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

▎ 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
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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
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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
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 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)
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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
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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
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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
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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
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 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
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The two companies also plan to evaluate booster needles at a dose level of 10 µg in children 5 to 12 years of age
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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.
S.
FDA and the European Medicines Agency (EMA).
) Approval and consent
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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
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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
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