Not an unknown vaccine
Research into mRNA technology has been ongoing worldwide for years. The extremely efficient principle is known primarily from cancer research. Nevertheless many people, particularly in Switzerland, are afraid of the technology, and this has led to a fairly low vaccination uptake rate to date. The Swissmedic Transplants team believes that such fears are misplaced. "We have scrupulously reviewed all the documentation relating to the authorisations. No major risks have emerged either from the large-scale comprehensive short-term or the still ongoing long-term studies. More importantly, the benefit greatly outweighs the risk."
Examples of storage and shelf life
When the quality documentation was being submitted a year ago, the results available from clinical trial batches and the first production batches were already being compared with each other. The outcome: The manufacturing processes were extremely robust. The results from hundreds of commercial batches have since been compared with each other, and the strategy adopted has proved to be entirely effective. To take one example, when the first vaccines arrived, as a precaution they were stored at a temperature of minus 80 degrees Celsius. We now have much more data, and the vaccines can safely be stored at minus 20 degrees Celsius. Furthermore, they remain stable even if they are stored in the refrigerator for a few days. Today, it emerges that the mRNA vaccines can be stored for longer than the originally approved period. In addition, the stability studies are still ongoing – new data are constantly being added.
One thing is clear: Side effects cannot be predicted for the next five or ten years. "At the time of authorisation, such scenarios cannot be anticipated for any specific drug with complete certainty. We now know that inflammation of the heart muscle or severe allergic reactions can occur in very rare cases, but fortunately these do have not serious consequences for the most part", confirms Julia Djonova. Such complications can occur both during a SARS-CoV infection or indeed with any other viral infection. However, numerous independent clinical and preclinical studies have been conducted; the side effects in the global vaccination campaigns have been closely monitored and new findings are emerging all the time. "After almost one year of use in several million people, and thanks to the abundance of scientific findings, we are now already very familiar with the safety profiles of the vaccines and are confident that no exceptional events occur."
The clinical authorisation studies were based on studies in 40,000 people from various age groups and with different pre-existing conditions worldwide. Obviously, it was not possible to consider all population groups. The individual immunity of a person also plays a major role. "How a person reacts to the vaccine depends on many factors, but one thing is clear: the vaccine provides effective protection against a serious episode of COVID", argues Djonova.
19 December 2020: Swissmedic was one of the first authorities worldwide to grant a temporary authorisation for the Pfizer BioNTech vaccine. "Since a rolling procedure was used, the process was extremely demanding and time-consuming. The data were repeatedly delivered in tranches, which didn't exactly make life easy for us. In the end, it took us two month to grant the temporary authorisation", recalls Julia Djonova. "The fact that the vaccine was authorised in such a short time is down to a number of reasons: Firstly, a lot of know-how was mobilised, and even more commitment and motivation were invested, to enable a vaccine to be reviewed and authorised as quickly as possible – naturally without making any compromises when it came to quality, safety and efficacy. Secondly, we shared information with a wide variety of experts worldwide. This enabled us to work extremely efficiently. Finally, we are a relatively small but effective authority; the decision-making paths are short and the interdisciplinary cooperation worked perfectly", explains Djonova in analysing the reasons for Swissmedic's outstanding efficiency.
"Over the years, Switzerland has established itself as an important centre of excellence for innovative products."
The COVID vaccines authorised by Swissmedic have since been authorised in numerous countries worldwide. The acceptance level is consistently high – as is their efficacy. Nevertheless vaccine alternatives, particularly those for treating or even preventing COVID-19, have become a topic of discussion among the general public. Whether alternatives to vaccination will emerge in future is being critically assessed by Julia Djonova's team. "Of course, we are prepared to review any applications for medicines that strengthen the immune system or prevent COVID. But the basic problem remains: We are dealing here with a virus that humanity has never encountered before. This means many people's immune systems are unable to generate an appropriate response." Julia Djonova illustrates the situation with a comparison: "It is as if we were suddenly able to communicate with each other only in Arabic. At the start, we know nothing and have no command of the language, but then we learn a basic vocabulary, the minimum foundation for enabling us to communicate."
The mRNA vaccines were also virgin territory for Swissmedic. Although the same rules applicable to other medicines also serve as the legal basis here (subject to authorisation and licensing obligations), a previously unused procedure was applied for the review process: the rolling procedure. This is a highly dynamic and demanding procedure. In contrast, the mRNA technology was certainly nothing new from the scientific standpoint, because the principle of how it works is very similar to that of a gene therapy product and extensive expertise in this field already exists.
The development of the mRNA vaccine has shown that this technology can also be used for other purposes. "This is the great advantage of global development. There are high hopes that this technology might also be used to treat Alzheimer's, HIV, malaria and, in particular, cancer. We now possess vast quantities of safety data, because the vaccine has since been administered to millions of people. For future developments, an appropriate target protein needs to be identified – then it will be much easier and quicker to adapt the vaccines than is possible with the current technologies." Julia Djonova and her team point out that it will also be possible to fight other dangerous pathogens, including Ebola or dengue viruses, in a more targeted manner. "The mRNA vaccine technology has proved successful. Protection levels of over 90 percent have never been achieved before. That is extremely encouraging."
Switzerland: a centre of excellence
When the SARS-1 virus was discovered almost 20 years ago, there were around 8,000 infections in 32 countries worldwide. Even now, it is still unclear why more people were not infected at the time. "We assume that it was less infectious", explains Julia Djonova, adding: "The biology of the virus has still not been fully researched. But we now have the data, findings and technology that we can use to control it. Over the years, Switzerland has established itself as an important centre of excellence for innovative products."