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(CNN) – In an unusual statement released early Tuesday, the National Institute of Allergy and Infectious Diseases said the independent board reviewing data from multiple COVID-19 vaccine candidates has raised concerns about AstraZeneca’s announcement of efficacy data from your vaccine trial.
“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” said the NIAID statement released early Tuesday.
“We urge the company to work with the DSMB to review the effectiveness data and ensure that the most accurate and up-to-date effectiveness data is released as soon as possible.”
On Monday, AstraZeneca had issued a press release saying its COVID-19 vaccine was 79% effective against symptomatic illnesses and 100% effective against serious illnesses and hospitalizations, citing data from long-awaited American trials. The latest figure was based on five total cases of serious illness or hospitalization in people who received the placebo, said NIAID Director Dr. Anthony Fauci during a briefing on the coronavirus on Monday.
In a statement Tuesday, AstraZeneca said the figures shared Monday were based on a pre-specified interim analysis with a February 17 data cutoff. He said that he had reviewed an initial assessment of his primary analysis and that those results were consistent with the interim analysis. .
“We will immediately engage with the Independent Data Safety Monitoring Board (DSMB) to share our main analysis with the most up-to-date efficacy data,” the statement said. “We intend to publish the results of the primary analysis within 48 hours.”
The DSMB is a group of independent experts that views trial data before drug companies, the doctors conducting the trials, or even the US Food and Drug Administration. It has the power to advise a company on positive interim conclusions. or to stop a trial for security reasons. That’s what happened to the AstraZeneca trial in September after a study participant developed neurological symptoms, for example.
Last year, the National Institutes of Health designated a common DSMB to monitor COVID-19 vaccine clinical trials that were being funded by the federal government, including AstraZeneca, Moderna, and Johnson & Johnson. This DSMB has 10-15 members with specialties including vaccine development, statistics, and ethics.
Fauci said on Good Morning America Tuesday that when the DSMB saw AstraZeneca’s press release, “they got concerned and wrote them a pretty tough note, and with a copy for me, saying that they actually felt that the data that was in the press release they were somewhat out of date and could actually be a bit misleading, and they wanted to clarify. “
An ‘unforced error’ could raise questions about the vaccine
AstraZeneca’s press release was “an unforced error” that may raise questions about what “is very likely to be a very good vaccine,” Fauci said. The data is “pretty good, but when they put it in the press release, it wasn’t entirely accurate.”
The fact that the DSMB noticed the discrepancy was an example of a safeguard around vaccines, Fauci said.
But having seen the letter from the supervisory board, “we could not leave it unanswered.”
“We just felt we couldn’t be silent,” Fauci told STAT on Tuesday. “Because if we stay silent, it’s understandable that they accuse us of covering up something. And we definitely didn’t want to be in that position.”
Still, a public statement challenging AstraZeneca’s data is unusual.
DSMBs sometimes disagree with researchers on the interpretation of trial results, Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said in a statement to the Science Media Center in the UK. But that’s usually done in private, he said, “so this is unprecedented in my opinion.”
Dr. Peter Hotez, a vaccine expert and dean of tropical medicine at Baylor School of Medicine, told CNN that the NIAID statement was “totally bizarre.”
“I can hardly understand the dispute or why they would make it so public,” Hotez said. “My concern is that this further erodes public confidence in the AZOX vaccine, especially for low- and middle-income countries. And we don’t have many options for Africa and Latin America right now.”
This is not the first time AstraZeneca has faced questions about its COVID-19 vaccine. In November, it was revealed that a trial error was made and some participants received the wrong dose.
More recently, several European countries, including Norway, France, and Denmark, temporarily suspended the launch of the AstraZeneca vaccine due to reports of blood clotting in patients.
An emergency investigation by the European Medicines Agency concluded that the benefits of the vaccine outweigh the risks, and said the vaccine is “safe and effective” in preventing coronavirus and “is not associated with an increased overall risk of events. thromboembolic or blood clots. “
There is no indication that the DSMB concerns noted in the NIAID statement were related to safety concerns with the AstraZeneca vaccine.
US application expected in April
AstraZeneca says it plans to apply for an emergency use authorization from the US Food and Drug Administration in early April. At that time, your vaccine data will go through a rigorous review and evaluation process.
On Tuesday, the White House’s senior adviser for the Covid response, Andy Slavitt, tried to assure the public that any licensed vaccine will be safe and effective.
“We’re talking about a fourth vaccine that hasn’t been approved by the FDA yet. And the reason we have an FDA process is exactly so that we don’t have to worry about the data. We don’t have to take the word of one company. therefore, with all due respect to companies, “Slavitt said during an interview on CNN on Tuesday.
“The public needs to be sure that nothing will be approved unless the FDA does a thorough analysis of this data, and when it does that thorough analysis, it will make a judgment on what the data says or what it says, and also whether or not will not be approved. “
This story was first published on CNN.com, “Trial Review Board Raises AstraZeneca Vaccine Data Concerns.”
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