Germany's vaccine commission said the AstraZeneca coronavirus vaccine should not be given to people older than 65 years, amid a bitter dispute between the European Union and the drugmaker over delayed supplies.
The Standing Committee on Vaccination (STIKO) at Germany's Robert Koch Institute (RKI), the country's main public health authority, found there is insufficient data on the effectiveness of the vaccine, developed by AstraZeneca and the University of Oxford, for this age group, according to a statement from the interior ministry on Thursday.
"Due to the small number of study participants in the age group ≥65 years, no conclusion can be made regarding efficacy and safety in the elderly. This vaccine is therefore currently recommended by STIKO only for persons aged 18-64 years," the panel said in its recommendation.
Melbourne company CSL is currently on track to deliver 50 million doses of AstraZeneca's vaccine to Australians, with delivery to be anticipated in the second quarter of 2021, pending regulatory approval.
Responding to the announcement, an AstraZeneca spokesperson said "latest analyses of clinical trial data for the AstraZeneca/Oxford Covid-19 vaccine support efficacy in the over 65 years age group."
The pharmaceutical company is awaiting a regulatory decision by the European Union medicines regulator, the spokesperson added.
The announcement by the German Interior Ministry came amid an ongoing dispute between the European Union and AstraZeneca over delays to the delivery of its coronavirus vaccine to the bloc.
AstraZeneca has said it can't deliver as many doses as the EU expected, citing production challenges. But the European Commission, which ordered the vaccine on behalf of EU member states, says this is unacceptable, and the company must find a way to increase supply.
The United Kingdom, whose regulator approved the Oxford/AstraZeneca vaccine nearly a month ago, has been administering doses to people older than 65.In its report, UK regulator MHRA, said there was "limited information available on efficacy in participants aged 65 or over, although there is nothing to suggest lack of protection."
Responding the German announcement, MHRA Chief Executive Dr June Raine said "current evidence does not suggest any lack of protection against COVID-19 in people aged 65 or over."
"The data we have shows that the vaccine produces a strong immune response in the over-65s. More data is continually becoming available for this age group and our Public Assessment Report, available on our website, will be updated to reflect this," her statement added.
The EU 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.
Source: 9News https://www.9news.com.au/world/coronavirus-germany-says-astrazeneca-vaccine-should-not-be-given-to-over-sixty-fives/1f8fb813-7d1b-45e9-8ef3-65b25e07c611