COVID-19 vaccines: Why safety always comes first

DISCLAIMER: All opinions in this column reflect the views of the author(s), not of EURACTIV Media network.

Stakeholder Opinion

Nathalie Moll: "For COVID-19 there are now multiple clinical trials underway with many thousands of participants. The work is complex, but their mission is simple: to determine whether a vaccine or therapy is safe enough and effective enough to be given to people around the world." [Shutterstock / Mongkolchon Akesin]

With the eyes of the world focused on the development of COVID-19 vaccines to address the devastating health and economic consequences of this truly global pandemic, the news that clinical trials of one of the candidate vaccines had been halted may have caused hearts to sink. In reality, it underlined the priority commitment to the safety of everyone involved in fighting the coronavirus, writes Nathalie Moll.

Nathalie Moll is the Director-General of the European Federation of Pharmaceutical Industries and Associations (EFPIA). She wrote this opinion piece exclusively for EURACTIV on the occasion of the World Patient Safety Day today (17 September).

It is a feature of a system built to protect the safety of clinical trial participants and the wider public for whom vaccines are developed.

In short it showed that the system is working.

In case you missed it, a clinical trial of one of several vaccines in development against COVID-19 was put on hold because a participant fell ill. This gave the study team and an independent advisory board time to evaluate whether the illness was associated with the vaccine. A few days later the trial was restarted.

To vaccine and medicines development experts in industry and academia, this is nothing out of the ordinary. For large studies, in which thousands of people are enrolled, this is standard procedure.

Any time a trial participant falls ill, irrespective of if the illness is related to the vaccine, the trial is halted, the situation investigated and the trial will only resume once everyone concerned is certain that it is safe to do so.

For COVID-19 there are now multiple clinical trials underway with many thousands of participants. The work is complex, but their mission is simple: to determine whether a vaccine or therapy is safe enough and effective enough to be given to people around the world.

Safety is paramount for every trial. Even before they begin, research ethics committees analyze study plans to ensure the protocol is well-designed and that robust safety measures are in place. When the trial begins, independent oversight is in place throughout, to ensure rules are followed.

Just like for any medicine, the required standard of safety is high for vaccines too. And rightly so, as vaccines are offered to healthy people to prevent illness. All vaccines currently available in Europe – against measles, polio, tetanus, cervical cancer and more – have been rigorously tested in clinical trials.

And even after approval, they are closely monitored for any extremely rare issues that might arise when millions of doses are administered.

New territory 

COVID-19 has taken us into new territory. The development of a vaccine has never before been so desperately needed. As a result, the whole world is eagerly watching vaccine trials. While the urgency is unprecedented, the core principles will not change.

Yes, vaccines against COVID-19 may go down in medical history as the fastest ever developed, but speed will never trump safety. Trials are being conducted with maximum efficiency, more people, resources and expertise are being focused on COVID-19 but there are no shortcuts on safety.

EFPIA and Vaccines Europe have underlined our ongoing commitment to the safety of COVID-19 vaccines. These vaccines will go through all stages of clinical trials before data is submitted to the European Medicines Agency (EMA) and other regulators.

If they are given the green light, it will be because they have met rigorous and objective standards of safety and efficacy.

There is a lot at stake. Getting this right could offer a path out of the pandemic. But we remain mindful that the success COVID-19 vaccinations is based on the public being confident in the safety and efficacy of the vaccines in question.

Great expectations 

Our industry will continue to test a range of vaccine options. With highly infectious diseases, we know that nobody is safe until everybody is safe.

The EMA estimates that it will take until at least the beginning of 2021 before any vaccine against COVID-19 is ready for approval. It should be noted that marketing authorization is not the end of the process – nor the end of the pandemic, for that matter.

Approved vaccines will still need to be manufactured, distributed, and administered in unprecedented numbers. Companies and health authorities are working around the clock to prepare for this.

While this may breed frustration as we all await to escape the threat to our health as well as to our social and economic lives, it would still be a record-breaking achievement. In the 1960s, a mumps vaccine was developed in four years. No vaccine has achieved this in the decades that have followed.

As we work to end this crisis, there will be good days and bad, challenges met, and new ones emerging. But our commitment to tackling to discover, develop and deliver diagnostics, treatments and vaccines for COVID-19 will not change.

#WeWontRest until we stop this pandemic in its tracks.

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