“The CDC and the FDA take these concerns about blood clots and the J&J vaccine seriously and are compiling the data diligently,” the official said.
An expert outside the government who knows the situation agrees that health officials take the matter seriously.
“The CDC is very concerned and they are working very hard on this and keeping a close eye on it,” said the expert, who spoke on the condition of anonymity due to the sensitive nature of the case.
The concern in the United States is not just about the Johnson & Johnson shot per se. At a time when U.S. health officials are urging Americans to be vaccinated as soon as possible, there is concern that news coverage of blood clots being studied with respect to the Johnson & Johnson vaccine may make some Americans more reluctant to get any Covid-19 vaccine. to get.
There is already a problem in the US for vaccinating vaccines and officials from the US Centers for Disease Control and Prevention and the US Food and Drug Administration is thinking about how they can communicate without creating the impression that something may be wrong with the [Johnson & Johnson] vaccine, ”said the federal health official.
Another expert familiar with the situation said it was the right approach, emphasizing the importance of communication without scaring people.
“I would hope that HHS now has a discussion about this,” the expert said, referring to the U.S. Department of Health and Human Services.
In a statement, Johnson & Johnson said the detection of side effects shows a small number of very rare incidents after vaccination. At present there is no clear causal link between these rare events [Johnson & Johson] Covid19 vaccine. ”
The FDA issued a statement last week that it was aware of reports of “serious thromboembolic events” taking place in the US “in some individuals after receiving the [Johnson & Johnson] COVID-19 vaccine “and that” at the moment we have not found any causal link with vaccination. “
J&J participant’s illness comes to light
What FDA scientists note, however, is that about the same number of people in the trial received a placebo – a shot of saline that does nothing – as the vaccine was received. However, when comparing the two groups, more study participants developed blood clots after receiving the vaccine than the placebo.
The FDA calls this a “minor numerical imbalance”. There were 15 events in 14 participants who received the vaccine, compared with 10 events in 10 participants who received the placebo.
The FDA report concluded that ‘vaccine cannot be ruled out as a contributing factor’, and that the FDA would recommend ‘surveillance’ for blood clots once the vaccine has been rolled out.
In this context, Andy Slavitt, senior adviser to the White House for Covid-19, said at a news conference on Monday that the United States is still on track to achieve its vaccination goals for Covid-19, even without additional doses of Johnson & Johnson.
Blood clot examination
This is not the first time that blood clots have appeared in connection with a Covid-19 vaccine.
The AstraZeneca vaccine, which is not approved in the United States, has been approved in more than 70 countries. The J&J vaccine and the AstraZeneca vaccines are similar – they both use adenovirus vectors to make it work.
By March, doctors in several European countries had begun noticing “very rare” cases of unusual blood clots among people who had received the AstraZeneca vaccine.
The agency noted that its safety committee reviewed 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic arterial thrombosis, 18 of which were fatal. The cases were reported at a time when 25 million people in Europe and the UK were receiving the vaccine.
The European agency has concluded that low-platelet abnormal blood clots should be listed as ‘very rare side effects’ of the AstraZeneca vaccine. While advising the public to look at the signs of blood clots, regulators say the benefits of the shot are still worth the risk.
The European Union approved J & J’s vaccine last month, and it is expected to be rolled out within the next few weeks.
A condition caused by vaccines
Hematologists say this is not the first time they have seen unusual blood clots with low platelet levels. Sometimes people who get a very common blood thinner called heparin can develop the condition.
But the people who received the AstraZeneca vaccine and developed the blood clots did not take heparin.
“It’s actually very interesting,” said Dr. Peter Kouides, immediate former president of the Thrombosis and Hemostasis Associations in North America, said. “The risk is very, very low, but it appears to be a real disorder caused by the vaccine.”
He said there are treatments for this ‘very serious condition’, but it does not always work.
“If you have [this] Hanny Al-Samkari, a hematologist and instructor at Harvard Medical School, says: “You can get clots anywhere. You can get them in your brain, in your stomach, in your limbs, in your heart – it does not matter “It can happen almost anywhere, and of course it is often problematic and / or fatal.”
Hard words for Johnson & Johnson
One part of J & J’s statement came from a prominent FDA vaccine adviser because there appear to be similar safety concerns about Pfizer and Moderna’s vaccines – which he says are simply not true.
“We are aware that thromboembolic events, including those with thrombocytopenia, have been reported with all COVID-19 vaccines,” the Johnson & Johnson statement said.
Since it is such a large number, it is not surprising that some in this group will experience thrombocytopenia, a condition with low platelets in the blood, said dr. Paul Offit, a member of the FDA’s advisory committee on vaccines and related biological products, said. The issue, he said, is whether the number of people is greater than would be expected if they were not vaccinated.
“It’s really irresponsible to say,” Offit said, referring to the J&J statement. “It will unnecessarily scare people into Moderna and Pfizer if there is not only evidence that it is a problem; there is evidence that there is not a problem,” Offit added.
A J&J spokesman declined to comment on Offit’s criticism.
CNN’s Lauren Mascarenhas, Michelle Watson and Jacqueline Howard contributed to this report.