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    Home > Active Ingredient News > Infection > FDA officially approves mRNA vaccine for three-needle vaccination for children

    FDA officially approves mRNA vaccine for three-needle vaccination for children

    • Last Update: 2022-08-15
    • Source: Internet
    • Author: User
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    Rapidly increasing child and adolescent vaccination rates against COVID-19 is an effective way to protect children and adolescents from COVID-1On May 17, 2022, the US FDA officially approved the mRNA new crown vaccine BNT162b2 booster for children aged 5-11 [1], which means that the scope of application of the booster will be extended to about 28 million suitable children, children aged 5-11 The BNT162b2 booster shot can be given at least 5 months after the second dose of the new crown vacci.
    On May 23, 2022, data from the Phase 2/3 trial of the third dose of BNT162b2 for children 6 months to under 5 years of age were also announced [
    To strengthen the safety, immunogenicity and vaccine efficacy of the injection, the test results show that after three doses of BNT162b2 in this age group, a strong immune response can be induced, and the vaccine is well tolerated by children, preventing new coronavirus infecti.
    The effective rate is 8
    FDA official Robert M also mentioned in his discussion that the severity of children infected with the new crown is lower than that of adults, but during the Omicron epidemic, more children were infected and hospitalized, and even mild infections in children may suffer from some long-term sequel.
    Continuing protection is available for childr.
    The recent release of a number of data on the vaccination of children and adolescents against the new crown has also brought us to focus on the immunization situation of this gro.
    The progress of children and adolescents' new crown vaccination is relatively lagging behi.
    Children and adolescents account for about 20% of the entire populati.
    New crown virus is susceptible to all groups, including children and adolescen.
    If children and adolescents are not vaccinated, the immune barrier of the population will be defective, so herd immunity The realization of children and adolescents is indispensab.
    According to data released by the US CDC on April 24, during the period when the Omicron variant was dominant, the incidence of COVID-19 in unvaccinated children aged 5-11 was 3 times higher than that of children who received a single dose of the vaccine [3]
    However, judging from the vaccination data of the new crown vaccine, the progress of the new crown vaccination of children and adolescents is relatively lagging behi.
    As of May 19, 2022, the number of children infected with the new coronavirus in the United States accounted for 10% of all new crown cases, and the cumulative incidence exceeded 17,000/100,000, as shown in Figure But at the same time, only 9 million (35%) of children aged 5-11 have received their first dose of the new crown vaccine, and only 1 million (28%) children have completed 2 doses, as shown in Figure The vaccination of children with new crown vaccine lags significantly compared with other groups [4,
    Figure 1 Figure 2 Children's vaccination against the new crown can effectively reduce children's multisystem inflammatory syndrome (MIS-C) MIS-C refers to the severe hyperinflammatory syndrome that occurs 2-6 weeks after children are infected with SARS-CoV-2, leading to various The occurrence of manifestations and complications is one of the sequelae of children infected with the new coronavir.
    In children with MIS-C, 60 to 70 percent of the patients become severe and 1 to 2 percent die [6,
    In the early days of the COVID-19 pandemic (April-June 2020), there was approximately 1 case of MIS-C per 3,000 SARS-CoV-2 infected persons <21 years old [
    A Danish study published in The Lancet Child and Adolescent Health showed [9] that during the Delta epidemic period, the incidence of MIS-C in unvaccinated individuals was 1 case/3400 (95%CI 2600-4600), The individual breakthrough infection of the vaccine was 1 case/9900 (95% CI 1800-390 000), as shown in Figure
    In addition, in individuals aged 5-17 years, the efficacy of two doses of BNT162b2 mRNA vaccine against MIS-C after delta variant infection was 94% (95% CI 55-99), which fully demonstrates that vaccination of children and adolescents with new crown vaccine can effectively prevent Occurrence of MIS.
    Figure 3 The GMT of children and adolescents receiving the third dose of mRNA vaccine has increased significant.
    The "Morbidity and Mortality Weekly Report (MMWR)" released by the US CDC on February 18, 2022 shows that [10], during the Omicron epidemic, the hospitalization rate of children increased significantly, and children The issue of whether adolescents need booster immunization has also begun to be formally judg.
    Data show that during the Omicron epidemic, adolescent mRNA vaccine booster vaccination can effectively improve vaccine efficacy [1
    On May 19, 2022, the US CDC announced the phase 2/3 clinical trial data of the mRNA new crown vaccine BNT162b2 inoculated with a third booster dose (10µg) in children and adolescents aged 5-12 [1
    In terms of safety, no new safety problems were found among the 401 subjects who received the third dose, and after the third dose, most of the adverse reactions were mild or moderate, with a short duration, similar to the second do.
    The adverse reactions observed were comparable, as shown in Figure In terms of immunogenicity, in the previously uninfected population, the seroconversion rate reached 95%, as shown in Figure 5; and compared with the GMT of 1259 one month after the two doses, the GMT one month after the third dose was 2729, GMR was 17 (76, 68), and the titer of neutralizing antibody increased significantly, as shown in Figure Figure 4 Figure 5 Figure 6 The mRNA new crown vaccine BNT162b2 has been included in the local government vaccination plan not only in the United States, but also in Hong Kong, Macao and Taiwan in China in 202Since 2022, the vaccination of children has also been accelerated local.
    Hong Kong has started vaccinating children aged 5-11 years with BNT162b2 (10µg) from February 16, 202
    On May 2, 2022, Taiwan extended the emergency use authorization of the mRNA new crown vaccine to children aged 5-1In addition, the Macao Special Administrative Region government also began to provide children with mRNA vaccine BNT162b2 vaccination from May 2Summary:Immunization of children and adolescents is an indispensable part of herd immunity, but the vaccination of children and adolescents in various countries is relatively lagging behind, and they are the most vulnerable groups to the virus during the current epidem.
    Therefore, it is necessary to speed up the vaccination of children and adolescen.
    wo.
    The new crown vaccine can not only prevent infection and severe illness, but also effectively reduce the incidence of multisystem inflammatory syndrome (MIS-C) in childr.
    The safety of the third dose of mRNA vaccine for children and adolescents is good, and the immunogenicity is significantly improv.
    Therefore, children and adolescents are recommended to receive the third booster do.

    Whether inactivated vaccines or mRNA vaccines, more and more research data have proved the protective effect of the new crown vaccine on children and adolescen.

    Children and adolescents are the future and hope of society and the count.

    Rapidly increasing the vaccination rate of children and adolescents against the new crown is to protect children and adolescents from An effective way for the new crown, and we also look forward to a better vaccine that can bring continuous protection to children and adolescen.
    Reference: [1] F.

    Coronavirus(COVID-19)Update:FDA Expands Eligibility for COVID-19 Vaccine Booste.

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    Pfizer and BioNTech Granted USEmergency Use Authorization for Booster Dose of Their COVID-19 Vaccine in Children 5 Through 11 Years of A.

    2022( https://investo.

    bionte.

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    Rates of COVID-19 Cases and Deaths by Vaccination Stat.

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    gov/covid-data-tracker/#rates-by-vaccine-status) [4] American Academy of Pediatri.

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    Summary of data publicly reported by the Centers for Disease Control and Preventi.

    2022 (https:// ] Feldstein LR, et .

    Characteristics and Outcomes of US Children and Adolescents With Multisystem Inflammatory Syndrome in Children(MIS-C)Compared With Severe Acute COVID-1JA.

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    2022091[7]Belay ED, et .

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    Incidence of Multisystem Inflammatory Syndrome in Children Among US Persons Infected With SARS-CoV-JAMA Netw Op.

    2021 Jun 1;4(6):e211642doi:11001/jamanetworkop.

    20216420[9]Nygaard U,Holm M,Hartling UB, et .

    Incidence and clinical phenotype of multisystem inflammatory syndrome in children after infection with the SARS-CoV-2 delta variant by vaccination status: a Danish nationwide prospective cohort study [published online ahead of print, 2022 May
    Lancet Child Adolesc Heal.

    2022;S2352-4642(22)00100-doi:11016/S2352-4642(22)00100-6[10]C.

    Morbidity and Mortality Weekly Report(MMW.

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    gov/mmWr/)[11]C.

    ACIP Presentation Slides:May 19,2022 Meeti.

    2022(https:// This article is only used to provide scientific information to medical and health professionals and does not represent the platform's positione211642doi:11001/jamanetworkop.

    20216420[9] Nygaard U, Holm M, Hartling UB, et .

    Incidence and clinical phenotype of multisystem inflammatory syndrome in children after infection with the SARS-CoV-2 delta variant by vaccination status: a Danish nationwide prospective cohort study[published online ahead of print, 2022 May
    Lancet Child Adolesc Heal.

    2022;S2352-4642(22)00100-doi:11016/S2352-4642(22)00100-6[10] C.

    Morbidity and Mortality Weekly Report(MMW.

    2022(https:// Presentation Slides:May 19,2022 Meeti.

    2022(https:/.

    gov/vaccines/acip/meetings/slides-2022-05-1html) This article is for the purpose of providing scientific information to healthcare professionals only and does not represent the platform's positione211642doi:11001/jamanetworkop.

    20216420[9] Nygaard U, Holm M, Hartling UB, et .

    Incidence and clinical phenotype of multisystem inflammatory syndrome in children after infection with the SARS-CoV-2 delta variant by vaccination status: a Danish nationwide prospective cohort study[published online ahead of print, 2022 May
    Lancet Child Adolesc Heal.

    2022;S2352-4642(22)00100-doi:11016/S2352-4642(22)00100-6[10] C.

    Morbidity and Mortality Weekly Report(MMW.

    2022(https:// Presentation Slides:May 19,2022 Meeti.

    2022(https:/.

    gov/vaccines/acip/meetings/slides-2022-05-1html) This article is for the purpose of providing scientific information to healthcare professionals only and does not represent the platform's positionIncidence and clinical phenotype of multisystem inflammatory syndrome in children after infection with the SARS-CoV-2 delta variant by vaccination status: a Danish nationwide prospective cohort study [published online ahead of print, 2022 May
    Lancet Child Adolesc Heal.

    2022; S2352-4642(22)00100-doi:11016/S2352-4642(22)00100-6[10]C.

    Morbidity and Mortality Weekly Report(MMW.

    2022(https:// /)[11]C.

    ACIP Presentation Slides:May 19,2022 Meeti.

    2022(https:// This article is only for Provides scientific information to healthcare professionals and does not represent the platform's positionIncidence and clinical phenotype of multisystem inflammatory syndrome in children after infection with the SARS-CoV-2 delta variant by vaccination status: a Danish nationwide prospective cohort study [published online ahead of print, 2022 May
    Lancet Child Adolesc Heal.

    2022; S2352-4642(22)00100-doi:11016/S2352-4642(22)00100-6[10]C.

    Morbidity and Mortality Weekly Report(MMW.

    2022(https:// /)[11]C.

    ACIP Presentation Slides:May 19,2022 Meeti.

    2022(https:// This article is only for Provides scientific information to healthcare professionals and does not represent the platform's positiongov/mmWr/)[11]C.

    ACIP Presentation Slides:May 19,2022 Meeti.

    2022(https:// This article Used only to provide scientific information to healthcare professionals and does not represent the platform's positiongov/mmWr/)[11]C.

    ACIP Presentation Slides:May 19,2022 Meeti.

    2022(https:// This article Used only to provide scientific information to healthcare professionals and does not represent the platform's position
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