U.S. health officials are questioning the results of AstraZeneca’s vaccinations

AstraZeneca results in a key US trial of its COVID-19 vaccine, issued by press release it exceeded the expectations of experts on Monday morning. A day later, U.S. health officials questioned the results, which have not yet been released in full.

In one trial More than 32,000 volunteers took part, two-thirds of whom were vaccinated when the shots were 79% effective in preventing symptomatic COVID-19, the company said. This was based on 141 cases of the disease that occurred in the arms of the test vaccine and placebo. There was no serious illness among the people who were vaccinated that required hospitalization. compared to placebo arm five, Anthony Aluci, head of the National Institute of Allergy and Infectious Diseases (NIAID), said at a news conference at the White House on Monday.

“The good news is that there was also comparable effectiveness in terms of ethnicity and age,” Fauci said.

But early Tuesday morning, NIAID issued an unusual statement questioning the company’s results report. The company “may have included outdated information from that trial,” the document said, “which could have provided an incomplete view of the efficiency data.”

The document says late Monday that the Data Security Monitoring Committee, an independent team of medical experts tasked with overseeing AstraZeneca’s U.S. trial, told NIAID and other health officials it was “concerned” with the way the results were presented.

On Tuesday morning, AstraZeneca responded to concerns raised by an independent panel of experts. “Numbers published they were based on a pre-determined interim study yesterday, with a data resolution on Feb. 17, ”the company wrote.“ We reviewed the preliminary assessment of the first analysis and the results were consistent with the interim study. We are now completing the validation of the statistical analysis. “

The company promised to work with the independent panel “immediately” to “share our first analysis with the latest efficiency data,” saying it would deliver results in the next two days.

“As a member of the FDA’s advisory board, I want to see all the data, all the data that’s been collected. Any experience with this. All that’s important for the decision,” said Paul Offit, a vaccination expert at Children’s Hospital Philadelphia, on the FDA’s vaccine advisory committee. “The most important thing we consider with these vaccines is safety. Security, safety, security “.

Appearing Good morning in America on Tuesday, Fauci said the DSMB wrote a “rather harsh note” to AstraZeneca, copying Fauci, saying the data in the press release “could actually be a bit misleading.”

“It’s really unfortunate that this has happened,” Fauci said. “This is what you call a non-mandatory mistake, because it’s a very good vaccine.”

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

“It’s a good vaccine, but these things related to public relations get mixed up and complicated. It’s harder for the public to look at what’s going on. We want a clean, easy-to-interpret process,” University of Florida Natalie Dean told BuzzFeed News. “It simply came to our notice then. But not everything looks good to anyone. ”

NIAID’s statement caught a lot of scientists.

“We are in a territory we do not know. DSMBs don’t usually do things like that,
and a federal agency bar to provide a statement of concern
it’s very, very high about a high-profile corporate test, ”John Moore, a virologist at Weill Cornell Medical College in New York, told BuzzFeed News in an email.

The statement from U.S. health officials is the latest in the problems AstraZeneca COVID-19 vaccine trials have had.

Previous results from the UK and Brazil trials – developed by the University of Oxford, which developed the vaccine – showed an overall efficiency of 70%. Scientists were critical of these trials, including a number of experimental subgroups with patients of different age ranges, doses, and intervals between the two vaccine shots. it is very difficult to interpret the numbers.

This meant that the Oxford team was unable to gather relevant data to answer a key question: Does the vaccine protect the most vulnerable elderly people from COVID-19? This affected some nations, initially including Germany delay the vaccination for use in older groups.

The new trial finally has enough data to answer that question, according to the company’s release. Analysis of the results for people 65 years of age and older showed an 80% efficacy in preventing symptomatic COVID-19.

“These findings confirm previous results seen in AZD1222 trials in all adult populations, but it is exciting to see similar results in people over 65 for the first time,” said Ann Halsey of the University of Rochester School of Medicine. AstraZeneca, the company said in a statement.

Essentially, the new trial in the US and many other countries much simpler design Rather than the one led by the Oxford group, only two experimental groups. Volunteers were given two doses of the vaccine within four weeks or two injections of salt as a placebo control.

Moore, who has been a notable critic of Oxford’s trials, described the U.S. trial last week to BuzzFeed News as a “rigid protocol” that should create findings that are easier to evaluate.

The company has not yet released any data beyond the results summarized in the press release, but said it will send “a document” for publication in a revised journal. ”The results will be sent as a focus of AstraZeneca’s request to the FDA to authorize emergency vaccination in the U.S.

“We are ready to send these findings to the U.S. Food and Drug Administration and provide millions of doses in America if the U.S. Emergency Use Vaccine were to be granted,” Mene Pangalos, vice president of AstraZeneca biopharmaceuticals, said in a statement Monday. .

Based on these results, AstraZeneca’s two-dose vaccine is more effective in preventing COVID-19 than a single shot by Johnson & Johnson 66% effective in the main experiment in disease prevention. Both appear to be more effective than two-shot vaccines by Pfizer / BioNTech and Moderna in that they exceed 90% effectiveness. It seems that all four vaccines have very high protection against severe COVID-19.

The new test results came last week after AstraZeneca feared the safety of the vaccine, when several European nations temporarily withdrew the vaccine from use. it reports a strange but severe blood clot.

The European Medicines Agency analyzed data on nearly 20 million people who were vaccinated and found 18 cases actual cerebral sinus thrombosis (CVST), bleeding from the brain and causing bleeding and seven cases extended individual coagulation (DIC), which causes clots in tiny blood vessels in the body. The agency could not rule out a link to the vaccine, but said the benefits of the vaccine in preventing COVID-19. it was much greater than the risk from these serious but very strange situations, and they recommended that the vaccine be restarted.

AstraZeneca said it did not find a CVST case at trial. This was expected, as the situation is very rare and only about 21,000 people were vaccinated in the test.

Even before a statement by U.S. health officials on Tuesday, some experts were concerned that the turbulent history of the vaccine could make it more appealing than alternatives already available to the U.S. public.

“The FDA has to make a decision now, but even approving that vaccine can be difficult to convince people,” Moore told BuzzFeed News on Monday. “Perception can become a reality in situations like this, and people’s confidence may not be there now.”

Last week, The Biden administration has announced AstraZeneca would deliver millions of pre-manufactured doses of the vaccine to Canada and Mexico, which have already been approved.

Dan Vergano has reported this story.