“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.”
Federal health agencies are now calling for an immediate pause in the use of Johnson & Johnson’s COVID vaccine after six American recipients of the product developed blood clots within about two weeks of vaccination.
All six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalized in critical condition.
Nearly seven million people in the United States have received Johnson & Johnson shots so far, and roughly nine million more doses have been shipped out to the states, according to data from the Centers for Disease Control and Prevention.
“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the C.D.C., said in a joint statement. “Right now, these adverse events appear to be extremely rare.”
The CDC’s Advisory Committee on Immunization Practices is meeting this week to discuss the six cases. The FDA has also launched an investigation into the cause of the clots and low platelet counts.
“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Anne Schuchat, principal deputy director of the CDC, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a joint statement.
They are recommending that people who were given the J&J vaccine who are experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the shot contact their health care provider.
U.S. health authorities cautioned doctors against using a typical clot treatment, the blood-thinner heparin. “In this setting, administration of heparin may be dangerous and alternative treatments need to be given,” the FDA and CDC said.
States in the process of distributing the vaccine have been caught off guard. So far, Michigan, Mississippi, and New York have ceased the distribution of the one-shot vaccine.
There are also concerns about increasing “vaccine hesitancy” among those who have not yet received doses.
Tuesday’s announcement caught state officials already struggling to meet demand with scant supply off-guard and raised immediate concerns about how the move might make Americans hesitant to get the vaccine even unwilling to do so.
“Honestly, your note is the first I’ve heard of this,” the chief of staff for a southern governor told CBS News when contacted early Tuesday.
A top aide involved in pandemic response for a northeastern governor called the pause “a very serious problem” and comes amid an already scheduled declining supply of the Johnson & Johnson that was causing changes in the system’s vaccine plans.
“This really impacts how many people you can full vaccinate by the summer. Additionally it may cause more hesitancy,” the official said.
I want to note that the national reproduction number is now one, which means the coronavirus is spreading at a level of one new person for one infected person, and the epidemic is nearing its end. Any action that delays the distribution can also halt many areas’ reopening, especially where blue state restrictive policies are preventing regular business and personal activities.
The wisdom of the decision is also being questioned, given the exceedingly small number of cases compared to the number of shots provided.
For context, clotting appeared in far fewer than 1 in a MILLION J&J recipients.
The Biden WH needs to make clear to the public that these vaccines are safe & effective. By getting them you assume roughly the same level of risk you do taking many OTC meds.
— Alyssa Farah (@Alyssafarah) April 13, 2021
I cannot believe they are pausing the vaccine when you have a 99.9992% chance you wont get these blood clots….assuming the vaccine even does cause them. This is ridiculous
— Geoff Keller (@kellerg2) April 13, 2021
My take: The CDC and FDA officials have enjoyed enormous sway over the American people for over a year. They are on the precipice of losing the spotlight, and this is one last gasp before the combination of natural immunity and vaccines returns them to the halls of the faceless behemoth of bureaucracy again.
It would also have helped if the American press reported news factually without the dramatics. Reporters have not gotten over their Trump-era hysteria yet.
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