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An advisory panel to the US Centers for Disease Control and Prevention (CDC) is recommending the Pfizer and Moderna COVID-19 vaccines over the Johnson/Janssen (J&J) vaccine after considering new data linking the J&J shot to a rare-but-serious blood clotting risk.
Voting 15-0, the CDC's Advisory Committee on Immunization Practices (ACIP) said the mRNA vaccines "are preferred" over the J&J option for everyone ages 18 and older
During an emergency meeting on December 16, ACIP members reviewed data revealing an elevated risk of thrombosis with thrombocytopenia syndrome (TTS), a condition that's been associated with the J&J vaccine but not the other two COVID-19 vaccines authorized for use in the US.
To date, 54 cases of TTS have been confirmed. Nine people—7 females and 2 males—have died.
While expressing preference for the mRNA vaccines, the panel did not go as far as recommending that the J&J vaccine not be used or that its use be limited to certain older adults at lower risk of TTS.
Earlier in the week, the US Food and Drug Administration (FDA) called out TTS concerns arising from the J&J vaccine. In a fact sheet for both doctors and patients, the FDA noted that people who have had a clotting problem after having a first dose of the vaccine should not receive another.
It's more than understandable to have questions about TTS and how it relates to the J&J vaccine. Here's a breakdown.
What is TTS?
TTS occurs when someone has blood clots (known as thrombosis) along with low blood platelet counts (known as thrombocytopenia), Isaac See, MD, a member of the CDC's COVID-19 response team, told ACIP members.
TTS is a new syndrome that can occur after someone receives an adenovirus COVID-19 vaccine, like the J&J and AstraZeneca COVID vaccines. (AstraZeneca's vaccine is not approved for use in the US.)
How is TTS different from CVST?
You may remember back in the spring how the J&J vaccine was tied to a condition called cerebral venous sinus thrombosis, or CVST. CVST is a type of clot that forms in the venous sinuses—spaces in the skull that allow blood to drain from the brain. A CVST keeps blood from draining out of your brain, which can lead to a stroke.
"CVST is a specific type of clot in a distinct anatomical location—the cerebral venous sinuses," infectious disease expert Amesh A. Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, tells Health. "TTS is a general syndrome, which may or may not include CVST, that involves abnormally low blood platelets and clot."
CVST can happen "with or without TTS also being present, and TTS can occur with or without a CVST also present," Dr. Adalja explains.
How common is TTS?
First, let's put TTS cases into perspective. A little more than 16 million Americans have received the J&J vaccine as part of their primary vaccination, according to CDC data. (That's well below the 73 million people who have received the Moderna vaccine and 113 million who have gotten the Pfizer-BioNTech vaccine.)
Overall, the ACIP counted 3.83 cases of TTS per million J&J doses. The highest rate of TTS—a little more than 10 per million doses—occurred in women between the ages of 30 and 49.
Which COVID-19 Booster Shot Should You Get? Here's What We Know So Far, to Help You Make a Decision
Who has developed TTS?
CDC data show that the median age of people with TTS has been 44.5, with the age range being 18 to 70. The majority of cases (37) have been in women, while 17 men have been impacted. The data show that 26 of those cases, or 48%, were in women under the age of 50.
Of the TTS cases that have been detected, 29 also had CVST. Seven of the people diagnosed with TTS had tested positive for COVID-19 in the past.
What-Is-TTS-AdobeStock_427763980_Editorial_Use_Only
ADOBESTOCK / DESIGN BY JO IMPERIO
What are the symptoms of TTS?
Symptoms of TTS usually start between seven and 14 days after a person has been vaccinated, the American Society of Hematology says. They can include:
Severe headache
Visual changes
Abdominal pain
Nausea and vomiting
Back pain
Shortness of breath
Leg pain or swelling
Tiny blood spots under the skin
Why has TTS emerged as a side effect of the Johnson & Johnson vaccine?
It's not clear. "The mechanism behind why this happens in response to an adenovirus vaccine is under investigation," Jamie Alan, PharmD, PhD, associate professor of pharmacology and toxicology at Michigan State University, tells Health. "One idea is that the immune system is involved in this reaction." But, she adds, there really aren't a lot of answers at this point.
A Small Number of People Developed This Rare Blood Disorder After Getting a COVID Vaccine—Here's What to Know
What does this mean for the Johnson & Johnson vaccine?
The FDA said in its updated patient-and-provider information sheet that the agency still thinks that the benefits of this vaccine outweigh the risks. What's more, ACIP recognizes that some patients, for whatever reason, simply don't want the mRNA vaccines; they'd rather take the J&J jab.
In a prepared statement, J&J said it remains confident in the benefit-risk profile of its COVID vaccine and that it strongly supports educating the public about rare events such as TTS.
J&J vaccine has been less popular with the general public and with many doctors, given that it has a much lower efficacy (66.3%) compared to the Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines, which are 95% and 94.1% effective at preventing COVID-19, respectively.
"I haven't recommended the Johnson & Johnson vaccine for anyone for a long time," Thomas Russo, MD, professor and chief of infectious disease at the University at Buffalo in New York, tells Health. The only "possible exception," he says, is in male patients between the ages of 16 and 40 with a history of myocarditis, an inflammation of the middle layer of the heart wall, which has been linked in rare cases to the mRNA vaccines.
"Johnson & Johnson made more sense early in the pandemic when vaccine supply was low," Dr. Russo says. "But the mRNA vaccines are the best in the world, from a safety and efficacy point of view. It makes more sense to go with them."
Alan stresses, though, that the overall risk of developing TTS is low. "The risks of developing other conditions with COVID, including blood clots, is very high," she says. "I would still recommend getting vaccinated. If you are concerned, mRNA vaccines do not carry this risk."
Voting 15-0, the CDC's Advisory Committee on Immunization Practices (ACIP) said the mRNA vaccines "are preferred" over the J&J option for everyone ages 18 and older
During an emergency meeting on December 16, ACIP members reviewed data revealing an elevated risk of thrombosis with thrombocytopenia syndrome (TTS), a condition that's been associated with the J&J vaccine but not the other two COVID-19 vaccines authorized for use in the US.
To date, 54 cases of TTS have been confirmed. Nine people—7 females and 2 males—have died.
While expressing preference for the mRNA vaccines, the panel did not go as far as recommending that the J&J vaccine not be used or that its use be limited to certain older adults at lower risk of TTS.
Earlier in the week, the US Food and Drug Administration (FDA) called out TTS concerns arising from the J&J vaccine. In a fact sheet for both doctors and patients, the FDA noted that people who have had a clotting problem after having a first dose of the vaccine should not receive another.
It's more than understandable to have questions about TTS and how it relates to the J&J vaccine. Here's a breakdown.
What is TTS?
TTS occurs when someone has blood clots (known as thrombosis) along with low blood platelet counts (known as thrombocytopenia), Isaac See, MD, a member of the CDC's COVID-19 response team, told ACIP members.
TTS is a new syndrome that can occur after someone receives an adenovirus COVID-19 vaccine, like the J&J and AstraZeneca COVID vaccines. (AstraZeneca's vaccine is not approved for use in the US.)
How is TTS different from CVST?
You may remember back in the spring how the J&J vaccine was tied to a condition called cerebral venous sinus thrombosis, or CVST. CVST is a type of clot that forms in the venous sinuses—spaces in the skull that allow blood to drain from the brain. A CVST keeps blood from draining out of your brain, which can lead to a stroke.
"CVST is a specific type of clot in a distinct anatomical location—the cerebral venous sinuses," infectious disease expert Amesh A. Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, tells Health. "TTS is a general syndrome, which may or may not include CVST, that involves abnormally low blood platelets and clot."
CVST can happen "with or without TTS also being present, and TTS can occur with or without a CVST also present," Dr. Adalja explains.
How common is TTS?
First, let's put TTS cases into perspective. A little more than 16 million Americans have received the J&J vaccine as part of their primary vaccination, according to CDC data. (That's well below the 73 million people who have received the Moderna vaccine and 113 million who have gotten the Pfizer-BioNTech vaccine.)
Overall, the ACIP counted 3.83 cases of TTS per million J&J doses. The highest rate of TTS—a little more than 10 per million doses—occurred in women between the ages of 30 and 49.
Which COVID-19 Booster Shot Should You Get? Here's What We Know So Far, to Help You Make a Decision
Who has developed TTS?
CDC data show that the median age of people with TTS has been 44.5, with the age range being 18 to 70. The majority of cases (37) have been in women, while 17 men have been impacted. The data show that 26 of those cases, or 48%, were in women under the age of 50.
Of the TTS cases that have been detected, 29 also had CVST. Seven of the people diagnosed with TTS had tested positive for COVID-19 in the past.
What-Is-TTS-AdobeStock_427763980_Editorial_Use_Only
ADOBESTOCK / DESIGN BY JO IMPERIO
What are the symptoms of TTS?
Symptoms of TTS usually start between seven and 14 days after a person has been vaccinated, the American Society of Hematology says. They can include:
Severe headache
Visual changes
Abdominal pain
Nausea and vomiting
Back pain
Shortness of breath
Leg pain or swelling
Tiny blood spots under the skin
Why has TTS emerged as a side effect of the Johnson & Johnson vaccine?
It's not clear. "The mechanism behind why this happens in response to an adenovirus vaccine is under investigation," Jamie Alan, PharmD, PhD, associate professor of pharmacology and toxicology at Michigan State University, tells Health. "One idea is that the immune system is involved in this reaction." But, she adds, there really aren't a lot of answers at this point.
A Small Number of People Developed This Rare Blood Disorder After Getting a COVID Vaccine—Here's What to Know
What does this mean for the Johnson & Johnson vaccine?
The FDA said in its updated patient-and-provider information sheet that the agency still thinks that the benefits of this vaccine outweigh the risks. What's more, ACIP recognizes that some patients, for whatever reason, simply don't want the mRNA vaccines; they'd rather take the J&J jab.
In a prepared statement, J&J said it remains confident in the benefit-risk profile of its COVID vaccine and that it strongly supports educating the public about rare events such as TTS.
J&J vaccine has been less popular with the general public and with many doctors, given that it has a much lower efficacy (66.3%) compared to the Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines, which are 95% and 94.1% effective at preventing COVID-19, respectively.
"I haven't recommended the Johnson & Johnson vaccine for anyone for a long time," Thomas Russo, MD, professor and chief of infectious disease at the University at Buffalo in New York, tells Health. The only "possible exception," he says, is in male patients between the ages of 16 and 40 with a history of myocarditis, an inflammation of the middle layer of the heart wall, which has been linked in rare cases to the mRNA vaccines.
"Johnson & Johnson made more sense early in the pandemic when vaccine supply was low," Dr. Russo says. "But the mRNA vaccines are the best in the world, from a safety and efficacy point of view. It makes more sense to go with them."
Alan stresses, though, that the overall risk of developing TTS is low. "The risks of developing other conditions with COVID, including blood clots, is very high," she says. "I would still recommend getting vaccinated. If you are concerned, mRNA vaccines do not carry this risk."
