Germany’s health minister said Friday he expects the AstraZeneca COVID-19 vaccine to be approved for emergency use later in the day but possibly only for restricted use.
Speaking at a Berlin news briefing, German Health Minster Jens Spahn said Europe’s drug regulator, the Europe Medicines Agency (EMA) could approve the new vaccine with restrictions because data on its use on the elderly was “insufficient.”
Spahn said it was important to point out the difference between insufficient data and “bad” data.
Speaking at the same news conference, Paul Ehrlich Institute (PEI) President Klaus Cichutek, said there had been heated debate regarding the vaccine during the approval process this past week, but he believed the “essential groundwork” had been laid to approve the drug without an age restriction.
He said, “the basis for approval has to be, especially for vaccines, that the benefits far outweigh the risks,” and he believed the drug met that standard. The PEI is the research and regulatory agency within Germany’s health ministry.
Also at the same news conference, Robert Koch Institute for Infectious Diseases (RKI) President Lothar Wieler warned of potential dangers from new COVID-19 variant strains.
He said characteristics of the variants aren’t fully known and it’s not known if they are more dangerous, and, in some cases, if people who already had COVID-19 or were vaccinated have immunity against them.
…
