European Commission approves first COVID-19 vaccine

Vaccination European Commission approves first COVID-19 vaccine

The European Commission has approved the  BioNTech/Pfizer vaccine, following the recommendation of the European Medicines Agency (EMA) for a conditional marketing authorisation. This applies to people over the age of 16. Vaccination can now begin in Germany.

EMA recommends approving vaccine.

On Monday the EMA recommended approving the BioNTech/Pfizer in der EU vaccine for use in the EU.

Photo: Getty Images/Leon Neal

The first COVID-19 vaccine is now available for use in the European Union. On Monday the European Commission approved the BioNTech/Pfizer vaccine for use. "Today we are adding an important chapter to our fight against COVID-19," stressed European Commission President Ursula von der Leyen following the decision.

The approval was based on the relevant recommendation of the European Medicines Agency (EMA). A few hours earlier it had recommended authorising the BioNTech vaccine. EMA Executive Director Emer Cooke said it was a scientific breakthrough. A new vaccine for a novel disease has been developed within one year. Federal Health Minister Jens Spahn described the process as a "milestone in the fight against the pandemic".

Safety is the top priority

The global effort has made it possible to develop a vaccine in an exceptionally short period of time. "This is really a historic scientific achievement," said the EMA Executive Director. Every effort has been made to speed up the processes involved in developing and approving the vaccine, but the top priority has always been to ensure that the vaccine is safe. The vaccine, she said, fully complies with the EU’s rigorous standards regarding efficacy and safety. The recommendation applies to people over the age of 16. Commenting on the new variant of the virus that has been identified in the United Kingdom, for instance, Emer Cooke said that at this moment there is no evidence to suggest that the vaccine will not be effective against the new variant.

EMA: All data will be made public

The market approval involves an obligation for all EU states to provide all available data to the EMA to enable it to monitor safety. Emer Cooke said it is clear that a vaccine can only be effective if the people trust it. That is why all data will be made public and presented in an transparent manner.

The BioNTech/Pfizer vaccine is a first step, but more vaccines are needed, declared Emer Cooke, which is why the EMA is in contact with other vaccine developers. She said she was delighted to issue the recommendation that the first vaccine in Europe be approved. But it will still take time to conquer the pandemic. "That is why we must all do our best to force back the disease; we must consistently respect all hygiene rules," she stressed.

Releasing the batches in Germany

Now that the vaccine has been approved at European level, the Paul Ehrlich Institute is responsible for releasing the vaccine batches in Germany, before it can be delivered to the 27 delivery centres in the 16 federal states. It is then up to each federal state to distribute the vaccine to its regional centres. Vaccinations are to begin on 27 December in Germany.

The order of vaccinations fixed in Germany

The vaccination drive will initially focus on nursing and care homes. "The primary goal of our vaccination drive is to protect the weakest," said Federal Health Minister Jens Spahn. On 18 December he presented the vaccination regulations, which set out which groups can be vaccinated in which order in Germany. Alongside the residents and staff of care and nursing homes, everybody over the age of 80 belongs to the group that will be given first opportunity to be vaccinated. This top priority group also includes the staff of home nursing and care services, and the staff working in intensive care units, accident and emergency and the ambulance services.

"By the end of this year, over 1.3 million doses of the vaccine will have been delivered to the federal states and they will have passed them on to the vaccination teams," tweeted Federal Health Minister Jens Spahn following the EU’s decision. In January at least another 670,000 doses a week will be delivered, he said. 

Click here to read the vaccination regulations in full (in German) and FAQs relating to the COVID-19 vaccination (in German).