First doses of Moderna vaccine arrive in Ireland as EU chief defends supply

The first shipment of the Moderna Covid-19 vaccine arrived in Ireland on Tuesday.

A spokesperson for the HSE confirmed that they had received the first 3,600 doses of the vaccine, approved for use by the European Medicines Agency (EMA) last week, and were "hopeful of increased deliveries in weeks to come".

“This small start represents a significant step as the Moderna vaccine joins our existing national Covid-19 vaccination programme. Our priority is to roll out this vaccine as soon as possible,” they said.

It is unclear as yet when the HSE will be ready to start administering the vaccine. Sources say it had not been expecting supplies to arrive until the middle of next week.

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Staff need to be trained in administering each of the different vaccines coming to market. The fact that Moderna is a first-time producer of a pharmaceutical product has increased the lack of clarity.

The news came as the European Union's Covid vaccine chief defended its efforts to secure adequate vaccine supplies for member states, and AstraZeneca finally applied formally to the EMA for approval for the jab it has developed with Oxford University.

Sandra Gallina said Brussels had built a portfolio that would yield sufficient quantities and timely delivery. Appearing before a European parliament committee, she said: "We bought as much as was offered. If I buy billions of doses [on paper] but they are not delivered, what's the use?"

Her comments came as the European regulator said it might approve the AstraZeneca vaccine by the end of January.

In a statement on Tuesday, the EMA said AstraZeneca and Oxford University had submitted an application for their Covid-19 vaccine to be licensed across the European Union.

The regulator said the company had sought for it to be green-lighted under an expedited process and that it could be approved by January 29th “provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete”.

The EMA has been conducting a rolling review of the AstraZeneca vaccine but had sought additional information following a series of issues that emerged in late stage clinical trials.

The Oxford-AstraZeneca vaccine is expected to be a key vaccine for many countries because of its low cost, availability and ease of use. It can be kept in refrigerators rather than the ultra-cold storage that the Pfizer / BioNTech vaccine – the most widely currently available – requires.

AstraZeneca has said it plans to make up to three billion doses by the end of 2021. The EU has already confirmed an order for 400 million doses of the vaccine, of which roughly 4.4 million would be destined for Ireland.

Advance purchase

The European Commission also said on Tuesday that it plans to conclude preliminary talks this week with French company Valneva over the advance purchase of its Covid-19 vaccine candidate.

“We intend to launch this week a tender procedure for Valneva,” Ms Gallina said.

She said the EU was also trying to conclude a supply deal with Novavax. "We hope to be buying doses of Novavax," she said. Preliminary talks with the US group for the supply of 200 million doses of its product concluded on December 17th.

Valneva started a phase I/II trial in mid-December of its vaccine while the Novavax alternative entered phase III trials at the end of last month.

Another vaccine, from Johnson & Johnson vaccine unit Janssen, expects to be ready to deliver results from the first of a number of phase III trials to the US regulator, the Food and Drug Administration (FDA), on January 21st, the company said on Tuesday. The Janssen J&J product differs from those on the market, and from the AstraZeneca one in that it requires just one injection.

Moncef Slaoui, the chief scientific adviser to the US Operation Warp Speed programme, has said the emergency clearance could be granted by US regulators by early February.

The European Union, which is also conducting a rolling review of the Janssen vaccine, has agreed an initial contract for 200,000 doses, assuming it secures regulatory approval.

Sinovac

Also on Tuesday, a coronavirus vaccine developed by China's Sinovac showed "general efficacy" of 50.4 per cent in a late-stage trial in Brazil, researchers said, barely enough for regulatory approval and far short of earlier indications.

The FDA has said it would consider approving any vaccine that exceeded 50 per cent efficacy, but the two approved so far have delivered efficacy of more than 90 per cent.

The letdown after a more promising partial data disclosure last week may also contribute to criticism that vaccines developed by Chinese manufacturers are not subject to the same public scrutiny as US and European alternatives.

– Additional reporting: Reuters and The Financial Times Limited 2021