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Janssen COVID-19 vaccine approved for use in EU

The Janssen-Cilag International N.V COVID-19 vaccine has received authorization for emergency use by the European Medicines Agency (EMA) on March 11. The vaccine was developed with fundamental support from the Molecular Virology group of the Leiden University Medical Centre (LUMC).

From left to right: Sebe Myeni, Eric Snijder, Marjolein Kikkert, Tim Dalebout, Shessy Torres

The vaccine by Janssen-Cilag International N.V is the fourth vaccine to be administered in the European Union. The Netherlands has ordered more than 11 million vaccine doses.

Janssen first approached the LUMC Molecular Virology group in February of 2020. 'A collaboration to support the development of the Janssen COVID-19 vaccine was proposed because they knew we had been studying coronaviruses for over 30 years', says Professor Eric Snijder of the LUMC department of Medical Microbiology. Together, Snijder and Dr Marjolein Kikkert were responsible for leading the project. Snijder emphasizes that they were able to rapidly assist with the first phase of vaccine development and testing due to LUMC’s well-established research infrastructure. 'Not only did we have the experience, but we also had trained staff available and a state-of-the-art Biosafety Level 3 (BSL-3) laboratory.'

Collaborative science environments

Various LUMC colleagues were involved in the research and development process of the successful Janssen COVID-19 vaccine. 'The LUMC molecular virology group specializes in exploring the replication and evolution of RNA viruses, aimed at understanding their interactions with the host on multiple levels, including immune responses. However, the project also relied on the participation of experts and support staff from other LUMC departments', says Snijder. For example, it was through collaboration with physicians working in LUMC’s clinical BEAT-COVID program that the patient materials were obtained that gave rise to the standardized virus preparations used during the vaccine project.

Neutralization tests

Molecular virologist Dr Sebe Myeni together with research technicians Tim Dalebout and Shessy Torres were then responsible for setting up and running crucial viral neutralization tests. Dalebout explains: 'After we derived our virus preparations from adequately processed patient materials, we began the viral neutralization tests to measure antibody responses to the vaccine candidates. Based on these and other test results, Janssen selected candidates to advance to the second stage of the project.' Snijder highlights: 'Project leaders are often the ones to get acknowledged for their research, but it’s important to note that – in addition to the colleagues running numerous neutralization tests - many others in our laboratory directly and indirectly supported the Janssen study and contributed immensely to its success.' 

The biosafety laboratory 3 at the LUMC

'Logical partnership'

In September of 2020, an important collaboration between the LUMC and the Centre for Human Drug Research (CHDR) was announced for the second phase of Janssen’s vaccine project. According to infectious disease specialist and project leader Dr Meta Roestenberg: 'The partnership was logical since the goal was to determine the optimal vaccination dose and schedule.' Principal CHDR investigator Ingrid Visser-Kamerling notes: 'As the LUMC has experience with vaccine technologies and the CHDR has considerable knowledge with early-phase drug research and connecting to industrial parties, we complement each other perfectly.'

Single-shot success story

The successful collaboration contributed to the first single-shot COVID-19 vaccine that has been approved for use in Bahrain, Canada, United States and, on March 11, the European Union as well. According to the World Health Organization, one-shot vaccines are the best option in pandemic settings as they significantly simplify the logistics of mass vaccination. “Such a triumphant story makes it puzzling to think that a few years ago we almost terminated our research activities on coronaviruses due to a general lack of interest and funding, notes Snijder. 'Without decades of basic academic research on coronaviruses and vaccination technologies this rapid solution to a global problem would not have been possible. The present challenge is to achieve a sustainable level of improved pandemic preparedness, including vaccine and drug development pipelines for coronaviruses and other viral threats. Clearly, knowledge about viruses and their transmission are key in efforts to prevent a future pandemic.'

Additional COVID-19 projects

The partnership between the LUMC and Janssen will hopefully translate into an impactful outcome for the world. For this reason, the collaboration is now entering a new phase, which focuses on tracking the evolution of SARS-CoV-2 variants to assess whether vaccine adjustments need to be made, now or in the future. As the fight against COVID-19 continues, LUMC virology experts are also engaged in research projects that explore alternative methods to combat disease-causing coronaviruses. For example, Dr Marjolein Kikkert is participating in the PREVENT nCoV-19 project to determine the effectiveness and safety of additional vaccine candidates. 'And despite a lot of attention being presently given to vaccine development, antiviral drugs remain an important first line of defense. This area is being explored by Martijn van Hemert and coworkers at the LUMC, who are involved in the European research projects SCORE (Swift Coronavirus Therapeutics Response) and CARE (Coronavirus Accelerated R&D in Europe)', adds Snijder. 

The LUMC-research for this project was made possible by crowdfunding #wakeuptocorona.

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