No EU decision on Moderna shot as blame game mounts

Michelle Chester, DNP, director, employee health services, Northwell shows the Moderna coronavirus disease (COVID-19) vaccine at Northwell Health's Long Island Jewish Valley Stream hospital in New York City, USA, 21 December 2020. [Pool/EPA/EFE]

The EU’s drugs watchdog held off authorising Moderna’s coronavirus jab on Monday (4 January), as criticism mounts of the bloc’s slow vaccine roll-out.

The Amsterdam-based European Medicines Agency (EMA) said it would resume talks on Wednesday on whether to give the green light to what would be the EU’s second vaccine.

Under pressure from EU nations to speed up, the regulator had earlier fast-tracked the meeting to decide on approval from 12 January to 6 January, and then again to 4 January.

Despite launching its vaccination campaign with the Pfizer-BioNTech vaccine, on 27 December, the EU’s progress has been much slower than in the United States, Britain or Israel.

“EMA’s committee for human medicines discussion on Covid-19 vaccine (by) Moderna has not concluded today. It will continue on Wednesday,” the EMA said on Twitter.

“No further communication will be issued today by EMA.”

The European Commission had earlier defended the bloc against criticisms of its slow roll-out, and said its plans would get the EU past “bumps on the road”.

“It’s obvious that such a complex endeavour is always going to bring with it difficulties,” spokesman Eric Mamer told journalists.

The Pfizer-BioNTech vaccine — developed in Germany — is the only one currently authorised for use in the European Union since its fast-track authorisation by the EMA on 21 December.

The United States uses it alongside the Moderna vaccine, while Britain as of Monday also started using one by UK pharmaceuticals giant, AstraZeneca.

Britain rolls out AstraZeneca shots as virus vaccinations gather pace

Britain on Monday (4 January) began rolling out the Oxford-AstraZeneca coronavirus vaccine, a possible game-changer in fighting the disease worldwide, while China raced to inoculate millions with a domestically made jab.

Moderna Inc said on Monday that Israel’s health ministry had authorized its COVID-19 vaccine, marking the vaccine’s third regulatory authorization and the first outside North America.

“Ministry of Health of Israel has secured 6 million doses and first deliveries (are) expected to begin in January,” Moderna said in a statement.

EU countries have been lagging far behind. France, for instance, has given a first jab to just over 500 people. Germany has started immunising 200,000.

The Netherlands, the last in the EU to start its vaccination programme, meanwhile said it was bringing forward the start of jabs — by two days to Wednesday.

The European Commission emphasised it had bought access to “almost two billion doses” of six potential vaccines — four times the population of the entire European Union.

US-based Moderna’s jab was found to be 94.1% effective in preventing Covid-19 compared to a placebo in a clinical trial of 30,400 people, performing slightly better in younger adults compared to the elderly.

The EMA said last week that the coronavirus vaccine developed by AstraZeneca and Oxford University, which was approved Wednesday in Britain, is unlikely to get a green light in the EU in the next month.

The fact that the watchdog moved from London to Amsterdam after Brexit has itself fuelled commentary about how Britain had been able to move faster after leaving the EU.

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