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Federal official: CDC, FDA take reports of blood clots and Johnson & Johnson Covid-19 vaccine ‘seriously’

“The CDC and the FDA are taking these concerns about blood clots and the J&J vaccine seriously and are diligently gathering the data,” the official said.

An expert outside the government familiar with the situation admitted that health officials were taking the issue seriously.

“The CDC is very concerned and they are working very hard on this and are monitoring this closely,” said the expert, who spoke on condition of anonymity due to the sensitive nature of the matter.

The concern in the United States is not just about the Johnson & Johnson shooting per se. At a time when U.S. health officials are urging Americans to get vaccinated as soon as they can, there are concerns that media coverage of the clots studied in connection with Johnson & Johnson’s vaccine may make some Americans more hesitant to get vaccinated against Covid-19.

Vaccine reluctance is already a problem in the United States, and officials from the United States Centers for Disease Control and Prevention and the United States Food and Drug Administration “are considering how to communicate about the problem without giving the impression that something is wrong with the [Johnson & Johnson] vaccine, ”said the federal health official.

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

“I hope the HHS is having a discussion about this right now,” the expert said, referring to the US Department of Health and Human Services.

In a statement, Johnson & Johnson said its tracking of side effects revealed “a small number of very rare events after vaccination. To date, no clear causal relationship has been established between these rare events and the [Johnson & Johson] Vaccine against covid19. ”

The FDA issued a statement last week that it was aware of reports of “serious thromboembolic events” in the United States occurring “in a few people after receiving the drug. [Johnson & Johnson] COVID-19 vaccines ”and that“ for the moment, we have not found a cause and effect relationship with the vaccination ”.

J&J study participant’s illness revealed

Last October, Johnson & Johnson put their vaccine trial on hold when a participant fell ill. He resumed the trial about two weeks later, saying there was “no evidence” that the vaccine caused the disease.
Publicly, the nature of the participant’s illness remained a mystery until February, when the FDA revealed that a 25-year-old study participant with no medical history and not taking any medication had received the vaccine and had undergone transverse sinus thrombosis. .
Federal official: CDC, FDA take reports of blood clots and Johnson & Johnson Covid-19 vaccine ‘seriously’
About 3 to 4 in 1 million people suffer from this blood clot each year, and 75% of adult cases are women, according to a 2005 study in the New England Journal of Medicine.
During the Johnson & Johnson clinical trial, other types of blood clots were also reported. Some are relatively common, such as deep vein thrombosis, so it is not surprising that among about 20,000 participants who have received the vaccine, some experience these clots.

What the FDA scientists pointed out, however, is that in the trial, about the same number of people were given a placebo – a dose of saline that does nothing – as the vaccine. However, when comparing the two groups, more study participants developed clots after receiving the vaccine than the placebo.

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

The FDA report concluded that given this imbalance, “the vaccine cannot be ruled out as a contributing factor” and that the FDA would recommend “monitoring” for blood clots once the vaccine is deployed.

Federal official: CDC, FDA take reports of blood clots and Johnson & Johnson Covid-19 vaccine ‘seriously’
The Johnson & Johnson vaccine was launched on March 3, days after this report was released by the FDA. Since then, more than 6.8 million people in the United States have received it, according to the CDC.
That’s a small number compared to Pfizer and Moderna, which were licensed in December. Since then, more than 36 million have been fully vaccinated with two doses of the Pfizer vaccine and more than 31 million have received two doses of the Moderna vaccine, according to the CDC.
Following manufacturing challenges, J & J’s vaccine allocations are expected to drop 84% this week, according to a CNN analysis of CDC data.

Against this backdrop, Andy Slavitt, White House senior advisor on Covid-19, told a press briefing on Monday that the United States is still on track to meet its Covid-19 vaccination goals even without additional doses of Johnson & Johnson.

Examining blood clots

This is not the first time that blood clots have appeared in connection with a Covid-19 vaccine.

The AstraZeneca vaccine, which has not been authorized in the United States, has been authorized in more than 70 countries. The J&J vaccine and the AstraZeneca vaccines are similar – they both use adenovirus vectors to make them work.

Federal official: CDC, FDA take reports of blood clots and Johnson & Johnson Covid-19 vaccine ‘seriously’

In March, doctors in several European countries had started noticing “very rare” cases of unusual blood clots in people who received the AstraZeneca vaccine.

The European Medicines Agency noted that most of these people had a type of blood clot in the brain called cerebral venous sinus thrombosis. Transverse sinus thrombosis – the clot experienced by the young participant in the Johnson & Johnson trial – is a type of cerebral venous sinus thrombosis.

The agency noted that its safety committee reviewed 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis, a type of blood clot in the abdomen, including 18 fatalities. The cases were reported at a time when 25 million people in Europe and the UK had received the vaccine.

The European agency concluded that unusual blood clots with low blood platelet counts should be listed as ‘very rare side effects’ of the AstraZeneca vaccine. While advising the public to look for signs of clots, regulators said the benefits of the shot were always worth the risk.

The European Union cleared the J&J vaccine last month, and it is expected to be rolled out there in the coming weeks.

A ‘vaccine-induced’ condition

Hematologists say it’s not the first time they’ve seen unusual blood clots with low platelet counts. Sometimes people who are given a very common blood thinner called heparin can develop the disease.

Federal official: CDC, FDA take reports of blood clots and Johnson & Johnson Covid-19 vaccine ‘seriously’

But the people who received the AstraZeneca vaccine and developed the clots had not taken heparin.

Writing about AstraZeneca’s vaccine in the New England Journal of Medicine last week, European doctors coined a new term: “vaccine-induced immune thrombotic thrombocytopenia.”

“It’s actually very interesting,” said Dr. Peter Kouides, past president of the Thrombosis and Hemostasis Societies of North America. “The risk is very, very low, but it appears to be a real vaccine-triggered disorder.”

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

“When you have [this] happen, all bets are off, “said Dr Hanny Al-Samkari, hematologist and instructor at Harvard Medical School.” You can get clots anywhere. You can have them in your brain, in your belly, in your extremities, in your heart – it doesn’t matter. They can occur just about anywhere and this is obviously often problematic and / or fatal. ”

Harsh words for Johnson & Johnson

Part of J&J’s statement angered a prominent FDA vaccine adviser, as it appeared to say that Pfizer and Moderna’s vaccines also raised similar safety concerns – which it said he stated, is just not true.

“We are aware that thromboembolic events, including those with thrombocytopenia, have been reported with all COVID-19 vaccines,” according to the Johnson & Johnson statement.

The company included a footnote to a study published in February that examined 20 case reports of thrombocytopenia in people who had taken Moderna and Pfizer vaccines as of February 2. By that time, more than 30 million people had received at least the first dose of one of these vaccines, according to the CDC.

Given that this is such a large number, it is no surprise that some members of this group suffer from thrombocytopenia, a condition characterized by low levels of platelets in the blood, said committee member Dr Paul Offit. FDA Advisory on Vaccines and Related Biologics. The question, he said, is whether this number of people has exceeded what one would expect if they had not been vaccinated.

He pointed to a presentation from the CDC in January which showed that people who received Moderna and Pfizer vaccines were actually less likely to experience thrombocytopenia or certain types of blood clots compared to those who were not vaccinated.

“It’s a really irresponsible thing to say,” Offit said, referring to J&J’s statement. “It will frighten people unnecessarily about Moderna and Pfizer when not only is there no evidence that it is a problem – there is evidence that there is no problem,” Offit added. .

A spokesperson for J&J declined to comment on Offit’s criticisms.

CNN’s Lauren Mascarenhas, Michelle Watson and Jacqueline Howard contributed to this report.


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