AstraZeneca provides to EU, vaccine efficacy for the aged in focus

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 battles on multiple fronts this week – defends its coronavirus vaccine against reports it may be less effective at protecting the elderly and faces 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 Over 65s are the primary target for the vaccine as they are at greater risk of serious illness and death.

Both quoted unnamed German government officials as saying that the vaccine has a poor rate of effectiveness in people over 65 and that this could affect 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 United Kingdom’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, efficacy data in these cohorts are currently limited by the low number limited of cases, but additional data will be available in future analysis. “CNBC asked AstraZeneca for comment following the reports.

On Tuesday morning, the German Ministry of Health announced that there is no data to suggest that AstraZeneca’s vaccine is only 8% effective in the elderly, Reuters reported.

Supply problems

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

The EU should receive 80 million doses of the AstraZeneca vaccine by March. According to a senior nameless official who spoke to Reuters last Friday, However, the drug manufacturer had told the EU that the range of doses would be reduced to around 31 million doses, a cut of around 60%.

“This new schedule is not acceptable for the European Union,” said EU Health Commissioner Stella Kyriakides said in a statement MondayThis signals 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 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 has asked AstraZeneca to provide a detailed plan for vaccine delivery and timing of distribution. 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 Also warned of temporarily reduced production in mid-January while they improved their production capacity.

Supply shortages are a severe blow to the EU, whose vaccination campaign began later (on December 27th) than in Great Britain and the USA

The EU has bought vaccines as a block (although some countries have also made their own unilateral agreements), with the shots being distributed based on population size, but individual country vaccination introductions. in Germany too have been very sluggish so far.