The AstraZeneca vaccination committee for COVID-19 should only be given to people between the ages of 18 and 64, the German vaccine committee recommended, a day before European regulators’ decision to approve the drugmaker’s shot.
The recommendation for Germany comes because the European Union, which is seeking vaccine supply, has warned AstraZeneca to deliver shots as promised, despite a shortage of its vaccine production in the first quarter, caused by a flaw in its European supply chain .
“There are currently insufficient data available to determine the efficacy of the vaccine from the age of 65,” the German committee, also known as STIKO, said in a draft recommendation made available by the German Ministry of Health on Thursday.
At the end of December, the European Union approved a vaccine developed by Pfizer and its German partner BioNTech, giving the green light to a survey made by Moderna in early January, both based on so-called mRNA technology.
The block’s drug regulator, the European Medicines Agency (EMA), is due to issue a recommendation on AstraZeneca’s vaccine, developed jointly by Oxford University, on Friday.
STIKO said that all three, apart from the age reservation for the AstraZeneca product, are equally suitable for use.
Its assessment was based on the same trial data published by the medical journal The Lancet on 8 December.
‘Strong antibody production’ in the elderly
On Monday, the drugmaker denied that the COVID-19 vaccine was not very effective for people over 65, after German media reports said officials feared the vaccine could not be approved in the European Union for use in the elderly.
A person with knowledge of the EMA’s regulatory procedures said that the watchdog, although it has a positive risk-benefit ratio in general, is likely to indicate a lack of data on the elderly and leave it to the member states. to decide if he will omit or include that demographic in their vaccination campaigns for now.
“I do not think there will be restrictions per age group,” the source said.
Only 5.7 percent of the 11,636 participants in the trial who were 65 years or older were according to data released by STIKO.
Within the older group, one in 341 vaccinated and one in a control group of 319 people without the vaccine became infected with the coronavirus, making a statistically reliable conclusion impossible.
AstraZeneca CEO Pascal Soriot said the company has less information than other drug manufacturers about the elderly because it is starting to vaccinate older people.
“But we have strong data showing very strong antibody production against the virus in the elderly, similar to what we see in younger people,” he said in an interview with the newspaper Die Welt earlier this week. He referred to blood analysis.
AstraZeneca said on Thursday that the latest analyzes of clinical trial data support efficacy in those over 65.
“We are awaiting the regulatory decision on the vaccine by the EMA in the coming days,” he added.
‘Very reassuring’ immune responses
Pfizer and BioNTech, a partner, have also announced delays in EU delivery in recent weeks, and German Health Minister Jens Spahn has warned that shortages will last until April.
Spahn said there were younger age groups with pre-existing conditions waiting to be vaccinated. The final recommendation on the use of the AstraZeneca shot would only follow after EU approval.
In addition to those over 80 and people living in senior citizens, Germany gives priority to medical and healthcare staff at the forefront.
At the end of December, the United Kingdom became the first country to approve the AstraZeneca vaccine.
The government at the time said it would not recommend one vaccine to another for different sections of the population, although information on the effectiveness of the AstraZeneca shot in older people is currently limited.
The UK’s main public health body said on Thursday it still supported the decision.
Although too few cases of infection were observed in the late stage of the experiment, the blood analysis of immune responses was ‘very reassuring’.
It began rolling out the vaccine in January in a campaign aimed at older people that gave more than seven million their first dose.
The UK also uses the vaccine developed by Pfizer and BioNTech.