The Mercury News

J&J COVID-19 vaccine pause is costing Americans their lives

- By Marc. A. Thiessen Marc. A. Thiessen is a Washington Post columnist.

The federal government’s decision to halt distributi­on of the Johnson & Johnson vaccine will cost American lives. Indeed, it will almost certainly kill more people by leaving them exposed to COVID-19 than might have died from extremely rare vaccine side effects.

Unfortunat­ely, their deaths do not factor into the calculatio­ns of the Centers for Disease Control and Prevention and the Food and Drug Administra­tion because no one will ever know the names of those who perished as a result of being denied this lifesaving vaccine.

Just eight people out of roughly 7.4 million who received the Johnson & Johnson vaccine have developed a blood-clot complicati­on. Only one person has died. A causal relationsh­ip between the vaccine and these blood clots has not yet been establishe­d.

Hundreds of Americans are dying every day from COVID-19. Demand for vaccines exceeds supply. There are no stockpiles of extra doses of the Pfizer and Moderna vaccines sitting on refrigerat­ed shelves in warehouses waiting to replace all the Johnson & Johnson doses the government has withheld.

Just before the FDA announced its pause on April 13, the United States was administer­ing approximat­ely 475,000 Johnson & Johnson doses per day. Pulling those vaccines from circulatio­n has led to canceled appointmen­ts at vaccine clinics across the country. Many of those who have had their Johnson

& Johnson vaccinatio­n appointmen­ts canceled are in vulnerable population­s.

Ashish Jha, dean of the Brown University School of Public Health, points out that an unvaccinat­ed person’s risk of getting COVID-19 may be as high as 1 in 1,000 per day, and that person’s chances of dying from COVID-19 once they get it is about 1 in 100. So, he calculates, each unvaccinat­ed day the risk of death is 1 in 100,000.

The risk of death after taking the Johnson & Johnson vaccine, by contrast, is 1 in 7.4 million. The danger of developing blood clots from COVID-19 is also far greater than from the vaccine. One study of more than 8,000 COVID-19 patients found that about 20% of those hospitaliz­ed with COVID-19 developed blood clots, which increased to 31% among patients in an intensive care unit. By contrast, 0.000001% of people who received the Johnson & Johnson vaccine have developed clots.

Withholdin­g the Johnson & Johnson vaccine will not only kill people who want to get immunized but can’t; it will also kill people by causing more vaccine hesitancy. An Economist/YouGov poll shows that since the pause took effect, the number of Americans who believe the Johnson & Johnson vaccine is safe has dropped from 52% to just 37%. This will prove deadly when demand is met among those who are eager to be vaccinated, and the government’s job shifts to convincing hesitant Americans to take them.

We will never know precisely how many Americans

died because of the decision to halt the Johnson & Johnson vaccine, or who they were. But their lives matter, and should factor into the government’s decision-making. They don’t because, while there are many good people at the FDA and CDC, they face perverse incentives. Former FDA commission­er Alexander M. Schmidt once told Congress, “In all of FDA’s history, I am unable to find a single instance where a congressio­nal committee investigat­ed the failure of FDA to approve a new drug. But the times when hearings have been held to criticize our approval of new drugs have been so frequent that we aren’t able to count them.”

As Joe DiMasi and Christophe­r-Paul Milne of the Tufts Center for the Study of Drug Developmen­t have explained, “When bad drugs are approved quickly, the FDA is scrutinize­d and criticized, victims are identified, and their graves are marked. In contrast, when good drugs are approved slowly, the victims are unknown.”

With the Johnson & Johnson vaccine, we now see the terrible outcome of these twisted incentives. The FDA approved the vaccine faster than usual because of the pressures of the pandemic. But now public health officials are pulling it back because of eight complicati­ons out of 7.4 million doses and a single death — even though many more people will likely die from the decision to withhold it.

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