Wednesday, May 11, 2022

Again? AstraZeneca faces vaccine PR problems as regulators push back on data and pundits shake their heads

Magic Mountain has nothing on the ups and downs of AstraZeneca’s COVID-19 vaccine.

The latest? An AstraZeneca press release yesterday touting its U.S. vaccine trial results, followed within hours by a rebuke from U.S. health agencies. The release “may have included outdated information,” the National Institute of Allergy and Infectious Disease said in a middle-of-the-night statement.

AstraZeneca then followed up Tuesday morning with an additional statement saying the “results were consistent with interim analysis.” It promised to issue a primary analysis and “most up-to-date efficacy data” within 48 hours.

Social media reacted swiftly—with many scientists and pundits stunned by both the admonishment from the independent Data and Safety Monitoring Board and National Institutes of Health, as well as AstraZeneca seeming to take another misstep.

Sentiments like “unprecedented,” “speechless,” “never seen anything like this” and even “debacle” sprung up across blue-check verified medical Twitter accounts.

RELATED: AstraZeneca scrambles to update COVID-19 vaccine data after NIH flags ‘concerns’ about Monday’s triumphant release

Epidemiologist and health economist Eric Feigl-Ding wrote “This is wild” in the first of his series of tweets explaining the back and forth between AZ and NIH. Just what did he mean by “wild,” someone asked? His answer: “This sort of thing never happens.”

Eric Topol, Medscape editor-in-chief and founder and director of the Scripps Research Translational Institute said it was unprecedented for a DSMB “calling out a company about their data being incorrect.”

Even President Joe Biden’s chief medical adviser Anthony Fauci called it an “unforced error” on AstraZeneca’s part.

“It really is unfortunate that this happened,” he said in an interview on Good Morning America Tuesday.

“It was not necessary—if you look at it, the data really are quite good, but when they put it into the press release it wasn’t completely accurate,” he added.

As Fauci also pointed out, the data squabble means little when it comes to the AZ vaccine’s approval process at the FDA. The agency and an expert committee will review the data independently before choosing whether to authorize the shot for emergency use.

RELATED: How can Johnson & Johnson and AstraZeneca fight vaccine misperceptions? Try straight talk

But no matter what happens next—FDA review and an emergency approval as expected—AstraZeneca is undoubtedly facing another public relations debacle. The U.S. misstep comes on the heels of a rolling series of stumbles, fumbles and roadblocks in Europe. Its initial data reports left out explanations about dosage mistakes that spawned confusing data. Limited data on efficacy among recipients over age 65 led to European countries holding off on using the shot in older people.

A Bloomberg columnist labeled AZ’s vaccine debut the worst PR flop of 2020—and that was in December, long before any 2021 issues occurred.

Just last week, the vaccine weathered another European kerfuffle; some countries halted vaccinations after serious blood clots cropped up in some recipients, only to restart days later after EU officials deemed the AZ shot safe. They didn’t rule out a link between the vaccine and clotting problems, though, and said they’d raise awareness of symptoms just in case.

Still, the upshot is that safety and efficacy perception problems are ramping up, with reports of some Europeans refusing to take the AZ shot. And now, experts worry the same may happen in the U.S.

Meanwhile, as Pfizer, Moderna and now Johnson & Johnson seemed to manage their rollouts more smoothly, AstraZeneca’s vaccine perception fares even worse by comparison.

Just a few weeks ago, J&J introduced its COVID-19 vaccine—which, like AstraZeneca’s, is adenovirus-based—with widespread and simple communications through the U.S. media, both paid and unpaid. CEO Alex Gorsky hit the TV news circuit to get the word out that the J&J vaccine is safe and effective the day after its emergency approval, while Fauci talked about the vaccine’s safety in White House Task Force videos on social media. 

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