"We monitor the safety and effectiveness of coronavirus vaccines internationally"

Olaf Klungel studies the safety and effectiveness of pharmaceuticals. He has been involved in research into the side effects of coronavirus vaccines since last year. Olaf Klungel focuses on the methods used: “All sorts of coronavirus research is currently being done around the world. Speed is of the essence at the moment, but the research should still be done properly.”

President of international professional association

In his research, Klungel collaborates with Miriam Sturkenboom, Professor of Observational data analysis at UMC Utrecht, and with side effects research centre Lareb. This year he was also named President of the ISPE, the International Society for Pharmacoepidemiology, which unites researchers from universities and businesses with supervisory bodies such as the EMA and the Dutch CBG. In this role, he has insight into how countries collaborate to monitor side effects after vaccination.

“The vaccines are safe and effective, and of course no steps were skipped during the testing phase”, says Klungel. “For example, the Pfizer vaccine was tested on more than 20,000 people, and the most common side effects observed were redness, swelling and discomfort at the point of injection. A few people experienced a slight fever and headache. Nevertheless, it is vital that safety be continuously monitored. It’s still possible that rare side effects could occur, for example in 1 out of 100,000 people vaccinated, and they would need to be identified.”

Linking databases

It is also vital to collect as much information as possible on which people were administered which vaccine, and when they received it. The implementation of the Netherlands’ vaccine programme is currently in the hands of the regional Municipal Health Services, which record the vaccines in their own systems. But if a vaccinated person develops any side effects, they would probably contact their general practitioner, and not the Municipal Health Service.

Klungel: “Several countries have linked large databases with data from physicians and pharmacists with those for hospital admissions. The challenge now is to link those to databases of coronavirus vaccines as quickly as possible. The RIVM has set up a centralised registration system that should facilitate that linkage. It’s not clear how many other countries will set up such a vaccine administration database.”