The Standing Committee on Vaccination (STIKO) at the German Robert Koch Institute (RKI), the country’s main public health authority, found that there is insufficient data on the efficacy of the vaccine, developed by AstraZeneca and the University of Oxford, for this age group, according to a Home Office statement Thursday.
“Given the small number of study participants in the 65 age group, no conclusion can be made regarding efficacy and safety in the elderly. Therefore this vaccine is currently recommended by STIKO only for people between the ages of 18 and 64,” he said in his recommendation .
The announcement by the German Interior Ministry on Thursday came amid an ongoing dispute between the European Union and AstraZeneca over the delay in delivering the coronavirus vaccine to the bloc.
AstraZeneca said it could not deliver as many doses as the European Union expected, citing production challenges. But the European Commission, which has requested the vaccine on behalf of EU member states, says this is unacceptable, and the drugmaker must find a way to increase supply.
The European Union has ordered 300 million doses of the AstraZeneca vaccine – which could be approved for use by the European Medicines Agency (EMA) as soon as Friday – with an option to purchase an additional 100 million doses.
An AstraZeneca spokesperson said he awaits a regulatory decision by the EMA soon. “Reports that the effectiveness of the AstraZeneca / Oxford vaccine is low in adults over 65 years old are not an accurate reflection of the totality of the data,” the spokesman said.
“Recent analyzes support efficacy in this age group, which we expect to be published by the EMA in the coming days. The latest Lancet publication showed that older adults showed strong immune responses to the vaccine, with 100% of the elderly generating spike-specific antibodies after the second dose.”
This was because the Oxford scientists who conducted the vaccine trials did not want to recruit the elderly until they “collected a lot of safety data” for those between the ages of 18 and 55, Suriot said.
He said: “Basically, because Oxford started vaccinating seniors at a later time, we don’t have a large number of elderly people who have been vaccinated. That is what the debate is about.” “But we do have strong data showing very strong production of antibodies to the virus in the elderly, similar to what we see in young people. It is possible that some countries, with caution, will use our vaccine for the younger group.”
Stephen Evans, professor of pharmacological epidemiology at the London School of Hygiene and Tropical Medicine, stressed that the German decision “was not a regulatory decision, but a draft advice on use” in comments to the UK Science Media Center.
“It is known that the clinical data for this vaccine was limited to those aged 70 and over,” he said, because AstraZeneca recruited older age groups later than younger age groups, allowing less time for cases to accumulate.
Evans said: “There is absolutely no reason for anyone in the UK or anywhere else to believe that this Oxford / AstraZeneca vaccine is ineffective at any age.” “Its ability to reach people in general practitioner surgeries and nursing homes makes it a vital component in attempts to reduce hospitalization and mortality, especially in the elderly.”
Jim Naismith, director of the Rosalind Franklin Institute and professor of structural biology at the University of Oxford, also sought to assuage concerns, noting that German scientists have concluded that the vaccine is safe and effective for those under the age of 65.
He told the Science Media Center, “Their assessment is that the efficacy has not yet appeared for more than 65 years. They have not said that the vaccine is ineffective for more than 65 years.”
“Good-faith discussions about what evidence is needed for vaccine efficacy are really important. Empirical evidence and rational debate, not sharp rhetoric, will solve this problem.”
The dispute between the European Union and AstraZeneca
With the ongoing row between the European Union and AstraZeneca over vaccine delays, the Belgian health authorities – at the request of the European Commission – conducted a “check” of the Belgian production facility in the UK and Sweden on Wednesday. France Damel, spokeswoman for Belgian Health Minister Frank Vandenbroek, said in a statement that the aim was “to ensure that the delay in delivering vaccines is indeed due to a problem in production at the Belgian site.”
“The Belgian experts are looking into the elements obtained during this inspection visit with Dutch, Italian and Spanish experts,” Damel said, adding that the report is expected within a few days.
German Health Minister Jens Spahn said, Thursday, that the German government expects the country to face a shortage of supplies of the Coronavirus vaccine for at least another 10 weeks, amid a violent reaction to the pace of the government’s vaccine deployment program.
Meanwhile, the number of coronavirus infections per 100,000 residents over a seven-day period in Germany has fallen below the critical threshold of 100 for the first time in three months, to 98, the German Royal Institute said on Thursday.
German Chancellor Angela Merkel fixes the government Plan to reduce the infection rate to less than 50 new infections per 100,000 residents within seven days so that you can track and trace the infection.
Nadine Schmidt writes from CNN and Claudia Otto from Berlin and Laura Smith writes Spark from London.