Harald Enzmann: Expert in the background

EMA

The EMA panel has spoken out in favor of the unrestricted approval of the Astra-Zeneca vaccine for people aged 18 and over.


(Photo: Reuters)

Harald Enzmann has already participated in many important decisions – and yet he never came into the limelight. As chairman of the Committee for Medicinal Products for Human Use at the European Medicines Agency (EMA), he centrally coordinates the deliberations on new medicinal products and their approval in the EU.

Formally, his Committee for Medicinal Products for Human Use (CHMP) only makes recommendations, while the approvals themselves are issued by the EU Commission. De facto, however, it is the committee that decides on new drugs in the EU.

Also last Friday, when the eagerly awaited decision on the British manufacturer’s Covid vaccine Astra-Zeneca the CHMP chairman stayed in the background. Enzmann left it to his deputy, the Portuguese pharmacologist Bruno Sepodes, to explain the CHMP’s judgment in a call with representatives of the press.

The EMA committee was in favor of the unrestricted approval of the vaccine for people aged 18 and over and saw – unlike the Standing Vaccination Commission at the Robert Koch Institute – no reason to limit the use of the vaccine to people under 65 years of age.

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However, it was obviously not easy to find consensus among the roughly three dozen members of the CHMP, as Sepodes later suggested. The deliberations lasted a few hours longer than originally planned. Until recently, the details of the analysis and the recommendation were struggled with. This is likely due not least to the still uncertain data situation in the case of the Astra-Zeneca vaccine.

In addition to the sensitive medical issues, the multinational composition of the CHMP is likely to make chairing this body a challenging job. The committee is made up of representatives from all regulatory authorities in the 27 EU Member States. There are also some experts appointed by the EMA.

As a doctor of medicine, Harald Enzmann has profound expertise and a lot of experience for his position at the head of the CHMP. He has been a member of the committee for more than 15 years and was appointed chairman in 2018.

In his main job, Enzmann is head of staff at the Federal Institute for Drugs and Medical Devices (Bfarm) in Bonn. He studied medicine at Heidelberg University and pathology at New York Medical College. For more than a decade he held various management positions in pharmaceutical research from Bayerbefore moving to the Bfarm in 2002.

More: EU Commission President von der Leyen spoke to the CEOs of the pharmaceutical companies about the delivery problems.

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