「華人戴明學院」是戴明哲學的學習共同體 ,致力於淵博型智識系統的研究、推廣和運用。 The purpose of this blog is to advance the ideas and ideals of W. Edwards Deming.

2021年3月24日 星期三

AstraZeneca’s vaccine efficacy figures. AstraZeneca says complete data shows its vaccine is still highly effective.

3.25

After results are questioned, AstraZeneca says complete data shows its vaccine is still highly effective.

AstraZeneca’s U.S. headquarters in Gaithersburg, Md.
Credit...Ting Shen for The New York Times

AstraZeneca reiterated on Wednesday that its Covid-19 vaccine was very effective at preventing the disease, based on more recent data than was included when the company announced the interim results of its U.S. clinical trial on Monday.

The company said in a news release that its vaccine was 76 percent effective at preventing Covid-19. That is slightly lower than the efficacy number that the company announced earlier this week.

The new results strengthen the scientific case for the embattled vaccine. But they may not repair the damage to AstraZeneca’s credibility after U.S. health officials and independent monitors issued an extraordinary rebuke of the company for not counting some Covid-19 cases when it announced its initial findings this week.

In a news release on Wednesday, the company said complete results from its 32,000-person study showed that its vaccine was 76 percent effective. On Monday, the company said the vaccine appeared to be 79 percent effective, based on an interim look at 141 Covid-19 cases that had turned up among volunteers before Feb. 17. The latest finding was based on 190 trial participants who had gotten sick with Covid-19.

AstraZeneca said on Wednesday that the vaccine was 100 percent effective in preventing severe disease and 85 percent effective in preventing Covid-19 in people over age 65.

When it unveiled its interim results on Monday, AstraZeneca ignored dozens of recently confirmed Covid-19 cases that had cropped up in trial volunteers before mid-February.

In a letter to the company and federal officials, the independent monitoring board that was helping oversee the clinical trial issued an unusual reprimand of AstraZeneca for appearing to cherry-pick data to make its vaccine appear more effective.

“Decisions like this are what erode public trust in the scientific process,” the letter said. The members of the monitoring board wrote that their statistical modeling had found that the vaccine might have a lower efficacy rate — between 69 and 74 percent — if the Covid-19 cases in question were included in the analysis.

The National Institute of Allergy and Infectious Diseases later disclosed the panel’s concerns via a public statement.

It was not clear why the monitoring board’s projection turned out to be lower than the figure in AstraZeneca’s complete results. The latest results could still change because there are still 14 possible Covid-19 cases that AstraZeneca representatives have not yet classified as actual cases.

Until they received the monitoring board’s letter, AstraZeneca executives weren’t aware that the panel expected them to include those cases in the results disclosed in their news release, according to a person familiar with the executives’ thinking.

The dust-up over AstraZeneca’s U.S. trial results followed a safety scare in Europe that prompted more than a dozen countries to temporarily suspend use of the vaccine. Regulators in Europe said last week that a review had found the shot to be safe after a small number of people who had recently been inoculated developed blood clots and abnormal bleeding. The U.S. trial did not turn up any signs of such safety problems.




Hanching Chung
3月23日上午6:43 ·









ABC News


3月23日上午6:39 ·

U.S. data shows AstraZeneca vaccine is effective against COVID-19 for all adults. Here's what to know: https://abcn.ws/3tIYtR3


ABC News


3月23日上午6:39 ·

U.S. data shows AstraZeneca vaccine is effective against COVID-19 for all adults. Here's what to know: https://abcn.ws/3tIYtR3




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On Monday, AstraZeneca announced positive results about the safety and efficacy of its vaccine from a trial with 32,000 people conducted mostly in America.
But later that evening, an American government agency that funded the trial questioned the announcement.
AstraZeneca, it said in a vaguely worded statement, “may have included outdated information” which “may have provided an incomplete view of the efficacy data”.
Anthony Fauci, President Biden's chief medical adviser on covid-19, said that the vaccine-maker appeared to have made an “unforced error”.
AstraZeneca reported that the jab was 79% effective against covid-19 symptoms but according to the Washington Post, Dr Fauci and other officials believe the efficacy figures the company should have published were between 69% and 74%.
The controversy is baffling—not much clarity has emerged so far from either side.
Read why the fresh controversy will hurt demand for AstraZeneca’s vaccine and global efforts to end the pandemic
Credit: Daniel Leal-Olivas/AFP

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