Milwaukee Journal Sentinel

US experts protest as Europe pulls vaccinatio­n

Move could tarnish all shots’ reputation­s

- Karen Weintraub

Countries across Europe are pausing their use of AstraZenec­a-Oxford University’s COVID-19 vaccine, saying they are acting out of caution, but U.S. scientists say it’s an irresponsi­ble move that threatens the global vaccinatio­n effort and the opportunit­y to end the pandemic.

“While it’s easy to scare people, it’s very hard to unscare them,” said Dr. Paul Offit, director of the Vaccine Education Center and an infectious­diseases specialist at Children’s Hospital of Philadelph­ia.

Taking the vaccine off the market – even temporaril­y – could doom the AstraZenec­a-Oxford vaccine and tarnish all the other vaccines as well, he said.

“It affects not only that vaccine. It creates the perception that these vaccines are dangerous,” he said. “The only way out of this pandemic is by vaccinatio­n, and if we make people reluctant to be vaccinated, we’re going to have a hard time getting out of this pandemic.”

None of the 370 participan­ts in the University of Wisconsin-Madison portion of the AstraZenec­a trial have experience­d blood clots, said William Hartman, the researcher leading the work in Madison and an assistant professor of anesthesio­logy at UW. UW participan­ts all received their second shots at least a month ago, and all of their data has been submitted to AstraZenec­a.

Hartman said he was not aware of any participan­ts in the entire U.S. trial having suffered blood clots.

Hartman expressed surprise that some AstraZenec­a patients have suffered blood clots, given that there have been no such problems with two vaccines made using the same method: the Johnson & Johnson and Russianmad­e Sputnik vaccines.

One woman in Denmark died after developing a blood clot soon after being vaccinated with the AstraZenec­aOxford vaccine, and 30 others across Europe reportedly developed blood clots within several weeks of vaccinatio­n.

France, Germany, Italy and other European countries have followed Denmark’s lead in taking the vaccine off the market while the cases are investigat­ed.

But blood clots are quite common. About 900,000 people suffer from them annually in the United States, about one of every 1,000 adults according to the U.S. Centers for Disease Control and Prevention.

Whether the clots were caused by the vaccine or occurred coincident­ally remains unclear.

The company has said that there were fewer blood clots among the vaccinated population than the general populace. Not enough data have been made public to understand whether there are any indication­s the vaccine might be causing these medical problems.

Offit and other American scientists said that decision may have seemed like a conservati­ve, responsibl­e one, but in fact was radical and risky.

“Unless there is an unusually high rate of blood clots among people receiving a particular vaccine, I just think it’s quite dangerous to draw these kind of conclusion­s of causality without knowing,” said Akiko Iwasaki, an epidemiolo­gist and immunobiol­ogist at Yale University.

Dr. William Schaffner, an infectious­disease specialist at the Vanderbilt University School of Medicine in Nashville, said he’s surprised that so many countries put their AstraZenec­a-Oxford vaccine programs on hold without knowing the outcome of investigat­ions.

Schaffner and the others said it would have made more sense to continue using the vaccine while investigat­ions are underway, rather than prematurel­y scare people about vaccinatio­n.

If the investigat­ions clear the vaccine, as seems likely based on current evidence, Schaffner said, European countries “will have to really work hard to restore confidence in the vaccine and the vaccinatio­n program.”

Any time a vaccine or treatment is given to a large segment of the population medical issues are likely to arise – just as they do at other times.

To show a vaccine is the cause of these problems, scientists have to connect the events in time, show one could be the cause of the other (car accidents are unlikely to be caused by vaccines, for instance) and that they are happening more frequently than in a general population.

In a statement, AstraZenec­a said that its vaccine was not causing an unusual number of clots. “Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population,” according to the statement.

The British drug regulatory agency also said evidence “does not suggest” the jab causes clots. And the World Health Organizati­on says there is no reason to stop using it.

Andrew Pollard, an Oxford University researcher, told the BBC that the risks from COVID-19 vastly outweigh the risks from the vaccine he helped develop.

“It’s absolutely critical that we don’t have a problem of not vaccinatin­g people and have the balance of a huge risk – a known risk of COVID – against what appears so far from the data that we’ve got from the regulators – no signal of a problem.”

He added there was “very reassuring evidence that there is no increase in a blood clot phenomenon here in the U.K., where most of the doses in Europe been given so far.”

Mark Johnson of the Journal Sentinel staff contribute­d to this report.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competitio­n in Healthcare. The Masimo Foundation does not provide editorial input.

 ??  ?? AstraZenec­a has said there were fewer blood clots among the vaccinated population than the general populace.
AstraZenec­a has said there were fewer blood clots among the vaccinated population than the general populace.

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