Moderna’s virus vaccine gets nod from EU agency

THE European Union’s medicines regulator gave the green light yesterday to Moderna’s COVID-19 vaccine, a decision that gives the 27-nation bloc a second vaccine to use in the desperate battle to tame the coronavirus outbreak rampaging across the continent.

The approval recommendation by the European Medicines Agency’s human medicines committee — which must be rubber-stamped by the EU’s executive commission — comes amid high rates of infections in many EU countries and strong criticism of the slow pace of vaccinations across the region of some 450 million people.

“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, Executive Director of EMA.

European Commission President Ursula von der Leyen welcomed the approval and added in a tweet: “Now we are working at full speed to approve it & make it available in the EU.”

The EMA has already approved a coronavirus vaccine made by American drugmaker Pfizer and Germany’s BioNTech.

Both vaccines require giving people two shots.

Ahead of the meeting on the Moderna vaccine, the agency said in a tweet that its experts were “working hard to clarify all outstanding issues with the company.” It did not elaborate on what those issues were.

Moderna also declined to comment.

Early results of large, but still unfinished studies show both the Moderna and the Pfizer/ BioNTech vaccines appear safe and strongly protective, although Moderna’s is easier to handle since it doesn’t need to be stored at ultra-frozen temperatures. The EU agency gave the green light to apply the Moderna vaccine on people aged 18 years and above.

Cooke stressed

that EU authorities will closely monitor data on the safety and effectiveness of the vaccine to ensure ongoing protection of the EU public.

“Our work will always be guided by the scientific evidence and our commitment to safeguard the health of EU citizens,” she said.

The United States, Canada and Israel have already approved use of the Moderna vaccine. The US gave it the green light for emergency use in people over 18 years on December 18, followed by Canada five days later with an interim authorization also for people over 18. Israel authorized the vaccine on Monday.

Moderna said on Monday that it is increasing its estimate for global vaccine production in 2021 from 500 to 600 million doses.

The company added it is “continuing to invest and add staff to build up to potentially 1 billion doses for 2021.”

Both Moderna’s and Pfizer/ BioNTech’s shots are messenger RNA vaccines, made with a ground- breaking new technology. They don’t contain any coronavirus — meaning they cannot cause infection.

Instead, they use a piece of genetic code that trains the immune system to recognize the spike protein on the surface of the coronavirus, ready to attack if the real thing comes along.

The EU officially began giving out Pfizer/ BioNTech vaccination shots on December 27, but the speed of each nation’s inoculation program has varied widely.

German Health Minister Jens Spahn, who has in the past been critical of the slow pace of the EMA, said he expected the Moderna vaccine to begin rolling out to EU member states next week.

“The problem is the shortage of production capacity with global demand,” he said.