Italy update: Currently available vaccines for Covid-19 infection are not being tested

Tar Friuli Venezia Giulia, sec. I, judgment no. 261 of 10 September 2021

The four products currently used in the vaccination campaign have been duly authorised by the Commission, subject to a recommendation from the EMA, through the conditional authorisation procedure.

This is an authorisation that can be granted even in the absence of complete clinical data, “provided that the benefits of the immediate availability on the market of the medicinal product in question outweigh the risk due to the fact that additional data are still needed“. The conditional nature of the authorisation does not affect the safety profiles of the medicine; as clarified by the ISS, in fact, a conditional authorization guarantees that the approved vaccine meets the strict EU criteria of safety, efficacy and quality and that it is produced and controlled in approved and certified plants, in line with pharmaceutical standards compatible with large-scale marketing.

Conditional authorisation, therefore, should not be regarded as a minus from the point of view of its legal value, requiring only the holder to complete the studies in progress or to conduct new studies in order to confirm that the risk/benefit ratio is favourable.

Also in this form, the authorization is located downstream of the usual phases of clinical trials that precede the placing on the market of any drug, without any negative impact on the completeness and quality of the study and research process.

The testing of vaccines has therefore ended with their marketing authorization following a rigorous scientific evaluation process.

It is not correct to say that the trial is still ongoing just because the authorisation was granted conditionally. The equating of vaccines with “experimental drugs”, therefore, is the result of a forced and ideologically conditioned interpretation of European legislation, which cannot be accepted.

By Quorum, Italy, a Transatlantic Law International Affiliated Firm. 

For further information or for any assistance please contact italy@transatlanticlaw.com

Disclaimer: Transatlantic Law International Limited is a UK registered limited liability company providing international business and legal solutions through its own resources and the expertise of over 105 affiliated independent law firms in over 95 countries worldwide. This article is for background information only and provided in the context of the applicable law when published and does not constitute legal advice and cannot be relied on as such for any matter. Legal advice may be provided subject to the retention of Transatlantic Law International Limited’s services and its governing terms and conditions of service. TransatlanticLaw International Limited, based at 42 Brook Street, London W1K 5DB, United Kingdom, is registered with Companies House, Reg Nr. 361484, with its registered address at 83 Cambridge Street, London SW1V 4PS, United Kingdom.