Vaccine from AstraZeneca and Oxford University: It is already approved in the UK
Photo: JASON CAIRNDUFF / REUTERS
Shortly before a possible approval of the corona vaccine from AstraZeneca and the University of Oxford, new bad news about the vaccine is circulating.
First the company had to admit that instead of 80 million vaccine doses it could only deliver 31 million doses to the European Union by the end of March.
Now the "Handelsblatt" reported, citing government circles, that the vector vaccine was only eight percent effective in people over 65 years of age.
The "Bild" newspaper also stated, citing government circles, that the vaccine should only receive approval from the European Medicines Agency (EMA) for people under the age of 65.
Germany would have to rethink its strategy of vaccinating the very old first for the product.
It is possible that the vaccine could be given primarily to medical personnel, who are also in the group with the highest priority.
Alternatively, people over 60 could receive the vaccination early instead of people over 80.
However, it is still unclear what is behind the reports by »Handelsblatt« and »Bild«.
AstraZeneca rejects the information: "Reports that the effectiveness of the vaccine from AstraZeneca / Oxford is only eight percent in adults over 65 years of age are completely wrong," the company said.
The federal government suspects an interpretation error in study data in the »Handelsblatt«, but there are also inconsistencies.
Studies show immune responses in very old people
In fact, no data has yet been made public to support the media report.
The data on the effectiveness of the AstraZeneca / Uni Oxford vaccine in the very old in the phase III study, which is crucial for approval, is thin.
But that doesn't mean that the vaccine is nearly ineffective for them.
In an interim evaluation, AstraZeneca published the data of 11,636 test subjects who had either been treated with the vaccine or an ineffective placebo in the specialist magazine “The Lancet” at the beginning of December 2020.
Depending on the vaccination schedule, it was found to be around 60 to 90 percent effective.
On average, AstraZeneca stated an effectiveness of 70 percent.
However, the majority of the subjects in these studies were no more than 55 years old.
Only a small subgroup, about eight percent, comprised people between the ages of 56 and 69.
An even smaller proportion of the test subjects, just under four percent, were people over the age of 70.
There was some criticism of that.
In a previous study, AstraZeneca had at least examined the immune response of older people to the vaccination.
Among 320 subjects over 56 years of age who had received the vaccine, all developed antibodies against the spike protein of the coronavirus, as planned, after the second vaccination.
There were also 200 people in the group who were 70 years of age or older.
Is it all just a misunderstanding?
Based on the numbers in the studies, users on Twitter speculated after a short time on Tuesday that the “Handelsblatt” report could be a misunderstanding.
The federal government shares this assessment: "At first glance it seems that two things were confused in the reports," said the Federal Ministry of Health, referring to the AstraZeneca study from December.
"Around eight percent of the subjects in the AstraZeneca effectiveness study were between 56 and 69 years of age, only three to four percent over 70 years," according to the ministry.
From this, however, an effectiveness of only eight percent in older people cannot be derived.
Why the "Handelsblatt" and the "Bild" name an age limit of 65 remains unclear and raises doubts as to whether the study was actually misinterpreted.
Federal Minister of Health Jens Spahn said on ZDF on Tuesday that the EMA and the Standing Vaccination Commission at the Robert Koch Institute (RKI) are currently evaluating data, on the basis of which a decision will be made next week as to which age groups would be vaccinated first with the AstraZeneca product.
In every age group there are people with previous illnesses who are hoping for vaccinations.
It actually sounds like the AstraZeneca / Uni Oxford vaccine may not be approved for the very old.
The EMA is currently expected to recommend the active ingredient for approval in the EU on Friday.
The EU Commission then has the last word, but its decision is a matter of form.
Basically weaker immune response is conceivable
In principle, it would not be surprising if the vaccine protected older people from Covid-19 a little less reliably than younger subjects.
This is also the case with the vaccines from BioNTech / Pfizer and Moderna, but it is a matter of a few percentage points and not an almost loss of effectiveness.
The Moderna product prevents almost 96 percent of the disease in people between the ages of 18 and 65, while the figure is 86 percent in people over 65.
However, the exact information in the older group should be treated with caution, as it is based on only 33 cases, 29 of which occurred in the placebo group.
It is similar with the BioNTech / Pfizer vaccine: It also protects people between 16 and 55 years of age 96 percent from Covid-19, in older groups it is around 94 percent, although the database for the elderly is thin here too.
No reliable statement can be made for people over 75.
It is unlikely, however, that the vaccination will suddenly no longer have any effect there.
The WHO recommends that vaccines be approved in the pandemic with an effectiveness of 50 percent.
(Read here why vaccines with a comparatively low protective effect can also save lives.) In the largest study subgroup to date, the agent from AstraZeneca and the University of Oxford achieved an effectiveness of a good 60 percent.
However, mainly people up to 55 years of age were involved.
It is conceivable that the value for the very old is actually below the 50 percent mark.
However, in a smaller study in which instead of two full doses first half a dose and then a full dose were vaccinated, the vaccine had shown 90 percent effectiveness beforehand.
There would be more buffer up to the 50 percent limit.
How the EMA evaluates the data is still uncertain.
Greater effectiveness, stronger vaccination responses
The fact that older people sometimes develop a weaker immune response to vaccines also offers an advantage for vaccination: vaccination reactions such as headache, tiredness and fatigue as well as pain at the injection site, which may particularly affect the elderly, are less common for them.
That makes sense, because vaccination response and effectiveness are closely related.
Intermittent pain at the puncture site is a sign that the body is reacting to the vaccine and sending defense cells to the puncture site, which trigger inflammation and get the rest of the immune system going.
The stronger the immune response, the stronger the unpleasant but temporary vaccination reactions can be.
Ultimately, it is a matter of finding vaccines that strike a middle ground: They have to be effective with a reasonable level of vaccination reactions.
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