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Cleveland Clinic Offers After J&J Vaccine Pause

Cleveland Clinic Offers Guidance after J&J Vaccine Pause

April 21, 2021
Cleveland Clinic's CEO explains the current controversy involving the J&J COVID-19 vaccine.

I’m from Cleveland, and when the Cleveland Clinic speaks we listen.

On April 20, Tomislav Mihaljevic, M.D., the CEO of the Cleveland Clinic, an internationally recognized healthcare system, sent out a note talking about the decision that the Food and Drug Administration (FDA) made to pause the Johnson & Johnson COVID-19 vaccine.

The US Centers for Disease Control and Prevention (CDC) said it was taking this action “because the safety systems that make sure vaccines are safe received a small number of reports of people who got this vaccine experiencing a rare and severe type of blood clot with low platelets.”

For a little background, on April 13, the CDC and the FDA released a statement:

As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. 

The US Centers for Disease Control and Prevention is recommending that people who experience certain symptoms after receiving the Johnson & Johnson Covid-19 vaccine seek immediate medical treatment. These symptoms include sudden, severe headache, backache, new neurological symptoms, severe abdominal pain, shortness of breath, leg swelling, tiny red spots on the skin, or new or easy bruising.

And the CDC noted that the people who have received the vaccine and develop who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their healthcare provider.

Now back to Dr. Mihaljevic. Putting these actions in perspective, he made the following statement.

This past week, we learned that the FDA made the decision to pause the Johnson& Johnson COVID-19 vaccine. This was done out of an abundance of caution after a small number of patients developed a blood clot disorder after receiving the vaccine. Right now, these instances appear to be extremely rare.

All of the cases occurred six to 13 days after vaccination. In these instances, the patients experienced a type of blood clot called cerebral venous sinus thrombosis (CVST), which is a rare form of stroke caused by a blood clot in the veins of the brain.

Studies show that the Pfizer and Moderna vaccines are highly effective against this specific variant.       

To keep the entire vaccination process in perspective, " Mihaljevic said that “after a steep decline in positive COVID-19 cases, we’re seeing the numbers rise again. This is, in part, due to a more contagious variant (called B1.1.7), which was first identified in the United Kingdom. About 25% of Cleveland Clinic patients who test positive for COVID-19 also have this variant. said "Mihaljevic. But remember, you’re not considered fully vaccinated until at least two weeks after your second dose."

As far as where the country is in terms of the number of people vaccinated, according to the Cleveland Clinic, currently 50.4% of eligible adults. have received at least one dose of the vaccine, while 32.5% are considered fully vaccinated. In those over age 65, 80% have received one dose of the vaccine and 64% are fully vaccinated. "But remember, you’re not considered fully vaccinated until at least two weeks after your second dose," Mihaljevic said.

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