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AstraZeneca Plc (NASDAQ:AZN) on Wednesday issued a fresh update of its phase three trial data for the COVID-19 vaccine after a U.S. health agency earlier this week questioned the accuracy of the trial data.
What Happened: The British drugmaker’s latest update claims the vaccine developed with Oxford University is 76% effective in protecting against symptomatic cases of the virus, from 79% efficacy reported on Monday.
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The company maintains that the vaccine is 100% effective against severe disease and hospitalization, adding it has 85% efficacy against symptomatic participants aged 65 years and above.
The U.S. National Institute of Allergy and Infectious Diseases (NIAID) had on Monday shared concerns related to AstraZeneca's outdated trial data and that it may have provided an incomplete view of the efficacy data.
The updated results include data collected from 190 symptomatic cases among 32,449 participants, or 49 more cases when compared with the previous report.
“The vaccine was well tolerated, and no safety concerns related to the vaccine were identified,” the company reiterated on Wednesday.
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The company said it is now looking forward to filing the regulatory submissions to secure Emergency Use Authorization in the United States and prepare for the rollout of millions of doses across America.
At a press briefing on Wednesday, White House Chief Medical Officer Anthony Fauci told reporters he believes the data suggests it's a good vaccine and the FDA will conduct the final analysis and certification of the vaccine.
“We are always concerned when there is an apparent miscommunication,” Fauci said.
“At the end of the day, everything is going to be open and transparent. And hopefully that will dispel any hesitancy that was associated with this little bump in the road that we happen to have, most recently with AZ (AstraZeneca).”
Why It Matters: On Tuesday, the U.S. said it is allocating 27 million doses across all channels this week, of which 4 million will be from Johnson & Johnson (NYSE:JNJ). Two-thirds of the 27 million doses will be going to states and jurisdictions, and the rest will go to other channels, primarily the pharmacy program.
So far, only 84 million people have received at least one dose of the vaccine, which is about one-fourth of the U.S. population and 45 million people have been fully vaccinated.
The fresh update could still delay the drugmaker’s plans to secure the emergency use authorization in the United States, which is already battling COVID-19 vaccine shortages, in the near future.
Price Action: AstraZeneca shares closed 1.23% lower at $48.79 on Wednesday, and those of Johnson & Johnson closed up about 1% at $161.91.
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