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The European Medicines Agency said Wednesday that blood clots should be listed as a possible but rare side effect of the AstraZeneca COVID-19 vaccine, stressing the shot's benefits outweigh the risks.
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Updated study results say the vaccine is 76% effective against symptomatic COVID-19 and 100% effective against severe disease. Independent monitors had been concerned about a previous report.
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In an unusual post-midnight statement, the National Institute of Allergy and Infectious Diseases said AstraZeneca might have used old data for its COVID-19 vaccine trial.
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Results of the trial, which involved more than 32,000 volunteers, showed two doses of the vaccine administered four weeks apart had an efficacy of 79% at preventing symptoms of COVID-19.
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A rare blood clotting condition has occurred in some people after receiving the AstraZeneca COVID-19 vaccine. If the new research is correct, it could mean that blood clots could be easily treated.
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"Its benefits continue to be far greater than its risks," said Dr. Sabine Straus of the agency's risk committee. It found no increase in the overall risk of blood clots with the vaccine.
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The two countries joined a number of other European nations that have temporarily suspended the shot after several people reportedly developed blood clots after receiving it.
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The pharmaceutical company made the announcement on Monday, saying that one dosing regimen showed the vaccine was 90% effective in preventing infection.