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ARCHIVED - Oxford-AstraZeneca covid vaccine approved for use in Spain
The European Medicines Agency (EMA) gave its approval on Friday
The approval comes in the midst of a row about the lack of supply being made available to the European Union.
On Friday the EMA, which is the EU's drugs regulator, gave its formal approval for the use of the Oxford-AstraZeneca Covid vaccine throughout the European Union.
Spain is part of the block buying group which is expecting to receive up to 400 million vaccines from AstraZeneca, and is depending on the outcome of feisty negotiations between the EU and the Anglo-Swedish drug-maker.
Last week the manufacturer said that up to 60% fewer doses than expected would be delivered to the EU during the first quarter of 2021. The EU has also received fewer than expected doses of the two other vaccines it has approved - from Pfizer-BioNTech and Moderna, leading to a shortage throughout the countries depending on these manufacturers in order to vaccinate their populations, amongst them Spain.
The European Medicines Agency (EMA) said the vaccine was about 60% effective in the trials on which it based its decision, and even though there have been questions about how well it works in people aged 65 and above, because there isn't as much data for that age group - fewer than 10% of the trial volunteers were in this age bracket, it is still sufficient evidence to suggest it works well in the more elderly members of the population for approval to be granted.
The dispute over whether AstraZeneca is breaking its vaccine delivery commitments to the EU has continued on Friday.
European Commission chief Ursula von der Leyen said in an interview with German radio on Friday morning that “"There are binding orders and the contract is crystal clear," making it absolutely plain that she will not back down and expects the manufacturer to deliver the vaccines as promised, based on the contract signed, even if this does mean diverting doses from its UK manufacturing plant to compensate for the manufacturing difficulties being experienced in Belgium. The company maintains that its other contractual obligations to the Uk for their vaccine roll-out, prevented this, but this point of view is being disputed by the EU, which is adamant that AstraZeneca's UK facilities are not back-up facilities; they are part of the main network, and are part of the overall supply chain for all of the vaccies in production; "This is not an option, it is a contractual obligation," they say.
On Friday afternoon the EU introduced controls on vaccines being made in the bloc in order to prevent their exportation to the UK via Northern Ireland by invoking Article 16 of the Northern Ireland protocol. The European Commission states: "This is justified as a safeguard measure pursuant to Article 16 of that Protocol in order to avert serious societal difficulties due to a lack of supply threatening to disturb the orderly implementation of the vaccination campaigns in the Member States."
DUP leader Arlene Foster described the move as "an incredible act of hostility" by the EU although this will not affect vaccine supply in Northern Ireland, which receives its vaccines from the UK. She said that the EU had “ placed a hard border between Northern Ireland and the Republic of Ireland”.
The EU has implemented mechanisms to prevent vaccines manufactured within the bloc leaving it, if the commitments made to the EU have not been fulfilled. The move also affects exports to countries such as Morocco, Algeria and Tunisia as well as Andorra.
UPDATE:However by Friday evening the EU had announced that it would not be implementing the measures as announced in order tnot to upset other partner nations which depend on the European supply chains.
The roll-out in Spain is a lot slower than had been anticipated and this week first vaccinations have been suspended in Madrid, Catalunya and other regions due to the shortage of doses. The Spanish authorities are insisting on applying both doses of the vaccines in order to guarantee the fullest degree of protection possible and have been allocating the small amount of stock being delivered to fulfilling second vaccinations, rather than continuing to vaccinate as many people as possible with a first vaccine.
This has caused a great deal of political argument this week, but the health ministry is concerned that the most vulnerable in society will be left without full protection if the two doses are not administered, and given the erratic supply of vaccines at the moment, has opted to complete as many vaccines as possible with the supplies available.
By Friday afternoon, Spain had only received a total of 1.7 million vaccines. 1,474,189 had been administered and the number of people who have received both doses is only 250,866 in total.
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