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Coronavirus: Germany approves first human trials of a vaccine

27 November 2019, Rhineland-Palatinate, Mainz: The headquarters of the biotechnology company BioNTech is located directly in front of a construction site on which an additional company building is currently being erected. BioNTech boss Sahin expects significant improvements in the detection of cancer in the coming years. Photo: Andreas Arnold/dpa (Photo by Andreas Arnold/picture alliance via Getty Images)
The headquarters of the biotechnology company BioNTech in Rhineland-Palatinate, Mainz, Germany. (Andreas Arnold/picture alliance via Getty Images)

The Paul Ehrlich Institute, Germany’s regulatory authority for vaccines, has given its approval to start trials of a potential coronavirus vaccine on healthy human volunteers.

The vaccine has been developed by Mainz-based BioNtech (BNTX) in cooperation with US pharma giant Pfizer (PFE).

The Institute said that granting approval came after a careful assessment of the potential risk/benefit profile of the vaccine candidate, and noted that the drug is only the fourth vaccine trial in the world to get testing approval so far. Testing, it said, could take up to five months, before larger, clinical trials could begin.

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“The speed with which we were able to move from the start of the program to trial initiation speaks to the high level of engagement from everyone involved,” said Ugur Sahin, BioNTech CEO and co-founder.

The vaccine will be tested first on 200 healthy adults aged between 18 and 55. The following phase would see it tested on a coronavirus risk group — people over 55 and those with pre-existing health conditions — of around 500 people.

Read more: Merkel warns 'we mustn’t think for one second that we are safe' as restrictions are eased

Albert Bourla, Pfizer chairman and CEO, said in a statement that they are “looking forward to and actively preparing for the potential start of this unique and robust clinical study program in the United States in the near future.”

The UK will also begin its first human trials of a vaccine developed at Oxford University this week. Health secretary Matt Hancock said that the government was allocating £20m ($25m) to help fund the research, and another £20m to vaccine research taking place at Imperial College London.

Governments and health experts agree that while curfews and lockdowns are helping to tackle the rampant spread of COVID-19, there is no way to ensure that infections won’t surge again without a vaccine.

The race to develop a vaccine caused tension between Berlin and Washington last month, after the US government was accused of trying to acquire German medical company CureVac, with the goal of ensuring its vaccine in development would be developed exclusively for the US.

Read more: Munich cancels Oktoberfest as risks too high

Germany’s health minister Jens Spahn responded that a US takeover of CureVac was “off the table,” and that if CureVac made a vaccine it should be available for the world, not for individual countries.

Swiss pharmaceutical giant Roche (RHHBY), said this week that it is unlikely to have a vaccine available before the end of next year. It plans to launch an antibody test in May, that will indicate if someone has already had coronavirus.

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