EU drug regulator recommends authorization of Moderna Covid-19 vaccine

The European Union drugs regulator has recommended granting Moderna’s Covid-19 vaccine a conditional marketing authorization, a move that will soon pave the way for the drug to become the second coronavirus vaccine to be distributed in the bloc.

Following the recommendation by the European Medicines Agency (EMA), the shot now must be formally authorized by the European Commission, which is expected to do so quickly.

On Wednesday, the European Parliament Committee on Environment, Public Health and Food Safety said on Twitter that they are “expected to follow the (EMA) recommendation and grant the authorization shortly after which the roll-out of the vaccine in the EU can begin.”

Emer Cooke, EMA executive director, said on Wednesday that “this vaccine provides us with another tool to overcome the current emergency.”

“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,” she said.

Ursula von der Leyen, president of the European Commission, said in a tweet that the EMA had found that the Moderna vaccine is “safe and effective” and that their decision is “Good news for our efforts to bring more #COVID19 vaccines to Europeans!”

“Now we are working at full speed to approve it & make it available in the EU,” she said.

The EU has secured the purchase of up to 160 million doses of the Moderna vaccine — enough to vaccinate 80 million people of its 448 million citizens — as part of a joint vaccine strategy aimed to ensure equitable access across the bloc.

It has also purchased up to 300 million doses of the Pfizer/BioNTech vaccine, which was authorized for use on December 21 and rolled out to all EU countries days later.

A challenging process

The 27-member bloc is already facing logistical challenges in rolling out the Pfizer/BioNTech vaccine.

As of January 1, the amount of people vaccinated in France stood at a paltry 516, according to data made available by the French health agency.

That rate seems to undermine the promise of French Prime Minister Jean Castex, who said that 1 million people would able to be vaccinated by the end of the month.

Jean Rottner, the head of France’s “Great East” region, which has been badly impacted by the second wave, said that the slow vaccination rate is “a state scandal,” and that he wanted territories to “take over” from the government.

“We are making fun of ourselves because today, being vaccinated has become more complicated than buying a car,” Rottner said on public broadcaster France 2.

“We need to accelerate, we are at war,” he said, “adding that “today, we need to vaccinate everywhere we can, with the means that are at our disposal.”

The German government has also come under pressure from both politicians and scientific experts for not securing enough doses of the Pfizer/BioNTech vaccine to roll out its vaccination program.

Germany has immunized 316,962 people — around 0.4% of the country’s population — according to Tuesday’s data from the Robert Koch Institute, the national agency for disease control and prevention.

Among those vaccinated were around 131,885 residents of nursing homes and around 149,727 medical staff, according to data collected from Germany’s federal states.

German health minister Jens Spahn rejected criticism of the delay in inoculations, saying in an interview with public broadcaster ARD on Tuesday that vaccination doses currently available in Germany are “exactly the order of magnitude I have been announcing for weeks.”

At the same time, Spahn emphasized that efforts to procure more vaccine doses for Germany are underway, with authorities “very actively” supporting the construction of a new BioNTech production plant in Marburg.

Experts have warned that the biggest challenge for the EU will be the actual rollout of the vaccine, given that both the Pfizer/BioNTech and Moderna shot, which uses new mRNA technology, differs significantly from other more traditional vaccines in terms of storage.

Moderna’s vaccine can be stored at temperatures of -20 Celsius (-4 Fahrenheit) for up to six months and at refrigerator temperatures of 2-8C (35-46F) for up to 30 days. It can also be kept at room temperature for up to 12 hours, and doesn’t need to be diluted prior to use.

The Pfizer/BioNTech vaccine presents more complex logistical challenges, as it must be stored at around -70C (-94F) and lasts just five days in a refrigerator. Vials of the drug also need to be diluted for injection; once diluted, they must be used within six hours, or thrown out.

Vaccine candidates such as Oxford/AstraZeneca’s offering — which is already being distributed in the UK and which experts believe is likely to be approved by European regulators next — can be kept at normal refrigerator temperatures for at least six months, a benefit to those countries which are ill-equipped to handle the additional demands of cold-chain storage.

A strong cold-chain network is just one aspect when it comes to effectively distributing vaccines, however.

Other factors such as monitoring systems, community engagement and human resourcing are also all crucial to a successful rollout.