Pharmaceutical firm AstraZeneca has been forced to defend its COVID-19 vaccine's efficacy, following German media reports saying officials doubted if people aged above 65 would be safely protected from the disease.
On Monday, German newspapers Handelsblatt and Bild reported that the government approximated the AstraZeneca's COVID-19 vaccine's efficacy for people aged over 65 years and at only eight percent, compared to the rate for younger groups at 70 percent.
A Euronews report said the vaccine, which has been rolled out in numerous countries which include the United Kingdom, Brazil, Mexico, and India, "is expected to be approved" on Friday by the European regulator.
In a statement it released, the British firm said reports that the efficacy of its COVID-19 vaccine is as low as eight percent in adults whose age is above 65 years "are completely incorrect."
AstraZeneca's Claim
Countering the said media reports, AstraZeneca also said in its statement in the UK, the Joint Committee on Vaccination and Immunisation or JCVI backed "use in this population," and Medicines and Healthcare products Regulatory Agency or MHRA included this group without adjusting the dose in the "authorization for emergency supply."
In November, the company said, it published data in The Lancet showing that older adults exhibited strong immune responses to the vaccine, with 100 percent of older adults producing spike-specific antibodies following their second dose.
Meanwhile, the German Health ministry did not confirm the reports, although, in a Tuesday statement, it said, "two things have been confused."
Roughly eight percent of the subjects in the efficacy trial of AstraZeneca, the ministry explained, were from 56 to 69 years old, and about three to four percent were above 70 years, based on MHRA approval Public Assessment Report.
Limited Data Provided
The clinical test results, which came out in The Lancet journal in November last year, followed around 560 participants, including 160 individuals aged 56 to 69 years old and 240 participants whose ages are 70 years and above.
The trial found that the vaccination appears to be "better tolerated in older adults" than younger adults and that "immunogenicity was the same" across all age groups following a boost jab.
Further results were released in December, this time, following over 11,600 participants, confirmed that the AstraZeneca vaccine is 70.4 percent efficient at preventing the virus a fortnight after getting a second shot.
However, Gregor Waschinski, a Handelsblatt journalist, said via Twitter, unnamed media officials referred to in the German media reports claimed AstraZeneca has released "limited data for participants aged 65 and older."
The officials reportedly questioned, too, a seemingly "lack of older participants in the clinical tests," as well as a "rocky rolling review process."
Another Challenge for British Firm
Waschinski also said the assessment inside the German administration is taking into account the data essential to the EMA decision, which is different from the UK regulator MHRA released "when granting emergency use approval on December 30."
This is yet another challenge for AstraZeneca. It earlier drew Brussels' ire after it announced it would deliver fewer COVID-19 vaccine doses than promised in the first couple of weeks after it gets authorized for use.
On Monday evening, the Commission announced it is considering blocking exports of COVID-19 vaccine developed in the bloc to nations outside of it because of "lack of clarity and inefficient explanations" from the British pharmaceutical firm.
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