they get the vaccine?

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. 

Can my child get the COVID-19 shot at the same time as other vaccines?

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.

source: cnet.com