Fast-tracking a safe and effective Covid vaccine?

Mr Jaggi, Swissmedic is currently working flat-out to approve the new Covid-19 vaccines. How does the approval process work?

The pharmaceutical company submits an approval application. There are international guidelines on what must be included with such an application and what form the documents must take. In Switzerland, applications must comply with the provisions of the Therapeutic Products Act and the Medicinal Products Licensing Ordinance. Usually the documents consist of several thousand pages – and in the past they had to be submitted in paper form. Today they are mostly submitted electronically via our digital portal.  

How long does the approval process for a vaccine usually take?

The standard procedure normally takes around 530 days, so roughly one and a half years. The application is with Swissmedic for around 300 days, and the rest of the time is spent consulting with the companies, for example when we have queries.  

The approval process has been much faster for the Covid vaccine.

There is a fast-track process, which only takes 280 days, with Swissmedic requiring around 135 days. More time is saved by the temporary approval that has been issued for the two Covid vaccines released so far. The advantage of a temporary approvalis that initial authorisation can be granted before the development of the medicinal product has been fully completed.  

Many people are worried about this fast-track approval? Does it provide sufficient time for a thorough review?

These concerns are understandable, but the safety of recipients always comes first. The requirements for vaccines in terms of efficacy, safety and quality are very high and have not been relaxed due to the special current situation. In other words, the process isn’t faster because we’re checking less carefully, but because we’re prioritising applications for vaccines or medications for Covid-19 and assigning entire teams to focus on a single substance instead of processing several applications at the same time. Furthermore, through preliminary discussions with the manufacturers, we already had good prior knowledge about the new vaccines before the applications were officially submitted.

Another major difference lies in the rolling or temporary approval – a special form that is used precisely in a pandemic, for example, allowing for faster approval of urgently needed medicines. In contrast to the standard procedure, pharmaceutical companies don’t have to provide complete documentation in one go, but can gradually submit their data from ongoing clinical trials to Swissmedic for approval. This allows us to get an idea of the risk-benefit profile of the vaccine before the trial is completed.

And last but not least, of course, the process is also accelerated thanks to the intensive international exchange with other approval authorities.  

Who reviews the submitted documents?

Interdisciplinary teams of scientific experts from Swissmedic – medical doctors, toxicologists, pharmacists, chemists or pharmacologists, as well as specialists in gene therapies. They review the results of all clinical trials, paying particular attention to potential immunological problems and manufacturing quality.  

And what if they have any questions?

The experts contact the applicants directly. For quality assurance purposes, interim results are also discussed with colleagues from the same field outside the case team, so-called peer reviews. And external councils of experts also provide recommendations.  

At what point does a vaccine or drug receive approval?

Once the documentation proves that the expected benefits are greater than the potential risks. Phase III studies involving a thousand or more test persons play a critical role here.  It is only at this stage that we have access to sufficient reliable data to assess the benefits and risks involved and can decide whether a drug or vaccine can be approved.

The risk-benefit profile is particularly critical for vaccines, because they are administered to healthy people who should be exposed to the lowest possible risk.  

That’s true, which is why no compromises are made in this regard. These benefits and risks are weighed up totally independently of the epidemiological situation.

Shouldn’t new vaccines such as those based on mRNA be tested more critically and extensively?

The mRNA platform isn’t completely new. mRNA vaccines have been used for many years as part of human clinical trials, for example, with a therapeutic tumour vaccine.

The mRNA vaccine teaches our cells how to make a protein that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies. Here too, the manufacturers of this technology must prove in the registration documents that these vaccines are just as safe, effective and qualitatively sound as conventional vaccines with inactivated or attenuated viruses or virus components.

When will the Covid vaccine also be released for children?

For ethical reasons, children don’t usually take part in initial studies for new drugs and vaccines – and this also applies for the Covid vaccine. As soon as studies have been conducted with children and young people and conclusive data is available, the companies can apply for an extension of indication.

Are there differences in the approval process for drugs and vaccines?

There are no significant differences. In the case of vaccines, there is only one special feature: a new release has to be made for each batch on the basis of laboratory analyses and an examination of the manufacturer’s batch documents.  

What is the next step for the approval of other Covid vaccines?

Swissmedic is currently reviewing two further approval applications: the so-called Oxford vaccine from AstraZeneca and one submitted by Janssen-Cilag/Johnson & Johnson. If all goes well and we get the safety and quality data we still need, hopefully at least one more vaccine can be licensed as early as the next few weeks.