Questioned that the data is out of date, AstraZeneca announces the clinical data of the new crown vaccine

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com Core Summary This week, AstraZeneca Vaccines "digging holes" for itself.

First, AstraZeneca announced the interim analysis of its Phase III clinical trial in the United States: the effective rate of symptomatic new crown infections reached 79%, especially for the protection of the elderly also reached 80%.

That night, it was rebutted by the internal data and safety monitoring committee appointed by the National Institutes of Health.
It was alleged that the numbers used in the press release were "not the latest and most complete.
"
On March 25, AstraZeneca issued another announcement stating that the vaccine has an effective rate of 76% for symptomatic new crown infections and 85% for the elderly.

Written by Wang Yudan | Wang Yiwei ● ● ● On Monday, March 22, the results of the interim analysis of AstraZeneca's new crown vaccine phase III clinical trial in the United States were announced, showing that the effective rate of preventing symptomatic new crown virus infection is 79%, which is good for people who want to It is undoubtedly great news for AstraZeneca, which has entered the United States.

Surprisingly, shortly after this data was released, it was questioned by the National Institute of Allergy and Infectious Diseases, and alleged that it might contain "outdated information.
"
 On March 25th, on Thursday morning Beijing time, AstraZeneca adjusted the effective rate of new crown virus prevention from 79% to 76% in its latest announcement (the number of confirmed cases of new crown also increased from the previously announced 141 to 190) , The effective rate for the elderly is 85% [1].

This adjustment data has not changed much, but its management of vaccine data is confusing.

"In the end, it was only a difference of 3%, and the elderly also increased by 5%.
I
really can't understand why the 79% was chosen before (data).

" An immunologist who is concerned about the progress of the new crown vaccine development commented to the "Intellectual".

Starting in August 2020, AstraZeneca vaccine has launched a large-scale Phase III clinical trial in the United States, Chile and Peru [2].

On March 22, 2021, the interim analysis data of the Phase III clinical trial was announced, showing that the vaccine has an effective rate of 79% in preventing symptomatic neocoronavirus infection, and an effective rate of 80% for subjects 65 years and older.
, The effective rate of preventing severe illness and hospitalization is as high as 100% [3].

 However, the "79% efficient" data was immediately questioned as soon as it was released.

On March 23, the National Institute of Allergy and Infectious Diseases (NIAID) issued a statement stating that the data in the results of the Phase III trial of AstraZeneca’s new crown vaccine may be “outdated”.
The information may provide "incomplete data on validity".

 According to the Washington Post, the Data and Safety Monitoring Board (DSMB), composed of independent experts, pointed out that the vaccine effectiveness figures that AstraZeneca chose to disclose were “in their best interest, not The latest and most complete.

” The latest data show that the effectiveness of AstraZeneca vaccine is between 69% and 75% [4].

According to multiple media reports, the Data and Safety Monitoring Committee stated that AstraZeneca should use the latest data as of March this year to recalculate, because there were new confirmed cases of new crowns in the March trial.

The NIAID also said that it would urge AstraZeneca to cooperate with the Data and Safety Monitoring Committee to review data and ensure that the most accurate and latest vaccine efficacy data are released as soon as possible [5].

 Subsequently, AstraZeneca responded that its published efficiency is based on statistics as of February 17, which is consistent with the results of the interim analysis previously announced.

And they will immediately share the latest vaccine data with DSMB, and will announce their preliminary analysis results within 48 hours [6].

 Therefore, this is the latest announcement issued by AstraZeneca on March 25: the effective rate of 76% for symptomatic new crown infections, the effective rate of preventing severe illness and hospitalization is 100%, and the prevention of symptomatic patients in people over 65.
The effective rate of new crown infection is 85%.

 However, Anthony Fauci, the director of NIAID and an American infectious disease expert, was "shocked" when AstraZeneca knew it had new data in March but chose to release the data as of February.

In a report by the American medical media STAT, Fauci said that AstraZeneca's move would "weak public trust" [7].

 Fauci said that the reason why NIAID made a rare announcement this time is because "We just feel that we shouldn't be silent about this.
If we don't say a word, we may be accused by the outside world to cover up the facts.
.
.
and we never want to tell ourselves Put it in this situation.

" [7] The new crown vaccine jointly developed by AstraZeneca and the University of Oxford has attracted attention since its inception.
It has been hailed as a "low-cost weapon against the new crown epidemic" and has been promoted in various parts of the UK.

As of March 16, about 20 million people in the UK and other parts of Europe have been vaccinated with AstraZeneca's new crown vaccine[8].

Currently, the United Kingdom has ordered 100 million doses of AstraZeneca's new crown vaccine, and the European Union has ordered 400 million doses [9].

 The clinical trials, promotion and vaccination experience of this "star vaccine" can be described as twists and turns.

 According to a Reuters report on February 1, the documents it obtained showed that in the late-stage clinical trial of AstraZeneca's new crown vaccine, due to measurement errors by researchers at the University of Oxford, about 1,500 first batch of volunteers were vaccinated with the wrong dose ( Only half of the normal dose was vaccinated).

However, after discovering the mistake, the researchers did not inform the volunteers that the vaccination made a mistake [10].

 Subsequently, the "adverse reactions" of the vaccine after vaccination in Europe attracted attention from all walks of life.

Many countries have suspended the use of AstraZeneca vaccine due to thrombosis in more than 30 vaccinators.

After reviewing millions of cases, the European Medicines Regulatory Agency (EMA) stated that the AstraZeneca vaccine has nothing to do with the overall increased risk of blood clots among vaccinators.
This has allowed some European countries to reactivate the vaccine.

 In addition, the effectiveness of the AstraZeneca vaccine against variant strains of the new crown virus has not received experimental support, which may also make it more and more distant from the first echelon of the new crown vaccine.

On March 16, an article published in the New England Journal of Medicine revealed that the results of two standard doses of AstraZeneca vaccine test showed that it was not effective against the South African mutated virus strain [12].

 The data problem this time may cast a shadow over AstraZeneca's image.

 However, Fauci referred to this error as an "unforced error" in the interview, thinking that AstraZeneca's vaccine is still "probably a good vaccine.
"
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-following-statement-by-niaid-on-azd1222-us-phase-iii-trial-data.
html 7.
://www.
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https://cn.
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-astrazeneca-to-seek-us-authorization-for-covid-19-vaccine-this-month-or-early-next-sources-idUSKBN2B42JN12.
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