AstraZeneca delivers to EU, deal with vaccine efficacy for the aged
A laboratory technician takes care of vials with the Covid-19 vaccine from Oxford University.
VINCENZO PINTO | AFP | Getty Images
British-Swedish drug maker AstraZeneca is fighting on several fronts this week. He is defending his coronavirus vaccine against reports that it may be less effective at protecting the elderly and facing mounting tensions with the EU over its late supply to the bloc.
On Monday, the drug maker defended its vaccine against reports in several German newspapers, Bild and Handelsblatt that the AstraZeneca vaccine, made in partnership with Oxford University, had a low rate of effectiveness (less than 10% and 8% of the newspapers said respectively) in the 65 and over are the primary target for the vaccine as they are at greater risk of serious illness and death.
Both cited nameless officials in the German government as saying that the vaccine has a poor rate of effectiveness in people over 65 and that this could have an impact on whether the vaccine is approved for use in the elderly.
AstraZeneca responded in a statement Monday evening: “Reports that the effectiveness of the AstraZeneca / Oxford vaccine is only 8% in adults over 65 years of age are completely false.”
“In November, we published data in The Lancet showing that older adults had a strong immune response to the vaccine, with 100% of older adults producing spike-specific antibodies after the second dose,” he added.
The UK’s Joint Committee on Vaccination and Immunization, which is advising the government on its vaccination strategy, had supported the use of the vaccine in the elderly. It was also said that blood tests of older study participants showed strong immune responses to the vaccine.
Older study participants were later admitted to Phase 3 clinical trials of the AstraZeneca vaccine, which took place in the UK and Brazil, and earlier in South Africa. Therefore, there is less data on the effectiveness of the shot in those over 65. Initial studies in the UK focused on those under 55 to see if the vaccine was effective for the majority of healthcare workers.
When AstraZeneca published its study results in the medical journal The Lancet in December, it said: “As older age groups were recruited later than younger, there was less time to record cases and, as a result, data on effectiveness in these cohorts are currently limited by the low number limited of cases, but additional data will be available in future analysis. “CNBC approached AstraZeneca for comment following the reports.
Tension has been brewing since last week when the drug maker announced that manufacturing problems would mean it would deliver far fewer doses to the EU than previously promised. The vast majority of AstraZeneca vaccine for distribution to the EU is made in the UK
According to a senior nameless official who spoke to Reuters last Friday, the EU should receive 80 million doses of the AstraZeneca vaccine by March, but the drug maker had informed the EU that the supply of doses would be reduced to around 31 million doses would be a cut of around 60%.
“This new schedule is not acceptable to the European Union,” said EU Health Commissioner Stella Kyriakides in a statement on Monday, signaling that the EU could tighten regulations on the export of Covid-19 vaccines.
“The European Union will take all necessary measures to protect its citizens and rights,” she said after previously declaring that “in the future, all companies that manufacture vaccines against Covid-19 in the EU must be notified in good time whenever they want to export vaccines to third countries. “
Any restrictions on vaccine exports from the EU could affect the delivery of the Belgian-made Pfizer / BioNTech shot to the UK
Commissioner Kyriakides said on Monday that talks with AstraZeneca representatives “have led to dissatisfaction with the ambiguity and inadequate explanations”.
She added: “EU member states agree: vaccine developers have social and contractual responsibilities that they must adhere to.” The EU asked AstraZeneca to provide a detailed plan for vaccine delivery and distribution timing. Further discussions are scheduled for Wednesday.
AstraZeneca’s vaccine has not yet been approved by the European Medicines Agency, but Kyriakdes said it could be by the end of the week.
Concerns about AstraZeneca’s shipments add to concerns from Pfizer and BioNTech, who also warned of temporary production cuts in mid-January while upgrading their production capacity.
Supply shortages are a severe blow to the EU, whose vaccination campaign began later (on December 27th) than in the UK and the US
The EU has bought vaccines as a block (although some countries have also made their own unilateral agreements), with shots being distributed based on population size, but vaccine launches by individual countries, including Germany, have been very slow so far.