AstraZeneca’s COVID-19 vaccine should only be given to people between the ages of 18 and 64, the German Vaccine Commission has recommended, one day before European regulators’ decision on whether or not to approve the medicine man’s injection.
The recommendation for Germany now comes as the European Union, which is seeking vaccine supplies, warned AstraZeneca to deliver injections as promised, despite a shortage in vaccine production in the first quarter due to a malfunction in the European supply chain.
“There is currently insufficient data available to assess the efficacy of the vaccine from the age of 65,” said the German Commission, also known as STIKO, in a draft recommendation made available to the German Ministry of Health on Thursday.
The European Union approved a vaccine developed by Pfizer and its German partner BioNTech at the end of December and gave the green light for an injection of Moderna, both based on the so-called mRNA technology, in early January.
The block’s regulator of drugs, the European Medicines Agency (EMA), will make a recommendation Friday on AstraZeneca’s vaccine, co-developed by Oxford University.
STIKO said that, aside from the age requirement for the AstraZeneca product, all three were equally suitable for use.
The review was based on the same research data published Dec. 8 by the medical journal The Lancet.
‘Strong antibody production’ in the elderly
On Monday, the drug company denied that its COVID-19 vaccine is not very effective for people over 65, after German media reported that officials fear the vaccine may not be approved in the European Union for use in the elderly.
A person with knowledge of the EMA’s regulatory procedures said the watchdog – while generally wanting to cite a positive risk-benefit ratio – will likely point to a lack of data on older people and leave it up to Member States to decide whether to omit them or record. that demographics in their immunization campaigns for now.
“I don’t think there will be any restrictions by age group,” the source said.
Only 5.7 percent of the 11,636 trial participants included in the analysis were 65 years of age or older, data released by STIKO found.
Within the older cohort, one of the 341 vaccinated people and one of a control group of 319 people without a vaccine became 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 drug makers because it later started vaccinating the elderly.
“But we have strong data showing very strong production of antibodies to the virus in the elderly, similar to what we see in younger people,” he said in an interview with Die Welt earlier this week, referring to blood analysis.
AstraZeneca said Thursday that the latest analyzes of clinical trial data support efficacy in people over 65.
“We are waiting for a regulatory decision on the vaccine by the EMA in the coming days,” it added.
“Very reassuring” immune responses
Pfizer and partner BioNTech have also announced delays for EU deliveries in recent weeks, and German Health Minister Jens Spahn warned that shortages would last well into April.
Spahn said there were younger age groups with pre-existing conditions waiting to be vaccinated, adding that the final recommendation on the use of the AstraZeneca shot would come after EU approval.
In addition to people over 80 and people living in retirement homes, Germany gives priority to first-line medical and care workers.
At the end of December, the UK became the first country to approve the AstraZeneca vaccine.
The government said at the time that it would not recommend one vaccine over another for different cohorts of the population, although data on the effectiveness of the AstraZeneca shot in the elderly is currently limited.
The UK’s main public health authority said on Thursday that it still supported that decision.
Although too few cases of infection were seen in late stage studies, prior blood analysis of immune responses was “very reassuring.”
It began rolling out the vaccine in January in a campaign targeting older people, with more than seven million people getting their first dose.
The UK also uses the vaccine developed by Pfizer and BioNTech.