よむ、つかう、まなぶ。
07【参考資料２】FDA Statement Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses（June 30, 2022） (1 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_26922.html |
| 出典情報 | 厚生科学審議会 予防接種・ワクチン分科会（第33回 7／22）《厚生労働省》 |
ページ画像
ダウンロードした画像を利用する際は「出典情報」を明記してください。
低解像度画像をダウンロード
プレーンテキスト
資料テキストはコンピュータによる自動処理で生成されており、完全に資料と一致しない場合があります。
テキストをコピーしてご利用いただく際は資料と付け合わせてご確認ください。
【参考資料２】
1
2
FDA Statement
3
Coronavirus (COVID-19) Update: FDA Recommends
4
Inclusion of Omicron BA.4/5 Component for COVID-19
5
Vaccine Booster Doses
6
The following is attributed Peter Marks, M.D., Ph.D., director of the FDA’s Center for
7
Biologics Evaluation and Research
8
9
For Immediate Release: June 30, 2022
10
Statement From: Peter Marks, M.D., PhD.
11
Director - Center for Biologics Evaluation and Research (CBER)
12
13
On Tuesday, the U.S. Food and Drug Administration’s independent experts on
14
the Vaccines and Related Biological Products Advisory Committee met to publicly
15
discuss whether a change to the current vaccine strain composition of COVID-19
16
vaccines for booster doses is necessary for the 2022 fall and winter seasons.
17
18
The COVID-19 vaccines that the FDA has approved and authorized for
19
emergency use have made a tremendous difference to public health and have
20
saved countless lives in the U.S. and globally. However, SARS-CoV-2, the virus
21
that causes COVID-19, has evolved significantly, with recent surges around the
22
world associated with the rapid spread of highly transmissible variants such as
23
omicron.
24
25
Currently available vaccines have helped reduce the most serious outcomes
26
(hospitalization and death) caused by COVID-19, but results from post-
27
authorization observational studies have shown that effectiveness of primary
28
vaccination wanes over time against certain variants, including omicron. And
29
while initial booster doses have helped restore protection against severe disease
30
and hospitalization associated with omicron, studies have also indicated waning
31
effectiveness of first booster doses over time.
1
1
2
FDA Statement
3
Coronavirus (COVID-19) Update: FDA Recommends
4
Inclusion of Omicron BA.4/5 Component for COVID-19
5
Vaccine Booster Doses
6
The following is attributed Peter Marks, M.D., Ph.D., director of the FDA’s Center for
7
Biologics Evaluation and Research
8
9
For Immediate Release: June 30, 2022
10
Statement From: Peter Marks, M.D., PhD.
11
Director - Center for Biologics Evaluation and Research (CBER)
12
13
On Tuesday, the U.S. Food and Drug Administration’s independent experts on
14
the Vaccines and Related Biological Products Advisory Committee met to publicly
15
discuss whether a change to the current vaccine strain composition of COVID-19
16
vaccines for booster doses is necessary for the 2022 fall and winter seasons.
17
18
The COVID-19 vaccines that the FDA has approved and authorized for
19
emergency use have made a tremendous difference to public health and have
20
saved countless lives in the U.S. and globally. However, SARS-CoV-2, the virus
21
that causes COVID-19, has evolved significantly, with recent surges around the
22
world associated with the rapid spread of highly transmissible variants such as
23
omicron.
24
25
Currently available vaccines have helped reduce the most serious outcomes
26
(hospitalization and death) caused by COVID-19, but results from post-
27
authorization observational studies have shown that effectiveness of primary
28
vaccination wanes over time against certain variants, including omicron. And
29
while initial booster doses have helped restore protection against severe disease
30
and hospitalization associated with omicron, studies have also indicated waning
31
effectiveness of first booster doses over time.
1