EU approves Moderna jab amid tensions over slow rollout of vaccines

Move should ease frustrations over low supplies of Pfizer vaccine and EU’s longer authorisation process

The European Medicines Agency has approved the Moderna vaccine, making it the second coronavirus shot to be cleared for general use across the EU, as tensions continued to rise over the slow progress of vaccination programmes in the bloc.

In a move that should ease frustrations over a shortfall in supplies of the Pfizer/BioNTech jab and the EU’s longer authorisation process, the Amsterdam-based regulator said on Wednesday it had granted a conditional marketing authorisation for Moderna’s Covid-19 vaccine for adults.

But Europe is lagging behind the US, Britain and Israel in vaccinations, with the bloc due to hold a virtual summit on the health crisis by the end of the month and the European council president, Charles Michel, describing mass inoculation as a “gigantic challenge”.

The European commission has agreed to buy 160m doses of the US-made vaccine, which has been shown in clinical trials to be 94% effective and should prove easier to deliver since it does not have to be kept as cold as the Pfizer jab.

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Separately, Germany said on Wednesday it would not follow the UK by delaying the second dose of the Pfizer jab to ensure more people were protected sooner, with the health minister, Jens Spahn, saying it would be better to observe the manufacturers’ recommendations.

“My impression is it makes a lot of sense, especially with sensitive issues where trust and reliability are important, to stick to the approval,” Spahn said, adding that Germany would also avoid switching between vaccines to speed up vaccination.

The EU began vaccinating on 27 December, but progress has so far been agonisingly slow: the US and UK have already vaccinated 1%-2% of their populations, while Israel is at 16%. Europe’s best performer, Germany, has managed barely 0.4%, while the Netherlands did not start until Wednesday.

Vaccinations globally

Both the commission and national governments have come under heavy fire for the disappointing pace of the bloc’s vaccine rollout, while tensions within the union have also increased, echoing those early in the pandemic over the sharing of medical equipment.

The EU’s executive has pointed out it that has secured more than 2bn doses from six different manufacturers for the bloc’s 450 million inhabitants, saying the problem is not so much that it failed to order enough vaccines, but that manufacturers are being slow to produce them, and countries slow to administer them.

“I don’t think that the issue is really the number of vaccines – it is the fact that we are at the beginning of a rollout,” said the commission spokesman Eric Mamer. “We’re all judging this as if this campaign is over; in fact, it is just starting.”

Mamer also defended the decision to place orders for a basket of different vaccines, some of which are not yet available. “We always knew it would be a complex operation. This is why the commission was so adamant that it was important we sign contracts with different companies,” he said.

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The US, which approved the Moderna shot on 19 December, and the UK, which this week added the Oxford/AstraZeneca jab to its vaccine armoury, gained a head start by using emergency approvals that offer governments fewer guarantees – and leave manufacturers less exposed in terms of liability in case of problems – than the EMA’s conditional marketing authorisation.

Mainly, however, Europe has suffered from a combination of a dearth of supplies – with BioNTech unable to deliver the 12.5m doses it promised by the end of December due to supply chain issues – and delivery problems in individual member states.

Some governments have underestimated the logistical problems of administering a vaccine such as the Pfizer/BioNTech jab, which must be stored at –70C, in environments such as care homes, while others – such as the vaccine-sceptical France – have opted for caution, with a lengthy individual consent process for each patient.

The delay is fast becoming a domestic political issue in several countries. France’s Emmanuel Macron and Germany’s Angela Merkel have come under attack from opposition politicians and health professionals, and tensions look set to continue rising as lockdowns tighten across the continent.

With the future leadership of Merkel’s Christian Democratic Union to be decided next week and a general election looming in the autumn, the German debate is particularly heated. The tabloid Bild blamed the “vaccine debacle” on the centrist chancellor’s push for a joint European procurement process.

Her party’s junior coalition partner, the Social Democratic party, meanwhile, has set its sights on Spahn, with the finance minister, Olaf Scholz, sending the conservative politician a list of 24 questions about the government’s handling of procurement.

Berlin has also come in for wider European criticism over its decision to reach a bilateral deal with BioNTech for an additional 30 million doses, while Paris has been accused in Germany of insisting that the EU buy less of the German firm’s vaccine in favour of one being developed by France’s Sanofi.

On Tuesday, France’s European affairs minister, Clément Beaune, rejected the accusation as “unacceptable and false”, saying it was “absurd to play countries and laboratories off against each other”.

Additional reporting by Philip Oltermann in Berlin

Contributor

Jon Henley Europe correspondent

The GuardianTramp

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