The EU regulator, the European Medicines Agency, is due to decide on approval of AstraZeneca's vaccine on 29 January, with a deal to purchase at least 300m doses.
AstraZeneca now expects to deliver 31 million doses due to “production problems” at a vaccine factory in Belgium although it has been reported that supplies to the UK would not be affected.
Stella Kyriakides has written to AstraZeneca, saying the EU “wants to see the return” of its investment in developing a vaccine.
The strongly-worded letter from Kyriakides says, “Last Friday, AstraZeneca surprisingly informed the Commission and Member States that it intends to supply considerably fewer doses in the coming weeks than agreed and announced. This new schedule is not acceptable to the European Union.”
She says AstraZeneca's vaccine is currently in the final stages of the approval process with the EMA and, if all requirements are met, the agency could recommend market authorisation by the end of this week.
But, she adds, “there is a problem on the supply side.”
The letter to the company, sent at the weekend, asks “important and serious questions.”
“It is of the utmost importance that these companies comply within the timeframe agreed with the Commission and do so with total transparency. Otherwise it would endanger the vaccination strategy of the Commission” Iratxe García Pérez, S&D leader
It says, “The European Union has pre-financed the development of the vaccine and the production and wants to see the return. The EU wants to know exactly which doses have been produced by AstraZeneca and where exactly so far and if or to whom they have been delivered.”
In a statement, she said the same questions were also discussed on Monday in the joint steering board of the Commission and Member States with AstraZeneca.
The commissioner said, “The answers of the company have not been satisfactory so far. That’s why a second meeting is scheduled.”
She said, “The EU wants the ordered and pre-financed doses to be delivered as soon as possible. And we want our contract to be fully fulfilled.”
“The European Union has supported the rapid development and production of several vaccines against COVID-19 with a total of €2.7 billion. We want clarity on transactions and full transparency concerning the export of vaccines from the EU.”
She goes on, “In the future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries. Humanitarian deliveries are of course not affected by this.”
She adds, “The EU will take any action required to protect its citizens and rights.”
“Last Friday, AstraZeneca surprisingly informed the Commission and Member States that it intends to supply considerably fewer doses in the coming weeks than agreed and announced. This new schedule is not acceptable to the European Union” Stella Kyriakides letter to AstraZeneca
The letter marks a strong riposte from the EU to severe criticism about its vaccine strategy, in particular the slow rollout compared with countries like the UK.
On Monday, the UK said it had vaccinated over 6.5m of its citizens.
The EU has so far approved vaccines from Moderna along with Pfizer and its German partner BioNTec.
The Commission says it has ordered 2.3 billion doses but it has come under fire for the slow rollout, and a report by the European Court of Auditors (ECA) said the COVID-19 pandemic has “tested the relatively limited” health powers of the EU.
The Socialists and Democrats group in Parliament have also urged AstraZeneca - and Pfizer - “to fulfil the obligations they engaged in when they signed the contract with the EU.”
Reacting to the news that their delivery of vaccines may be delayed, the leader of the S&D Group, Iratxe García Pérez, said, “It is of the utmost importance that these companies comply within the timeframe agreed with the Commission, and do so with total transparency. Otherwise it would endanger the vaccination strategy of the Commission, which aims to have 70 percent of the EU population vaccinated by the end of the summer.”
“There is still time, but the Commission must react with determination and force these companies to comply with the legal duties acquired, and a precise calendar.
“At the same time, I fully support the joint efforts by the Commission, Member States and the EMA to work with these and other pharmaceutical companies to maximise vaccine manufacturing capacity to speed up the vaccination process.”
“We must keep our unity and join forces to ensure that we can protect lives and get back to normality as soon as possible.”
Further comment came from the S&D environment committee coordinator, Jytte Guteland, who said, “There is no more time to waste. We expect all pharmaceutical companies to honour their contractual agreements with the EU without further delay.”
“The more time we wait, the more our citizens’ lives and our economy recovery are at risk. It is of the utmost importance for the health of our citizens that we have a wide and rapid distribution of vaccines.”
She added, “Europe must continue on the path of coordination and joint undertakings. The agreed contracts are vital to enable all EU countries to access vaccines in a manner of solidarity and fairness. Together we are stronger.”
“Nobody is really safe until everyone is safe.”