AstraZeneca released additional information regarding their latest COVID-19 vaccine trial after government officials expressed concern that they were using outdated information.
The newly released data, unveiled on Thursday, show a vaccine efficacy lower than the data previously released. After they released the data on Monday, which showed a 79% efficacy in preventing symptomatic cases, the National Institutes of Health’s committee of clinical trial analysts “expressed concern that AstraZeneca may have included outdated information from that trial.”
The updated trial data show that the vaccine has a 76% efficacy against symptomatic COVID-19, while it has a 100% efficacy against severe or critical disease and hospitalization. The efficacy against symptomatic cases of the coronavirus is 3% lower than the initial data.
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“The primary analysis is consistent with our previously released interim analysis and confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 years and over,” Mene Pangalos, the executive vice president of BioPharmaceuticals R&D, said in a statement. “We look forward to filing our regulatory submission for Emergency Use Authorization in the U.S. and preparing for the rollout of millions of doses across America.”
Of the more than 32,000 participants, less than half of 1%, 0.59% or 190 people, experienced a symptomatic case of the coronavirus. The number of symptomatic cases increased by 49 in the new data.
AstraZeneca’s vaccine has been approved in Europe but not in the United States.
A handful of European countries suspended the use of the AstraZeneca vaccine amid concerns that it could cause blood clots. There have been about 30 cases of blood clots among 5 million people who received their vaccine. Denmark was the first nation to suspend the AstraZeneca vaccine. Since then, other countries, including the Netherlands, Norway, Iceland, France, Germany, Italy, Spain, Portugal, the Democratic Republic of the Congo, Bulgaria, and Thailand, have followed.
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The European Medicines Agency said there is “no indication” that the vaccine causes blood clots.