J&J Vaccine ‘Pause’ Reveals U.S. Regulators’ Abundance of Recklessness
It seems obvious that a rapid, widespread vaccination campaign offers our nation the best chance of bringing the COVID-19 pandemic to a swift end.
That observation is apparently lost on federal public health officials. Last week, the Centers for Disease and Control and Prevention and the Food and Drug Administration told healthcare providers to stop administering Johnson & Johnson’s one-dose COVID-19 vaccine over concerns that the shot could cause blood clots in rare cases. Dr. Anthony Fauci, the head of National Institute of Allergy and Infectious Diseases, predicted this past Sunday that the pause would end on Friday, April 23.
COVID-19 poses a far more dangerous threat to public health than J&J’s vaccine. By halting this shot, federal regulators put many more American lives in danger.
The CDC initially hit pause on J&J’s vaccine after six Americans who had received the shot developed blood clots. By that time, 6.85 million doses of the vaccine had been administered to patients. So the chances of experiencing this side-effect were literally one in a million.
Regulators made their decision out of “an abundance of caution.” And the pause was originally supposed to last a few days. That was before the CDC advisory panel charged with determining whether to move forward with the shot demanded more data. If Dr. Fauci’s prediction holds up, we will have lost nearly two weeks of vaccination time — and next to nothing will have changed.
How could officials whose job it is to keep this country safe and healthy systematically deny Americans this life-saving vaccine in the middle of a pandemic? COVID-19 continues to kill nearly 700 Americans every day, while infecting more than 66,000.
The J&J vaccine was shown to be 100 percent effective at preventing hospitalization and death from the disease. And it achieves these results with just a single dose, eliminating some of the logistical challenges that come with two-dose vaccines like Moderna’s or Pfizer’s.
The six blood clots occurred exclusively in women ages 18 to 48. Ninety-five percent of those who have died from COVID-19 in the United States are age 50 or older. At the very least, regulators could have limited the pause to younger Americans and let older patients continue to get the jab.
What they have done instead is neither cautious, nor science-based, nor in the best interest of Americans. It’s a reckless maneuver intended to protect the jobs and reputations of federal regulators. They’re unlikely to be blamed when more Americans die of COVID-19. But they know they’ll take heat if there’s even one excess adverse reaction to a vaccine. So the vaccine stays locked up.
This mindset has impeded America’s COVID-19 response for more than a year now. From the tragically slow ramp-up in COVID-19 testing last spring, to the noble lies advising people not to mask up early in the pandemic, to the shortages of personal protective equipment created by outdated regulations, to the delayed authorization of AstraZeneca’s vaccine, America’s overly risk-averse regulatory bureaucracy has consistently made the worst health crisis in a generation even worse.
This risk-aversion would be a little more palatable if the risks being avoided concerned the health of Americans. But from the look of things, healthcare regulators seem mainly to care about risks to their own careers, political influence and public image.
People will die because of the pause of J&J’s vaccine. Tragically, they’ll be only the latest casualties of regulatory sclerosis.
Sally C. Pipes is president, CEO, and the Thomas W. Smith fellow in healthcare policy at the Pacific Research Institute. Her latest book is “False Premise, False Promise: The Disastrous Reality of Medicare for All,” (Encounter 2020). Follow her on Twitter @sallypipes.Read More