EU decision on AstraZeneca due on Friday but age restriction possible

A decision on whether to approve AstraZeneca's Covid-19 vaccine for the European Union should come on Friday, but there is a low amount of data on its use in older people from trials, European Medicines Agency (EMA) executive director Emer Cooke has said.

"The assessment is currently under finalisation, and we're very much hoping for a conclusion this week," she told a European Parliament committee in response to questions from MEPs.

The British-Swedish pharmaceutical multinational is at the centre of controversy after it announced delays in the delivery of doses to the EU, prompting the bloc to consider imposing restrictions on the export of vaccines to other countries.

AstraZeneca has since offered to bring forward the start of deliveries of its Covid-19 vaccine to the EU to February 7th, and the bloc has asked the firm if it can divert doses of the vaccine from elsewhere to make up for a shortfall in promised supplies. Sources said AstraZeneca had also revised upwards its supply target for February after a near 60 per cent cut for the first quarter was announced last week.

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There have been questions over whether the vaccine will be approved for use in older populations, because a relatively small number of elderly people took part in the AstraZeneca trials.

Germany’s Bild tabloid and Handelsblatt business daily reported on Tuesday that the vaccine had an efficacy of merely 8 per cent among older people. The report sparked alarm, as this age group is most at risk of dying with Covid-19.

A spokesman for Germany’s federal health ministry said the reports had mixed up information from clinical trial data.

“About 8 per cent of the subjects in the ... trial were between 56 and 69 years of age, and only 3-4 percent were over 70 years of age,” the spokesman said. “However, this does not imply an efficacy of only 8 per cent in the elderly.”

Vaccines for UK

German health minister Jens Spahn said he would not participate in speculation about the vaccine’s efficacy, but indicated it would be usable – even if only for younger people.

Mr Spahn did not mince his words on AstraZeneca’s delivery difficulties. He was reacting to information provided to the federal government in Berlin that vaccines for the UK were being prioritised at the firm’s Belgian production facility.

“It makes sense to introduce an obligatory EU-level permit for export of vaccines,” he said.

Chancellor Angela Merkel also weighed in to the debate, demanding a “fair” distribution of Covid-19 vaccines across the world.

Ms Cooke told MEPs that any approval granted would be based on the evidence available. She noted that in general it was possible to grant vaccine approval only for certain age groups.

If approval of the AstraZeneca vaccine were to be granted for younger age groups only, it could be a blow to an EU aim to vaccinate all older people and health workers within months.

Asked about production delays, Ms Cooke said she shared the “frustrations” over the issue and said the EMA would do everything it could to help to speed up production by helping to add extra manufacturing capacity.

New variants

Regarding mutations of Covid-19 and vaccine effectiveness, Ms Cooke said in-vitro trials suggested that the already-approved vaccines from Pfizer-BionNTech and Moderna were effective "at least against the UK variant".

The South African variant “is more complicated” and further study is required to establish whether the vaccines work against it, the EMA chief added. The regulator is currently examining how it could speedily approve possible future tweaks of the vaccines to make them effective against new variants.

The EMA is currently reviewing evidence on an additional vaccine made by Johnson & Johnson, and has been in touch with 50 vaccine developers, Ms Cooke said. However, none of them have yet applied for approval.

Meanwhile, German drug company BioNTech, developer of the first Covid-19 vaccine licensed for use in the EU, has hit back at claims its product is more complicated to ship and administer.

Media reports have suggested the BioNTech vaccine requires extreme refrigeration before use. The Mainz-based company said vaccine vials originally cooled to -75 degrees could later be stored in nothing more complicated than dry ice.

“Once thawed, the vaccine vial can be stored for up to five days at refrigerated (2-8 degrees) conditions,” the company added.