BRUSSELS (AP) – Amid a dispute over expected deficits, the European Union is looking for legal ways to ensure delivery of all doses of the COVID-19 vaccine it has purchased from AstraZeneca and other pharmaceuticals, as regulators should consider approval of the company’s Anglo-Swedish vaccine for use in the 27 EU countries.
The European Medicines Agency is due to authorize on Friday the use of the AstraZeneca vaccine developed with the University of Oxford. It would be the third one released for use in the EU, after the BioNTech-Pfizer and Moderna vaccines.
However, officials in Brussels argued with AstraZeneca after the pharmaceutical company said it would deliver smaller-than-expected supplies to EU member countries. The bloc’s executive committee asked the Belgian authorities to inspect a factory in Belgium that is part of AstraZeneca’s vaccine production chain.
To increase uncertainty, a draft recommendation by a German expert committee called for the Oxford-AstraZeneca vaccine to be offered only to people under 65 for the time being.
European authorities are under pressure after a slow start to the EU’s vaccination campaign in its first month, and AstraZeneca serum would add much-needed extra supplies.
In response to a letter he received from four European government leaders, EU Council President Charles Michel said the EU “must explore all options and make use of all legal means and enforcement measures at our disposal. “, if the negotiations with the pharmaceutical companies do not satisfy income.
The EU is at odds with AstraZeneca over expected delivery delays. AstraZeneca said last week that it plans to cut initial deliveries in the EU from the 80 million doses scheduled for the first quarter of the year to 31 million doses. The company cited low yields from its factories in Europe, but the EU suspects that the doses produced in Europe were directed elsewhere.
Michel said the EU could invoke an article from one of its treaties that allows members to take action “if serious difficulties arise in the supply of a particular product”.
Michel wrote that the use of Article 122 “would give the EU and Member States the legal means, by taking appropriate urgent measures, to ensure the effective production and supply of vaccines for our population. I believe that this solution would demonstrate the strength and reliability of the EU in protecting the health of its citizens, above all other considerations. “
The European Commission also plans new rules to strengthen the control of vaccine exports to ensure that the doses purchased are delivered to residents of the bloc.
In Germany, the draft recommendation added a question mark on the extent of its use – although the country’s health minister emphasized that the final decision will not be taken before the EMA meeting on Friday.
Germany’s vaccination advisory committee, an independent panel advising the government, has asked for the use of the AstraZeneca vaccine for the 18- to 64-year-old age group based on currently available information. He said that “there is currently insufficient data to assess the effectiveness of vaccination from age 65”.
AstraZeneca said after the German draft was released on Thursday that “the latest analysis of clinical trial data for the AstraZeneca / Oxford COVID-19 vaccine supports effectiveness in the age group over 65.” He added that he is awaiting the decision of the EMA.
The company noted earlier this week that British regulators supported its use in the older age group, despite the lack of data on the effectiveness of the final stage. He pointed to earlier stage data published in Lancet in November “demonstrating that older adults showed strong immune responses to the vaccine, with 100% of older adults generating specific antibodies to spike after the second dose.”
But doubts remain about how well the vaccine protects the elderly. Only 12% of AstraZeneca’s survey participants were over 55 and were enrolled later, so there was not enough time to see if they fell ill at a lower rate than those who did not get the vaccine.
German Health Minister Jens Spahn said there had been a discussion about the lack of data on the issue since the fall, but it was still unclear “how concretely” it would affect the authorities’ decisions.
AstraZeneca said Thursday that the latest analysis of clinical trial data “supports effectiveness in the age group over 65” and awaits the decision of the EMA.
The EU, which has 450 million inhabitants, has signed agreements for six different vaccines. In total, he ordered up to 400 million doses of the AstraZeneca vaccine and closed deals with other companies for more than 2 billion vaccines.
The inspection requested by the European Commission on the production of the factory of the manufacturer Novasep in Seneffe, Belgium, has already been carried out and the data collected will be analyzed in the coming days, said the Belgian authorities.
The EU said the Belgian plant is one of four AstraZeneca sites included in the contract sealed by the Commission and the company to produce vaccines for the EU market.
Stella Kyriakides, the European commissioner for health and food safety, said that AstraZeneca should supply vaccines from its UK facilities if it is unable to fulfill its EU plant commitments. Kyriakides also made it clear that the EU would find out if some of the doses made in the EU were diverted elsewhere.
The company’s CEO, Pascal Soriot, argued in an interview with the newspaper Die Welt this week that the UK government helped develop the vaccine and signed its contract three months before the EU reached an agreement. He said the contract with the British authorities specifies that vaccines produced in UK units must go to the UK first.
However, the Commission said it remains confident that AstraZeneca’s delay will not affect its plans to ensure that at least 80% of EU citizens over 80 are vaccinated by March. Health policy spokesman Stefan de Keersmaecker said the target is based on the availability of doses manufactured by Pfizer-BioNTech and Moderna.
“It is an ambitious goal, but we believe it is realistic,” he said.
More than 400,000 EU residents with COVID-19 have died since the pandemic began.
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Moulson reported from Berlin. Danica Kirka in London and Sylvain Plazy in Brussels contributed to this story.
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