The results of a key U.S. trial of AstraZeneca’s COVID-19 vaccine, Press release On Monday morning, the experts’ expectations were exceeded. But less than a day later, US health officials questioned the results, but the results have not yet been fully announced.

in a Trial The company said that these vaccines involved more than 32,000 volunteers, of which about two-thirds received the vaccine injections, and these vaccines are 79% effective in preventing symptomatic COVID-19. This is based on the 141 cases of disease that occurred in the vaccine and placebo groups of the trial. There are no serious diseases that require hospitalization among the vaccinated people, Compared to five in the placebo groupAnthony Fauci, president of the National Institute of Allergy and Infectious Diseases (NIAID), said at a White House press conference on Monday.

Fauci said: “The good news is that different races and age groups are equally effective.”

but Tuesday morning, NIAID issued a very unusual statement that cast doubt on the company’s performance report. The statement said that the company “may have included outdated information about the trial and may not provide a complete view of the efficacy data.”

The statement said that late Monday, the independent committee of medical experts responsible for overseeing AstraZeneca’s clinical trials in the United States, the Data Security Monitoring Committee, notified NIAID and other health officials that they were “concerned” about the way the results were reported.

On Tuesday morning, AstraZeneca responded to the concerns raised by the independent expert panel. “digital Published Yesterday’s data is based on a pre-set mid-term analysis, and the deadline is February 17. “The company wrote. “We have reviewed the preliminary assessment of the preliminary analysis, and the results are consistent with the interim analysis. We are now completing the verification of the statistical analysis. “

The company promised to “contact immediately” with an independent team to “share our main analysis results with the latest efficacy data,” and said it would release the results within the next two days.

“As a member of the FDA Advisory Committee, I want to see all the data-all the data that has been collected. Any experience. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, said that he is anything related to the decision. Feo Special Children’s Hospital is a member of the FDA Vaccine Advisory Committee. “Because we are considering the use of these vaccines, the most important thing is safety. Safe, safe, safe. “

Appear in Good Morning America Fauci said on Tuesday that DSMB had written “quite harsh instructions” to AstraZeneca, plagiarizing Fauci, and said they believed the data in the press release “may actually mislead others.”

“It’s unfortunate,” Fauci said. “This is actually a so-called non-mandatory error, because the fact is probably a very good vaccine.”

Other experts have expressed similar concerns about how the company presents its data.

“This is a good vaccine, but this kind of public relations thing makes it more confusing and complicated. For the public, it is more difficult to analyze what happened. We only hope that there is a simple, easy-to-understand clean Process,” Natalie Dean, a biostatistician at the University of Florida, told BuzzFeed News. “We really don’t have any details. But it’s just that none of this has brought any benefit to anyone.”

NIAID’s statement caught many scientists by surprise.

“We are in uncharted territory. DSMB usually does not do such things,
A statement of concern issued by a federal agency
John Moore, a virologist at the Weill Cornell Medical College in New York, told BuzzFeed News via email.

The statement by US health officials is just the latest in a series of issues facing AstraZeneca’s COVID-19 vaccine trial.

Early results of trials conducted by Oxford University in the United Kingdom and Brazil indicate that the overall efficacy of the drug is about 70%. Oxford University developed the vaccine.But scientists are critical of these trials. These trials include a series of experimental subgroups. These subgroups have different ages, doses, and intervals between two vaccine injections. Therefore, Hard to explain the numbers.

This also means that the Oxford team cannot collect enough data to answer a key question: Can the vaccine protect the elderly who are most vulnerable to COVID-19 from getting sick?This resulted in some countries including Germany initially Delayed approval of vaccine Suitable for older people.

According to the company’s announcement, the new trial eventually has enough data to answer this question. An analysis of the results for people 65 years and older shows that the efficacy of preventing symptomatic COVID-19 is 80%.

Ann Halsey of the University of Rochester School of Medicine co-chaired,” AstraZeneca said at the company’s press conference.

Crucially, the new trial in the United States and several other countries is a Simpler design Compared to those of the Oxford Research Group with only two experimental groups. Volunteers were given two doses of vaccine every two weeks, or two injections of normal saline as a placebo control.

Moore was a well-known critic of the Oxford University experiment. Last week, Moore described the U.S. experiment on BuzzFeed News as a “rigid procedure” that should produce findings that are easy to evaluate.

In addition to the results summarized in the press release, the company has not released any data, but stated that it “will submit a paper for publication in a peer-reviewed journal.” The results will also be the core content of AstraZeneca’s application to the FDA to authorize The vaccine received emergency use in the United States.

Mene Pangalos, executive vice president of AstraZeneca Biopharmaceuticals, said in a press release on Monday: “We are preparing to submit these findings to the U.S. Food and Drug Administration. If the vaccine is authorized for emergency use in the U.S., Millions of doses will be promoted in the United States.”.

These results indicate that AstraZeneca’s two-dose vaccine is more effective than the single-dose vaccine produced by Johnson & Johnson in preventing COVID-19. 66% effective Prevent disease in its main experiment. Both seem to be less effective than the two injections produced by Pfizer/BioNTech and Moderna, the latter being more than 90% effective. All four vaccines seem to provide very strong protection against severe COVID-19.

The new test results came after last week’s panic about the safety of AstraZeneca’s vaccine, when many European countries temporarily withdrew their use after vaccination. Rare but serious reports of blood clots.

Then, the European Medicines Agency (European Medicines Agency) analyzed the data of nearly 20 million people vaccinated with the vaccine and found 18 cases Cerebral Venous Sinus Thrombosis (CVST), which can prevent blood loss from the brain and cause bleeding, including 7 cases Disseminated intravascular coagulation (DIC), will cause the small blood vessels of the whole body to coagulate.Although the agency cannot rule out a link with the vaccine, it says the vaccine’s benefits in preventing COVID-19 Far exceeds the risk In these serious but very rare cases, it is recommended to re-vaccinate.

AstraZeneca said no cases of CVST were found in its trial. This is to be expected, because this situation is very rare, and only about 21,000 people received the vaccine in the trial.

Even before the announcement by US health officials on Tuesday, some experts worried that the troublesome history of the vaccine might make it less attractive to the American public than existing alternatives.

Moore told BuzzFeed News on Monday: “The FDA must make a decision now, but even if it approves this vaccine, it will be difficult to convince the public to take it.” “Under such circumstances, perception can become a reality, and public trust may now be possible. It doesn’t exist at all.”

Last week, The Biden administration announced It will lend millions of doses of AstraZeneca pre-made vaccines to Canada and Mexico, where it has been approved.

Dan Vergano provided coverage for this story.