Highly sensitive Covid vaccine could be a test of resilience for the EU-FMD anti-counterfeiting elements

Article Updated 6th Jan

A long winter…

Just before the holidays we set the good news about the roll-out of COVID-19 vaccines gathering speed in context against some considerations as vaccination programs begin in earnest.
While the fast-moving developments – including the arrival of new variants of the virus – have not changed the basics of our article, we wanted to take the opportunity to bring our piece from 21st December up to date.

A silver lining to the cloud

On Saturday 19th December, Swissmedic¹ became the second regulator in Europe to approve Pfizer / BioNTech’s mRNA COVID-19 vaccine, the first vaccine developed in the western world, after the UK’s MHRA announcement on 2nd December.²

The decision by Switzerland’s regulatory authority marks an important milestone because unlike the temporary supply permission given by the UK MHRA for an initial number of batches, the Swiss regulator has granted Pfizer/BioNTech’s vaccine, under the brand name Comirnaty®, a regular marketing approval. The Swiss decision therefore constitutes the world’s first approval following an ordinary marketing authorisation procedure.

Since then, things have moved in the EU as well, with the European Commission’s conditional marketing approval for Comirnaty® on 24th December 2020 ³ and the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CMPH) recommendation for approval of the Moderna vaccine on 6th January 2021. ⁴

These developments clearly mark the long-awaited turning point in the fight against this pandemic when even though the roll-out of vaccinations will need to gather significant pace.

More dark clouds on the horizon

There will be new battles ahead, of course, as recent warnings by Interpol⁵ and Europol⁶ about the emerging threats of counterfeit vaccines show, and the rush to bring the vaccine to the patients as quickly as possible must not be at the cost of jeopardising the security of the medicines supply.

It could, of course, be argued that threats are negligible in Europe where the supply chain for regulated medicines is highly secure, in no small part thanks to the European Medicines Verification System (EMVS) that has been established to fulfil the requirements of the EU Falsified Medicines (EU-FMD) directive. The EMVS provides a very high level of protection against counterfeiting (and other criminal activities) but – and this is an important ‘but’ – only if the products are supplied in compliance with the EU-FMD/EMVS processes. All medicines supplied, including Covid vaccines, need to be serialised, tamper-evidenced and their unique identifiers (UIs) must be recorded twice. Once when the UIs are uploaded to the European Hub at the time of batch release and for a second time at the point of dispense, when every pack UI is checked against the appropriate National Medicines Verification System.

A good shot – but no silver bullet

There may be calls to bypass these additional hurdles in order to rush out the long-awaited vaccines as quickly as possible. This is understandable, and it is likely that temporary exemptions may be granted for the first batches of vaccines. However, extending such exemptions beyond the initial batches would negate the full protection that the EU-FMD offers. It may be tempting to seek to avoid these obligations often portrayed as ‘onerous’ in the face of a novel and extraordinary situation, but this will ultimately deprive patients the benefit of the security that the EU-FMD and the EMVS system and processes have established.

It is reassuring to see that the labelling appendix to the product information for both the BioNTech/Pfizer ⁷ and the Moderna vaccine ⁸ 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 that was authorised in the UK on 30th December 2020 is also serialised though 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 (though the EU-FMD infrastructure and practice remains in place in Northern Ireland).

While the regular supply chain will offer a solid degree of protection for patient, like always it will be the most vulnerable part of the supply chain and population would be preyed upon by counterfeiters. This is why Brand protection needs to be integrated as a key element in the commercialization of the sensitive, and sadly less sensitive, products. At the forefront of that battle, the Excellis Brand protection team keep 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 the 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) ⁹ 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 soon as possible.

EU alerts: a dark lining to the silver cloud

While this has to be welcomed, at Excellis as a leading provider of a service to manage EU-Alerts to many pharma companies, we are concerned that a perfect storm is going to hit the industry: The 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 manufactures 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 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 need to ensure that their organisation and processes are ready to scale and flex up to this additional challenge that will be facing them once the vaccine roll-out begins in earnest.

Excellis, as a leading provider services to manage EU-Alerts to many pharma companies – including some of the big players who will be directly affected by the Covid vaccine – have direct experience in just how demanding handling EU-Alerts in a compliant and timely fashion can be.

Excellis are world-leading experts in serialisation and brand protection in the pharmaceutical and medical device supply chain – contact us if you want to discuss your concerns and stay tuned for updates as the situation is still rapidly evolving.

1. https://www.swissmedic.ch/swissmedic/en/home/news/coronavirus-covid-19/covid-19-impfstoff_erstzulassung.html
2. https://www.gov.uk/government/news/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine
3. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C:2020:447I:FULL&from=EN
4. https://www.ema.europa.eu/en/events/extraordinary-meeting-committee-medicinal-products-human-use-chmp-21-december-2020
5. https://www.interpol.int/News-and-Events/News/2020/INTERPOL-warns-of-organized-crime-threat-to-COVID-19-vaccines
6. https://www.europol.europa.eu/newsroom/news/europol-predictions-correct-for-fake-covid-19-vaccines
7. https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_en.pdf
8. https://www.ema.europa.eu/en/documents/product-information/covid-19-vaccine-moderna-product-information_en.pdf
9. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdf