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FDA sharply limits use of Johnson & Johnson shot due to rare blood clots
Source: Washington Post
Federal regulators announced new restrictions Thursday on the Johnson & Johnson coronavirus vaccine, saying the risk of a rare and life-threatening blood clot syndrome outweighed the benefits of the vaccine for people who are 18 or older and can get another shot, unless they would otherwise remain unvaccinated.
The FDA said only people who are unable to receive other vaccines because they are not accessible or clinically appropriate should receive the Johnson & Johnson vaccine.The Johnson & Johnson vaccine has been associated with a rare, but potentially deadly blood clotting and bleeding syndrome called thrombosis with thrombocytopenia syndrome, or TTS.
The condition usually occurs within one to two weeks of vaccination, and a commonly used treatment to treat clotting, heparin, can cause additional harm.“This is not a new safety signal — it is based on updated information showing that it is a persistent safety signal,” Peter Marks, the FDA’s top vaccine official, said in an interview. He said there are other, safer vaccines that can be used to inoculate people against the coronavirus.
Centers for Disease Control and Prevention officials in December already had made a recommendation that other vaccines should be used instead of the Johnson & Johnson shot, but additional data persuaded the FDA that a stronger limitation was needed. An updated analysis of safety data through March 18 found that there were 60 confirmed cases of the blood-clotting syndrome, including nine that resulted in death. Even with quick treatment, vaccine recipients can rapidly worsen, with long-term health consequences.
Read more: https://www.washingtonpost.com/health/2022/05/05/fda-johnson-and-johnson-vaccine/
This was similar to the earlier AstraZeneca vaccine in Europe, etc.
Here is the press release - https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-janssen-covid-19-vaccine-certain-individuals
FDA News Release
Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals
For Immediate Release: May 05, 2022
Today, the U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
Key Points:
“We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community. Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions. We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA. The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information.”
Background
The Janssen COVID-19 Vaccine was authorized for emergency use on Feb. 27, 2021. On April 13, 2021, the FDA and the Centers for Disease Control and Prevention (CDC), announced a recommended pause in administration of the vaccine to investigate six reported cases of TTS, and to help ensure that health care providers were made aware of the potential for TTS and could plan for proper recognition and management due to the unique treatment required for TTS.
On April 23, 2021, following a thorough safety evaluation, including two meetings of the CDC’s Advisory Committee on Immunization Practices (ACIP), the FDA and CDC lifted the recommended pause regarding the use of the Janssen COVID-19 Vaccine. The agencies confirmed a total of 15 cases of TTS had been reported to the Vaccine Adverse Event Reporting System (VAERS), including the original six reported cases, out of approximately 8 million doses administered.
These data, plus the deliberations and recommendations by the ACIP, helped with FDA’s assessment that the known and potential benefits of Janssen COVID-19 Vaccine outweighed its known and potential risks in individuals 18 years of age and older. The available data suggested the chance of TTS occurring was remote, but investigation into the level of potential excess risk due to vaccination and specific risk factors continued. At that time the Fact Sheet for Healthcare Providers Administering Vaccine was revised to include a warning pertaining to the risk of TTS and the Fact Sheet for Recipients and Caregivers was also revised to include information about blood clots in combination with low blood platelets after receiving the Janssen COVID-19 Vaccine.
In December 2021, after reviewing updated vaccine effectiveness and safety data, the ACIP made a preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen COVID-19 Vaccine in all persons 18 years of age and older in the United States. The ACIP recommended and CDC endorsed that the Janssen COVID-19 Vaccine may be considered in some situations: when a person has a contraindication to receipt of mRNA COVID-19 vaccines, when a person would otherwise remain unvaccinated for COVID-19 due to limited access to mRNA COVID-19 vaccines, and when a person wants to receive the Janssen COVID-19 Vaccine despite the safety concerns identified.
Current Status
The FDA and CDC have continuously monitored for and investigated all suspected cases of TTS reported to VAERS. In an updated analysis of TTS cases following administration of the Janssen COVID-19 Vaccine that were reported to VAERS through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases. The FDA has determined that the reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered.
In making the determination to limit the authorized use of the Janssen COVID-19 Vaccine, the agency considered that reporting rates of TTS and TTS deaths following administration of the Janssen COVID-19 Vaccine are not appreciably lower than previously reported. Furthermore, the factors that put an individual at risk for TTS following administration of Janssen COVID-19 Vaccine remain unknown. The FDA also considered that individuals with TTS may rapidly deteriorate, despite prompt diagnosis and treatment, that TTS can lead to long-term and debilitating health consequences and that TTS has a high death rate. The agency also considered the availability of alternative authorized and approved COVID-19 vaccines which provide protection from COVID-19 and have not been shown to present a risk for TTS.
Examples of individuals who may still receive the Janssen COVID-19 Vaccine include: individuals who experienced an anaphylactic reaction after receipt of an mRNA COVID-19 vaccine, individuals who have personal concerns with receiving mRNA vaccines and would otherwise not receive a COVID-19 vaccine and individuals who would remain unvaccinated for COVID-19 due to limited access to mRNA COVID-19 vaccines.
Ongoing Safety Monitoring
The FDA has a robust safety surveillance system in place to monitor the safety of COVID-19 vaccines approved and authorized for emergency use. The FDA is monitoring COVID-19 vaccine safety through both passive and active safety surveillance systems in collaboration with the CDC, the Centers for Medicare and Medicaid Services, the Department of Veterans Affairs and other academic and large non-government healthcare data systems.
The revised EUA for the Janssen COVID-19 Vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson.
Related Information
###
Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals
For Immediate Release: May 05, 2022
Today, the U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
Key Points:
After conducting an updated analysis, evaluation and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine. The FDA has determined that the known and potential benefits of the vaccine for the prevention of COVID-19 outweigh the known and potential risks for individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and for individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. The Fact Sheet for Healthcare Providers Administering Vaccine now reflects the revision of the authorized use of the Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS. Additionally, information on the revision to the authorized use of the vaccine and updated information on this risk of blood clots with low levels of blood platelets has been added to the Fact Sheet for Recipients and Caregivers.
“We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community. Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions. We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA. The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information.”
Background
The Janssen COVID-19 Vaccine was authorized for emergency use on Feb. 27, 2021. On April 13, 2021, the FDA and the Centers for Disease Control and Prevention (CDC), announced a recommended pause in administration of the vaccine to investigate six reported cases of TTS, and to help ensure that health care providers were made aware of the potential for TTS and could plan for proper recognition and management due to the unique treatment required for TTS.
On April 23, 2021, following a thorough safety evaluation, including two meetings of the CDC’s Advisory Committee on Immunization Practices (ACIP), the FDA and CDC lifted the recommended pause regarding the use of the Janssen COVID-19 Vaccine. The agencies confirmed a total of 15 cases of TTS had been reported to the Vaccine Adverse Event Reporting System (VAERS), including the original six reported cases, out of approximately 8 million doses administered.
These data, plus the deliberations and recommendations by the ACIP, helped with FDA’s assessment that the known and potential benefits of Janssen COVID-19 Vaccine outweighed its known and potential risks in individuals 18 years of age and older. The available data suggested the chance of TTS occurring was remote, but investigation into the level of potential excess risk due to vaccination and specific risk factors continued. At that time the Fact Sheet for Healthcare Providers Administering Vaccine was revised to include a warning pertaining to the risk of TTS and the Fact Sheet for Recipients and Caregivers was also revised to include information about blood clots in combination with low blood platelets after receiving the Janssen COVID-19 Vaccine.
In December 2021, after reviewing updated vaccine effectiveness and safety data, the ACIP made a preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen COVID-19 Vaccine in all persons 18 years of age and older in the United States. The ACIP recommended and CDC endorsed that the Janssen COVID-19 Vaccine may be considered in some situations: when a person has a contraindication to receipt of mRNA COVID-19 vaccines, when a person would otherwise remain unvaccinated for COVID-19 due to limited access to mRNA COVID-19 vaccines, and when a person wants to receive the Janssen COVID-19 Vaccine despite the safety concerns identified.
Current Status
The FDA and CDC have continuously monitored for and investigated all suspected cases of TTS reported to VAERS. In an updated analysis of TTS cases following administration of the Janssen COVID-19 Vaccine that were reported to VAERS through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases. The FDA has determined that the reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered.
In making the determination to limit the authorized use of the Janssen COVID-19 Vaccine, the agency considered that reporting rates of TTS and TTS deaths following administration of the Janssen COVID-19 Vaccine are not appreciably lower than previously reported. Furthermore, the factors that put an individual at risk for TTS following administration of Janssen COVID-19 Vaccine remain unknown. The FDA also considered that individuals with TTS may rapidly deteriorate, despite prompt diagnosis and treatment, that TTS can lead to long-term and debilitating health consequences and that TTS has a high death rate. The agency also considered the availability of alternative authorized and approved COVID-19 vaccines which provide protection from COVID-19 and have not been shown to present a risk for TTS.
Examples of individuals who may still receive the Janssen COVID-19 Vaccine include: individuals who experienced an anaphylactic reaction after receipt of an mRNA COVID-19 vaccine, individuals who have personal concerns with receiving mRNA vaccines and would otherwise not receive a COVID-19 vaccine and individuals who would remain unvaccinated for COVID-19 due to limited access to mRNA COVID-19 vaccines.
Ongoing Safety Monitoring
The FDA has a robust safety surveillance system in place to monitor the safety of COVID-19 vaccines approved and authorized for emergency use. The FDA is monitoring COVID-19 vaccine safety through both passive and active safety surveillance systems in collaboration with the CDC, the Centers for Medicare and Medicaid Services, the Department of Veterans Affairs and other academic and large non-government healthcare data systems.
The revised EUA for the Janssen COVID-19 Vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson.
Related Information
Janssen COVID-19 Vaccine COVID-19 Vaccines Emergency Use Authorization for Vaccines Explained
###
5 replies
= new reply since forum marked as read
= new reply since forum marked as read
(my mother's baby brother) who will be 79 this year, got the Janssen (J&J) vaccine because he is homebound and it was promoted as a good "single dose" means of protection. It was also targeted to those who are homebound and who are in the transient population, where it would be difficult to get them the 2nd dose of the original 2-dose series of the mRNA vaccines.
Here was the VA's presser back when they received it and began to distribute it - https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5632
Office of Public and Intergovernmental Affairs
VA receives Janssen COVID-19 vaccine
March 4, 2021, 10:24:00 AM
VA receives Janssen COVID-19 vaccine
WASHINGTON — The Department of Veterans Affairs (VA) received 71,400 doses of the Janssen COVID-19 vaccine, March 3, authorized by the U.S. Food and Drug Administration under an Emergency Use Authorization.
In clinical trials, the Janssen vaccine showed an efficacy of 66% against moderate to severe/critical COVID-19 disease occurring at least 28 days after vaccination — and demonstrated greater than 85% efficacy in preventing severe/criticalCOVID-19 disease occurring at least 28 days after vaccination.
“VA now has a third highly effective vaccine to support the department’s critical efforts in vaccinating Veterans,” said Acting VA Under Secretary for Health Richard Stone M.D. “This one-dose vaccine will help us vaccinate more people faster and will help us effectively reach more Veterans, including those in rural areas.”
As of March 3, VA provided Pfizer-BioNTech and Moderna COVID-19 vaccine first doses to more than 1,648,000 Veterans, employees and federal partners — and both doses to more than 925, 000 of these individuals.
Veterans who are enrolled and receiving health care in VA are eligible to get the vaccine when their facility has vaccine supply and reaches their risk category. Veterans are required to enroll with VA in order to receive health care. However, to receive care in VA, enrollees must meet certain eligibility requirements under current law, which may include income limits.
Veterans can get the latest information and sign up to receive updates on VA’s COVID-19 vaccine webpage.
###
VA receives Janssen COVID-19 vaccine
March 4, 2021, 10:24:00 AM
VA receives Janssen COVID-19 vaccine
WASHINGTON — The Department of Veterans Affairs (VA) received 71,400 doses of the Janssen COVID-19 vaccine, March 3, authorized by the U.S. Food and Drug Administration under an Emergency Use Authorization.
In clinical trials, the Janssen vaccine showed an efficacy of 66% against moderate to severe/critical COVID-19 disease occurring at least 28 days after vaccination — and demonstrated greater than 85% efficacy in preventing severe/criticalCOVID-19 disease occurring at least 28 days after vaccination.
“VA now has a third highly effective vaccine to support the department’s critical efforts in vaccinating Veterans,” said Acting VA Under Secretary for Health Richard Stone M.D. “This one-dose vaccine will help us vaccinate more people faster and will help us effectively reach more Veterans, including those in rural areas.”
As of March 3, VA provided Pfizer-BioNTech and Moderna COVID-19 vaccine first doses to more than 1,648,000 Veterans, employees and federal partners — and both doses to more than 925, 000 of these individuals.
Veterans who are enrolled and receiving health care in VA are eligible to get the vaccine when their facility has vaccine supply and reaches their risk category. Veterans are required to enroll with VA in order to receive health care. However, to receive care in VA, enrollees must meet certain eligibility requirements under current law, which may include income limits.
Veterans can get the latest information and sign up to receive updates on VA’s COVID-19 vaccine webpage.
###
Apparently they have a "sign up" thing to request/track vaccines and/or to get info "sooner" (their words) on the vaccine news - https://www.va.gov/health-care/covid-19-vaccine/stay-informed
I found the VA did seem to send something out about the "pauses" but it looks like they think all vets are "millennials"
and I'm mainly finding the info via their twitter account -
Link to tweet
Office of the Secretary of Veterans Affairs
@SecVetAffairs
·
Apr 13, 2021
VA is following CDC and FDA guidance to pause in providing the Janssen vaccine. This pause is due to a concern about possible rare side effects. Your safety is our top priority. For more information, go to the CDC website. https://cdc.gov/media/releases/2021/s0413-JJ-vaccine.html
(1)
cdc.gov
Coronavirus Disease 2019
CDC provides credible COVID-19 health information to the U.S.
Office of the Secretary of Veterans Affairs
@SecVetAffairs
If you have a vaccine appointment scheduled, your VA health facility will work with you to determine what to do next. https://va.gov/find-locations (2)
va.gov
Find VA Locations | Veterans Affairs
Find a VA medical center, clinic, hospital, national cemetery, or VA regional office near you. You can search by city, state, postal code, or service. You'll get wait times and directions.
12:34 PM · Apr 13, 2021
@SecVetAffairs
·
Apr 13, 2021
VA is following CDC and FDA guidance to pause in providing the Janssen vaccine. This pause is due to a concern about possible rare side effects. Your safety is our top priority. For more information, go to the CDC website. https://cdc.gov/media/releases/2021/s0413-JJ-vaccine.html
(1)
cdc.gov
Coronavirus Disease 2019
CDC provides credible COVID-19 health information to the U.S.
Office of the Secretary of Veterans Affairs
@SecVetAffairs
If you have a vaccine appointment scheduled, your VA health facility will work with you to determine what to do next. https://va.gov/find-locations (2)
va.gov
Find VA Locations | Veterans Affairs
Find a VA medical center, clinic, hospital, national cemetery, or VA regional office near you. You can search by city, state, postal code, or service. You'll get wait times and directions.
12:34 PM · Apr 13, 2021
In a search, I saw many states were sending out the warnings and updated guidance during the "pause", and local chapters of veterans social organizations were doing the same (eg., American Legion).
So the one thing that you could do is sign up for that VA "vaccine" thing and they might have a way to email updates (or perhaps call - I haven't delved into how they are doing the informational updates).
And as a disclaimer, my dad was a WW2 vet and worked for the VA for 20 years as a programmer (from the mid-50s to the mid-70s before he died - which was back when it was called the "Veterans Administration" ) so I grew up in a household knowing about the agency, now department.
And as you know, because there are so many active and former military, that it would be almost impossible to get to them all. As it is, so many facilities probably don't have the "latest" either, so they end up dropping the ball.
I am a retired federal civil service employee and know that we often get left out of the loop too (although OPM will notify us on occasion regarding some things).
So all of us are left having to "hunt" for the info ourselves. 
