EMA Approves BioNTech/Pfizer Covid Vaccine

The European Medicines Agency (EMA) has issued approval for regular use to the coronavirus vaccine developed by German company BioNTech and its American partner, pharmaceutical giant Pfizer. The EMA’s announcement came as the body presented its evaluation of the medication in Amsterdam on Monday, December 21.

The vaccine has already been approved in the US, the UK and other countries, but not as definitively as in the EU.

“In the US and the UK, the BioNTech/Pfizer vaccine received emergency approval, whereas in the EU, the regular approval process was followed,” explains Germany Trade & Invest health industry expert Gregor Kemper. “This takes a bit longer but might be beneficial in the long run because the high requirements for regular approval could increase trust among the population in the safety and efficacy of the vaccine. Also, Covid-19 vaccines are procured on a European level, so it makes sense for the approval process to be European rather than national.”

Like other European countries, Germany prepared to distribute and administer the vaccine even before it received approval. Authorities have set up inoculation centers across the country, and plans are being drawn up to get the vaccine to people.

“Germany is a country with a large and internationalized industrial base, so many prerequisites for a rapid distribution have already been fulfilled,” says Kemper. “They include a dense logistics network and an industry that can produce critical materials such as vials and syringes - not only for the German vaccination campaign, but also for those of other countries. The logistic requirements of vaccine distribution bring some new challenges, such as the need for a -70°C cold chain, but several companies in Germany have shown their ability to come up with innovative solutions to meet them.”

The EMA is expected to decide on approval for a second coronavirus vaccine developed by American biotech company Moderna in early January.