AstraZeneca has been forced to defend the efficacy of its COVID-19 vaccine after German media reports said officials had doubts it could safely protect people over the age of 65.
German newspapers Handelsblatt and Bild said on Monday that the government estimated the efficacy of AstraZeneca vaccine for over-65s at just eight per cent, compared to a 70 per cent rate for younger groups.
The vaccine, which has been rolled out in multiple countries including the UK, Brazil, Mexico and India, is expected to be approved by the European regulator on Friday.
The British company said in a statement that “reports that the AstraZeneca/Oxford vaccine efficacy is as low as 8% in adults over 65 are completely incorrect.”
“In the UK, the JCVI [Joint Committee on Vaccination and Immunisation] supported use in this population and MHRA [Medicines and Healthcare products Regulatory Agency] included this group without dose adjustment in the authorisation for emergency supply.
“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.
The results of the clinical trial released in The Lancet journal in November tracked 560 participants, including 160 aged 56-69 and 240 aged 70 years and older.
It found that the jab “appears to be better tolerated in older adults than in younger adults” and that “immunogenicity was similar across all age groups after a boost vaccination”.
Further results published in December, this time tracking more than 11,600 participants, confirmed that the vaccine is 70.4 per cent effective at preventing COVID-19 a fortnight after receiving a second dose. The study has since been extended to include tens of thousands more participants.
But unnamed media officials cited in the German media reports said that AstraZeneca has provided “limited data for participants aged 65 and older,” Handelsblatt journalist Gregor Waschinski said on Twitter.
They also questioned “an apparent lack of older participants in the clinical trials” and a “rocky rolling review process”.
“The assessment inside the German government takes into account the data relevant to the EMA decision which is NOT the same data the UK regulator MHRA published when granting emergency use approval on Dec 30,” Waschinski added.
The controversy comes at an already tricky time for AstraZeneca which has drawn the ire of Brussels after announcing it would deliver fewer doses than promised in the first few weeks after it is authorised for use.
The Commission announced on Monday evening that it is considering blocking exports of COVID-19 vaccine manufactured in the bloc to countries outside of it due “to the lack of clarity and insufficient explanations” from AstraZeneca.