* AP…
The U.S. is recommending a “pause” in using the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots.
The Centers for Disease Control and Prevention and the Food and Drug Administration said Tuesday they were investigating unusual clots that occurred 6 to 13 days after vaccination. The clots occurred in veins that drain blood from the brain and occurred together with low platelets. All six cases were in women between the ages of 18 and 48; there was one death and all remained under investigation.
* IDPH…
In accordance with recommendations from the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), the Illinois Department of Public Health (IDPH) will pause the use of the Johnson & Johnson (J&J) COVID-19 vaccine out of an abundance of caution. The CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type blood clot in individuals after receiving the J&J vaccine.
IDPH has notified all Illinois COVID-19 providers throughout the state to discontinue use of the J&J vaccine at this time. In order to keep appointments, IDPH is strongly advising providers to use Pfizer-BioNTech and Moderna vaccines.
Moderna and Pfizer make up the vast majority of doses on hand in the State of Illinois. This week, the state’s allocation of J&J was 17,000 doses. For the week of April 18, 2021, the expected allocation for the State is 483,720 total doses. Of that total allocation, 5,800 doses were expected to be J&J.
Per the federal health authorities, people who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Patients with other clinical questions should contact their health care provider.
IDPH will continue to update the public as additional information becomes available.
*** UPDATE 1 *** Johnson & Johnson…
The safety and well-being of the people who use our products is our number one priority. We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine.
In addition, we have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe.
We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public.
The CDC and FDA have made information available about proper recognition and management due to the unique treatment required with this type of blood clot. The health authorities advise that people who have received our COVID-19 vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.
For more information on the Janssen COVID-19 vaccine, click here.
A commenter asked how many people would die from contracting COVID-19 as a result of this pause. It’s a good question.
…Adding… Another good point…
*** UPDATE 2 *** Block Club Chicago…
The state will send 50,000 doses of the Moderna and Pfizer vaccines to Chicago as the city suspends using its Johnson & Johnson doses. […]
The pause is only expected to last several days, officials have said.
The one-shot vaccine has been administered to tens of thousands of people in Chicago, and officials hoped that, as supply of the doses increased, it would play a significant role in getting residents vaccinated as quickly as possible — especially with cases on the rise in the city.
*** UPDATE 3 *** IDPH…
The Illinois Department of Public Health (IDPH) is developing and implementing plans to move forward with COVID-19 vaccinations in Illinois after putting a pause on administration of the Johnson & Johnson (Janssen) vaccine, including robust communication with all providers and the transfer of 50,000 doses of COVID-19 vaccine to Chicago.
Earlier today, at the recommendation of the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), IDPH paused the use of the J&J COVID-19 vaccine out of an abundance of caution. The CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type blood clot in individuals after receiving the J&J vaccine, out of a total of more than six million Americans who have received the J&J vaccine. In Illinois, of the total 7.3 million doses administered to date, 4% or approximately 290,000 have been J&J. These individuals remain fully vaccinated and do not need to seek out an alternate vaccine. People vaccinated with J&J should consult with their medial provider if they develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination.
“Public health officials made a commitment that any safety signals that came up concerning COVID-19 vaccines would be fully addressed in a transparent manner, which is what is occurring right now with the J&J vaccine,” said IDPH Director Dr. Ngozi Ezike. “The blood clot cases appear to be extremely rare and there are no reported cases associated with either the Pfizer-BioNTech or the Moderna vaccines. IDPH is taking immediate action to ensure as little disruption to Illinois residents as possible during this pause, and I strongly encourage people to continue to get vaccinated. Millions upon millions of people have already been safely vaccinated and it will take millions more before we can put this pandemic behind us.”
Upon learning of the recommendation, IDPH took the following actions to ensure COVID-19 vaccine providers and health care workers in Illinois were aware of the pause and received the support they needed to adjust their planning:
• Immediately sent notification about the pause to COVID-19 providers, local health departments, and health care providers via the State of Illinois Rapid Electronic Notification system, which included follow-up calls, text, and emails.
• Directly emailed and called all local health departments through IDPH Emergency Response Coordinators, to assess impact and work to mitigate using Pfizer-BioNTech and Moderna vaccines.
• Connected with all mass vaccination sites, Illinois National Guard vaccination missions, and one-day J&J clinics scheduled in EMTrack to develop alternate plans where necessary and ensure the least amount of disruption possible on individuals with appointments.
• Sent notification to hospitals, emergency departments, physicians, and other health care providers about treatment for this specific type of blood clot
The pause on the J&J vaccine will not have a large impact on state vaccination efforts as the Moderna and Pfizer-BioNTech vaccines make up the vast majority of doses on hand in the State of Illinois. No state-supported mass vaccination sites will be closed and no rapid response team clinics, faith-based or equity clinics, or rural clinics have been cancelled at this time. They will all move forward with a different type of vaccine.
The total allocation of J&J vaccine to Illinois, including Chicago, is 760,300, of which 290,615 doses have been administered. This week, the state’s allocation of J&J was 17,000 doses. For the week of April 18, 2021, the expected allocation for the State is 483,720 total doses. Of that total allocation, 5,800 doses were expected to be J&J.
In an effort to vaccinate as many people as possible across Illinois, the State is allocating 50,000 first doses of Moderna and Pfizer-BioNTech vaccine to the City of Chicago over the next seven days to help meet demand. The State will also be allocating 50,000 doses to Chicago when second doses come due to be administered.
IDPH encourages people to register with V-safe After Vaccination Health Checker, a smartphone-based tool that uses text messages and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccine. For more information on v-safe, go to https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html.
- Larry Bowa Jr. - Tuesday, Apr 13, 21 @ 10:19 am:
I wonder how many people will die as a result of this pause. It will be a lot more than the 1 death potentially tied to the J&J. We seem to be in a race against the variants at this point and I’m losing what optimism I had that humanity is capable of getting and remaining in front of it such that our prior ‘normal’ could return.
- Dotnonymous - Tuesday, Apr 13, 21 @ 10:29 am:
The fates seem inclined against us.
Mother Earth takes Her timely revenge?
- ChrisB - Tuesday, Apr 13, 21 @ 10:33 am:
6 out of the ~6 Million shots administered.
Driving a car is more dangerous.
- Rich Miller - Tuesday, Apr 13, 21 @ 10:38 am:
===I wonder how many people will die as a result of this pause===
Valid question.
- Ducky LaMoore - Tuesday, Apr 13, 21 @ 10:39 am:
Seriously…? Okay I get it. I’m just a little frustrated…. My wife was supposed to get her J&J vaccine today. She is on Facebook way too much and even though her mom almost died of Covid, she was hesitant to get the vaccine. (deep exhale)
- Montrose - Tuesday, Apr 13, 21 @ 10:46 am:
I get that the government is dealing with a trust issue that requires them to be extra cautious. I just hope the pause is very short and folks don’t hesitate to take J&J when the pause ends.
- former southerner - Tuesday, Apr 13, 21 @ 10:46 am:
There is a significant but minimal risk for clots associated with birth control pills. I wonder how many of the 6 reported cases also involved this more likely factor?
- TinyDancdr(FKASue) - Tuesday, Apr 13, 21 @ 10:50 am:
=There is a significant but minimal risk for clots associated with birth control pills.=
Good point. All are women between the ages of 18 and 48.
- Ok - Tuesday, Apr 13, 21 @ 10:59 am:
It is the same question posed in every freshman year philosophy class and every suspense/thriller film:
If faced with the choice, if you had the power to save one individual right in front of you, even if it meant dozens would die indirectly, would you save that individual with your direct actions, or do nothing?
- AC - Tuesday, Apr 13, 21 @ 10:59 am:
It makes sense that IDPH would follow the FDA/CDC recommendations, after all we remember the fiasco with Blago and flu vaccines, but the decision by the feds to temporarily pause the use of this vaccine seems difficult to understand from the standpoint of relative risk. The current best estimates from the CDC for deaths per million is 500 for people 18–49 years old, and much higher for people older that that. That doesn’t even take into account people who suffer long term injuries from the virus. J&J has been shown to be highly effective at preventing deaths and hospitalizations. We are in a pandemic, some states are seeing a surge, and for some people this single dose vaccine is the only one that is practical. I suspect this will lead to more vaccine hesitancy, even if the FDA quickly reverses the decision. It’s hard to imagine a scenario where this doesn’t result in the deaths of more people.
- Responsa - Tuesday, Apr 13, 21 @ 11:03 am:
The AP article linked above is quite detailed and worth a read. The J&J and AstraZeneca vaccines use an entirely different technology than the Pfizer and Moderna jabs do. AstraZeneca has not been approved for emergency use in the U.S. after reported problems in Europe– and J&J was only approved for use here in late February, so collected data is slim. I don’t fault the Feds for being cautious here with respect to J&J based on what internists are apparently seeing can develop days and weeks after the shot was administered.
- @misterjayem - Tuesday, Apr 13, 21 @ 11:04 am:
“If faced with the choice, if you had the power to save one individual right in front of you, even if it meant dozens would die indirectly, would you save that individual with your direct actions, or do nothing?”
Except in this case the numbers of people harmed or benefited by either action are still unknown.
– MrJM
- Joe Bidenopolous - Tuesday, Apr 13, 21 @ 11:05 am:
==I get that the government is dealing with a trust issue…==
And it’s going to get worse because of this pause. Vaccine hesitancy will rise as this proliferates through social media/stupidbook and it’s going to make it that much harder to get to the other side. All because of 6 out of over 6 million. SMDH
- Ok - Tuesday, Apr 13, 21 @ 11:06 am:
“Except in this case the numbers of people harmed or benefited by either action are still unknown.”
I would say it rarely is ever known.
- @misterjayem - Tuesday, Apr 13, 21 @ 11:14 am:
“J&J was only approved for use here in late February, so collected data is slim.”
As it stands, it appears that the problem arises in less than one out of a million vaccinations, and it’s highly unlikely that one million people participated in the J&J trial.
Which is to say, based on what we know at this moment, it was probably impossible for this vanishingly rare problem to be detected before the vaccine was rolled out to the general public in a big way.
– MrJM
- Quibbler - Tuesday, Apr 13, 21 @ 11:14 am:
== Except in this case the numbers of people harmed or benefited by either action are still unknown. ==
It’s even more tenuous than that. We know that the vaccine prevents COVID. We don’t have any proof that the vaccine is linked to a single blood-clot-related death.
- Homebody - Tuesday, Apr 13, 21 @ 11:15 am:
All aboard the COVID trolley problem[banned punctuation]
As a guy who has had blood clots before, I’m just happy I (through luck of the draw) didn’t get the J&J shot now.
- Julian Perez - Tuesday, Apr 13, 21 @ 11:15 am:
“so collected data is slim”
Six cases out of six million.
Regrettably, even once the pause is lifted, many will now refuse the vaccine. Not only the J&J vaccine. All the vaccines.
Complete Overreaction
- Oswego Willy - Tuesday, Apr 13, 21 @ 11:19 am:
=== Complete Overreaction===
While I know I’ll never know how many lives will be lost with this pause or the damage to trust and it’s measure, an overreaction, “complete” or not is predicated on a current unknown people far-far more intelligent than me on the issue want to research further.
We have two other vaccines currently being used. Keeping pace with those two is the priority in this short term.
- Cool Papa Bell - Tuesday, Apr 13, 21 @ 11:26 am:
Right now the Orr Building in Springfield seems to be almost at “walk in” appointment status. You still need to register but they have wall to wall open times starting today.
They jab the Pfizer shot, I hope this will not curtail those on the fence from getting a vaccine. But any minor problem with one of these shots will be twisted into something major.
I’m keenly watching for FDA approval for youth 12 and over. I’ll be in line with my 13 year old a soon as I can.
- lake county democrat - Tuesday, Apr 13, 21 @ 11:37 am:
Nate Silver on Twitter today:
“Say there’s a 1 in 100 chance someone acquires COVID because of a delayed vaccine (maybe conservative in the US where spread is still quite high) and a 1 in 150 chance they die from it. That’s a 1 in 15,000 chance vs. 1 blood clot death in 7,000,000 doses so far.”
- from 40,000 ft and eternally skeptical - Tuesday, Apr 13, 21 @ 11:38 am:
This situation implies that there have been no injuries or deaths from the mRNA vaccines to warrant a pause.
Interesting.
By the way, Mr JM, that’s what’s known as the classic trolley problem in the moral philosophy of utilitarianism. An interesting thought experiment.
- Grandson of Man - Tuesday, Apr 13, 21 @ 11:42 am:
A few days ago a study came out showing the Pfizer vaccine is less effective against the South Africa variant. Today some news headlines blare out alarmism, giving the impression that it’s some big failure. The vaccine still offers protection, just not as much. I do not want to succumb to needless alarmism, after what we’ve been through. The vaccines so far have shown great efficacy, with minimal problems. Hoping the J&J issue gets resolved as quickly as possible.
- Simple Simon - Tuesday, Apr 13, 21 @ 11:46 am:
The statistics are clearly in favor of continuing vaccination. However, a pause on administering it to women below the age of 50 seems sensible as monitoring continues. It would quickly narrow down the factors involved without causing much or any additional damage or slowdown.
- Norseman - Tuesday, Apr 13, 21 @ 11:49 am:
=== I wonder how many people will die as a result of this pause ===
None have to die. I remember one of the trusted public health experts (certainly not one of the Trump hacks) note that masking and social distancing is more effective than vaccinations. The problem is we have too many babies who refuse to follow the recommendations. Besides the initial Covidiots we now have folks who see the vaccinations as an indicator that masks are no longer needed. These folks and the politicians opening things up to all are a greater risk for expanded deaths than the holdup of J&J. Also remember, Pfizer and Moderna supplies are supposed to be sufficient to cover the population. J&J was seen as a great addition to make it easier to reach underserved areas.
Bottom Line: Keep the Mask On until CDC and IDPH say otherwise.
- snakepliskin69 - Tuesday, Apr 13, 21 @ 11:50 am:
Could also provide more concern about the overall safety of the shots and the speed with which they were approved. Could decrease likelihood some who were on fence will get vaccinated, possibly increasing the amount of lives lost
- yinn - Tuesday, Apr 13, 21 @ 11:58 am:
The NIU students were going to get J&J in mass clinics at the Convo Center this coming weekend. There’s no Plan B. How unfortunate.
- PublicServant - Tuesday, Apr 13, 21 @ 12:08 pm:
The CDC and J&J are doing the right thing with the pause. Meanwhile, 28 million doses of Pfizer and Moderna were shipped this week, and we are administering 3.5 million doses on average a day.
- Anon221 - Tuesday, Apr 13, 21 @ 12:21 pm:
As someone who got the J&J last week, I’m grateful for the guidance on how to treat the blood clots if they do occur. You don’t use traditional heparin treatments, and that could be lifesaving in the case of a reaction. https://www.cdc.gov/media/releases/2021/s0413-JJ-vaccine.html
- cermak_rd - Tuesday, Apr 13, 21 @ 12:23 pm:
The problem is J&J is pretty much the only game in town for vaccinating the homeless population which as a rule has extra challenges for keeping follow-up appointments. It was also ideally suited (compared to the other two) for Vaccine-mobile operations.
Can’t they just administer it to men?
- PublicServant - Tuesday, Apr 13, 21 @ 12:27 pm:
The other good news here is that the CDC made the call to pause. The White House didn’t know about that until last night. Can’t imagine that happening under Trump.
- Give Me A Break - Tuesday, Apr 13, 21 @ 12:33 pm:
This was great to news to wake up to this AM given that my along with me, my wife and one daughter got the J&J vaccine yesterday.
Really interesting how people react to the vaccine. Me, up all night with a pounding headache, aches and stomach cramps, my wife just feels a little tired our daughter, no issues at all.
- harp5339 - Tuesday, Apr 13, 21 @ 2:06 pm:
Just became eligible yesterday, had a 9:00 a.m. appointment today to get the J&J shot.
“Missed it by that much”
- TinyDancer(FKASue) - Tuesday, Apr 13, 21 @ 2:24 pm:
So, the six vaccinated women……were any of them also on birth control pills?
- Groundhog Day - Tuesday, Apr 13, 21 @ 3:46 pm:
Of note, the AstraZeneca vaccine uses the same adenovirus base for the vaccine as J&J, and has had the same blood clot issues in Europe. available data from Europe is that these blood clots are 50 times more common with AZ than the 2 mRNA vaccines.
So in Europe, they have stopped using the AZ for anyone under 30.