完整标题:
Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two
COVID-19 Vaccines for Older and Immunocompromised Individuals
发稿单位:美国FDA
发稿时间:March 29, 2022
撰 稿 者:美国FDA
原文连结:https://bit.ly/3wMHcv2
FDA在今日(3/29)核准辉瑞BNT和莫德纳的第二追加剂(second booster dose)
施打的目标对象群是长者跟特定的免疫力低下族群
之前FDA已经核准了一剂追加剂,施打在已施打完基础加强剂的目标群上
本次核准透过施打第二追加剂,
将能够对那些重症高危险群提供更多的免疫保护力,避免重症住院甚至死亡。
目前的证据指出第二追加剂可以提供更高的保护力,无任何新的安全疑虑。
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.
可接受施打的对象(疫苗标准参照美国FDA/CDC标准):
1.50岁以上的成年人
且完成第一次追加剂接种4个月后
2.曾因为接受器官移植等造成免疫力低下
且完成第一次追加剂接种4个月后
(辉瑞BNT年龄12岁以上、莫德纳18岁以上)
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.
(其余段落省略)