Key test results from AstraZeneca in the US for its COVID-19 vaccine, written by the press On Monday morning, it exceeded the expectations of experts. But less than a day later, health officials in the United States questioned the results, which were not fully released.
Mu trials With more than 32,000 volunteers, about two-thirds of those who received the vaccine, the shot was 79% effective against the COVID-19 mark, the company said. This led to 141 cases of disease that occurred during vaccination with placebo arm trials. There were no serious medical conditions among the vaccinated population, compared with five in placebo, Director of the National Institute of Allergy and Infectious Diseases (NIAID) Anthony Fauci said at a press conference at the White House on Monday.
“The interesting thing is that there was a similar work for all races and ages,” Fauci said.
But early Tuesday morning, NIAID issued an unusual statement and cast doubt on the company’s report on its results. The company “could have incorporated the previous information in the trial,” he said.
The document said on Monday, the Data Safety Monitoring Board, an independent medical team overseeing the testing of AstraZeneca in the US, had informed NIAID and other health officials that they were “concerned” about how the results were presented.
On Tuesday morning, AstraZeneca responded to the challenges posed by an independent expert team. “Numbers published yesterday took the preliminary analysis and the data reduction on February 17, “the company wrote.” We also reviewed the preliminary analysis and the results were consistent with the periodic analysis. We are now finalizing the figures. “
The company has promised to “participate immediately” with the independent team to “share our initial analysis with the most recent information,” saying it will provide results in the next two days.
“As a member of the FDA advisory committee I would like to see everything – everything that has been collected. Every event is this. Anything related to this decision,” said Paul Offit, a vaccine specialist at Children’s Hospital of Philadelphia, who sits on the FDA vaccination advisory committee. . “Because the most important thing we consider is vaccination and safety. Security, safety, security. ”
Clicking on Good morning America On Tuesday, Fauci said the DSMB had written “painful” to AstraZeneca, in reference to Fauci, saying he felt that what was published in the newspaper “could be slightly misleading.”
“It’s unfortunate that this happened,” Fauci said. “This is what you call the unrestrained problem, because the truth is that it is the best vaccine.”
Some analysts also commented on the company’s complaints.
“It’s a good vaccine, but the kind of social network makes it both confusing and difficult. It is very difficult for people to know what is going on. We just want a clear, easy-to-understand way, “Natalie Dean, a biologist at the University of Florida, told BuzzFeed News.” We don’t have much. But just looking good doesn’t help everyone. “
The statement from NIAID confused many scientists without realizing it.
“We are in an unknown area. DSMBs do not do things like this,
and a place for the federal agency to make a statement of concern
about high corporate testing is very high, ”says John Moore, a medical specialist at Weill Cornell Medical College in New York, via email at BuzzFeed News.
Reports from U.S. health officials are the latest in a number of cases involving AstraZeneca COVID-19 vaccine.
Preliminary results of trials in the UK and Brazil – run by the University of Oxford, which developed the vaccine – showed approximately 70% effectiveness. But scientists were opposed to the trial, which included small experimental groups with patients of different ages, dosages, and intervals between vaccines, making very difficult to interpret numbers.
This also means that the Oxford team failed to gather enough data to answer an important question: Does the vaccine protect adults at high risk of COVID-19 from becoming ill? This led to the introduction of other countries, including Germany delayed vaccination for use in older groups.
The new lawsuit was settled out of court, according to a report released by the company. Outcome measures among people aged 65 and over showed 80% efficacy in preventing COVID-19 symptoms.
“These results confirm the previous results observed in the AZD1222 trial in all adults but it is interesting to see similar results for people over 65 for the first time,” Ann Halsey of the University of Rochester School of Medicine, who presided over the AstraZeneca trial, said after the company was released.
In particular, the new case, which is taking place in the US and several other countries, is a simple design than those run by the Oxford team, they have only two test teams. Volunteers are given two vaccines every four weeks with the exception of two injections of salt as a control method.
Moore, who has been a defendant in the Oxford-run lawsuit, last week described the U.S. case in BuzzFeed News as “a rigorous way” that should produce what is easy to analyze.
The company has not yet released anything but the results which are summarized in its statement but said the paper “will be submitted for publication in a peer-reviewed newspaper.” The results will also be presented as a prerequisite for AstraZeneca’s work with the FDA for the vaccine to be approved for emergency use in the US.
“We plan to roll this out to the U.S. Food and Drug Administration and get the vaccine available to millions in the United States if the vaccine is approved by the US Emergency Use Authorization,” Mene Pangalos, AstraZeneca’s vice president of biopharmaceuticals, said Monday. .
These results show that the dual-drug vaccine AstraZeneca is more effective in preventing COVID-19 than the vaccine vaccinated by Johnson & Johnson, a former 66% effective for the prevention of disease in his great trials. All of this seems to be more ineffective than a two-shot vaccine developed by Pfizer / BioNTech and Moderna, which exceeds 90% strength. All four vaccines appear to be very protective against COVID-19.
The new results come in the wake of the deadly AstraZeneca vaccine last week, when many European countries abolished the vaccine for a short period of time. rare but dangerous blood reports.
The European Medicines Agency then analyzed the data of about 20 million people who received the vaccine, and found 18 cases of Diseases of venous sinus thrombosis (CVST), which can prevent brain hemorrhage and cause bleeding, as well as seven cases of proliferation of blood vessels (DIC), which causes the build-up of small blood vessels throughout the body. Although the agency was unable to make contact with the vaccine, it said the benefits of the vaccine were to prevent COVID-19. than risk about these complications but very rare, and recommended that the vaccine be resumed.
AstraZeneca said it did not find any CVST charges against him. This is to be expected, as the disease is very rare and only about 21,000 people have been vaccinated in the trial.
Even before Tuesday’s arrival from health officials in the United States, some experts were concerned that a tense history could make the U.S. population less enjoyable than other alternatives already available.
“The FDA has to make a decision, but even if the vaccine is approved, it can be difficult to persuade people to drink it,” Moore told BuzzFeed News on Monday. “Awareness can happen somewhere like this, and trust in people may not be there yet.”
Last week, a Biden officials announce to borrow millions of AstraZeneca vaccines from Canada and Mexico, where they have already been approved.
Dan Vergano reported on the matter.