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) (4 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》 |
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1
an improved level of cross-neutralization against previous VOCs as well as current
2
Omicron and possibly future Omicron sublineages in the Northern hemisphere
3
winter season of 2022. While initial recommendations might be restricted to
4
booster doses, additional data may enable using adapted vaccines also to be used
5
for primary series in the future.
6
7
In addition, there might be a possibility that vaccines with a different VOC
8
included, e.g. Beta, could still provide an adequate immune response to Omicron
9
and its subvariants and could be considered for regulatory approval. Moreover, it
10
is not excluded that different types of strains could be prevalent among regions,
11
which might require some regional flexibility for selection of variants incorporated
12
in vaccines.
13
14
Effectiveness studies with variant-adapted vaccines should be conducted to
15
determine the level of protection conferred over time in real-life conditions
16
against different clinical endpoints such as disease, hospitalization and death.
17
Furthermore, depending on vaccine availability and national recommendations,
18
as a general principle, elderly and vulnerable populations should be prioritized in
19
the vaccination campaigns ahead of the Northern hemisphere winter season.
20
Finally, regulatory strategies for approval of variant vaccines will be fine-tuned in
21
the future considering the experience gathered so far with various vaccine
22
compositions and across different platform technologies.
4
an improved level of cross-neutralization against previous VOCs as well as current
2
Omicron and possibly future Omicron sublineages in the Northern hemisphere
3
winter season of 2022. While initial recommendations might be restricted to
4
booster doses, additional data may enable using adapted vaccines also to be used
5
for primary series in the future.
6
7
In addition, there might be a possibility that vaccines with a different VOC
8
included, e.g. Beta, could still provide an adequate immune response to Omicron
9
and its subvariants and could be considered for regulatory approval. Moreover, it
10
is not excluded that different types of strains could be prevalent among regions,
11
which might require some regional flexibility for selection of variants incorporated
12
in vaccines.
13
14
Effectiveness studies with variant-adapted vaccines should be conducted to
15
determine the level of protection conferred over time in real-life conditions
16
against different clinical endpoints such as disease, hospitalization and death.
17
Furthermore, depending on vaccine availability and national recommendations,
18
as a general principle, elderly and vulnerable populations should be prioritized in
19
the vaccination campaigns ahead of the Northern hemisphere winter season.
20
Finally, regulatory strategies for approval of variant vaccines will be fine-tuned in
21
the future considering the experience gathered so far with various vaccine
22
compositions and across different platform technologies.
4