Translate vaccine information properly and allay fears

Besides the regulatory authorities, there is another party that decides the economic success of a medicinal product: the patient. If the patient‘s trust is squandered with substandard product information, a customer is lost. Nobody reads the package leaflet, anyway? Patients are not even given printed package leaflets for vaccines. Yet, therein lies a risky assumption when you consider the commotion over the effectiveness of the vaccines and acute supply shortages. Due to the outbreak of the pandemic, pharmacists can nevertheless be sure of having a wide-awake readership for their product information leaflets. Worried members of the public procure their vaccine information for themselves on the internet and follow the ongoing reporting.

Sceptics, especially, will dissect every word. And there’s enough scope for error because, in the centralized authorization procedure, documents are translated into the 24 EU languages; that's the scale of the potential readership.

EU standards for medicinal product authorization unwaveringly high

No matter how urgently a vaccine is needed, the quality, safety and effectiveness requirements remain as high as ever. And that‘s just as well!

Specifically for vaccines to curb the pandemic, the speed of processing has changed. There are certainly no shortcuts to the non-clinical and clinical study phases. However, the "rolling review" process being used means that there does not need to be a complete authorization application, with all the data this requires; instead, individual successively submitted data packets are reviewed as soon as they are available. The assessment is carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee. The COVID-19 EMA pandemic task force (COVID-ETF) is providing support for COVID vaccines. This is speeding up the process without compromising quality checks of rigor and diligence.

Even though less time is available, EMA requires

• translation into 24 EU languages
• compliance with standards and norms
• adherence to the specified deadlines.

As the individual phases are not cut short by the consolidation of time, the time frame for professional medical translation has remained the same. The rolling review process is only unfamiliar in that the updates to the individual phases succeed each other more quickly than with normal authorization procedures.

Vaccine manufacturers can take advice from translation specialists in order to forward-plan upcoming tasks and processes, along with deadlines, realistically.

The stony path to vaccine authorization

The authorization process leaves no room for delays because it follows a phase timetable specified by the authorities.

Authorizations, such as the vaccine authorizations, can be delayed by communication difficulties and misunderstandings with the competent authorities. Translations can also be delayed due to strict specifications, coordination errors or time and staffing shortages. Even so, the English product information has to be translated into the 24 EU languages within a few weeks. Ultimately, it is not only delays, but also translation errors, that are matters for concern. They adversely affect quality and, in the worst-case scenario, can jeopardize the authorization.

Due to the pandemic, the population itself is very much more sensitive to minor inconsistencies. In the coronavirus crisis, doctors have no influence over which vaccine they can administer to their patients. However, when they do have the choice, doctors will have to heed which vaccine finds more acceptance among the population when making their purchases.

Translation errors are bad for the image

Publicly accessible product information, in particular, requires great care because the public make up their minds based on it. A professional image is expected and, if expectations are not fulfilled, trust in the vaccine wanes. At the same time, trust in the manufacturer and its brand(s) also wanes.

Turn stones into milestones

A seasoned expert can draw on his or her experience of translation and official processes to smooth the way. Above all, he or she can do so quickly and on schedule, and this is essential for the authorization process.

To prevent misunderstandings with the authorities, the expert can play the role of intermediary. They can then take over communications with the manufacturer‘s in-country representatives and the national authorities.

Speed is also of the essence in the final stages. One of the last stages is the meeting held by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This body issues recommendations as to the vaccine’s suitability to be authorized.

A medicinal product authorization (Regulatory Affairs) can indeed fail due to errors in the labelling documents. The choice of language service provider to carry out the translations is therefore of key importance.

If the committee agrees to the authorization only under certain conditions, the applicant has to rectify the shortcomings. These conditions can also concern the labelling documents, the product information. If the Committee for Medicinal Products for Human Use requests changes to the text, the language service provider has to incorporate them into all 24 language versions in next to no time.

If the applicant and its language service provider are unable to implement the requested changes on time, the European Commission can refuse the application even just short of the goal.

To prevent this, mt-g’s project managers work with the specialist medical translators and quality checkers even on the weekend at this stage. In addition, the specialist translators are very well acquainted with all requirements in the medicinal product authorization field and will already have been working with mt-g successfully for years.

One soothing side effect: Due to continued project completion successes, mt-g can always qualify new specialist medical translators. Even in peak periods, colleagues work at optimum capacity and can accommodate new projects. In this way, operations run according to plan even in the final stage, despite deadline pressure.

The project managers in the Global Regulatory Affairs section look after the medicinal product authorization area, with a reliable routine and with expertise acquired over the course of years. They can coordinate communication with the authorities and they comply optimally with all required specifications. Not even the subsequent checking process (linguistic review) by the national authorities presents an obstacle to them; rather, it‘s a milestone agreed regularly with the client.