AstraZeneca vaccine: Independent review board raises concerns about trial data

AstraZeneca vaccine: Independent review board raises concerns about trial data

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“The DSMB expressed concern that AstraZeneca may have included outdated information from that study, which may have provided an incomplete view of the efficacy data,” said the NIAID statement released on Tuesday.

“We urge the company to work with the DSMB to review effectiveness data and ensure that the most accurate and up-to-date effectiveness data is made public as soon as possible.”

On Monday, AstraZeneca issued a press release saying its Covid-19 vaccine was 79% effective against symptomatic diseases and 100% effective against serious illness and hospitalization, citing long-awaited US test data. 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 coronavirus meeting on Monday.

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in the statement on Tuesday, AstraZeneca said the figures shared on Monday were based on a pre-specified interim analysis with a February 17 data cut.

“We will immediately contact the independent data security monitoring board (DSMB) to share our primary analysis with the most up-to-date efficacy data,” said the statement. “We intend to issue the results of the primary analysis within 48 hours.”

The DSMB is a group of independent experts who see test data before pharmaceutical companies, the doctors who conduct it, or even the U.S. Food and Drug Administration. He has the power to advise a company on positive interim findings or to interrupt a study for security reasons. It happened with the AstraZeneca study in September, after a study participant developed neurological symptoms, for example.

Last year, the National Institutes of Health appointed a joint DSMB to monitor the Covid-19 vaccine clinical trials that were being funded by the federal government – including AstraZeneca, Moderna and Johnson & Johnson. This DSMB has 10 to 15 members with specialties, including vaccine development, statistics and ethics.

Fauci said on Good Morning America on Tuesday that when the DSMB saw the AstraZeneca press release, “they were concerned and wrote a rather rough note for them – and a copy for me – saying that they actually felt that the data that was in the press release was a bit outdated and may actually be a little bit misleading, and they wanted them to fix that. “

‘Unforced error’ may raise doubts about vaccine

AstraZeneca’s press release was “an unforced error” that may raise doubts about what “is most likely a very good vaccine,” said Fauci. The data is “really very good, but when it was published in the press release, it was not entirely accurate”.

The fact that the DSMB noticed the discrepancy was an example of a safeguard against vaccines, said Fauci.

But, having seen the letter from the monitoring committee, “we couldn’t just leave it unanswered.”

FDA, CDC advisers say they expect many questions about the AstraZeneca Covid-19 vaccine
“We felt that we could not be silent,” Fauci told STAT on Tuesday. “Because if we were to remain silent, we could be accused of covering up something. And we definitely didn’t want to be in that position.”

Still, a public statement questioning AstraZeneca’s data is unusual.

DSMBs sometimes disagree with researchers about the interpretation of the study results, said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, in a statement to the UK’s Science Media Center. But this is usually done privately, he said, “so this is unprecedented in my opinion.”

Dr Peter Hotez, a vaccine specialist and dean of tropical medicine at Baylor medical school, told CNN that the NIAID statement was “totally strange”.

“I can barely understand the dispute or why they would make it so public,” said Hotez. “My concern is that this will further erode 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 at this time.”

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This is not the first time that AstraZeneca faces doubts about its Covid-19 vaccine. In November, it was revealed that there was an error in the trial and some participants received the wrong dose.

More recently, several European countries, including Norway, France and Denmark, have temporarily suspended their launches of the AstraZeneca vaccine due to reports of blood clotting in patients.

An emergency investigation by the European Medicines Agency found that the vaccine’s benefits outweigh the risks, saying the vaccine is “safe and effective” in preventing coronavirus and “is not associated with an increased overall risk of thromboembolic events or blood clots . “

There is no indication that the DSMB concerns noted in the NIAID statement were related to safety problems with the AstraZeneca vaccine.

US order expected in April

AstraZeneca says it plans to apply for emergency use authorization from the U.S. Food and Drug Administration in early April. At that time, your vaccine data will undergo a rigorous review and evaluation process.

On Tuesday, the White House senior consultant to Covid’s response, Andy Slavitt, tried to assure the public that any authorized vaccine will be safe and effective.

“We are now talking about a fourth vaccine that has not yet been approved by the FDA. And the reason we have an FDA process is exactly so that we don’t have to question the data. We don’t need to take a company’s word for it, with all respect for companies, “said Slavitt during an interview with CNN on Tuesday.

“The public must be sure that nothing will be approved unless the FDA does a thorough analysis of that data and, when it does that thorough analysis, it will make a judgment about what the data says, or what it is saying, and also whether or will not be approved. “

Naomi Thomas, Nadia Kounang, Jo Shelley and Jason Hoffman contributed to this report.

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