IPFA position on acceptance criteria for Covid-19 vaccinated donors
Dr Françoise Rossi,
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 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 recommends:
- A minimum deferral of 4 weeks for investigational vaccines (clinical trials) of any type
- No deferral period for mRNA or protein vaccines
- A minimum of 4 weeks for viral vector-type vaccines when considered “attenuated virus” (as per Directive 2004/33).
On Dec 12th, 2020, the PEI published its recommendation concerning post vaccination donor deferral in line with the above stating that:
“On the basis of the current state of knowledge, no donor deferral is required after vaccination with the SARS-CoV-2 vaccines under approval, which contain inactivated viruses or non-infectious virus components such as mRNA. All other default criteria set out in the Hemotherapy Directive remain fully applicable. “ (in German: https://www.pei.de/EN/medicine-safety/haemovigilance/guidelines/guidelines-node.html;jsessionid=12DF32D0B1D6547F1004A53F0749348D.intranet211 )
On January 19, 2021, FDA published an Updated Information for Blood Establishments Regarding the COVID-19 Pandemic and Blood Donation recommending
- individuals who received a nonreplicating, inactivated, or mRNA-based COVID-19 vaccine can donate blood without a waiting period,
- individuals who received a live-attenuated viral COVID-19 vaccine, refrain from donating blood for a short waiting period (e.g., 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 “Currently available data and evidence suggest a low probability of whole blood and plasma donation by asymptomatic individuals in the early phase of TTS, posing a very low risk of venepuncture bleeding or post-transfusion thrombocytopenia by passive transfer of anti-platelet antibodies. Therefore, no additional blood and plasma safety measures related to the occurrence of suspected adverse reactions to COVID-19 vaccines are recommended.”
Whilst IPFA strongly 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 accordingly advocates caution in the development of any future regulatory actions, based on the precautionary principle, concerning donor deferral which may further worsen plasma collection and consequently Plasma derived medicinal products supply.