ROKOTE LABORATORIES Finland on Tuesday announced it is preparing to organise human trials of its coronavirus vaccine after the turn of the year.
The nasal-spray vaccine is expected to serve primarily as a booster vaccine for people who have already received two vaccine doses or recovered from the coronavirus disease and, consequently, developed an immune response naturally.
Kalle Saksela, a professor of virology at the University of Helsinki and co-founder of Rokote Laboratories, stated to Helsingin Sanomat that the startup has secured funding for phases one and two of human trials. Rokote Laboratories in July received a funding injection of nine million euros, consisting of 3.5 million euros in equity funding and a loan of 5.5 million granted by Business Finland.
What remains unclear is how the efficacy of the vaccine can be demonstrated in a way that is approved by the European Medicines Agency (EMA).
“We’ll have to reach final understanding on how efficacy should be demonstrated for a vaccine that’s used primarily as a booster, rather than to protect the unvaccinated population,” he stated to the daily newspaper.
Final results on the efficacy of vaccines are not received until the third stage of human trials, which typically include thousands if not tens of thousands of test subjects. The third stage, however, is unlikely to be relevant for the nasal spray vaccine in its traditional form, as it would be unethical to using an unvaccinated control group in the trial would be unethical in the prevalent circumstance, according to Saksela.
The efficacy, he added, could be measured with a smaller number of subjects with the help of tracers.
“The second, more labour-intensive and difficult approach is to compare the efficacy to the vaccine that’s the standard at the time. The downside of a study like this is that it requires a larger group of subjects than a traditional placebo-controlled trial,” he noted.
Saksela said the vaccine functions based on the same principle as the other coronavirus vaccines in use today, despite its unusual delivery method. The method is advantageous in that it produces a response that also protects mucous membranes in the nose, thus preventing not only the serious disease but possibly also the virus from spreading better than intramuscular vaccines.
It employs a safe adenovirus carrier similarly to AstraZeneca. While the AstraZeneca vaccine has been linked to rare cases of blood clots, the clots are presently not believed to be a risk with the nasally delivered vaccine, told Saksela.
Although he is hopeful about securing funding for the third stage of human trials, he reminded that carrying out the trials and, ultimately, receiving market authorisation will be a long process.
“Even in the best-case scenario, bringing the vaccine to market could take place well into next year,” he admitted to Helsingin Sanomat.
Aleksi Teivainen – HT