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AstraZeneca Responds To NIAID Concerns Regarding COVID-19 Vaccine, Says Data As Of 17 Feb

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AstraZeneca Plc’s (NASDAQ: AZN) vaccine prospects were looking bright on Monday when the company reported its COVID-19 demonstrated 79% efficacy in Phase 3 U.S. trials.

  • Then, sometime after midnight, U.S. officials took an unusual step of publicly questioning if that data was complete.
  • “AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the National Institute of Allergy and Infectious Disease said in a statement overnight.
  • Also, in that statement, NIAID said it had urged AstraZeneca to round up any missing data and publish up-to-date numbers “as quickly as possible.”
  • AstraZeneca said that the published numbers were based on an interim analysis with a data cut-off of February 17. The company is now conducting its review of the trial’s primary analysis.
  • “We will immediately engage with the independent data safety monitoring board to share our primary analysis with the most up to date efficacy data,” AstraZeneca said. “We intend to issue results of the primary analysis within 48 hours.”
  • In the large, 32,000-plus participant trial, investigators tracked 141 total cases of symptomatic COVID-19. The company didn’t say how many of those cases cropped up in the placebo group versus the vaccine recipients.
  • Price Action: AZN shares are trading 2.42% lower at $49.96 in premarket on the last check Tuesday.
 

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Posted-In: COVID-19 Vaccine Phase 3 TrialBiotech Government News Health Care FDA General

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