Pharma giant AstraZeneca could face strict new export rules from the European Union that could restrict supply of its Covid-19 vaccine outside the bloc, as officials pressure the company to explain production shortfalls, while the company denies claims in German media that its vaccine is mostly ineffective in seniors.
Citing government sources, two German papers reported Monday that the efficacy of the vaccine AstraZeneca developed with the University of Oxford was “less than 10%” and 8% in those over 65.
AstraZeneca said the claims are “completely incorrect” and go against published data from its clinical trials which showed a significant response in over-65s..
Oxford University , which developed the vaccine with AstraZeneca, told the Financial Times there is “no basis for the claims of very low efficacy.”
The German health ministry also rejected the reports Tuesday, suggesting that the newspapers had got confused with the statistics.
The confusion comes as tensions between AstraZeneca and the European Union soar to new levels, with the bloc furious at the company’s apparent inability or refusal to explain why it cannot honor its agreements and threatening to introduce new export rules for vaccines leaving the Union.
Forbes has contacted AstraZeneca to find out whether its supply chain issues and export rules could threaten vaccine supply to other parts of the world.
On Friday, AstraZeneca informed Brussels that production issues meant it would be unable to honor its contractual commitments to provide doses to the EU. The vaccine is expected to be approved shortly and the delays mark another setback for the bloc’s vaccination efforts, which are already being hampered by a temporary reduction in deliveries from Pfizer while it makes changes to its production site.
The EU stopped short of directly accusing AstraZeneca of reneging on its contracts in order to sell doses elsewhere, but said: “The European Union 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,” Stella Kyriakides, the European Commissioner for Health and Food Safety, said in a statement. Later, Kyriakides tweeted that discussions with the pharma giant “resulted in dissatisfaction” and there was a “lack of clarity and insufficient explanations.”
What To Watch For
The EU may follow through on its threat to implement new vaccine export rules. This would require companies to seek permission before exporting internationally.
31 million. This is how many doses the bloc is now expecting before the end of March, an EU official told Reuters. That amounts to a 60% cut.
Enraged at AstraZeneca over shortfall, EU calls for vaccine export controls (Politico)
AstraZeneca: German reports on low efficacy on over-65s ‘completely incorrect’ (DW)
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