BRUSSELS (AP) – Amid a dispute over expected shortages, the European Union is looking at legal ways to guarantee the delivery of all the COVID-19 vaccine doses it has purchased from AstraZeneca and other drug manufacturers, as regulators consider approving the English-Swedish. company’s vaccine for use in the EU of 27 countries.
The European Medicines Agency is expected to give permission on Friday for the use of the vaccine that AstraZeneca has developed with the University of Oxford. It would be the third to be cleared for use in the EU, after the BioNTech-Pfizer and Moderna vaccinations.
However, officials in Brussels argued with AstraZeneca after the pharmaceutical company said it would supply smaller than expected supplies to EU member states. The bloc’s executive commission has asked Belgian authorities to inspect a plant in Belgium that is part of AstraZeneca’s vaccine production chain.
In addition to the uncertainty, a draft recommendation from a German expert committee requested that the Oxford-AstraZeneca vaccine be offered to people under 65 only for the time being.
European authorities are under pressure after a slow start to the EU vaccination campaign in the first month, and the AstraZeneca serum would add much-needed extra supplies.
In a reply to a letter he received from four European heads of government, Charles EU President Charles Michel stated that the EU “must explore all options and make use of all legal means and enforcement measures at our disposal” if negotiations with drug companies do not. yield satisfaction.
The EU is at odds with AstraZeneca over expected delays in deliveries. AstraZeneca said last week that it plans to reduce initial deliveries in the EU from the scheduled dose of 80 million for the first quarter of the year to 31 million doses. The company quoted the yields of its factory plants in Europe, but the EU suspects that doses produced in Europe are directed elsewhere.
Michel said the EU could invoke an article from one of its treaties allowing members to take action “if serious problems arise with the supply of certain products.”
Michel wrote that the use of Article 122 “would give the EU and the member states the legal means by taking appropriate urgent measures to ensure effective production and supply of vaccines for our population. I believe that this solution will demonstrate the EU’s strength and reliability to protect citizens’ health above and beyond other considerations. ”
The European Commission also plans to strengthen new rules that strengthen the control of vaccine exports to ensure that the doses it buys are delivered to the residents of the block.
In Germany, the draft recommendation added a question mark over how widely it could be used – although the country’s health minister stressed that a final decision would only be taken after Friday’s EMA meeting.
Germany’s vaccination advisory committee, an independent panel advising the government, has asked to use AstraZeneca’s vaccine for the 18-64 age group based on the available information. It is said that “there are currently insufficient data to determine vaccination effectiveness from age 65.”
AstraZeneca said after Thursday’s announcement of the German draft that “the latest clinical trial analyzes for the AstraZeneca / Oxford COVID-19 vaccine support efficacy in the age group of over 65 years.” It added that it was awaiting the EMA’s decision.
The company noted earlier this week that UK regulators support its use in the older age group despite the lack of effectiveness data in the late stages. It pointed to earlier data published in the November issue of the journal Lancet “showing that older adults show strong immune responses to the vaccine, while 100% of older adults generate a specific antibody after the second dose.”
But there are still questions about how well the vaccine protects older people. Only 12% of AstraZeneca research participants were older than 55 and they were enrolled later, so there was not enough time to see if they got sick at a lower dose than those who did not get the vaccine.
German health minister Jens Spahn said there had been a lack of data on the subject since the autumn, but it was not yet clear “how concrete” it would ultimately affect the authorities’ decisions.
AstraZeneca said on Thursday that the latest analyzes of clinical trial data support ‘efficacy in the age group over 65’ and that it is awaiting the EMA’s decision.
The EU, which has 450 million people, has negotiated for six different vaccines. In total, it has ordered up to 400 million doses of the AstraZeneca vaccine and closed deals with other companies for more than 2 billion shots.
The inspection requested by the European Commission for production at Novasep’s plant in Seneffe, Belgium, and the data collected will be analyzed in the coming days, Belgian authorities said.
The EU said the Belgian plant was one of four AstraZeneca sites included in the contract concluded by the Commission and the company to manufacture vaccines for the EU market.
Stella Kyriakides, the European Commissioner for Health and Food Safety, said AstraZeneca should supply vaccines from its UK facilities if it is unable to meet the obligations of factories in the EU. Kyriakides has also made it clear that the EU will find out whether some of the doses produced in the EU will be diverted elsewhere.
The company’s CEO Pascal Soriot said in an interview with the newspaper Die Welt this week that the British government had helped develop the vaccine and signed his contract three months before the EU reached its agreement. He said the contract with the UK authorities stipulated that vaccines produced on UK websites should first go to the UK.
However, the Commission said it was confident that the delay in AstraZeneca would not affect its plans to ensure that at least 80% of EU citizens over the age of 80 were vaccinated by March. Health policy spokesman Stefan de Keersmaecker said the target was based on the availability of doses manufactured by Pfizer-BioNTech and Moderna.
“It’s an ambitious target, but we believe it’s a realistic goal,” he said.
More than 400,000 EU citizens with COVID-19 have died since the start of the pandemic.
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Moulson from Berlin reported. Danica Kirka in London and Sylvain Plazy in Brussels contributed to this story.
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