EMA Recommends Oxford/AstraZeneca Vaccine

Peter Russell

January 29, 2021

Editor's note, 30 January 2021: This article was updated to include the latest developments.

The AstraZeneca/Oxford vaccine has been approved by the European drug regulator.

The decision by the European Medicines Agency (EMA) came during a turbulent dispute between the EU and the pharmaceutical firm over contract obligations.

The human medicines committee said it was granting a conditional marketing authorisation for the vaccine for people aged 18 and over.

It said assessment showed a 59.5% reduction in the number of symptomatic COVID-19 cases in people given the vaccine compared with people given control injections.

It said that as most of the participants in trials were aged 18 to 55, it was not possible to show efficacy in older age groups.

The EMA said the second dose should be given between 4 and 12 weeks after the first.

Emer Cooke, executive director of the EMA, said: "We have further expanded the arsenal of vaccines available to EU and EEA member states to combat the pandemic and protect their citizens."

Pascal Soriot, AstraZeneca's chief executive, said: "Today’s recommendation underscores the value of AstraZeneca’s COVID-19 vaccine which is not only effective and well-tolerated, but also easy to administer and, importantly, protects fully against severe disease and hospitalisations.

"We are deeply grateful to Oxford University, participants in the clinical trials and AstraZeneca colleagues for their unwavering commitment to providing this lifesaving vaccine to millions of Europeans."

Experts Welcomed the Decision

Dr Michael Head, senior research fellow in global health at the University of Southampton, said that with high levels of COVID-19 across Europe, it was "good to see the EMA recommend the use of the Oxford/AstraZeneca vaccine in all age groups, including older populations".

Andrew Pollard, professor of paediatric infection and immunity at Oxford University, and chief Investigator on the Oxford vaccine trial, described it as "an important milestone".

Last week AstraZeneca said vaccine supplies would be reduced because of problems in one of its EU factories.

The European Union Commission today published its contract with the Anglo-Swedish company to demonstrate its claim that the company was failing to supply the contracted number of vaccine doses to member states.

Commissioner Stella Kyriakides said today that contracts were binding.

Later on Friday, the EU said it would trigger Article 16 of the Northern Ireland Protocol that forms part of the Brexit withdrawal deal to control vaccine exports. However, this was later withdrawn.

In a statement the European Commission said: "To tackle the current lack of transparency of vaccine exports outside the EU, the Commission is putting in place a measure requiring that such exports are subject to an authorisation by Member States.

"In the process of finalisation of this measure, the Commission will ensure that the Ireland/Northern Ireland Protocol is unaffected. The Commission is not triggering the safeguard clause."

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