The European Medicines Agency (EMA) has approved the use of AstraZeneca’s COVID-19 vaccine for people over the age of 18.

The news came amid a row between the EU and the company over supplies of the vaccine, which led the European Commission earlier today (29 January) to publish the contract it signed with the company.

The EU has also announced a temporary measure which will require pharmaceutical companies to notify the authorities in member states about any intention to export vaccines produced in the EU.

The commission said the aim was to tackle “the current lack of transparency” on the issue, adding that the move would cover only COVID-19 vaccines for which the EU had signed advance purchase agreements.

Protection for older people expected

Earlier this week, Germany’s regulator said there was not enough evidence for it to say whether the AstraZeneca vaccine was effective for those aged 65 or over.

The EMA acknowledged that, in the two studies it considered, there were not yet enough results in older participants to provide a figure for how well the vaccine would work in this group.

“However, protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines; as there is reliable information on safety in this population, EMA’s scientific experts considered that the vaccine can be used in older adults.” the agency said.

This is the third COVID-19 vaccine approved for use in the EU. The EMA will continue to monitor the AstraZeneca vaccine, having given it a conditional marketing authorisation, which means the decision is based on less comprehensive data than normally required.

The vaccine is given as two injections into the arm, the second between four to 12 weeks after the first.

EU dissatisfied

Ahead of the EMA decision, the EU and AstraZeneca had been at loggerheads after the company said it would be supplying fewer doses than anticipated in the coming weeks due to production issues at a plant in Belgium.

Under the deal, EU member states are able to purchase 300 million doses of the AstraZeneca vaccine, with an option for a further 100 million doses, to be distributed on a population-based pro-rata basis.

“The view that the company is not obliged to deliver because we signed a ‘best effort' agreement is neither correct nor is it acceptable,” commissioner Stella Kyriakides said earlier this week, adding that the EU was dissatisfied with “insufficient explanations” from AstraZeneca.

Two of the four plants manufacturing the vaccine are in the UK, which approved the vaccine late last year, and the EU has argued that these should also be used to supply doses to the EU under the terms of the contract.

Section 5.4 of the contract published today (29 January) says AstraZeneca will use its “best reasonable efforts” to manufacture the vaccines at sites located in the EU, “which, for the purpose of this Section 5.4 only, shall include the United Kingdom”.