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資 料４－２－➁ 令和４年度第２回安全技術調査会の審議結果について➁ (170 ページ)
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| 出典情報 | 薬事・食品衛生審議会 薬事分科会血液事業部会（令和4年度第2回 9／14）《厚生労働省》 |
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IPFA position on acceptance Criteria for Covid-
19 vaccinated donors
2 0ctober 2021
Dr Francoise ROSSi,
Director of Scientific and Requlatory 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 programmes 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 recommendSs:
* Aminimum deferral of 4 weeks for investigational vaccines (clinical trials) of
any type
* Nodeferral 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:/wwwr.ecdc.europa.eu/sites/default/files/documents/covid-19-supply-
substances-human-origin-second-update.pdf
On Dec 12th, 2020, the PEI published its recommendation concernind post
vaccination donor deferral in line with the above stating that:
“O 妨e pgs/S 07 妨e Cu77e77 Sg7e O7 7OW7ege, の OOr のe7e/7g/ /S /69077 g訂er
VCC7g7の7 M7訪 のe SA4RS-Co2 gcc廊eS 7のe7 pp/OV3/ M力/C力 COの7お加
加gCが87 V77USeS の7 の万-7776CがO0S V7りS CO77DOne77S Soカカ gs 7が避M4. 47 o娘e/
ge計g/7 c/77fe77g se7 ouf 7 妨e e77o妨ergpy の/yecがve /e/77877 7/ルpp/caの/e. "(in
German: https:/www.pei.de/EN/medicine-
safety/haemovigilance/quidelines/quidelines-
node.htmliisessionid=12DF32D0B1D6547F1004A53F0749348D.intranet211 )
On January 19, 2021, FDA published an Updated Infor
Establishments Regarding the COVID-19 Pandemic and Blood Donation
recommendinqg
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
donatinq 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
"CO/7e77ル 2379の/6 379 27び ee7Ce Su996S7 9 /OW p/ののgaの太のチ M力Oo/e の/Oo9 237の
p/gs778 0O7g2がO7 のy 2SW7D7の7がC 7のMg/S 万 妨e eag7/ルpase oO7 77S POS加99
Ve/ル7/OW /7S o7 venep077C77e の/ee/79 の7 OSたかが37S7/S/O77 妨/O77のOcCy7Ope77/8 のy
2SS/Ve か27S76/ の7 27がり/g7e/e7 2がりOのjes. 7カe/e7O7@, 7O 2777が77g/ の/OoO gagの
p/gs7773 S27e /76gS07GS /@/g7eO 7の 妨@ OCCu/7e7Ce O7 SUSOeC7G 2びVe/S@ /6gC7がOS
7o COの-79 gcc/7eS 3/@ /@CO77777677eの“
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 accordinaly advocates caution in the development of any
future requlatory actions, based on the precautionary principle, concerning donor
deferral which may further worsen plasma collection and consequently Plasma
derived medicinal products supply.
36
19 vaccinated donors
2 0ctober 2021
Dr Francoise ROSSi,
Director of Scientific and Requlatory 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 programmes 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 recommendSs:
* Aminimum deferral of 4 weeks for investigational vaccines (clinical trials) of
any type
* Nodeferral 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:/wwwr.ecdc.europa.eu/sites/default/files/documents/covid-19-supply-
substances-human-origin-second-update.pdf
On Dec 12th, 2020, the PEI published its recommendation concernind post
vaccination donor deferral in line with the above stating that:
“O 妨e pgs/S 07 妨e Cu77e77 Sg7e O7 7OW7ege, の OOr のe7e/7g/ /S /69077 g訂er
VCC7g7の7 M7訪 のe SA4RS-Co2 gcc廊eS 7のe7 pp/OV3/ M力/C力 COの7お加
加gCが87 V77USeS の7 の万-7776CがO0S V7りS CO77DOne77S Soカカ gs 7が避M4. 47 o娘e/
ge計g/7 c/77fe77g se7 ouf 7 妨e e77o妨ergpy の/yecがve /e/77877 7/ルpp/caの/e. "(in
German: https:/www.pei.de/EN/medicine-
safety/haemovigilance/quidelines/quidelines-
node.htmliisessionid=12DF32D0B1D6547F1004A53F0749348D.intranet211 )
On January 19, 2021, FDA published an Updated Infor
Establishments Regarding the COVID-19 Pandemic and Blood Donation
recommendinqg
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
donatinq 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
"CO/7e77ル 2379の/6 379 27び ee7Ce Su996S7 9 /OW p/ののgaの太のチ M力Oo/e の/Oo9 237の
p/gs778 0O7g2がO7 のy 2SW7D7の7がC 7のMg/S 万 妨e eag7/ルpase oO7 77S POS加99
Ve/ル7/OW /7S o7 venep077C77e の/ee/79 の7 OSたかが37S7/S/O77 妨/O77のOcCy7Ope77/8 のy
2SS/Ve か27S76/ の7 27がり/g7e/e7 2がりOのjes. 7カe/e7O7@, 7O 2777が77g/ の/OoO gagの
p/gs7773 S27e /76gS07GS /@/g7eO 7の 妨@ OCCu/7e7Ce O7 SUSOeC7G 2びVe/S@ /6gC7がOS
7o COの-79 gcc/7eS 3/@ /@CO77777677eの“
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 accordinaly advocates caution in the development of any
future requlatory actions, based on the precautionary principle, concerning donor
deferral which may further worsen plasma collection and consequently Plasma
derived medicinal products supply.
36