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AstraZeneca may have used stale data in a vaccine trial in the United States.

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AstraZeneca may have used stale data in a vaccine trial in the United States.
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AstraZeneca may have used stale data in a vaccine trial in the United States.

AstraZeneca may have used stale data in a vaccine trial in the United States.

 

The results of a US trial of AstraZeneca’s COVID-19 vaccine may have used “outdated material,” according to a statement released by US federal health officials early Tuesday.

The Data and Safety Monitoring Board expressed concern late Monday that AstraZeneca may have presented an inaccurate view of the efficacy data in a statement.

The Data and Safety Monitoring Board expressed concern late Monday that AstraZeneca had used obsolete information from that trial, which may have resulted in an inaccurate view of the efficacy data.

In a long-awaited U.S. research, AstraZeneca’s COVID-19 vaccine offered good safety for adults of all ages, a result that could help restore public trust in the shot around the world and bring it closer to approval in the United States.

The vaccine was shown to be 79 percent effective in reducing symptomatic cases of COVID-19 in a study of 30,000 people, including older adults. There were no serious infections or hospitalizations among vaccinated volunteers, compared to five such cases among dummy shot participants — a small amount, but consistent with reports from the United Kingdom and other countries that the vaccine protects against the disease’s worst symptoms.

AstraZeneca also stated that the study’s independent safety monitors discovered no significant side effects, such as an elevated risk of unusual blood clots like those seen in Europe, which prompted many countries to temporarily halt vaccinations last week.

The company expects to send an application to the Food and Drug Administration in the coming weeks, and before the department makes a decision, outside advisors to the government will debate the facts publicly.

After a comprehensive analysis of the data by independent advisory committees, the Food and Drug Administration and the Centers for Disease Control and Prevention will decide on authorization and recommendations for use of the vaccine in the United States.

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