Moderna: EU medicines agency approves second COVID-19 vaccine

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.”

Good news for our efforts to bring more #COVID19 vaccines to Europeans!
@EMA_News assessed that the @moderna_tx vaccine is safe & effective.

Now we are working at full speed to approve it & make it available in the EU.

— Ursula von der Leyen (@vonderleyen) January 6, 2021

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.

EU vaccination programmes stuttering

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.

Al Jazeera’s Step Vaessen, reporting from the EMA’s headquarters in Amsterdam, said the agency had been “taking their time” to approve the Moderna vaccine compared with regulators in other countries.

“Everybody was really waiting for it [this decision],” she said.

“There has been pressure coming from Germany, because they have been using only the Pfizer-BioNTech vaccine for the past two weeks, and have been vaccinating very quickly, so they were running out.”

The United States, Canada and Israel have already approved the Moderna vaccine.

The US gave it the green light for emergency use in people older than 18 on December 18, followed by Canada. Israel authorised the vaccine on Monday.

Moderna to ramp up production

 

Moderna on Monday said it is increasing its estimate for global vaccine production in 2021 from 500 to 600 million doses. The company said it is “continuing to invest and add staff to build up to potentially 1 billion doses for 2021”.

Both Moderna and Pfizer-BioNTech’s shots are mRNA vaccines, made with groundbreaking new technology.

They do not contain any coronavirus – meaning they cannot cause infection. Instead, they use a piece of genetic code that trains the immune system to recognise the spike protein on the surface of the virus, ready to attack if the real thing comes along.