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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） (2 ページ)
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| 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》 |
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1
2
The American public can be assured that any COVID-19 vaccine authorized or
3
approved by the FDA meets our standards for safety and effectiveness. We
4
encourage those who are currently eligible for a booster to get one.
5
6
As we move into the fall and winter, it is critical that we have safe and effective
7
vaccine boosters that can provide protection against circulating and emerging
8
variants to prevent the most severe consequences of COVID-19. Following a
9
thorough discussion on June 28, 2022, an overwhelming majority of the advisory
10
committee voted in favor of including a SARS-CoV-2 omicron component in
11
COVID-19 vaccines that would be used for boosters in the U.S. beginning in fall
12
2022.
13
14
Following the vote, and striving to use the best available scientific evidence, we
15
have advised manufacturers seeking to update their COVID-19 vaccines that they
16
should develop modified vaccines that add an omicron BA.4/5 spike protein
17
component to the current vaccine composition to create a two component
18
(bivalent) booster vaccine, so that the modified vaccines can potentially be used
19
starting in early to mid-fall 2022.
20
21
As we expect this coming year to be a transitional period when this modified
22
booster vaccine may be introduced, we have not advised manufacturers to change
23
the vaccine for primary vaccination, since a primary series with the FDA-
24
authorized and approved COVID-19 vaccines provides a base of protection
25
against serious outcomes of COVID-19 caused by circulating strains of SARS-
26
CoV-2.
27
28
Vaccine manufacturers have already reported data from clinical trials with
29
modified vaccines containing an omicron BA.1 component and we have advised
30
them that they should submit these data to the FDA for our evaluation prior to
31
any potential authorization of a modified vaccine containing an omicron BA.4/5
32
component. Manufacturers will also be asked to begin clinical trials with modified
2
2
The American public can be assured that any COVID-19 vaccine authorized or
3
approved by the FDA meets our standards for safety and effectiveness. We
4
encourage those who are currently eligible for a booster to get one.
5
6
As we move into the fall and winter, it is critical that we have safe and effective
7
vaccine boosters that can provide protection against circulating and emerging
8
variants to prevent the most severe consequences of COVID-19. Following a
9
thorough discussion on June 28, 2022, an overwhelming majority of the advisory
10
committee voted in favor of including a SARS-CoV-2 omicron component in
11
COVID-19 vaccines that would be used for boosters in the U.S. beginning in fall
12
2022.
13
14
Following the vote, and striving to use the best available scientific evidence, we
15
have advised manufacturers seeking to update their COVID-19 vaccines that they
16
should develop modified vaccines that add an omicron BA.4/5 spike protein
17
component to the current vaccine composition to create a two component
18
(bivalent) booster vaccine, so that the modified vaccines can potentially be used
19
starting in early to mid-fall 2022.
20
21
As we expect this coming year to be a transitional period when this modified
22
booster vaccine may be introduced, we have not advised manufacturers to change
23
the vaccine for primary vaccination, since a primary series with the FDA-
24
authorized and approved COVID-19 vaccines provides a base of protection
25
against serious outcomes of COVID-19 caused by circulating strains of SARS-
26
CoV-2.
27
28
Vaccine manufacturers have already reported data from clinical trials with
29
modified vaccines containing an omicron BA.1 component and we have advised
30
them that they should submit these data to the FDA for our evaluation prior to
31
any potential authorization of a modified vaccine containing an omicron BA.4/5
32
component. Manufacturers will also be asked to begin clinical trials with modified
2