U.S. health officials question the results of the astragenera vaccine


Original US test results for the COVID-19 vaccine of AstraZeneca, Press release issued On Monday morning, experts exceeded expectations. Less than a day later, however, U.S. health officials questioned the results, which have not yet been fully released.

In this Judgment The agency said that with more than 32,000 volunteers involved, about two-thirds of whom received the vaccine, the shots had a 79% effectiveness in preventing significant CVID-19, the agency said. It was created on the basis of 141 cases of the disease that occurred across test vaccines and placebo weapons. There were no serious cases of hospitalization among the vaccinated people, Compare that to the five on the placebo armAnthony Fawcett, head of the National Institute of Allergy and Infectious Diseases (NIAID), told a news conference at the White House on Monday.

“The good news is that there was comparative effectiveness across races and ages,” Fawcett said.

But Tuesday morning, NIAID has issued a highly unusual statement expressing some skepticism over the agency’s results report. The statement said, “the agency may include outdated data from that trial,” which could provide an incomplete view of the performance data. “

The statement said late Monday night that the Data Safety Monitoring Board had informed the Independent Panel of Medical Experts, NIAID and other health officials to oversee the U.S. trial of AstraZeneca, “concerned” about how the results were presented.

On Tuesday morning, AstraZeneca responded to concerns raised by an independent panel of experts. “Numbers Published The data cut-off yesterday, February 17, was based on a pre-determined inter-analysis, “the company wrote.” We have reviewed the initial evaluation of the preliminary analysis and the results are consistent with the inter-analysis.

The company has promised to “share our initial analysis with the most up-to-date performance data” with an “instantly involved” independent panel, releasing results within the next two days.

“As a member of the FDA Advisory Committee, I would like to see all the data collected. No experience with it. Anything relevant to the decision, “said Paul Offit, a vaccine specialist at Philadelphia Children’s Hospital, who sits on the FDA’s vaccine advisory committee.

Appeared Good morning America On Tuesday, Fawcett said that the DSMB had written a “rather harsh note” to AstraZeneca, stating a copy of Fawcett that they felt the data contained in the press release “might be somewhat misleading.”

“It’s really unfortunate that this happened,” Fawcett said. “That’s what you actually call an unintentional error, because the truth is it’s probably a very good vaccine.”

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

“It’s a good vaccine, but this kind of public content has made it a little worse and more complicated. It is more difficult for the people to analyze what is going on. We just want a clear straightforward process that is easy to explain, “Natalie Dean Buzzfeed, a biologist at the University of Florida, told the News.” We don’t really have any details.

The NIAID statement caught many scientists off-guard.

“We are in unfinished territory. DSMBs don’t usually do such things,
And a federal agency to issue a statement raising concerns
Very high about a high-profile corporate trial, of course, ”John Moore, a virologist at Well Cornell Medical College in New York, told BuzzFeed News via email.

The statement from US health officials was the latest in a series of problems that have led to testing for the AstraZeneca Cavid-19 vaccine.

Previous tests in the United Kingdom and Brazil, conducted by Oxford University, which developed the vaccine, indicated an overall efficacy of about 70%, but scientists criticized the experiments, which included patients of different ages, one of the experimental subgroups, which included doses and two shots of the vaccine. Arrays were included The numbers are very difficult to explain.

This also meant that the Oxford team was unable to gather enough data to answer a key question: Does the vaccine protect older people from the most risky illnesses of COVID-19? As a result, some nations, including Germany, were initially formed Vaccine approval delay For use in older groups.

The new test finally has enough data to answer this question, according to the company’s disclosure. Analysis of the results in people 65 years of age or older showed 80% efficacy in significant COVID-19 prevention.

“These studies reaffirmed previous results observed in AZD 1222 trials across all adult populations but was surprising to see the same efficacy results for the first time in people over 655 years old,” said An-Halsi, co-author of the University Gave. AstraZeneca, the company’s release said.

Seriously, the new trial, conducted in the United States and several other countries, is one Very simple design There are only two experimental teams run by the Oxford team. Volunteers were given either two doses of the vaccine four weeks apart or two saline injections as a placebo control.

Moore, who has been a vocal critic of the Oxford-run trial, last week described the U.S. trial to BuzzFeed News as a “strict protocol” that could lead to easier diagnoses.

The agency has not yet released any information beyond the summary results in its press release, but said a peer would “be submitted for publication in a peer-reviewed journal.” The results will be submitted to the FDA as a focal point for the application of estrogen for the vaccine to be approved for emergency use in the United States.

“We are preparing to submit these results to the U.S. Food and Drug Administration and the U.S. should authorize the emergency use of this vaccine to extract millions of doses across the United States,” said Man Pangalos, executive vice president of AstraZeneca of Biopharmasticals, in a statement issued Monday. .

These results suggest that the AstraZeneca double-dose vaccine is slightly more effective in preventing CVV-11 than the single shot vaccine developed by Johnson and Johnson. 66% effective Its big test is disease prevention. Both appear to be less effective than the two-shot vaccines made by Pfizer / Bioentech and Moderner, which exceed 90% efficacy. All four vaccines appear to provide very strong protection against severe COVID-19.

The new test results came last week after concerns were raised about the safety of the AstraZeneca vaccine, when many European countries temporarily withdrew the vaccine after use. Rare but severe blood clots are reported.

The European Medicines Agency then analyzed data from about 20 million people who had been vaccinated, and discovered 18 of them. Cerebral venous sinus thrombosis (CVST), which can stop bleeding from the brain and cause bleeding, and in seven cases Distributed intravascular coagulation (DIC), which forms clots in tiny blood vessels throughout the body. Although the company has been unable to spread any link to the vaccine, it says the vaccine has the advantage of preventing Covid-119. The risk has been exceeded This is a serious but very rare condition, and it is advisable to resume vaccination.

AstraZeneca said it was not found in any of the CVST tests. This was expected, since the condition is very rare and about 21,000 people were vaccinated in this test.

Even before speaking to U.S. health officials on Tuesday, some experts expressed concern that the problematic history of the vaccine could make it less attractive to the U.S. public than the options already available.

Moore told BuzzFeed News on Monday that the FDA would have to make a decision now, but that even if the vaccine was approved, it would be difficult to persuade the public to accept it. “Under such circumstances, realization may become a reality and public confidence may not be there now.”

Last week, The Beadon administration has announced It will lend millions of pre-produced donors of the Astragenica vaccine to Canada and Mexico, where it has already been approved.

Dan Vergano contributed reporting for this story.





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