It is reassuring to see that the labelling appendix to the product information for both the BioNTech/Pfizer and the Moderna vaccine specify the application of a 2D DataMatrix carrying the EU-FMD’s Unique Identifier (Annex IIIA, section 17) for the purpose of serialisation.
AstraZeneca’s vaccine - authorised in the UK on 30th December 2020 - is also serialised, although the EU-FMD no longer applies to most of the UK (England, Scotland, and Wales) after the UK’s exit from the European Union, and there is therefore no longer the facility for end-users in Great Britain to be connected to the EMVS - although the EU-FMD infrastructure and practice remain in place in Northern Ireland.
While the regular supply chain will offer a solid degree of protection for patients, it will - as always - be the most vulnerable part of the supply chain and population that are preyed upon by counterfeiters. This is why brand protection must be integrated as a key element in the commercialization of sensitive, and sadly less sensitive, products.
At the forefront of that battle, the Excellis brand protection team keeps hammering this hard truth: hoping to be safe from counterfeiting is not a strategy. Recognising that the EU-FMD provides solid protection, there is no denying that the EMVS obligations will bring novel challenges for COVID vaccinations across Europe.
COVID vaccines will be dispensed in the course of a mass-vaccination programme, the likes of which has never been seen before. This means large numbers of products will be dispensed in a very short time, often in different locations, by different actors, using different protocols to regular medicines.
The EU-FMD has foreseen this, and there are provisions in the Delegated Regulation (Article 23) giving member states the scope to allow for medicines to be dispensed outside hospitals or pharmacies in non-routine supply scenarios. At the latest count, 11 EU member states have indicated they may want to make use of these provisions to be able to vaccinate as many people as possible, as quickly as possible.
EU alerts: a dark lining to the silver cloud
While this must be welcomed, we at Excellis are concerned that a perfect storm is going to hit the industry. A combination of new players, dispensing large numbers of products in non-standard scenarios and at locations where the scanning technology and processes have not yet been established as routine, is highly likely to generate a spike of EU-FMD alerts that manufacturers will need to deal with.
There is a real concern that many manufacturers are, even today, ill-prepared to deal with the routine number of EU-Alerts in a timely manner and that they will be swamped by a flood of new alerts that are likely to arise due to technical issues, processing errors and – inevitably – human error.
Ignoring these alerts, even if the vast majority are going to be false alerts, is not an option, and manufacturers must ensure that their organisations and processes are ready to scale and flex up to this additional challenge they face once the vaccine roll-out begins in earnest.