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AstraZeneca missteps threatens to additional undermine confidence if the corporate seeks US approval

A medical syringe and vial in front of the logo of UK biopharmaceutical company AstraZeneca in this illustrative photo taken on November 18, 2020.

STR | NurPhoto | Getty Images

U.S. health officials released a bizarre statement early Tuesday that AstraZeneca may have based the results of its Covid-19 vaccine study on outdated information.

The company’s fumbling was just the latest “self-inflicted wound” in a series of missteps that threaten to undermine public confidence in his shot, public health and vaccine experts told CNBC.

On Monday, AstraZeneca announced the long-awaited results of its Phase 3 clinical trial of the Covid-19 vaccine it was developing at Oxford University. He said it was 79% effective in preventing symptomatic illness and 100% effective against serious illness and hospitalization. According to the company, the analysis was based on 32,449 participants in 88 test centers in the USA, Peru and Chile.

Results questioned

The National Institute of Allergy and Infectious Diseases questioned the accuracy of these findings early Tuesday when it was informed by the Data and Safety Monitoring Committee that oversees the study that the UK-based company may have information in the results of its U.S. Vaccine studies included that have provided an “incomplete view of efficacy data”.

“We urge the company to work with the DSMB to review efficacy data and ensure the most accurate and up-to-date efficacy data is released as soon as possible,” said a NIAID statement.

NIAID director Dr. Anthony Fauci said the DSMB, an independent group of experts overseeing clinical trials in the United States, has raised concerns with the agency that the results in AstraZeneca’s press release are more favorable than more recent data from the vaccine study showed, according to STAT News. “I was kind of stunned,” Fauci told STAT, The agency could not be silent.

Unusual statement

The statement by NIAID, which is part of the National Institutes of Health, is highly unusual, health experts said. The last time a US agency statement attracted so much attention was in September when one of its panels said there was “not enough data” to show convalescent plasma work against the coronavirus, in line with claims of the then FDA commissioner Dr. Stephen Hahn disagreed.

AstraZeneca’s data hiccup is just the latest example in a series of mistakes the company has made that could affect people’s willingness to take the vaccine, which may be approved as early as next month in the U.S., said Isaac Bogoch, an infectious disease expert sat on numerous data and security oversight boards.

The problems first started in September after the company failed to promptly inform Food and Drug Administration officials that it called off its trial worldwide after a participant in a study fell ill, according to the New York Times. The company would face other issues later, including criticism, after volunteers were given incorrect vaccine doses in its studies and countries asked if its vaccine was suitable for use in people over 65. Most recently, countries suspended the use of the shot after reports of temporary blood clots in some vaccinated people.

Avoidable defects

“This has been an endless roller coaster ride of what I might call an avoidable communication mistake,” Bogoch told CNBC. “You have to be open, you have to be honest, you have to be transparent. That includes both the good and the bad news.”

Bogoch said the missteps were not good for public confidence in the vaccine, adding, “We are already dealing with issues of public confidence in the launch of the vaccine [overall] and one must have public trust to have a successful public health initiative. “

Dr. Leana Wen, professor of public health at George Washington University and former Baltimore health commissioner, said AstraZeneca’s recent hiccups could damage not only public confidence in the company’s vaccine, but all Covid-19 vaccines.

“At this point it is really important that there is complete transparency. We need to know what happened. Why does there seem to be this discrepancy in the data?” Said Wen. “I don’t remember seeing public disagreements like this one. And that is again throwing red flags at a time when we can least afford it.”

‘Be assured’

During an interview on CNN Tuesday, President Joe Biden’s senior advisor on the pandemic, Andy Slavitt, attempted to reassure Americans about the vaccines, saying, “The public should be confident that nothing will be approved if the FDA does not thoroughly analyzed. ” Data.”

When the AstraZeneca vaccine is reviewed by the FDA, the agency will “judge what the data says or what it says and whether or not it is approved. Until then, this is all just stuff that will do it.” happen in the background, “said Slavitt.” We believe this transparency and scientific independence are critical to public trust.

While Americans may not trust the vaccine, the data debacle is unlikely to affect the FDA’s review of the shot once the company submits it for emergency approval, said Lawrence Gostin, a law professor and director of the Collaborating Center on National and International the World Health Organization Global Health Law.

Pivot

“It certainly doesn’t help if the NIH rebukes you shortly before the application for approval,” Gostin said, adding that the number of “self-inflicted wounds” the company had “was astounding.” “AstraZeneca has a good and safe vaccine that I think will help vaccinate America and the world.”

Dr. William Schaffner, an epidemiologist who previously sat on two data security supervisory boards for staphylococcal vaccines, said the eventual FDA approval will be crucial not only for the US but for other countries as well, as AstraZeneca’s vaccine is cheaper and easier to sell than its competitors.

“That would resonate around the world and give other health ministries confidence in this vaccine,” said Schaffner.

Correction: This story has been updated to correct the AstraZeneca vaccine dosing regimen. It requires two doses.

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