CDC, FDA receive reports of blood clots and J & J Covid-19 vaccine “seriously” :: WRAL.com

Elizabeth Cohen, CNN Senior Medical Correspondent

CNN — US health agencies are “seriously” concerned about blood clots and the Johnson & Johnson Covid-19 vaccine and are working to assess whether the shots are associated with a negligible increase in the risk of rare blood clots. Federal officials told CNN that they were.

“The CDC and FDA take these concerns about blood clots and J & J vaccines seriously and are enthusiastically collecting data,” officials said.

Non-governmental experts familiar with the situation agreed that health officials took the matter seriously.

“The CDC is very concerned and is very keen on this and is closely monitoring it,” said an expert who spoke of the condition of anonymity due to the delicate nature of the problem.

According to European health officials, “four serious cases of abnormal blood clots” have been reported after vaccination with the Johnson & Johnson vaccine. Like the US response agency, European authorities are still investigating these cases and say it is “currently unknown” whether there is a causal link between the vaccine and the blood clot.

Johnson & Johnson’s shots themselves are not the only concern in the United States. Some Americans are vaccinated with the Covid-19 vaccine, according to news reports about blood clots being studied in connection with Johnson & Johnson’s vaccine, as U.S. health officials recommend vaccination of Americans as soon as possible. There are concerns that you may hesitate more.

Vaccine hesitation is already a problem in the United States, and officials from the US Centers for Disease Control and Prevention and the US Food and Drug Administration said, “How about the problem without giving the impression that something might be wrong. I’m thinking about telling. [Johnson & Johnson] Vaccine “.

Another expert familiar with the situation said it was the right approach and emphasized the importance of communicating without scaring people.

“I hope HHS now has a conference on this,” said an expert referring to the US Department of Health and Human Services.

In a statement, Johnson & Johnson said that tracking side effects “revealed a small number of very rare events after vaccination. Currently, these rare events and [Johnson & Johson] COVID19 vaccine. “

The FDA released a statement last week that it knew of reports of a “serious thromboembolic event” in the United States. [Johnson & Johnson] “COVID-19 vaccine” and “No causal relationship with vaccination has been found at this time.”

Illness of J & J research participants revealed

Last October, Johnson & Johnson suspended vaccine testing when participants became ill. Saying “no evidence” that the vaccine caused the disease, it resumed trials about two weeks later.

Publicly, the nature of the participants’ illness revealed that the FDA had experienced transverse sinus thrombosis vaccinated by a 25-year-old male study participant who had no previous medical history and was not taking medication. It remained a mystery until February.

According to a 2005 study by the New England Journal of Medicine, about 3-4 people per million experience this blood clot each year, and 75% of adult cases are women.

Other types of blood clots were also reported during Johnson & Johnson’s clinical trials. It was not surprising that some of the approximately 20,000 vaccinated participants experienced these blood clots, as some are relatively common, such as deep vein thrombosis.

However, FDA scientists noted that in this study, nearly as many people who received the vaccine received placebo (a shot of saline that does nothing). However, comparing the two groups, more study participants developed blood clots after vaccination than placebo.

Calling it a “slight numerical imbalance,” the FDA has 15 events in 14 participants who received the vaccine, compared to 10 events in the 10 participants who received the placebo. Said that.

Given this imbalance, the FDA’s report concludes that “vaccines cannot be ruled out as a factor” and that once the vaccine is deployed, the FDA recommends “monitoring” of blood clots. ..

The Johnson & Johnson vaccine was launched on March 3, a few days after the FDA published its report. Since then, more than 6.8 million people in the United States have received it, according to the CDC.

This is a small number compared to Pfizer and Moderna, which were approved in December. Since then, more than 36 million people have been fully vaccinated with two doses of Pfizer vaccine and more than 31 million have been vaccinated with two doses of Modana vaccine, according to the CDC.

Following manufacturing challenges, J & J’s vaccine allocation is expected to decline by 84% this week, according to CNN analysis of CDC data.

In this regard, Andy Slavitt, senior adviser to Covid-19 at the White House, said at a press conference on Monday that the United States is still targeting Covid-19 vaccination without additional doses from Johnson & Johnson. He said he was on track to reach.

Scrutiny of blood clots

This is not the first time a blood clot has developed in connection with the Covid-19 vaccine.

The AstraZeneca vaccine, which is not licensed in the United States, is licensed in more than 70 countries. The J & J vaccine and the AstraZeneca vaccine are similar-both work using adenovirus vectors.

By March, doctors in several European countries had begun to notice “very rare” cases of abnormal blood clots among people vaccinated with AstraZeneca.

The European Medicines Agency said most of these people experienced a type of blood clot in the brain called cerebral sinus thrombosis. Transverse sinus thrombosis (a blood clot experienced by young participants in the Johnson & Johnson trial) is a type of dural venous sinus thrombosis.

Authorities noted that the Safety Commission examined 62 cases of cerebral venous sinus thrombosis and 24 cases of visceral venous thrombosis (a type of abdominal thrombosis), 18 of which were fatal. Cases were reported when 25 million people in Europe and the United Kingdom were vaccinated.

European agencies have concluded that abnormal blood clots with low platelets should be listed as a “very rare side effect” of the AstraZeneca vaccine. Regulators advised the public to be aware of signs of blood clots, but said the benefits of shots were still worth the risk.

The European Union approved the J & J vaccine last month and will be rolled out in the coming weeks.

“Vaccine-induced” state

Hematologists say this is not the first time they have seen an abnormal blood clot with low platelet levels. People who receive a very common anticoagulant called heparin may develop this condition.

However, those who received the AstraZeneca vaccine and developed blood clots were not taking heparin.

European doctors who wrote about AstraZeneca’s vaccine in the New England Journal of Medicine last week invented the new term “vaccine-induced immune thrombotic thrombocytopenia.”

“It’s actually very interesting,” said Dr. Peter Coudes, a former president of the North American Thrombosis and Hemostasis Society. “The risk is very low, but it seems to be a real disorder caused by the vaccine.”

He said there are cures for this “very serious condition”, but they don’t always work.

“When you have [this] “Blood clots can occur anywhere,” said Dr. Honey al-Samkari, a hematologist and instructor at Harvard Medical School. You can put them in your brain, your belly, your limbs, your heart-it doesn’t matter. They can occur almost everywhere, and obviously it is often problematic or fatal. “

Strict words for Johnson & Johnson

Some of J & J’s statements seemed to state similar safety concerns with Pfizer and Modana vaccines, causing anger from prominent FDA vaccine advisers-that’s simply not true. He said.

“We recognize that thromboembolic events, including thrombocytopenia, have been reported with all COVID-19 vaccines,” according to a statement by Johnson & Johnson.

The company included a footnote to a study published in February that examined 20 case reports of thrombocytopenia in people who received the Moderna and Pfizer vaccines on February 2. According to the CDC, it is one of these vaccines.

Dr. Paul Offit, a member of the FDA’s Vaccine and Related Biological Products Advisory Board, said that given the sheer number of this, some members of this group experience thrombocytopenia, a condition with low platelet levels. Is not surprising. The question, he said, was whether that number exceeded what would have been expected if he had not been vaccinated.

He said at a CDC presentation in January that people vaccinated with Moderna and Pfizer were less likely to actually experience thrombocytopenia or certain types of thrombosis than those who were not vaccinated. Was shown.

“That’s really irresponsible,” Ofitt said, referring to a statement from J & J. “Not only is there no evidence that it’s a problem, but when there’s evidence that it’s not a problem, it will unnecessarily scare people about Moderna and Pfizer,” Ofitt added.

A J & J spokesman refused to comment on Offit’s criticism.