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※ 本文為 MindOcean 轉寄自 ptt.cc 更新時間: 2022-03-30 18:48:14
看板 nCoV2019
作者 skbb2553 (星祈)
標題 [新聞] 美國FDA核准輝瑞BNT跟莫德納第二次追加劑
時間 Wed Mar 30 00:26:21 2022


完整標題:
Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two
COVID-19 Vaccines for Older and Immunocompromised Individuals

發稿單位:美國FDA
發稿時間:March 29, 2022
撰 稿 者:美國FDA
原文連結:https://bit.ly/3wMHcv2
Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals | FDA
[圖]
The FDA authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised ...

 


FDA在今日(3/29)核准輝瑞BNT和莫德納的第二追加劑(second booster dose)
施打的目標對象群是長者跟特定的免疫力低下族群

之前FDA已經核准了一劑追加劑,施打在已施打完基礎加強劑的目標群上

本次核准透過施打第二追加劑,
將能夠對那些重症高危險群提供更多的免疫保護力,避免重症住院甚至死亡。

目前的證據指出第二追加劑可以提供更高的保護力,無任何新的安全疑慮。

Today, the U.S. Food and Drug Administration authorized a second booster dose
of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older
people and certain immunocompromised individuals. The FDA previously
authorized a single booster dose for certain immunocompromised individuals
following completion of a three-dose primary vaccination series. This action
will now make a second booster dose of these vaccines available to other
populations at higher risk for severe disease, hospitalization and death.
Emerging evidence suggests that a second booster dose of an mRNA COVID-19
vaccine improves protection against severe COVID-19 and is not associated
with new safety concerns.

可接受施打的對象(疫苗標準參照美國FDA/CDC標準):
1.50歲以上的成年人
  且完成第一次追加劑接種4個月後
2.曾因為接受器官移植等造成免疫力低下
  且完成第一次追加劑接種4個月後
  (輝瑞BNT年齡12歲以上、莫德納18歲以上)

The agency amended the emergency use authorizations as follows:

    A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Moderna
COVID-19 Vaccine may be administered to individuals 50 years of age and older
at least 4 months after receipt of a first booster dose of any authorized or
approved COVID-19 vaccine.

    A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be
administered to individuals 12 years of age and older with certain kinds of
immunocompromise at least 4 months after receipt of a first booster dose of
any authorized or approved COVID-19 vaccine. These are people who have
undergone solid organ transplantation, or who are living with conditions that
are considered to have an equivalent level of immunocompromise.
    A second booster dose of the Moderna COVID-19 Vaccine may be administered
at least 4 months after the first booster dose of any authorized or approved
COVID-19 vaccine to individuals 18 years of age and older with the same
certain kinds of immunocompromise.


(其餘段落省略)

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