Vaccine development takes time because safety and efficacy must be ensured carefully

Rokote Laboratories Finland Oy is developing a coronavirus vaccine and the clinical trials should start during 2023. The development of the company’s FINCoVac vaccine has been rapid as it is based on knowledge gained from long-term research. Despite this, the journey of a vaccine from innovation to a drug product takes years. ​

The nasally administered FINCoVac 2.0 coronavirus vaccine developed by Rokote Laboratories Finland Oy is based on the expertise and cooperation of Professor Kalle Saksela, Academician Kari Alitalo and Academic Professor Seppo Ylä-Herttuala. After long-term research and development, the vaccine candidate developed by the professors in 2020 has since been refined into a new investigational product version, FINCoVac 2.1, which will soon enter larger-scale production for clinical trials.  

Vaccine development has been rapid since the basic structure of coronaviruses was already known ​

Developing a vaccine typically takes at least a decade. However, coronavirus vaccines have entered the market at a faster rate than this, since researchers around the world have gathered plenty of information on previous coronaviruses, such as SARS-CoV-1 and MERS, even before the COVID-19 pandemic. Both of these viruses are close relatives of the SARS-CoV-2 virus that causes the COVID-19 disease. Based on this previous knowledge, it could be concluded which structures of SARS-CoV-2 can be used to achieve an immunological response.  

The vaccine by Rokote Laboratories Finland Oy is vector-based, meaning that it uses the adenovirus, which has been proven to be safe, as its vector. The vector contains a clone of the DNA strand of the coronavirus spike protein, but the vaccine does not contain the SARS-CoV-2 virus itself. In practice, this means that the ‘preparation instructions’ of the virus protein are delivered to the cells like in a COVID-19 infection, but the vector virus in the vaccine is harmless, as opposed to a real infection. With the help of the vaccine, the vaccinated person’s own cells are programmed to produce the virus protein, which activates the immune system to prepare for the virus that causes the disease. 
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“The efficacy of conventional vaccines is based on viruses that have been weakened or inactivated, or they are based on purified surface proteins or parts of them that resemble the structure of the coronavirus spike protein, in the case of COVID-19. This stimulates the cells in the person’s immune system to produce antibodies against the virus or its surface structures. Conversely, the FINCoVac 2.1 vaccine uses a technique in which the cells of a vaccinated person start producing the spike protein themselves, which activates the production of antibodies,” Director of R&D Erkko Ylösmäki explains the mechanisms. 

Manufacturing vector vaccines is faster than conventional vaccines ​

To prepare conventional vaccines, pathogenic viruses are either attenuated prior manufacture or fully inactivated following the manufacture. These steps require a lot of time to make sure the vaccine preparation is safe and does not cause disease in healthy people. The manufacturing of vector vaccines does not require these steps, which makes the process a bit more streamlined. 
 
“The FINCoVac 2.1 coronavirus vaccine is a biological medicinal product that is produced in a production cell line designed for this purpose. Manufacturing the vaccine candidates at laboratory scale is rapid as dozens of them can be made in a few months. However, testing the candidates is slow, since long pre-clinical trials are required to evaluate the efficacy,” Ylösmäki says. ​

The manufacturing process of a biological vaccine requires expertise ​

Now, Rokote Laboratories Finland Oy is ready for the manufacturing of the FINCoVac 2.1 coronavirus vaccine for clinical trial. The company selected a Belgian contract manufacturer that is specialised in biological medicinal products to manufacture its nasal vaccine. 
 
“At the moment, the production volume of our vaccine in our own laboratories is a few hundred millilitres, but the scale required for the first clinical trials is ten litres. For clinical trials, the vaccine must be manufactured following the EU’s Good Manufacturing Practice (GMP). This means that the investigational product should be manufactured in similar conditions to the vaccines already on the market. Laboratory conditions are not sufficient,” Ylösmäki explains. 
 
Taking the production of a biological vaccine from millilitres to dozens of litres requires experience and accuracy. Its manufacturing process is sensitive to even the smallest changes. This is why the purity of the components, and the stages of the production process must be tested and standardised especially carefully. The batch of vaccines manufactured will be tested with dozens of different tests so that the high quality and safety of the vaccine can be ensured. 
 
“Ensuring high quality and safety takes its time, and the process can’t be accelerated. It is important that people can trust that the vaccines are of high quality right from the early clinical trials,” Ylösmäki states. ​

Vaccines are tested on people at many phases before applying marketing authorisation ​

Once a sufficient amount of the vaccine has been manufactured and the tests show that it is clean and safe and has an appropriate shelf-life, the clinical trials begin. They ensure the safety and efficacy of the vaccine. At the first phase, the vaccine and its administration method are tested on a few dozen people. 
 
“In the phase I clinical trial, we study the safety and adequate dose and administration method of the vaccine. In the trial, all criteria must be met before we can proceed to the next phase,” says Clinical Trial Manager Katriina Lavikainen. 
 
The clinical trials are strictly monitored, scientifically reliable, ethically conducted, and compliant with regulatory requirements. When all the required clinical trial phases have been completed, a marketing authorisation can be applied for with the European Medicines Agency. The application for marketing authorisation goes through an evaluation lasting several months that involves experts from all EU member countries. Once the marketing authorisation is granted, it is valid in all EU countries. Outside the EU, different countries have different marketing authorisation procedures, and Rokote Laboratories Finland Oy aims to bring its coronavirus vaccine to the global market. 

Further information:

Erkko Ylösmäki 
Research and Development Director, Rokote Laboratories Finland Oy 
erkko.ylosmaki(at)rokote.com 
p. 040 5836604 

​Text: Anni Turpeinen
Image: iStock