TheOctopus
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- #101
The very rare hematological disorders seen in European recipients are perhaps the most worrisome development for the vaccine, but many scientists are still unsure what to make of them. Germany, Italy, Austria, Norway, and Denmark have all reported cases of people who developed widespread blood clots, low platelet counts, and internal bleeding; at least seven have died. “It's a very special picture” of symptoms, says Steinar Madsen, medical director of the Norwegian Medicines Agency. “Our leading hematologist said he had never seen anything quite like it.”
In the global battle against COVID-19, the vaccine made by British-Swedish firm AstraZeneca has been a source of great hope. It's easy to store—requiring only refrigeration, not a deep freeze—and the firm has partnered with several other manufacturers as part of its pledge to make the vaccine, developed by researchers at the University of Oxford, available to countries around the world at low cost.
But the vaccine's journey has been anything but smooth. The company's early efficacy claims were confusing and, in some cases, disappointing. And over the past 2 weeks, the waters got particularly choppy. More than 20 European countries suspended use of the shots after more than a dozen recently vaccinated people developed unusual clotting disorders. Immunizations resumed in most countries after the European Medicines Agency (EMA) investigated the matter.
Then, the company announced the long-awaited results of a large trial in the Americas that seemed to end lingering doubts about the vaccine's efficacy—only to be rebuffed by the Data and Safety Monitoring Board (DSMB) overseeing the study, which, in a highly unusual clash, suggested the company had presented “outdated information” on efficacy. “It appears that [AstraZeneca] may have been using the most favorable data, and the DSMB wanted to make sure they corrected that,” says Anthony Fauci, director of the U.S. National Institutes of Allergy and Infectious Diseases (NIAID), which appointed the DSMB and made the discord public in a 23 March statement. (The DSMB saw no safety concerns, however.)
The company promised to publish more up-to-date data by 25 March. But the drama left public health experts reeling and raised fears that trust in the vaccine would erode further.
New problems erode confidence in AstraZeneca's vaccine | Science
In the global battle against COVID-19, the vaccine made by British-Swedish firm AstraZeneca has been a source of great hope. It's easy to store—requiring only refrigeration, not a deep freeze—and the firm has partnered with several other manufacturers as part of its pledge to make the vaccine, developed by researchers at the University of Oxford, available to countries around the world at low cost.
But the vaccine's journey has been anything but smooth. The company's early efficacy claims were confusing and, in some cases, disappointing. And over the past 2 weeks, the waters got particularly choppy. More than 20 European countries suspended use of the shots after more than a dozen recently vaccinated people developed unusual clotting disorders. Immunizations resumed in most countries after the European Medicines Agency (EMA) investigated the matter.
Then, the company announced the long-awaited results of a large trial in the Americas that seemed to end lingering doubts about the vaccine's efficacy—only to be rebuffed by the Data and Safety Monitoring Board (DSMB) overseeing the study, which, in a highly unusual clash, suggested the company had presented “outdated information” on efficacy. “It appears that [AstraZeneca] may have been using the most favorable data, and the DSMB wanted to make sure they corrected that,” says Anthony Fauci, director of the U.S. National Institutes of Allergy and Infectious Diseases (NIAID), which appointed the DSMB and made the discord public in a 23 March statement. (The DSMB saw no safety concerns, however.)
The company promised to publish more up-to-date data by 25 March. But the drama left public health experts reeling and raised fears that trust in the vaccine would erode further.
New problems erode confidence in AstraZeneca's vaccine | Science