L 173/38
EN
Official Journal of the European Union
30.6.2022
(4)
As a result of those developments and to enlarge the scope of the different types of diagnostic tests that may be used for the issuance of an EU Digital COVID Certificate, the definition of rapid antigen tests should be amended to include laboratory-based antigenic assays.
It should thus be possible for Member States to issue test certificates and, following the adoption of Commission Delegated Regulation (EU) 2022/256 (4), certificates of recovery on the basis of the antigen tests included in the EU common list of COVID-19 antigen tests agreed, and regularly updated, by the Health Security Committee as meeting the established quality criteria.
Given that Member States' COVID-19 testing strategies differ, the possibility for Member States to use antigen tests for the issuance of recovery certificates should thus remain optional, to be used in particular when there is a shortage of NAAT capacity due to a high number of infections in the area concerned or for another reason.
Where sufficient NAAT capacity is available, Member States can continue to issue certificates of recovery only on the basis of NAAT tests, which are considered as the most reliable methodology for the testing of COVID-19 cases and contacts.
Similarly, during periods in which there is an increase in SARS-CoV-2 infections, resulting in high demand for testing or a shortage of NAAT tests, Member States could have the possibility, temporarily, of issuing certificates of recovery based on antigen tests.
When infections decrease, Member States can continue to issue certificates of recovery only on the basis of NAAT tests.
(5)
In accordance with Article 5 of Regulation (EU) 2021/953, vaccination certificates issued by Member States are to include the number of doses administered to the holder.
It is necessary to clarify that this requirement is intended to reflect all doses administered, in any Member State, not just those administered in the Member State issuing the vaccination certificate.
To include only those previous doses received in the Member State issuing the vaccination certificate could lead to a discrepancy between the total number of doses actually administered to a person and the number indicated on the vaccination certificate, and could prevent holders from making use of their vaccination certificate when exercising the right to free movement within the Union.
The administration of previous doses in other Member States is proven by means of a valid EU Digital COVID Certificate.
A Member State should not require additional information or evidence from Union citizens holding such vaccination certificates, such as the batch number of previous doses.
It should be possible for a Member State to require a person to present valid proof of identity and a previous vaccination certificate or certificate of recovery.
In this context, the rules for accepting vaccination certificates issued by other Member States set out in Article 5(5) of Regulation (EU) 2021/953 apply.
In addition, certificates covered by an implementing act adopted pursuant to Articles 3(10) and 8(2) of Regulation (EU) 2021/953 are, for the purpose of facilitating the holders’ exercise of their right to free movement, to be accepted under the same conditions as EU Digital COVID Certificates issued by Member States.
In accordance with Article 3(4) of Regulation (EU) 2021/953, the holder of an EU Digital COVID Certificate is entitled to request the issuance of a new certificate if the personal data contained in the original certificate are not accurate, including with regard to the vaccination of the holder.
(6)
In accordance with Article 5(1) of Regulation (EU) 2021/953, the Member State in which a COVID-19 vaccine was administered is to issue a vaccination certificate to the person concerned.
Nevertheless, this should not be understood as preventing a Member State from issuing vaccination certificates referred to in point (a) of Article 3(1) of Regulation (EU) 2021/953 to persons who provide proof that they have been vaccinated in another Member State.
(7)
In particular in light of the emergence of new SARS-CoV-2 variants of concern, the continued development and study of COVID-19 vaccines is a crucial factor in the fight against the COVID-19 pandemic.
In that context, it is important to facilitate the participation of volunteers in clinical trials, that is, studies performed to investigate the safety or efficacy of a medicine, such as a COVID-19 vaccine.
Clinical research plays a fundamental role in the development of vaccines and voluntary participation in clinical trials therefore needs to be encouraged.
Preventing participants in clinical trials from obtaining vaccination certificates could constitute a major disincentive to participating in such trials, delaying the conclusion of such trials and, more generally, having a negative impact on public health.
In addition, the integrity of clinical trials, including in terms of data blinding and confidentiality, should be preserved to ensure the validity of their results.
It should therefore be possible for Member States to issue vaccination certificates to participants in clinical trials that have been approved by Member States’ ethical committees and competent authorities, regardless of whether the participant received the COVID-19 vaccine candidate or, to avoid undermining the studies, the dose administered to the control group.
(4) Commission Delegated Regulation (EU) 2022/256 of 22 February 2022 amending Regulation (EU) 2021/953 of the European Parliament and of the Council as regards the issuance of certificates of recovery based on rapid antigen tests (OJ L 42, 23.2.2022, p. 4).