EMA gives green light to Pfizer/BioNTech Covid-19 vaccine

The European Medicines Agency (EMA) gave a green light for the Pfizer and BioNTech vaccine to prevent Covid-19. With the approval, issued on Monday, the vaccine is expected to be available on the European market before Christmas. The first EU countries plan to start vaccinating from December 27, while in the Netherlands, the inoculation program is set to begin on January 8.

The Pfizer/BioNTech product, Cominarty, is the first of several vaccine candidates to win EMA approval. It was approved for use by people 16 years of age and older. The Netherlands is expected to take delivery of a first batch of 500 thousand doses of the vaccine by the end of the year, with two doses recommended per person.

“Today’s positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for so many,” said EMA Executive Director Emer Cooke. “We have achieved this milestone thanks to the dedication of scientists, doctors, developers and trial volunteers as well as many experts from all EU Member States."

The EMA decision opens the door for all 27 EU Member States to begin inoculating their residents against the coronavirus. Austria, Germany and Italy plan to begin vaccinating people from December 27. Austria will begin with its health care workers, while Germany planned to also initially inoculate people over 80 years of age.

The Netherlands will invite health care workers, including home care providers and nursing home staff, to contact municipal health service GGD from January 4 to schedule an appointment. There were still questions about the GGD's ability to establish IT systems in time to log and track vaccine delivery, and the Dutch government has not yet revealed full details of the logistics for providing the vaccines starting on January 8.

Cominarty is given as an injection into the arm, and then a second injection at least three weeks later. "The most common side effects with Comirnaty were usually mild or moderate and got better within a few days after vaccination. They included pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills and fever," the EMA said in a statement.

“Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards. However, our work does not stop here. We will continue to collect and analyze data on the safety and effectiveness of this vaccine to protect people taking the vaccine in the EU,” Cooke said. The approval was based upon thousands of pages of data and research, including information about the production process, preparation, dosage, and testing. The Dutch Medicines Evaluation Board CBG was involved in the review on behalf of The Netherlands.

The vaccine is already being used in the United Kingdom and in the United States. In those countries, the Pfizer/BioNTech vaccine was approved earlier this month, albeit only for emergency use. In lengthy reports from the American Drug Authority (FDA) and the British Medicines and Healthcare products Regulatory Agency (MHRA), the drug's effectiveness, possible side effects, and safety are outlined in detail. Both the Americans and British cite as common side effects a sore arm, fatigue, and headaches.

“In principle, the vaccine does not have to meet other requirements on the European market than in the US and Great Britain,” says a spokesperson for the Dutch regulator CBG. “Our standing points are the same. There may be differences in interpretation, for example in how we evaluate laboratory data. But we don’t expect that.”

We are now waiting for the European Commission to officially authorize the drug on the EU market. This will probably happen by Wednesday at the latest. In addition, the Health Council in the Netherlands will issue new advice on the vaccination strategy this week. Currently, the plan is to vaccinate healthcare workers first, but perhaps this will change based on the information presented by the EMA.