Will the current vaccines be sufficiently effective if new virus variants emerge? Can you combine two vaccines while there is a shortage? Does it make sense to vaccinate children? These kinds of questions are expected to be answered by VACCELARATE: a European network set up for clinical trials with COVID-19 vaccines in 21 countries. The UMC Utrecht is coordinating the capacity building of the trial sites.

With vaccination programs against COVID-19 gaining steam in most European countries, there is still much that we do not know, says pediatric epidemiologist

Patricia Bruijning. “Do vaccinees pass on the virus to other people or not? How safe and effective are the vaccines for pregnant women? What about children? Does vaccination help suppress the circulation of the virus among them and do they benefit from vaccination themselves? What about people with an impaired immune system? When do we start with repeat injections? These are all questions that are relevant to vaccination policy.”

Combined vaccination

And there are more. The coronavirus is, as Patricia calls it, a ‘moving target’. “We need to be able to make constant adjustments. Perhaps new variants will emerge in the near future for which we need to quickly update existing vaccines. Or you may want to combine different vaccines in a situation of shortage – now or in the future.” The question is then whether this can be done safely, for example giving someone a BioNTech/Pfizer vaccine first and AstraZeneca as a second shot. Such a combined vaccination can have logistical advantages, allowing you to vaccinate more people more quickly. The combination can even result in health benefits, if both vaccines – precisely because of their differences – complement each other and together offer more protection.

VACCELERATE

Patricia says, “Of course, in vaccine research, you should never take any chances. Duration of protection, side effects, everything relevant needs to be scientifically researched, even while we are in the middle of a pandemic.” In order to do this not only carefully but also quickly and efficiently, VACCELERATE was launched: a European network for clinical vaccine trials, in which 16 EU member states and 5 associated countries, including Israel and Switzerland, participate. VACCELERATE will work closely with, for example, vaccine developers, the European Medicines Agency (EMA) and the World Health Organization (WHO). EUR 12 million of European funding has been set aside to establish the network, which aims to facilitate cooperation in clinical trials with COVID-19 vaccines. The network is also established to prepare Europe for future infectious diseases.

Clinical trial sites

Within VACCELERATE, Patricia coordinates the capacity building of clinical trial sites in the 21 participating European countries. Patricia says, “At the UMC Utrecht, we have already gained a lot of experience with establishing CLIN-NET, a similar network of trial sites for COMBACTE, a European partnership to combat antibiotic resistance. That helps enormously. The idea is now to be able to rapidly start European vaccine trials for different vaccine types and for different age and patient categories. Large groups of people are needed for this. And for vaccines you need not only patients but also healthy volunteers. As such, trial sites must meet specific requirements. Think, for example, of hospitals, general medicine practices and consultancies but also of area health authorities. Suppose you want to investigate whether there is a difference between schools where children have been vaccinated and schools where children have not been vaccinated. Then you hook up with the area health authority in the relevant region, for example.”

Training

“We not only look at suitable trial sites, but also provide training,” she continues. Not everywhere is there sufficiently knowledge available yet to participate, and of course the participating professionals must be qualified to conduct the trials according to the applicable standards.” This involves issues as diverse as participant screening, medical checks and data collection, standardized record keeping, and procedures for allocating placebo or vaccine. But also practical matters such as administering the vaccine and disposing of the waste. “All of these processes have to be done according to certain steps and their quality must be in order.”

European plan against virus variants

VACCELERATE is part of a larger European program to combat new variants of the coronavirus: HERA Incubator. In addition to research into and rapid production of modified or new COVID-19 vaccines, this program focuses on the detection and analysis of new virus variants and accelerating formal approval of vaccines.