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April 14, 2021

News • April 14, 2021

What the CDC and FDA have to say about the pause on the Johnson & Johnson COVID-19 vaccine

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MCHENRY COUNTY – An announcement was made by the McHenry County Department of Health (MCDH) on April 13, that they will be replacing all future J&J clinics with either Moderna or Pfizer until further notice.

This was in response to a recommendation issued that same day by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) warning of six women, ages 18 to 48, having developed a rare and severe type of blood clot six to 13 days after having been vaccinated with the J&J (Janssen) vaccine.

A few officials from both the CDC and FDA held a press conference to answer questions from the media. There, Peter Marks, director for the FDA Center for Biologics Evaluation and Research, explained that the blood clot condition known as cerebral venous sinus thrombosis (CVST) cannot be treated by the typical treatment protocol usually involving an anticoagulant drug called heparin. Alternative, individualized treatment must be administered to people displaying symptoms of CVST to avoid possible fatalities.

“Of the clots seen in the United States, one case was fatal and one patient is in critical condition,” Marks stated.

The CDC’s principal deputy director Anne Schuchat, went to further explain that more that six million doses of the J&J vaccine have been administered in the U.S., pushing the CDC’s Advisory Committee on Immunization Practices (ACIP) to carefully review the data on the initial cases and move forward with next steps in the days to come.

“I know there are people who have gotten the vaccine and are probably very concerned. For people who got the vaccine more than a month ago, the risk for them is very low at this time. For people who recently got the vaccine within the last couple weeks, they should be aware to look for any symptoms,” Schuchat said. “If you receive the vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath you should contact your healthcare provider and seek medical treatment.”

While the Moderna and Pfizer vaccines are known to have their own set of side-effects, both Schuchat and Marks explained they should not be compared to the more severe CVST blood clots as a side-effect of the J&J vaccine.

“These symptoms are different from the mild flu-like symptoms, fever and so-fourth, that many people experience in the couple days after receipt of the vaccine. Importantly, there are three vaccines available and we are not seeing these clotting events with low platelet counts with the other two vaccines,” Schuchat said.

Marks explained that it was too soon to have a definitive cause as to what is responsible for the blood clots, though he can only speculate based on information gathered from the AstraZenica COVID-19 vaccine, that is displaying similar reactions in Europe.

“The probable cause that we believe maybe involved here that we can speculate, is a similar mechanism that may be going on with the other adenoviral vector vaccine. That is that this is an immune response that occurs very, very rarely after some people receive the vaccine and that immune response leads to activation of the platelets and these extremely rare blood clots,” he said.

Janet Woodcock, the FDA’s acting commissioner, stated that the pause on the J&J vaccine all depends on what is learned in the next few days. Though Marks did state that the pause is only a recommendation and not at all a mandate.

“We’re recommending that the vaccine be paused in terms of its administration. However, if an individual healthcare provider has a conversation with an individual patient and they determine that the benefit risk for the individual patient is appropriate, we’re not going to stop that provider from administering the vaccine,” Marks said.

As for how this will impact the supply of COVID-19 vaccines, Woodcock explained that the J&J vaccine was providing the minority of all of the vaccine doses.

“Every dose is precious and we’re keen to get as many doses as possible administered as rapidly as possible and as equitably as possible, but it’s too early for us to know the impact on the supply, longer term,” she said.