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



    The FDA might give approval for a COVID-19 vaccine for youngsters underneath 5 as quickly as late February.

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    For probably the most up-to-date information and details about the coronavirus pandemic, go to the WHO and CDC web sites.

    Pfizer and BioNTech requested the US Meals and Drug Administration to authorize its COVID-19 vaccine for children 6 months through 4 years on Tuesday. Whereas the vaccine for youngsters underneath age 5 is anticipated to be a three-dose vaccine sequence (it is one-Tenth the scale of Pfizer’s vaccine for individuals 12 and up), Pfizer is asking the FDA to evaluate knowledge on the primary two doses as a part of a “rolling submission” course of. 

    The FDA stated it scheduled a meeting with its advisory committee for Feb. 15 to debate whether or not to authorize the vaccine for youngsters as younger as six months. As soon as given the inexperienced mild from the FDA, a committee that advises the US Facilities for Illness Management and Prevention usually meets to debate whether or not to advocate a vaccine sequence. Then, if the CDC accepts the advice, mother and father of infants and preschoolers will be capable to begin the method of vaccinating their youngsters in opposition to COVID-19.

    “Having a protected and efficient vaccine obtainable for youngsters on this age group is a precedence for the company and we’re dedicated to a well timed evaluate of the info, which the company requested Pfizer to submit in mild of the current omicron surge,” Dr. Janet Woodcock, FDA commissioner, stated in a press release Tuesday. 

    In December, Pfizer introduced that whereas two doses of the vaccine have been efficient in youngsters 6 months to 2 years, two photographs failed to advertise a powerful sufficient immune response in youngsters ages 2 to 4 years. This prompted the corporate to begin testing a three-dose model of the vaccine for youngsters underneath age 5. Within the coming months, that knowledge may also be submitted to the FDA for authorization. 
    In October, the FDA approved a smaller dose of Pfizer-BioNTech’s mRNA vaccine for youngsters ages 5 to 11. Pfizer’s vaccine has full FDA approval for individuals age 16 and up.

    Earlier this month, Pfizer researcher Alexandra Gurtman stated the corporate was additionally taking a look at a booster for youngsters ages 5 to 11, given six months after their second dose. Proper now, solely children 12 and older can get a Pfizer booster.

    Because the COVID-19 panorama continues to evolve, this is what we learn about COVID-19 vaccines for teenagers and youths. Plus, find out about the possibility of a fourth booster shot and how to find an at-home COVID-19 test

    Can youngsters 4 or youthful get a COVID-19 vaccine?

    Not fairly but. The FDA has a gathering with an impartial panel of consultants that opinions security and effectiveness knowledge scheduled ffor Feb. 15. If approved by the FDA, after which beneficial by the CDC and its personal panel of consultants, the primary doses of the anticipated three-dose sequence can begin rolling out to the youthful age group. 

    In December the FDA authorized Eli Lilly’s COVID-19 monoclonal antibody therapy for younger youngsters, even newborns, in the event that they’re at excessive threat of extreme COVID-19. Final week, although, the FDA halted the emergency-use authorization of the therapy as a result of it is not efficient in opposition to the omicron variant, so it will not be obtainable within the US so long as omicron is accountable for most COVID-19 instances.

    When can my baby get a booster shot?

    Kids as younger as 12 can get now get a 3rd dose of Pfizer’s COVID-19 vaccine, given a minimum of 5 months after their second shot.

    Most children youthful than 12 cannot get a booster, though the CDC recommends a 3rd dose of the Pfizer vaccine for youngsters 5 and up who’re immunocompromised. They’re eligible for a booster 28 days after their second dose.  

    The place can my child get a booster shot?

    Since solely Pfizer’s COVID-19 vaccine is presently accepted for anybody underneath 18, it is typically solely obtainable in physician’s places of work and public well being clinics, not pharmacies and different mass vaccination websites.

    Name your pediatrician or native well being clinic for a advice on the place to go. Dad and mom may text their ZIP code to 438829 or use this vaccine finder link to discover a clinic close to them that has the kid vaccine obtainable. 

    Do children actually need a COVID-19 vaccine? 

    Based on recent CDC data, 1.5 million youngsters ages 4 and underneath are presently contaminated with COVID-19. Whereas it is true youngsters are a lot much less prone to get severely sick from the virus than adults, Fauci stated, “The danger isn’t zero.” 

    The CDC stories 362 youngsters ages 5 and underneath years have died from COVID-19; 230 children ages 5 to 11; 266 children ages 12 to fifteen; and 273 children ages 16 to 17.

    An an infection, even a gentle case, requires quarantining and doubtlessly sending classmates out of the classroom and again to distant studying. And children can expertise harmful complications from COVID-19, together with long COVID and MIS-C

    Based on a report from the American Academy of Pediatrics, in January COVID-19 instances in youngsters reached their highest case rely because the starting of the pandemic: Almost 7.9 million youngsters have examined optimistic for COVID-19 because the starting of the pandemic, or one in 10 youngsters, the AAP reported. (The AAP says the definition of “baby” varies by the states reporting.) 

    There are additionally racial disparities in how sick youngsters get from COVID-19: Children ages 5 to 11 who’re Black, Native American or Hispanic are 3 times extra prone to be hospitalized with COVID-19 than white youngsters, in keeping with an FDA advisory panel. Of that group, about one in three would require admission to the ICU.

    Are booster photographs protected for youngsters?

    In a statement following its authorization of booster doses for teenagers 12 to fifteen, the FDA stated it reviewed real-world knowledge from greater than 6,300 youngsters in Israel, ages 12 to fifteen, who obtained a booster shot a minimum of 5 months after their second dose of Pfizer.

    No extra security considerations have been reported so far in these people, in keeping with the FDA. 

    “These extra knowledge enabled the FDA to reassess the advantages and dangers of the usage of a booster within the youthful adolescent inhabitants within the setting of the present surge in COVID-19 instances,” the company stated. “The info reveals there are not any new security considerations following a booster on this inhabitants.”

    What unintended effects can children get from a COVID-19 vaccine or booster? 

    Vaccine unintended effects in children ages 5 to 11 are principally gentle and just like these adults could expertise, according to the CDC, together with soreness on the injection website, fever, muscle soreness, nausea and fatigue. In a Dec. 13 report from the company, the CDC reviewed reports from safety monitoring systems on greater than 8 million doses of Pfizer’s vaccine given to children ages 5 to 11, confirming that youngsters’s immune programs reply properly to the vaccine with widespread gentle unintended effects, and that severe adversarial occasions are hardly ever reported. 

    Irritation of the center muscle, referred to as myocarditis, and of the muscle’s outer lining, known as pericarditis, are rare and typically mild side effects linked to the Moderna and Pfizer vaccines, principally in adolescent males and younger males ages 12 to 29. (Myocarditis may happen after an infection with COVID-19.)

    In a single research, the CDC said that 54 recipients out of one million males ages 12 to 17 skilled myocarditis following the second dose of Pfizer-BioNTech’s Comirnaty vaccine. In distinction, children ages 5 to 11 who catch COVID-19 have a better threat of multisystem inflammatory syndrome, or MIS-C, a doubtlessly severe complication involving irritation of the center, lungs, kidneys, mind, pores and skin, eyes or different organs. 

    “The underside line is that getting COVID is way riskier to the center than something on this vaccine, it doesn’t matter what age or intercourse you might be,” Dr. Matthew Oster, a pediatric heart specialist at Kids’s Healthcare of Atlanta, advised the CDC in November, ABC News reported.

    How is Pfizer’s baby vaccine for teenagers underneath 12 completely different?

    Although it is nonetheless delivered in two photographs given three weeks aside, Pfizer’s vaccine for teenagers 5 to 11 is one-third the dose given to everybody 12 and up. Pfizer’s vaccine for teenagers will also be saved for up to 10 weeks in a fridge, making it simpler to manage, and the cap on the vial is orange instead of purple and gray to keep away from mix-ups. 

    And if it helps to place your children comfortable, the needle used to manage the kid’s dose of vaccine can be smaller. 

    For extra details about Pfizer’s vaccine for youthful youngsters, check out this fact sheet by the FDA


    Sarah Tew/CNET

    Do I would like to provide consent for my younger baby to get vaccinated? 

    Sure, mother and father typically must consent to their youngsters receiving medical care, together with Pfizer’s COVID-19 vaccine. That is very true for youthful youngsters. 

    Nevertheless, depending on which state you live in, there could also be a authorized precedent for teenagers and different children to request the vaccine with out your permission: Tennessee’s vaccine director, Michelle Fiscus, was fired in August allegedly partly for sending out a memo detailing Tennessee’s “mature minor doctrine,” which explains how minors could search medical care with out the consent of their mother and father. 

    If my baby has a severe well being situation, can they get a 3rd shot? 

    The CDC beneficial a 3rd dose for youngsters as younger as 5 who’re “reasonably to severely” immunocompromised, 28 days after their second shot. This steering for immunocompromised youngsters (together with children who’ve had an organ transplant or are taking drugs that suppress the immune system) is in line with guidance for adults whose our bodies do not mount an excellent immune response to the COVID-19 vaccines.

    My baby has allergic reactions. Can they get the vaccine?

    Sure, although you is perhaps requested to stay across the ready room so well being care suppliers can monitor them for (extremely rare) allergic reactions that may happen after any vaccination. 

    “If the kid has a historical past of anaphylaxis or different extreme allergic reactions, then the commentary time after the injection could also be half-hour as a substitute of 15,” stated Dr. Anne Liu, an infectious illness specialist with Stanford Hospital and Clinics and the Lucile Packard Kids’s Hospital. Kids who’ve been prescribed an EpiPen for any purpose ought to deliver it to their vaccine appointment, Liu added. 

    As with adults, youngsters with an allergy to an ingredient in Pfizer’s COVID-19 should not take it. You’ll find an inventory of elements in Pfizer’s vaccine for teenagers ages 5 to 11 on the FDA’s fact sheet

    Can my baby get the COVID-19 shot similtaneously different vaccines?

    According to the CDC, your baby could get different vaccines after they go in for his or her COVID shot with out ready 14 days between appointments. Flu shots will be given to youngsters ages 6 months and older.

    The knowledge contained on this article is for academic and informational functions solely and isn’t supposed as well being or medical recommendation. All the time seek the advice of a doctor or different certified well being supplier concerning any questions you might have a few medical situation or well being targets.

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