AstraZeneca’s COVID-19 vaccine should only be administered to people between the ages of 18 and 64, recommended the vaccine committee in Germany, the day before European regulators decided to approve the pharmaceutical vaccine.
The recommendation for Germany comes at a time when the European Union, which is fighting for vaccine supplies, has alerted AstraZeneca to deliver the vaccines as promised, despite a drop in first quarter vaccine production caused by a chain failure European supply chain.
“Currently, there is not enough data available to assess the vaccine’s effectiveness from the age of 65,” said the German committee, also known as STIKO, in a draft recommendation made available by the German Ministry of Health on Thursday.
The European Union approved a vaccine developed by Pfizer and its German partner BioNTech in late December and gave the green light to an injection made by Moderna in early January, both based on so-called mRNA technology.
The bloc’s drug regulator, the European Medicines Agency (EMA), is due to issue a recommendation on the AstraZeneca vaccine, co-developed by the University of Oxford, on Friday.
STIKO said that, in addition to the age warning for the AstraZeneca product, all three were equally suitable for use.
His assessment was based on the same trial data published by the medical journal The Lancet on December 8.
‘Strong antibody production’ in the elderly
On Monday, the drugmaker denied that the COVID-19 vaccine is not very effective for people over 65, after German media reports say authorities fear the vaccine may not be approved in the European Union for use in the elderly. .
A person with knowledge of EMA regulatory procedures said that the watchdog – although set to declare a positive risk-benefit balance in general – is likely to point to a lack of data on the elderly and leave it to Member States to decide whether to omit or include this demographic group in their immunization campaigns for now.
“I don’t think there will be age restrictions,” said the source.
Only 5.7 percent of the 11,636 study participants included in the analysis were 65 or older, according to data released by STIKO.
In the older cohort, one of 341 vaccinated people and one in a control group of 319 people without the vaccine were infected with the coronavirus, making a statistically reliable conclusion impossible.
AstraZeneca Chief Executive Pascal Soriot said the company had less data on the elderly than other pharmaceutical companies because it started vaccinating the elderly later.
“But we have solid data showing very strong antibody production against the virus in the elderly, similar to what we see in younger people,” he told the newspaper Die Welt in an interview earlier this week, referring to blood tests.
AstraZeneca said on Thursday that the latest analysis of clinical trial data supports effectiveness in people over 65.
“We look forward to a regulatory decision on the vaccine by the EMA in the coming days,” he added.
“Very comforting” immune responses
Pfizer and partner BioNTech also announced delays in EU deliveries in recent weeks, and German Health Minister Jens Spahn warned that the shortage would last until April.
Spahn said there were younger age groups with existing conditions that were waiting to be vaccinated, adding that the final recommendation on using the AstraZeneca injection would only come after EU approval.
Like those over 80 and people living in nursing homes, Germany is prioritizing first-rate medical and health care staff.
In late December, the United Kingdom became the first country to approve the AstraZeneca vaccine.
The government said at the time that it would not recommend one vaccine instead of another for different population cohorts, although data on the effectiveness of the AstraZeneca injection in the elderly are currently limited.
The UK’s leading public health agency said on Thursday it still supports that decision.
Although there were very few cases of infection seen in the final stage tests, previous blood tests on immune responses were “very comforting”.
He started launching the vaccine in January, in a campaign that targeted older people and saw more than seven million receive their first dose.
The UK has also used the vaccine developed by Pfizer and BioNTech.