The FDA announced the pause after six individual cases of blood clots in women between the ages of 18 and 48. Nearly 7 million one-dose shots have been administered since the vaccine was approved for emergency use in late February.
“6 cases out of 7 million people. What a disaster,” Silver reacted on Twitter. “This is going to get people killed. And it’s going to create more vaccine hesitancy. These people don’t understand cost-benefit analysis. They keep making mistakes by orders of magnitude.”
The political polling guru told another Twitter user the FDA had “failed” its “high-stakes test” of messaging, since those skeptical of taking the vaccine may also write off the Pfizer and Moderna vaccines following the announcement. Silver also cited data showing public confidence in the AstraZeneca vaccine has plummeted in Europe following that vaccine’s pause.
“Why did the FDA recommend the pause anyway? Because of a combination of institutional culture, cognitive biases, and bureaucratic imperatives incentives, they greatly overweight the importance of rare adverse effects relative to people dying from COVID,” Silver argued. “But unless they know about that institutional culture, it’s understandable that regular folks may think ‘hmm, maybe there’s more going on’. Especially when public health officials have eroded trust by telling a lot of ‘noble lies’ to people, e.g. in the early days re: masks.”
Silver then compared the FDA’s logic to a scenario in which California Gov. Gavin Newsom closed all beaches “out of an abundance of caution” in order to investigate rare shark attacks, writing “that’s not likely to get more people to go out to the beach, even once beaches reopen.”
“I think it’s important though that there *hadn’t* been a particular public/media panic about blood clots and the J&J vaccine, at least not yet,” Silver tweeted. “So the FDA is sort of creating a Streisand Effect and giving these concerns more salience.”
Silver also acknowledged that while he “could be wrong,” he stressed that the pandemic has become a “political/media focal point” and wondered if the FDA consults “experts” who can address broader concerns about such a decision.
In a statement, the FDA noted that the blood clots “appear to be extremely rare” and added that the Centers for Disease Control and Prevention (CDC) “will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance”. The FDA will then review that analysis.
However, the FDA said it is “recommending this pause” until that review is completed.
In a statement to Fox News, Johnson & Johnson said the “safety and well-being of people who use our products” remains the company’s number one priority, and that it was aware of an “extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine.”
Fox News’ Brian Flood and Alexandria Hein contributed to this report.