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In our latest series on COVID-19, Lionbridge experts offer perspectives on the ecosystem of clinical development and regulatory approvals during the pandemic and in the future.
With our scale, service excellence and suite of language, communication and technology solutions, Lionbridge is well positioned to help you develop and deliver safe medicines and market them globally.
What is an emergency use authorization?
An emergency use authorization, or EUA, allows the use of otherwise unapproved medical products in crisis situations. The U.S. Food and Drug Administration (FDA) has the authority to grant these exceptions in situations that have no viable alternatives. Previous EUAs include those granted during the Zika and Ebola public health emergencies. Since the FDA declared the COVID-19 pandemic just such an emergency in February, it has granted many EUAs ranging from diagnostic tests to treatments. And at long last, vaccines are also up for evaluation.
An advisory committee meets on December 10 to discuss the Pfizer-BioNTech vaccine for COVID-19.
How would a COVID vaccine be approved in other regions?
The European Medicines Agency (EMA) has the power to authorize vaccines in the EU. It can grant accelerated assessment of promising medicine and grant conditional marketing authorization. This type of approval requires that applicants continue to study the medical product even as it is being distributed.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) were asked to examine a vaccine from AstraZeneca and Oxford University. The region has already approved the Pfizer-BioNTech vaccine.
Once approved, how can companies distribute the vaccine?
For the EU in particular, distribution of a vaccine will require a multilingual approach. Regulatory requirements for documentation mean vaccine manufacturers need precise translations into medical professionals’ and patients’ native languages. Partnering with a language services provider (LSP) is a key element to implement accelerated processes like these.
Documents like consent forms and instructions for use need to be readable by and accessible to everyone involved in the process. Especially when building prevention and treatment options at such breakneck speed, developers and manufacturers would be wise to find support for this linguistic work. Lionbridge’s experience with life sciences and decades-long reputation for linguistic excellence make it an obvious choice for comprehensive and comprehensible translation and transcreation for any organization involved in the race to slow COVID-19.
How will governments and citizens track vaccinations?
Several of the vaccine candidates that are farthest along in the approval process (including those being distributed) require two shots for full immunity. This means someone—government entities, medical providers or patients themselves—need to make sure the recipients get the correct second dose on the correct timeline.
To do this, countries have proposed wallet-sized cards as well as national databases. In the US, these cards will be in both English and Spanish. In the EU, the tracking system is less clear. Many EU regulations require medical documentation in native languages as well as the official languages of the EU. It is likely tracking systems will be multilingual as well.
What could delay vaccine distribution?
The newness of the technologies used to design some of the more promising vaccines making transportation and community acceptance more difficult than with other vaccines.
Both of the mRNA vaccines moving swiftly through the UK, European and American pipelines need unusually cold storage and can only survive at regular freezer or refrigerator temperatures for a short period of time.
Potential recipients of the vaccine may also be wary of a vaccine that doesn’t use a traditional dead virus mechanism, which people are more familiar with, like the vaccine for each new iteration of the flu. The accelerated timelines are also prompting some skepticism, although developers and regulatory agencies alike insist they would not approve a vaccine unless risks were manageable and acceptably low.
In particular, politicians and cultural leaders have pointed out that previous interactions between the scientific community and communities of color have left some groups especially suspicious of new and/or experimental medicine. Approximately 2 in 5 Americans told pollsters in late November that they would not take the COVID vaccine once it becomes available.
The role of language in vaccine compliance
Distributors are in for an uphill battle helping potential recipients understand the risks and benefits of a new vaccine. As always, communication is at the center of the public health effort. From translating into a native speaker’s language to finding the proper tone of voice, scientific, medical and government professionals need to reach all their constituencies about the vaccine options.
In the EU, for example, regulatory agencies require availability of medical information in all major EU languages as well as the language where the medical device or treatment is being distributed.
Small language service providers and translation agencies may be unable to meet the demand for a fully flexible service model which is subject to frequent changes and parallel execution of clinical trials. Advanced services such as linguistic validation, clinical labeling and migration of COAs to eCOAs will demand agile, automated workflows that can accommodate swift change requests.
Language services are critical for both clinical trial execution and regulatory authorization. Language services providers like Lionbridge with decades of experience in the life sciences specifically can support companies at any point in the development and distribution pipeline, from the most technical biological description of a vaccine to a relatable campaign convincing an at-risk audience why they should take the vaccine.
