The German health ministry has offered more details on what prompted the country to temporarily halt rollout of AstraZeneca's COVID-19 vaccine AZD1222 this week amid safety concerns. Germany initially said it would stick with the vaccine after suspensions from Denmark, Norway and others since late last week over concerns of blood clots, but now says its Paul Ehrlich Institute may have "evidence of a connection" between vaccination with AZD1222 and a few cases of cerebral vein thrombosis (CVT) in the country.
According to a Q&A page updated Tuesday on the health ministry's website, seven CVT cases have been registered in Germany since inoculations began there with AstraZeneca's vaccine, and three of these have been fatal. Out of the seven, three have surfaced since last Friday, including two of them yesterday. The ministry said a total of 1.6 million doses of the vaccine have so far been administered in Germany since it was authorised by EU regulators in late January, but "despite the high number" of vaccinations with AZD1222, the rate of CVT among recipients is "above average."
It suggested that about 1 to 1.4 cases of CVT would normally be expected with that many vaccinations in the 14-day period after a dose is given, but there have been six in Germany as of March 15, while the seventh is considered to be a "medically comparable" case. The Paul Ehrlich Institute's report states that "according to this calculation, more cases of sinus thrombosis have been reported than would be expected statistically by chance," and the medical advisory body unanimously concluded that these "could be related to the vaccination." The health ministry said it is still looking into who is impacted, but said "it is noticeable…that younger people are also affected - especially women."
EMA continues to "firmly" back vaccine
Details about Germany's decision came as the head of the European Medicines Agency (EMA) said Tuesday that there is "no indication" that AZD1222 is the cause of blood clots reported in some recipients. However, Emer Cooke indicated that the focus on venous thromboembolic events lately has produced more reports as attention to them spreads.
Still, she reiterated the EMA's stance that it remains "firmly convinced" that the benefits of AstraZeneca's vaccine outweigh its risks, but a "very rigorous analysis" is ongoing. The agency's review is focused on AZD1222, but is also looking at reports of clotting in people who have received other coronavirus vaccines, including Pfizer and BioNTech's Comirnaty. However, Cooke said instances of severe clotting have been rare across all vaccines. The EMA is currently reviewing the incidents to determine whether they represent a broader risk, with their findings due to be presented this Thursday.
Meanwhile, Germany's health ministry acknowledged that the temporary ban on AZD1222 could end up resulting in more deaths than any risks associated with AstraZeneca's vaccine, but said it is legally obliged to monitor safety as part of the state's immunisation campaign "and to react to appropriate signals." Moreover, it noted that while thromboses are also a rare side effect of oral contraceptives, this risk is listed on those drugs' labels, whereas the rare side effect of CVT has not yet been included on the information sheet for AstraZeneca's vaccine. "Trust and transparency are always important when prescribing drugs, but especially when it comes to vaccinations because they are widely used in healthy people," the ministry said.
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