Howard Dean Says FDA 'Went Too Far' in Pausing Johnson & Johnson Vaccine

Former Democratic Vermont Governor Howard Dean joined numerous lawmakers and doctors Tuesday in criticizing the U.S. Food and Drug Administration, saying it "went too far" when it "paused" Johnson & Johnson vaccinations, citing scattered reports of resulting blood clots.

On Tuesday morning, officials at the FDA and Centers for Disease Control and Prevention recommended a "pause" in application of the single-shot "J&J" vaccine for COVID-19. Acting FDA Commissioner Janet Woodcock said the delay should only last a "matter of days" and is part of a precautionary response to investigative reports of potentially dangerous blood clots developing in some recipients. Dean, a physician and former Democratic National Committee chairman, said the agency may have overstepped its regulatory boundaries in calling for the pause.

But Dean earlier shared a post Tuesday morning which said the U.S. news media and American public at large shouldn't conflate the precautionary Johnson & Johnson halt with unproven claims that "the J&J vaccine is not safe and the others may not be either."

"I think the FDA went too far here. If there were a clinical trial of this size with this data, the drug would be licensed with appropriate warning," Dean tweeted Tuesday morning.

The 2004 Democratic presidential candidate's criticism was in reply to a Twitter user who said she was "glad" to have previously received the Johnson & Johnson vaccine, adding that she'd experienced "no side effects." Dean also retweeted statistics guru Nate Silver's take on the news, where he challenged the FDA's response as an overly guarded, knee-jerk reaction.

I think the FDA went too far here. If there were a clinical trial of this size with this data, the drug would be licensed with appropriate warning https://t.co/xMO1xKG5RA

— Howard Dean (@GovHowardDean) April 13, 2021

"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 wrote in the Tuesday morning tweet shared by Dean.

Numerous lawmakers from both political parties joined physicians and journalists on social media in saying the federal public health agencies could have communicated the vaccine "pause" much more effectively. Walid Gellad, M.D. at Pittsburgh Public Health, said the "release of this information to the public could have been better, stressing the positive...But everyone else should also pause their analysis for 2 days until FDA reviews the data."

Dean on Tuesday also shared a thread from journalist Matthew Gertz, who warned about the communication issues stemming from the FDA and CDC announcement. Gertz noted that Fox News and right-wing conspiracy theorists are already capitalizing on confusion on whether the Johnson & Johnson vaccine—or any of the vaccines—are safe at all:

"I am extremely skeptical of the ability of public messaging to disaggregate 'the J&J vaccine is under review as a precaution' from 'the J&J vaccine is not safe and the others may not be either' in the minds of normal people. An incredibly crucial, high-stakes test for the press."

Newsweek has reached out to representatives for Dean as well as the FDA and CDC for any additional reaction to the Johnson & Johnson pause.

Howard Dean
Howard Dean stated on Tuesday the FDA "went too far" in pausing the Johnson & Johnson vaccine. Here the former Vermont governor delivers remarks at the Democratic National Convention on July 26, 2016 in Philadelphia. Aaron P. Bernstein/Getty Images