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参考資料１－４ 浜口班の議論における参考資料（令和３年12月21日開催） (4 ページ)
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| 公開元URL | https://www.mhlw.go.jp/stf/newpage_24719.html |
| 出典情報 | 薬事・食品衛生審議会 薬事分科会血液事業部会安全技術調査会(令和3年度第6回 3／29）《厚生労働省》 |
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IPFA position on acceptance criteria for Covid-
19 vaccinated donors
2 October 2021
Dr Francoise RoSSsi,
Director of Scientific and Regulatory Affairs
First published Jan 2021, Rev. July 2021
IPFA position on acceptance Criteria for Covid-19 vaccinated donors
In anticipation of the regulatory approval for use of a number of Covid-19 vaccines
and the commencement of national mass vaccination proqrammes the European
Centre for Disease Prevention and Control (ECDC) has published its updated
technical guidance - Coronavirus disease 2019 (COVID-19) and supply of
Substances of human origin in the EU/EEA - second update.
The guidance in respect of donor deferral following vaccination recommends:
s Aminimum deferral of 4 weeks for investigational vaccines (clinical trials) of
any type
* No deferral period for mRNA or protein vaccines
* Aminimum of 4 weeks for viral vector-type vaccines when considered
“attenuated virus" (as per Directive 2004/33).
https://www.ecdc.europa.eu/sites/default/files/documents/coyvid-19-supply-
substances-human-origin-Second-update.pdf
On Dec 12th, 2020, the PEI published its recommendation concernind Dost
vaccination donor deferral in line with the above statinq that:
German: https://www.pei.de/EN/medicine-
safety/haemovigilance/guidelines/quidelines-
node.htmlijisessionid=12DF32D0B1D6547F1004A53F0749348D.intranet211 )
On January 19, 2021, FDA published an Updated Information for Blood
Establishments Regarding the COVID-19 Pandemic and Blood Donation
recommending
s individuals who received a nonreplicatina, inactivated, or mRNA-based COVID-
19 vaccine can donate blood without a waiting Deriod,
s Individuals who received a live-attenuated viral COVID-19 vaccine, refrain from
donating blood for a short waiting period (e.q., 14 days) after receipt of the
vaccine
On 3 Jun 2021, the ECDC published a report on Suspected adverse reactions to
COVID-19 vaccination and the safety of substances of human origin, stating that
Whilst IPFA stronqly Supports the above current recommendations it iS also
important to recognise the impact on the global blood and plasma supply of the
Covid pandemic and accordinagly advocates caution in the development of any
future requlatory actions, based on the precautionary Drinciple, concerninq donor
deferral which may further worsen plasma collection and consequently Plasma
derived medicinal products supply.
4
19 vaccinated donors
2 October 2021
Dr Francoise RoSSsi,
Director of Scientific and Regulatory Affairs
First published Jan 2021, Rev. July 2021
IPFA position on acceptance Criteria for Covid-19 vaccinated donors
In anticipation of the regulatory approval for use of a number of Covid-19 vaccines
and the commencement of national mass vaccination proqrammes the European
Centre for Disease Prevention and Control (ECDC) has published its updated
technical guidance - Coronavirus disease 2019 (COVID-19) and supply of
Substances of human origin in the EU/EEA - second update.
The guidance in respect of donor deferral following vaccination recommends:
s Aminimum deferral of 4 weeks for investigational vaccines (clinical trials) of
any type
* No deferral period for mRNA or protein vaccines
* Aminimum of 4 weeks for viral vector-type vaccines when considered
“attenuated virus" (as per Directive 2004/33).
https://www.ecdc.europa.eu/sites/default/files/documents/coyvid-19-supply-
substances-human-origin-Second-update.pdf
On Dec 12th, 2020, the PEI published its recommendation concernind Dost
vaccination donor deferral in line with the above statinq that:
German: https://www.pei.de/EN/medicine-
safety/haemovigilance/guidelines/quidelines-
node.htmlijisessionid=12DF32D0B1D6547F1004A53F0749348D.intranet211 )
On January 19, 2021, FDA published an Updated Information for Blood
Establishments Regarding the COVID-19 Pandemic and Blood Donation
recommending
s individuals who received a nonreplicatina, inactivated, or mRNA-based COVID-
19 vaccine can donate blood without a waiting Deriod,
s Individuals who received a live-attenuated viral COVID-19 vaccine, refrain from
donating blood for a short waiting period (e.q., 14 days) after receipt of the
vaccine
On 3 Jun 2021, the ECDC published a report on Suspected adverse reactions to
COVID-19 vaccination and the safety of substances of human origin, stating that
Whilst IPFA stronqly Supports the above current recommendations it iS also
important to recognise the impact on the global blood and plasma supply of the
Covid pandemic and accordinagly advocates caution in the development of any
future requlatory actions, based on the precautionary Drinciple, concerninq donor
deferral which may further worsen plasma collection and consequently Plasma
derived medicinal products supply.
4
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