Claus Bolte is Head of Swissmedic's Authorisation Division. Below he explains the difference between authorising vaccines and authorising medicinal products, describes the complex manufacturing process for vaccines and explains the situation as regards security of supply in Switzerland.
Vaccines are different
“Unlike medicinal products, vaccines are used in healthy children and adults. In other words, they are intended to prevent rather than treat disease. The requirements that vaccines have to fulfil in terms of efficacy, safety and quality are extremely stringent and comply with international standards. Just imagine: until recently one single authorisation involved two truckloads of data, all of which had to be reviewed in detail. Nowadays the data is read in and processed digitally. The data is automatically assigned and distributed to the members of our interdisciplinary case team. Before approving a vaccine, the team assesses the results of all clinical trials and reviews the product for potential immunological problems and manufacturing quality. The case team consists of toxicologists, pharmacists, chemists, pharmacologists and medics. During the review process they send questions to manufacturers or set out their objections in writing. Manufacturers have to answer the questions or resolve the objections within the specified deadline, otherwise their product will not be approved. Only then is the review process ended and the vaccine is approved.”
«Since there are no longer any vaccine manufacturers in Switzerland, we are reliant on foreign producers.»
Manufacturing vaccines is a particularly complex process
“Vaccines consist of antibodies derived from living cells. All vaccines are based on a complex process, regardless of whether they’re for polio, tuberculosis, rubella or mumps. Until not so long ago most vaccines were for individual diseases. Combining several vaccines into what is known as a polyvalent vaccine is a fairly recent development, and one that is most pronounced in basic childhood vaccinations. In manufacturing terms, the process is even more complex than building a small car and is comparable in terms of workload. An additional problem is that vaccines are manufactured and filled in different countries. Since there are no longer any vaccine manufacturers in Switzerland, we are reliant on foreign producers. The Swiss SMEs that used to produce vaccines have now been bought up or have ceased research and production. We can’t force companies to manufacture vaccines in Switzerland. These days, the big conglomerates split the market between them. An additional problem is that from a manufacturer’s perspective, the Swiss market is small and complicated. There is no central purchasing, and the packaging materials and inserts have to be produced in the three official languages. What’s more, there are supply bottlenecks not only for vaccines, but increasingly also for medicinal products. The problem is particularly pronounced for antibiotics.”
«Vaccines are intended to prevent rather than treat disease.»
Ensuring supply is a tricky business
“Each year, we receive between 12,000 and 15,000 applications for authorisation, which are reviewed by a total of 150 employees. These may be new authorisations, extensions of indications or variations to compositions and production methods. Vaccines account for less than two percent of the total. Our dependency on the international market causes the supply bottlenecks I've just mentioned, and which are often met with incomprehension by the public.
«Vaccines account for less than two percent of all authorisation applications received by Swissmedic.»
We at Swissmedic are frequently accused of not authorising enough vaccines. The sad fact is, though, that many vaccines never get submitted to us for authorisation in the first place.”