The U.S. government’s recommended pause on use of the Johnson & Johnson Covid-19 vaccine is unlikely to be lifted for at least another week or 10 days, after a committee of independent experts declined Wednesday to vote on whether use of the vaccine should resume.
The Food and Drug Administration and the Centers for Disease Prevention and Control urged states to stop using the J&J vaccine on Tuesday to seek advice from the expert panel on some rare but serious clotting problems seen in a small number of people who received the vaccine. Six cases have been identified — and J&J officials indicated a possible seventh is being investigated. One person has died.
Many members of the Advisory Committee on Immunization Practices said they felt they had too little information to be able to estimate the benefits and risks of the vaccine, or to recommend its use be restricted to people in certain age groups.
“To be very frank, I do not want to vote on this issue today. I do not want to vote not to recommend the vaccine — I think that is not really something I necessarily believe. But I do not feel that we have … enough information to make an evidence-based decision,” Beth Bell, a global health professor at the University of Washington who is the chair of the committee’s Covid vaccines work group, said near the end of an afternoon of presentations and discussion.
The committee’s executive secretary, CDC scientist Amanda Cohn, appeared to try to steer the committee toward lifting the pause for certain subsets of the population, but the group sidestepped that suggestion. One member of the committee, Drexel University pediatrics professor Sarah Long, recommended the pause be extended for at least a month, but CDC staff suggested additional data could be pulled together over a shorter time frame.
While most voting members of the committee — which advises the CDC — appeared to support extending the pause, some warned that inaction will have serious consequences for the effort to vaccinate people against Covid, both in the United States and beyond.
Camille Kotton, clinical director of the transplant and immunocompromised host infectious diseases program at Massachusetts General Hospital, called the decision to suspend use of the vaccine “devastating” to efforts to vaccinate difficult-to-reach populations such as people who are housebound.
And Nirav Shah, president of the Association of State and Territorial Health Officers, also expressed concern about the committee’s approach.
“We are in a situation where not making a decision is tantamount to making a decision,’’ said Shah, who is a non-voting representative to the ACIP. “Any decision to pause will invariably result in the fact that the most vulnerable individuals in the United States, who were prime candidates for the Johnson & Johnson vaccine, will remain vulnerable. The most at risk will remain at risk.”
Some outside experts who were watching the proceedings were also highly critical.
“What they did is they punted,” said Paul Offit, a vaccine expert from Philadelphia Children’s Hospital who is on an FDA advisory committee that originally recommended the J&J vaccine be given emergency use authorization.
“People look to recommending bodies … to make a recommendation. And I just think they didn’t do that. And now we’re just floating out there,” he said.
The decision to recommend that states stop using the J&J vaccine came after scientists monitoring a reporting system for adverse events following vaccination spotted what appeared to be a signal of a rare but serious problem experienced by some people who got the J&J vaccine. Tom Shimabukuro, a vaccines safety scientist at the CDC, called it “a success story” for the surveillance systems set up to look for rare side effects possibility linked to vaccination.
The illnesses all occurred in women, though one man in the clinical trial of J&J’s vaccine also experienced these symptoms. The women were aged 18 to 48.
Within a week or two of being vaccinated with the J&J vaccine, these women developed serious blood clots, while also having thrombocytopenia — low platelet levels in their blood. That is an unusual combination of conditions, because platelets help the blood to clot. The most troubling manifestation of the syndrome is something called cerebral venous sinus thrombosis or CVST, though some people also had pulmonary embolisms or clots in their lungs and clots in limbs.
“These are significant blood clots,” Shimabukuro said. “This is unusual.”
In announcing the decision to pause use of the vaccine, Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, noted that there was a serious need to inform health care providers of the possibility that patients seeking care might be suffering from this syndrome. The normal course of treatment — a blood thinner called heparin — would actually be dangerous to use in these patients.
A similar problem has been seen with AstraZeneca’s Covid vaccine, which led to a temporary pause of its use in some countries. Most now have resumed using the vaccine but many have limited its use to older adults.
Many ACIP members stressed that the U.S. has other vaccine options. Neither of the mRNA vaccines, made by Moderna and the Pfizer-BioNTech partnership, have been seen to induce this problem. But several other committee members expressed concern about the message the U.S. pause could be sending about the J&J vaccine to the rest of the world, where the one-dose, inexpensive vaccine is expected to play a key role.
“I recognize that our responsibility at ACIP is to individuals in the U.S. But I also feel the weight of the burden of a global responsibility that we all have and the impact that our decision making could potentially worsen inequities,” said Grace Lee, a pediatrician at Stanford University School of Medicine.
Bell stressed that people shouldn’t interpret the ACIP’s decision not to recommend lifting the hold as evidence that the problem is more serious than first believed or that there is something fundamentally wrong with the vaccine. “That’s not the message that I want to send,” she said.
But Offit said there was little other way to read the committee’s move.
“I think you can’t help but interpret it as that,” he said.
Correction: A previous version of this story misspelled Amanda Cohn’s surname.
These cases are not unique to J and J, there are reports following Moderna and Pfizer vaccines. The bigger issue here is the autoimmune response these cases represent. They could be a canary in a coal mine for immune mediated longer term complications. I think the FDA, CDC, ACIP should continue the J and J pause for 3 weeks, the high end of when thrombotic complications were observed. During that period, as someone mentioned, the additional cases will come to light and should be evaluated. The NIH should fund research into who this is happening to, why and how.
During the 10 day pause, the number of clots will go from 6 to 10, then 20.
But the much bigger problem is their efficacy. For example, so called “milder” Covid cases were often not counted. These “milder” cases often led to long Covid neurological problems, brain fog, chronic fatigue, vision problems, etc. Counting these cases, the efficacy is likely only ~60%.
Therefore ~40% can escape the vaccine induced immune defense:
40%*10 Million people = 4 Million infections
~30% will have significant health problems caused by Covid
30%* 4 Million = 1.2 Million people’s health will still be compromised
I am much more concerned about these 1.2 Million people who will be injured by Covid.
Note: For countries without access to various vaccines, 60% protection is still much better than 0%.
Moderna, CureVac, Biontech and Novavax are clearly superior in both efficacy (>90%) and safety. The much higher antibody levels also made them more effective against the variants.
The rapid rise of variants (UK variant became the dominant strain in the US and EU in just ~2 months) have to be closely monitored worldwide using gene sequencers by Pacific Bioscience as well as Illumina. Other new variants (from India, Middle East, Indonesia) will soon come up during next 3 months.
Moderna has developed a new version for the S. African variant.
Biontech and CureVac should develop for the raging Brazilian variant (has been killing ~5000 people/day). mRNA vaccines can be tuned in a few weeks.
We should immediately double viral genetic sequencing, and increase to 10 times by the end of the year. Aim to have genetic sequencer machines in major hospitals and universities in US, EU and around the world to have real time IDs of the viral mutations.
mRNA vaccines can then rapidly code for these newly sequenced variants to keep them in check.
There is a serious problem when FDA / HHS does not recognize during a pandemic that not completing vaccination appointments will cause more deaths, and there is a portion of the population that is convinced the only alternative (RNA vaccinations) are problematic.
Also has anyone noticed the massive economic consequences of the pandemic?
How was HHS/FDA free from concern about the impact of the J&J halt on the rest of the country, including emergence from the pandemic, as well as the cost this decision will have on mortality?! “First do no harm”?!
I’m just so confused why everyone is freaking out about 6 people out of 7 million getting blood clots. FYI this specific blood clot occurs naturally in 1 out of 1 million people so this outcome is completely normal (6 out of 7 million). Everyone needs to take a step back and look at how ridiculous this is all getting. Are we now at the point where if there is ANY chance of death then we dont do that thing??? Please lets get back to common sense and move on.
Trying to figure out Dr. Fauci’s thinking – after a confrontation with Dr. Rand Paul, Dr. Fauci gave, as a reason to keep wearing masks after vaccination, fear of the variants which might escape vaccine induced immunity.
He has also given, as a reason to not change our vaccine protocol, fear of breeding new variants, that a person with partial immunity will get sick, not be able to get rid of the virus, and it will mutate in his body to become more pathogenic.
So, he is really scared of variants – with very good reason in my opinion – Brazil is going through almost a brand new, but worse, outbreak, due to their variant.
The data on the JJ shot indicates low efficacy against the South African variant – it will probably not do much against the Brazilian type either, but the South African type is more common here, at least right now.
It may be they do not think there is all that much value in administering the JJ shot – it will stop the dominant strain we have right now, by all reports – but if the variants rise, the JJ people may get sick in large numbers – and need another shot.
If the mRNA vaccines are significantly more effective, it may be better for the people who would have gotten a JJ shot to wait and get the mRNA shots.
This MIGHT be what is going on – I realize the committees deciding what to do are not directly subordinate to Dr. Fauci, and they are not giving us this as a reason, but it would make some sense.
Otherwise, as another poster said, it would make sense to pivot, let only men keep getting this shot while evaluating further. At least if we are in the grave situation that is claimed.
The official reasons we are given for actions taken do not really make sense. My best guess is, Dr. Fauci et al are in great fear of the variants, but they think if they say so, the anti-mask and anti-vax people will go into complete revolt, and that will make things worse. So the only thing to do is get as many vaccines in arms as you can, and, from all I can see, HOPE they work well enough.
I do not endorse getting medical advice from rightwing TV talk shows, but if the vaccine works, why continue to advise restrictions on vaccinated people? Something does not add up.
And I don’t endorse getting medical advice from left wing talk shows either, especially when they lie about what the OTHER side is saying, as CNN did about Tucker Carlson’s views about vaccines (he’s a supporter, not a skeptic), when Fauci was on the other day, calling Carlson a “conspiracy theorist.”
As for the variants, here’s the bigger question: when does THIS end? You know, THIS.
Fauci has three main problems.
First, he’s not a scientist, he’s a guesser, and pontificator. He not only left the lab years ago, he left the scientific method in the rear view mirror as well.
Second, if we keep our entire society and economy shut down or highly restricted based upon a Fauci speculation, spoken or unspoken, about the extent of these variants and the degree to which they will somehow someway be — well, something — we are not engaging in sensible risk management.
See, I can play this game.
“Perhaps we should try to understand how widespread variants REALLY are. MAYBE we SHOULD let those variants run their course since we COULD have a sufficient degree of immunity already from previous vaccine regiments that MIGHT work to mediate their affect and then we COULD get back to a normal economy and civilization so we MIGHT forestall the POSSIBLE consequences of ongoing lockdowns.”
Hey, I can play Fauci too.
Third and finally, he has not only moved the goalposts, he has engaged in willful deceptions in an effort to shape public policy. He has not only pontificated about subjects he does not fully understand, he has acted arrogantly and unethically. He should be banished to retirement and his lucrative government pension.
“Many members of the Advisory Committee on Immunization Practices said they felt they had too little information to be able to estimate the benefits and risks of the vaccine, or to recommend its use be restricted to people in certain age groups.”
Who are these people? What’s enough information? Millions have taken this vaccine with no side effects. This decision is not that hard. Examine the medical records and common demographics of these individuals. All in an age range? All but one female? Were all or most on hormone therapy? Were they taking blood thinners to begin with? Obese? Diabetic? Hypertensive?
Start with a constellation of shared characteristics and then advise a halt for that subset. But for heaven’s sake, don’t grind the whole enterprise to a halt.
My daughter was not going to have a vaccination then decided too. She is scared as she had J&J. How will she know if she had a clot and will the cost of card be paid?? She has very little money — she is 45.
Linda, how is her health? On hormone replacement therapy? And where is she located? City? Suburban? Rural? How is her area doing?
The risks are probably low, but so too are the risks of NOT taking the vaccine at this point, if she is relatively healthy. Most individuals who get really sick from the virus are older, 65++. with a constellation of inflammatory syndromes — heart disease, diabetes, uncontrolled hypertension.
Meanwhile make sure your daughter is taking Vitamin D.
Linda – I think there are recommendations for what to look for if you have already had the vaccine – you need to look online – they were talking about pain in legs, headache, and swelling.
Keep an eye out for the symptoms they mention but do not freak out, so far it looks rare. Please look up all the symptoms, then call her a couple of times to make sure she does not have them. IF she has clear symptoms, go to the doctor and worry about paying for it later. The chance she will get it is tiny, but if she does get it, she needs medical help.
I took the shot on sunday April 11 and the shot site is still sore and I really don’t feel like myself I feel weak at times I just pray I don’t get a blood clot I need to continue to work and keep my family safe
Females between 18 – 48.
For Gods’ let those outside of the range to go forward.
Keep looking for the 18-48 factor but don’t hold up the vaccine that so many people wanted, including me.
I don’t understand your rationale.
AstraZeneca I believe still has an age restriction of 55 years +.
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