British-Swedish drugmaker AstraZeneca is fighting battles on several fronts this week — defending its coronavirus vaccine from reports that it could be less effective in protecting the elderly and facing increasing tensions with the EU over its delayed supplies to the bloc.
On Monday, the drugmaker defended its vaccine from reports in several German newspapers, Bild and Handelsblatt, that the AstraZeneca vaccine, created in conjunction with the University of Oxford, had a low efficacy rate (of less than 10% and 8%, the papers said, respectively) in the over-65s, the main target group for having the vaccine as they are more at risk of serious disease and death.
Both cited unnamed officials in Germany's government as saying that the vaccine had a poor efficacy rate among people aged over 65 and said this could affect whether the vaccine is authorized for use among the elderly.
AstraZeneca responded Monday evening, saying in a statement to CNBC: "Reports that the AstraZeneca/Oxford vaccine efficacy is as low as 8% in adults over 65 years are completely incorrect."
"In November, we published data in The Lancet demonstrating that older adults showed strong immune responses to the vaccine, with 100% of older adults generating spike-specific antibodies after the second dose," it added.
It said the U.K.'s Joint Committee on Vaccination and Immunisation, which advises the government on its vaccination strategy, had supported the vaccine's use in the elderly.
Elderly trial participants were admitted later to phase three clinical trials of the AstraZeneca vaccine, which took place in the U.K. and Brazil, and earlier on in South Africa, and so there is less available data on the efficacy of the shot in the over-65s. Initial trials in the U.K. focused on the under-55s to examine whether the vaccine was effective for the majority of healthcare workers.
When AstraZeneca published its trial findings in the medical journal The Lancet in December, it said, "as older age groups were recruited later than younger age groups, there has been less time for cases to accrue and as a result, efficacy data in these cohorts are currently limited by the small number of cases, but additional data will be available in future analyses." CNBC has contacted AstraZeneca for comment following the reports.
On Tuesday morning, the German health ministry said there is no data that would suggest an efficacy of only 8% among older people for AstraZeneca's vaccine, Reuters reported.
Tensions have been brewing since last week when the drugmaker announced that production issues would mean it would deliver far fewer doses to the EU than were promised previously. The vast majority of the AstraZeneca vaccine for distribution to the EU is being made in the U.K.
The EU was meant to receive 80 million doses of the AstraZeneca vaccine by March, according to a senior unnamed official who spoke to Reuters last Friday, but the drugmaker had informed the EU that the supply of doses would be reduced to some 31 million doses, a cut of around 60%.
"This new schedule is not acceptable to the European Union," EU's Health Commissioner Stella Kyriakides said in a statement Monday, signaling that the EU could tighten the rules on the exports of Covid-19 vaccines.
"The European Union will take any action required to protect its citizens and rights," she noted, having stated earlier that "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."
Any limitations on vaccine exports from the EU could affect supplies of the Pfizer/BioNTech shot, which is manufactured in Belgium, to the U.K.
Commissioner Kyriakides said on Monday that discussions with AstraZeneca representatives had "resulted in dissatisfaction with the lack of clarity and insufficient explanations."
She added that "EU Member States are united: vaccine developers have societal and contractual responsibilities they need to uphold." The EU has asked AstraZeneca to provide it with a detailed plan of vaccine deliveries and when distribution will take place, with further discussions set for Wednesday.
AstraZeneca's vaccine has not yet been approved for use by the European Medicines Agency but Kyriakdes said that could come by the end of the week.
The concern over AstraZeneca supplies comes on top of one from Pfizer and BioNTech who also warned in mid-January of temporarily reduced output while they upgraded their production capacity.
Shortages of supply are a bitter blow to the EU, whose vaccination drive already started (on Dec.27) later than those in the U.K. and U.S.
The EU has purchased vaccines as a bloc (although some countries have also pursued their own unilateral deals too) with shots set to be distributed based on population size, but individual countries' vaccination rollouts, including in Germany, have been very sluggish so far.