Brussels, January 6 (RHC)-- The European Union’s medicines regulator has given the green light to Moderna’s COVID-19 vaccine, the second shot it has approved after Pfizer-BioNTech’s product. Wednesday’s approval recommendation by the European Medicines Agency (EMA) is expected to soon be rubber-stamped by the EU’s executive body.
The move comes amid high rates of infections in many EU countries, and mounting criticism over what some view as a slow pace of vaccinations across the region, home to 450 million people.
Meanwhile, European countries are also racing to contain two new COVID variants found in South Africa and the United Kingdom, that are more transmissible and have driven a surge in infections. “This vaccine provides us with another tool to overcome the current emergency,” said EMA Executive Director Emer Cooke.
“It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO.”
Early results of large, still unfinished studies show the Moderna and the Pfizer-BioNTech two-shot vaccines appear safe and strongly protective, although Moderna’s is easier to handle since it does not need to be stored at ultra-frozen temperatures.
The EMA gave the green light to use the Moderna vaccine on people aged 18 and older. It said side effects “were usually mild or moderate and got better within a few days after vaccination”.
The most common side effects are “pain and swelling at the injection site, tiredness, chills, fever, swollen or tender lymph nodes under the arm, headache, muscle and joint pain, nausea and vomiting”, the EMA said.
European Commission President Ursula von der Leyen welcomed Wednesday’s approval, writing on Twitter: “Now we are working at full speed to approve it & make it available in the EU.” The EU has ordered 80 million doses of the Moderna vaccine – which proved to be about 95 percent effective at preventing illness in clinical trials – with an option for a further 80 million. The bloc has also committed to buying 300 million doses of the Pfizer-BioNTech vaccine.
German health minister Jens Spahn said he expects the Moderna vaccine will be made available in EU nations next week. Germany would get two million doses in the first quarter and 50 million in all of 2021, Spahn told reporters in Berlin. “The problem is the shortage of production capacity with global demand,” he said.
The campaign to vaccinate Europe has gotten off to an uneven start, with officials in Germany and France frustrated at the slow rate of progress. The EU officially began giving out Pfizer-BioNTech vaccination shots on December 27, but the speed of each nation’s inoculation programme has varied widely.
France vaccinated approximately 500 people in the first week, while Germany vaccinated 200,000. The Netherlands was only beginning to inoculate people on Wednesday, the last EU nation to start doing so.
