The announcement had the effect of a cold shower.
While the European Medicines Agency (EMA) is due to vote this week on AstraZeneca / Oxford's anti-Covid-19 vaccine, two German media have argued that its effectiveness is very low in seniors.
Information immediately denied by the Swedish-British laboratory, the University of Oxford and the German government.
Where do the data mentioned by journalists come from?
Was there any confusion?
We take stock.
The business daily Handelsblatt first assured Monday evening that “the German government expects the vaccine to be effective only in 8% of people over 65”.
A figure well below the overall efficacy of 70% in adults, reported by researchers in November.
Same story with the newspaper Bild, which headlined as follows: “No AstraZeneca homologation for seniors!
"
The two media claimed to have the information from government sources.
"This is not an academic pre-publication, but a (political) report that tries to shed light on the decision-making processes and the obstacles in the race for the Covid vaccine", will specify later on Twitter the author of the Handelsblatt article.
"Some make up stories"
The main parties very quickly denied the information.
The AstraZeneca / Oxford vaccine, already deployed in the UK, is eagerly awaited by European countries.
It has the advantage of being less expensive to produce than its rivals, while being easier to store and transport.
The University of Oxford said there was "no basis for very low efficacy claims."
Peer-reviewed publications "have shown similar immune responses in younger and older adults."
“In addition, preliminary efficacy data in the elderly supports the importance of this vaccine for use in this population.
"
Pascal Soriot, CEO of AstraZeneca, also told Le Figaro that the figure of 8% was “false”.
“Why did this statement come out?
I do not know.
Again, emotions are running high at the moment and some are making up stories.
Why?
Maybe there are local political considerations sometimes?
I can't say it, ”he said.
In Germany, the Ministry of Health strongly contradicted the information of the two media, citing an "error of interpretation of the data".
Confusion with the proportion of seniors in the study?
“At first glance, the articles appear to have confused two things”: the share of people “between 56 and 69 years old” who participated in the vaccine evaluation studies amounting to “around 8%” and their rate of effectiveness for those over 65, wrote the German authorities in a statement.
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AstraZeneca data published in the Lancet at the beginning of December indeed show a small representative percentage of people over 56 years old: around 12% for the 56-69 age group and around 8% for those over 70 years old. .
Was there any confusion between the demographic proportion and the effectiveness of the vaccine?
(Screenshot.) / The Lancet
Another hypothesis, raised by Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine: what if the 8% represented the lower limit of a "very wide confidence interval" calculated on a small sample of people?
"A very low efficiency value would be found, which would be misleading," he told the Science Media Center.
And to recall that "the randomized data on immunogenicity do not suggest that the efficacy of the Oxford-Astrazeneca vaccine will be notably lower at older ages".
The Handelsblatt reiterates its claims
Far from retracting once the controversy has started, the Handelsblatt reiterated its assertions in a new article, quoting "a senior official of the Ministry of Health": "It is impossible to mix the figures.
According to the data available to us, the effectiveness in people over 60 years of age is less than 10%, ”the latter allegedly told them.
The daily speaks of "new data" which would have been transmitted to the European Medicines Agency (EMA) because "the number of older participants was still too low" in the Lancet publication "to provide statistically significant data on the 'vaccine efficacy'.
"We have reported immunogenicity data showing similar immune responses after vaccination with two doses […] in older adults, […] compared to those under 55 years old," the researchers said in the study published by The Lancet, however acknowledging "limited data".
As the older groups “were recruited later than” the younger ones, “there was less time for cases to accumulate and, therefore, efficacy data in these cohorts are currently limited by the small number of cases, ”they explained, before ensuring that“ additional data ”would be available“ in future analyzes ”.
New data?
Did the German government sources cited by Handelsblatt and Bild have access to these “future analyzes”?
According to the British daily The Guardian, however, the EMA has not received "additional data", only "answers to questions on existing data".
Contacted by the Parisian, the European agency did not wish to comment, because "the vaccine is being evaluated by the scientific committee".
A scientific opinion could be issued by January 29, "provided that the data submitted on the quality, safety and efficacy of the vaccine is sufficiently robust and complete and that any additional information required to complete the assessment is submitted quickly, ”says the EMA.
"In the studies that have been carried out, in what has been published so far, only a very small number of elderly people were included," Emer Cooke, executive director of the EMA, told the European Parliament on Tuesday. .
“But our scientific committee will look at all of the data, looking at what it means in terms of populations studied and what can be reasonably expected in populations not yet studied,” she added without giving further details.