echemi logo
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Infection > Express delivery is aimed at children between 6 months and 5 years old. Pfizer/BioNTech modified the experimental design to evaluate the effect of enhanced needles

    Express delivery is aimed at children between 6 months and 5 years old. Pfizer/BioNTech modified the experimental design to evaluate the effect of enhanced needles

    • Last Update: 2021-12-30
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit
    ▎ WuXi AppTec content team editor On December 17, 2021, Pfizer and BioNTech announced that they would revise a large-scale clinical trial to evaluate their new crown vaccine for children 6 months to 5 years old

    This sub-test will evaluate the efficacy and safety of the third vaccination at a dose level of 3 µg in this age group that has completed the two main vaccination at least two months after the second vaccination

    If positive results from this trial are obtained, Pfizer and BioNTech expect to submit data to regulatory agencies in the first half of 2022 to seek approval for the emergency use authorization (EUA) of the new crown vaccine booster injection for children 6 months to 5 years old

     This large-scale clinical trial enrolled 4,500 children from 6 months to under 12 years old (regardless of previous evidence of new coronavirus infection), and aimed to evaluate the Pfizer/BioNTech vaccine two-dose vaccination regimen (with an interval of about 21 days) at 3 ages Safety, tolerability and immunogenicity in the group (5 years old to under 12 years old; 2 years old to under 5 years old; 6 months to under 2 years old)

    Based on the phase 1 dose escalation part of the trial, in the phase 2/3 trial, children aged 5 to 12 years old received two doses of 10 µg each time vaccination regimen, while children under 5 years old received a lower 3 Vaccination at the µg dose level

    Although the trial is still ongoing and remains blind, the researchers performed a pre-specified immunogenicity analysis on a subset of subjects one month after the second vaccination

    The analysis results show that compared with the 16-25 year-old age group that has confirmed the high immune protection effect of the new crown vaccine, the 6-24-month-old age group meets the non-inferiority standard, but the 2-5 year-old age group does not

    In addition, the analysis found no safety issues, and the 3 µg dose level showed favorable safety characteristics in the age group of 6 months to under 5 years of age

     Written by WuXi AppTec's content team.
    In addition, Pfizer and BioNTech have initiated sub-tests at low dose levels of 10 µg or 30 µg among approximately 600 adolescents aged 12-17 years to evaluate the safety and immunogen of the third dose of the new coronavirus vaccine Sex

    The two companies also plan to evaluate booster needles at a dose level of 10 µg in children 5 to 12 years of age

    These decisions are based on data on the effectiveness of 3 doses of vaccine in people 16 years and older, and early laboratory data observed for Delta and other variants of interest (including Omicron), and have been obtained from the U.
    FDA and the European Medicines Agency (EMA).
    ) Approval and consent

    These data indicate that people who have been vaccinated with three doses of the new crown vaccine may be able to obtain a higher degree of immune protection

    Reference: [1] Pfizer And Biontech Provide Update On Ongoing Studies Of Covid-19 Vaccine.
    Retrieved December 17, 2021, from https:// -and-biontech-provide-update-ongoing-studies-covid-19[2] Pfizer Plans To Study A Third Shot For Its Covid-19 Vaccine In The Youngest Kids, Pushing Back Its Timeline Farther.
    Retrieved December 17, 2021, from https://endpts.
    com/pfizer-plans-to-trial-a-third-shot-for-its-covid-19-vaccine-in-the-youngest-kids-pushing-back-its-timeline-farther/ Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress

    This article is for the purpose of information exchange only.
    The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article

    This article is not a treatment recommendation either

    If you need guidance on the treatment plan, please go to a regular hospital for treatment

    This article is an English version of an article which is originally in the Chinese language on and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to with relevant evidence.