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Safety for pregnant women using COVID-19 treatments and vaccines

July 29 2020

With over 160 vaccines in development and hundreds of drugs being evaluated for use against COVID, finding effective solutions seem a matter of time. But what about safety for pregnant women? How can we make sure that women can safely use these vaccines and drugs? Within the IMI project ConcePTION, ttopstart aims to establish a sustainable solution, also beyond COVID.

A European ecosystem for efficitively monitor drug safety

Ever since the 1950s’ thalidomide tragedy, drug safety has been high on everyone’s agenda. And although major advances have been made, the field has yet to converge to an effective way to ensure safety during pregnancy and lactation. Particularly painful is that available data is not being used to its full potential. The European Medicines Agency (EMA) is preparing an infrastructure to effectively monitor future vaccines in the real-world as soon as they are authorised and support the safe and effective use of COVID-19 vaccines and medicines. ConcePTION aims to address just that: create a European ecosystem that connects existing data sources in a way that delivers better and more timely evidence.

ttopstart is in the lead to ensure the ecosystem will be sustainable beyond the project funding. We are happy to share that EMA just endorsed our approach in the context of COVID-19, which is a huge achievement and a major milestone towards a sustainable ecosystem. In recent months, three contracts for observational research projects have been signed between the EMA and academic and private partners. One of the projects is the CONSIGN project (‘COVID-19 infectiOn aNd medicineS In preGNancy’) with Utrecht University and University Medical Center Utrecht as coordinators and builds upon the ConcePTION ecosystem. 

The CONSIGN project: COVID-19 medicine for pregnant women

The CONSIGN project will collect data on the impact of COVID-19 in pregnancy in order to guide decision-making about vaccine indications, vaccination policies, and treatment options for COVID-19 disease in pregnant women. CONSIGN will analyse existing data sources (e.g. electronic health records, hospital data) and cohorts of pregnant women to provide information on the effect of infection and its treatments in different trimesters of pregnancy and on neonates.It will do so by leverage the novel data models and analysis tools as developed within ConcePTION.

How we are part of the solution

As discussed in one of our previous blogs on patient engagement, ttopstart plays a role as project manager of sustainability and engagement of the IMI ConcePTION consortium. Our managing director Jasper Levink on the ConcePTION project:

At ttopstart we are proud to support ConcePTION. The project’s mission is very well aligned with ours. To realise our common goals, we need to break through both technical and institutional hurdles, and we need to align many stakeholders with each varying goals and priorities of their own. The creativity and drive this requires is what defines us.

Read the full EMA article here.

More about ConcePTION

ConcePTION aims to establish a trusted ecosystem that can efficiently, systematically, and in an ethically responsible manner, generate and disseminate reliable evidence-based information regarding effects of medications used during pregnancy and breastfeeding to women and their healthcare providers. This will be achieved by generating, cataloguing, linking, collecting and analysing data from pharmacovigilance, modelling, routine healthcare, breastmilk samples through a large network.

The research leading to these results has received support from the EU/EFPIA Innovative Medicines Initiative. IMI2 – Call 13 – Topic 9 (H2020-JTI-IMI2-2017-13-two-stage submitted for H2020-JTI-IMI2-2017-13-two-stage / 06 Sep 2018)

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ir. Jasper Levink