European Commission gives final approval to AstraZeneca Covid-19 vaccine amid distribution dispute

A vial and sryinge are seen in front of a displayed AstraZeneca logo in this illustration taken on January 11, 2021.
A vial and sryinge are seen in front of a displayed AstraZeneca logo in this illustration taken on January 11, 2021. © Dado Ruvic, REUTERS
9 min

The European Commission gave approval on Friday for the use in adults of the Covid-19 vaccine developed by AstraZeneca, the final step to allowing Europe to use it across the Union. It came amid criticism that the bloc is not moving fast enough to vaccinate its population.

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The European Medicines Agency's (EMA) expert committee unanimously recommended the vaccine to be used in people 18 and over, though concerns had been raised this week that not enough data exist to prove it works in older people, and some countries indicated they may not give it to the elderly.

The shot is the third Covid-19 vaccine given the green light by the European Medicines Agency after ones by Pfizer and Moderna.

With trials showing about 60 percent efficacy, the vaccine appears to offer less protection than ones already authorized, but experts have said any vaccine with an efficacy rate of over 50 percent could help stop outbreaks.

There were not yet enough results for people over the age of 55 to determine how well the vaccine would work for this group, EMA said. However, it said protection was expected and that the vaccine can be given to older people.

“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to combat the pandemic and protect their citizens,” said Emer Cooke, Executive Director of EMA.

Europe urgently needs more shots to speed up its inoculation programme with suppliers such as AstraZeneca and Pfizer facing difficulties in delivering the quantities promised for the early months of the year.

The AstraZeneca vaccine is administered via two injections into the arm, the second between four and 12 weeks after the first.

Germany's vaccine commission on Friday maintained its advice against using AstraZeneca's coronavirus vaccines on older people, despite the EU regulator's decision to authorise it for all adults in the bloc over 18 years old.

"Because of currently available data, the Covid-19 vaccine by AstraZeneca is recommended only for people aged 18 to 64 years old. The reason is because there is currently insufficient data on the effectiveness of the vaccines on people above 65 years old," said the commission known as STIKO.

Further vaccines expected

The EU's medicines watchdog said on Friday that it also expects Johnson & Johnson to submit an application for its coronavirus vaccine "shortly" after it published "promising" results from a large trial.

"We've just heard some promising results from the Janssen vaccine, which we hope to be submitted shortly to us," European Medicines Agency chief Emer Cooke told a press conference, referring to Johnson & Johnson's European subsidiary Janssen-Cilag.

"This is currently subject to a rolling review which precedes the formal marketing authorisation application submission," said Cooke.

The more vaccines available, the better, health authorities said.

If a vaccine demonstrates it is safe and efficient against the coronavirus, European Health authorities must at least review its possible use, Alain Fischer, the immunologist coordinating France's vaccination strategy, said on Friday.

Fischer made the comments on BFM television after being asked about Hungary agreeing to buy doses of Chinese firm Sinopharm's vaccine.

EU and drugmaker tension

The approval of the AstraZenica vaccine comes amid tensions between the drug maker and the European Union, which agreed Friday to make public a heavily redacted version of their coronavirus vaccine agreement, which lies at the heart of a dispute over how many shots the pharmaceutical company should be supplying the EU's 27 nations.

The contract, agreed to last year by the European Commission and the drugmaker, allows the EU’s member countries to buy 300 million doses of the AstraZeneca vaccine, with an option for a further 100 million doses. It’s one of several contracts the EU’s executive branch has with vaccine makers to secure a total of more than two billion shots.

As part of the “advanced purchase agreement" with vaccine companies, the EU has invested €336 million ($408 million) to finance the production of AstraZeneca vaccines at four factories.

But the EU lashed out at the British-Swedish drugmaker this week after it said it would not be able to deliver the 80 million doses that it hoped to provide initially and could only supply 31 million. Brussels claimed AstraZeneca would supply even less than that, just one quarter of the doses due between January and March, and as a result member countries began to complain.

The European Commission, which is the EU's executive arm, is concerned that doses meant for Europe might have been diverted from an AstraZeneca plant on the continent to the United Kingdom, where two other company sites are located. The EU also wants doses at two sites in Britain to be made available to European citizens.

AstraZeneca CEO Pascal Soriot told Germany's Die Welt newspaper this week that the UK government helped create the vaccine, since it was developed with Oxford University, and signed its contract three months before the EU did. Soriot said that under the British contract, vaccines produced at UK sites must go to the UK first.

The “advanced purchasing agreement” with the EU was signed in August, before the Oxford-AstraZeneca vaccine had been properly tested.

Much of the 41-page document made public was blacked out, making it very difficult to establish which side is in the right. Details about the price of the vaccine were notably redacted. The UK is thought to be paying far more for the vaccine than EU countries.

An EU official said 95 percent of the blackened text is a result of requests from AstraZeneca.

Asked about details concerning the heart of the row – exactly how many doses were promised to be delivered to the EU and when – European Commission spokesman Eric Mamer said: “We cannot give you the numbers, they have been redacted from the contract.”

To the uninitiated, the contract is not easily understood. However, it is laden with references to a “Best Reasonable Effort” being made on items like deliveries and volumes, given the uncertainty surrounding the development of the vaccine when it was drafted.

AstraZeneca might say only it can decide whether it’s doing its best, but the EU argues that this is a legal term and that only a judge can decide whether the company has made a “Best Reasonable Effort”, meaning the truth of the matter might lay in the hands of the two sides' lawyers.

To head off further such disputes and allay fears that vaccines might be diverted, the Commission will present plans later Friday to tighten rules on the exports of shots produced in the 27 EU countries.

The proposed “vaccine export transparency mechanism″ would be used to block shipments to non-EU countries and ensure that any exporting company based in the EU first submits its plans to national authorities.

Customs agencies would be allowed to check the plans before the Commission gives its authorisation or refusal.

“We want to put in place export licences to know what comes out of each production unit, where these doses go, and if some of them go outside the union even though they have been ordered by the EU,” EU Justice Commissioner Didier Reynders told broadcaster RTBF.

Humanitarian deliveries would not be affected by the new mechanism.

Delivery delays across the EU

In addition to the dispute with AstraZeneca, delays or production problems with the Pfizer-BioNTech vaccine have caused a political uproar across the EU.

Nearly two weeks after France extended its vaccine campaign to people over 75 years old, elderly residents in Paris are flocking to vaccination centres amid fears that daily injection rates will soon drop because of a vaccine shortfall.

In Italy, virus czar Domenico Arcuri blasted the delivery delays, which he said had so far deprived the country of 300,000 doses and drastically slowed down its campaign to inoculate older adults.

Arcuri said drugmaker Moderna had joined Pfizer and AstraZeneca in announcing delays, saying the pharmaceutical company had advised the Italian government of a 20 percent cut in planned deliveries of the Moderna vaccine the week of February 8.

“A vaccine is not a soft drink or a snack,” Arcuri said. “With all due respect to soft drinks and snacks, the vaccine is the only antidote to get out of this [dark] night that has lasted a year.”

(FRANCE 24 with AFP, AP, REUTERS)

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