よむ、つかう、まなぶ。
08【参考資料３】International Coalition of Medicines Regulatory Authorities SARS-CoV-2 Variant Workshop（Thursday 30 June 2022） (3 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
neutralization of Omicron BA.4/BA.5 from the ongoing clinical trials with
2
monovalent or bivalent mRNA vaccines incorporating a BA.1 Omicron and
3
ancestral strain, as well as data from different types of vaccines, such as subunit
4
Beta variant booster vaccines, are awaited.
5
6
Conclusions and next steps
7
Based on the data presented, there was agreement that currently approved
8
COVID-19 vaccines are still recommended for primary series and booster doses
9
as they offer protection against severe disease and death, especially following the
10
administration of booster doses. In this context, new vaccines including the
11
ancestral, or a close-to ancestral, strain are currently still valid candidates for
12
booster vaccination. However, continuous viral evolution is expected, likely
13
resulting in reduction in protection, especially from infection and symptomatic
14
disease. Independent from the strain included in the vaccine, current vaccines are
15
designed to provide protection primarily against symptomatic and severe disease.
16
17
With the further evolution of Omicron descendent lineages, regulatory agencies
18
have requested safety and immunogenicity clinical studies be conducted by
19
vaccine developers, and those data are now being assessed to determine the
20
suitability of Omicron adapted vaccines to protect against recently emergent and
21
existing VOCs. Based on emerging clinical data with investigational vaccines
22
incorporating the Omicron BA.1 variant in mRNA vaccines, and as Omicron and
23
its subvariants remain dominant, an Omicron variant strain should be included in
24
adapted versions of currently approved vaccines to offer increased protection that
25
would ideally be longer lasting.
26
27
To expand upon this recommendation, the objective of adapted vaccines is to
28
provide a larger breadth of immunity against SARS-CoV-2 strains including
29
Omicron, as it is currently unknown which strains will be circulating next. With
30
the increasing circulation of Omicron-descendent lineages, bivalent vaccines
31
incorporating an Omicron descendent lineage and ancestral (index) virus would
32
be preferred for adapted versions of vaccines already in use, as they may provide
3
neutralization of Omicron BA.4/BA.5 from the ongoing clinical trials with
2
monovalent or bivalent mRNA vaccines incorporating a BA.1 Omicron and
3
ancestral strain, as well as data from different types of vaccines, such as subunit
4
Beta variant booster vaccines, are awaited.
5
6
Conclusions and next steps
7
Based on the data presented, there was agreement that currently approved
8
COVID-19 vaccines are still recommended for primary series and booster doses
9
as they offer protection against severe disease and death, especially following the
10
administration of booster doses. In this context, new vaccines including the
11
ancestral, or a close-to ancestral, strain are currently still valid candidates for
12
booster vaccination. However, continuous viral evolution is expected, likely
13
resulting in reduction in protection, especially from infection and symptomatic
14
disease. Independent from the strain included in the vaccine, current vaccines are
15
designed to provide protection primarily against symptomatic and severe disease.
16
17
With the further evolution of Omicron descendent lineages, regulatory agencies
18
have requested safety and immunogenicity clinical studies be conducted by
19
vaccine developers, and those data are now being assessed to determine the
20
suitability of Omicron adapted vaccines to protect against recently emergent and
21
existing VOCs. Based on emerging clinical data with investigational vaccines
22
incorporating the Omicron BA.1 variant in mRNA vaccines, and as Omicron and
23
its subvariants remain dominant, an Omicron variant strain should be included in
24
adapted versions of currently approved vaccines to offer increased protection that
25
would ideally be longer lasting.
26
27
To expand upon this recommendation, the objective of adapted vaccines is to
28
provide a larger breadth of immunity against SARS-CoV-2 strains including
29
Omicron, as it is currently unknown which strains will be circulating next. With
30
the increasing circulation of Omicron-descendent lineages, bivalent vaccines
31
incorporating an Omicron descendent lineage and ancestral (index) virus would
32
be preferred for adapted versions of vaccines already in use, as they may provide
3