The study of Johnson & Johnson’s Covid-19 vaccine has been paused due to an unexplained illness in a study participant.

A document sent to outside researchers running the 60,000-patient clinical trial states that a “pausing rule” has been met, that the online system used to enroll patients in the study has been closed, and that the data and safety monitoring board — an independent committee that watches over the safety of patients in the clinical trial — would be convened. The document was obtained by STAT.

Contacted by STAT, J&J confirmed the study pause, saying it was due to “an unexplained illness in a study participant.” The company declined to provide further details. 

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“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the company said in a statement.

J&J emphasized that so-called adverse events — illnesses, accidents, and other bad medical outcomes — are an expected part of a clinical study, and also emphasized the difference between a study pause and a clinical hold, which is a formal regulatory action that can last much longer. The vaccine study is not currently under a clinical hold. J&J said that while it normally communicates clinical holds to the public, it does not usually inform the public of study pauses.

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The data and safety monitoring board, or DSMB, convened late Monday to review the case. J&J said that in cases like this “it is not always immediately apparent” whether the participant who experienced an adverse event received a study treatment or a placebo.

Though clinical trial pauses are not uncommon — and in some cases last only a few days — they are generating outsized attention in the race to test vaccines against SARS-CoV-2, the virus that causes Covid-19.

Given the size of Johnson & Johnson’s trial, it’s not surprising that study pauses could occur, and another could happen if this one resolves, a source familiar with the study said.

“If we do a study of 60,000 people, that is a small village,” the source said. “In a small village there are a lot of medical events that happen.”

On Sept. 8, a large study of another Covid-19 vaccine being developed by AstraZeneca and Oxford University was put on hold because of a suspected adverse reaction in a patient in the United Kingdom. It’s believed that the patient had transverse myelitis, a spinal cord problem. Studies of the vaccine resumed roughly a week after it was paused in the United Kingdom, and have since been restarted in other countries as well. It remains on hold, however, in the United States. 

Johnson & Johnson began enrolling volunteers in its Phase 3 study on Sept. 23. Researchers planned to enroll 60,000 participants in the United States and other countries.

  • “If we do a study of 60,000 people, that is a small village”
    Just a comment on semantics. I don’t think there are many “villages” in the world with 60,000 people in them outside of the NYC Metropolitan area. Maybe rarely in India and China. But generally – a village is like 50 to 5,000 individuals. 60,000 to me is a small to medium sized city.

    And I don’t think they even recruited 6,000 volunteers yet for this stage of the clinical trial/study. Hopefully just a minor unrelated illness here and with the Eli Lilly antibody treatment trials.

  • I am shocked that such a big company with “expert” scientists would not have taken detailed notes on who got the placebo and who got the actual vaccine. That seems a little suspect. My high school biology students, would have received an F if they took those kind of notes. Can’t imagine you get to that level, of research at Johnson and Johnson, and not know who received the placebo and who received the actual vaccine; that’s basic biology, control and variable, research skills.

    • @jonh: uhhh… double blind means blinded to the people receiving the med (or placebo) and blinded to the people administering it – NOT to everyone involved in overseeing the study! If that were the case, there’d be no data to evaluate when the study was over. So your dismissive response to Bex is pretty goofy and uninformed. They ought to be able to determine that easily.

    • “it is not always /immediately/ apparent”
      Everyone involved with this person needs to be blind to the condition (ie everyone recording their info). The data obviously exists, but it should not be easily accessible, and so a one day delay seems more than reasonable.

    • @RM and @Bex: That’s not how blinding works in a clinical trial these days. In a clinical trial of 60000 people, the company doesn’t maintain a ‘List’ of every patient name and the arm they are on because that’s a major privacy concern. You also can’t maintain the list at the research site as that is a potential for a blinding breach. Patients are randomized using a system (IWRS/IVRS or IXRS), where a patient is randomly assigned to one arm or another and the computer maintains that list. DSMB would not unblind a patient unless there was a specific need to blind the patient – this is so you can maintain data integrity and ensure that the patient remains evaluable. As soon as you unblind a patient, that patient becomes inevaluable after that point. The main reason you would unblind the patient is if information on which arm the patient was randomized to is important for the follow-up care to the adverse events. JNJ has thousands of scientists which includes PhDs, Medical Doctors, Epidemiologists, statisticians, computer programmers. You’re armchair quarterbacking a clinical trial with your high school diploma. Leave it to the experts on clinical trial design and development of new drugs. They’ve been doing this for over 100 years, with hundreds, if not thousands, of drugs tested on hundreds of thousands, if not millions of patients.

  • I’m glad they are being safe with their study. Before the pandemic vaccines typically took 6-10 years to complete their safety studies. When the proper safety measures have not been taken there have been long term and terrible consequences.

  • The detouring into anti-vaxx land by several comment writers is nausiating. Only if you want to decimate the world population should you be against vaccinations. Clearly, the junk-material on the internet needs to be curbed, as resulting mentality could lead to absence of herd immunity – and that will have a detrimental effect on the global population. Good thing that in many nations several vaccinations are simply mandatory.

  • I love it how a lot of “tin foil hat people” fail to realize that massive campaigns of vaccination were already in place by the last years of the 1700s. “Take away our freedom” “we don’t need vaccines, we have our own antibodies” come on people, vaccines have been in place for almost as long as the US has existed. The worst part is that these buffoons go to different places preaching their ideals (especially 3rd world countries) where the locals die do not have the same medical attention we have in the USA, and the buffoons are very happily treated with the most sophisticated treatments the first world has to offer.

    • It may interest readers to know that smallpox and measles managed to wipe out Louis XIV’s son who, as the Dauphin, was the heir to the throne; then they took the lives of the Dauphin’s son, then his grandson. Vaccines were available at the time, but Louis was a non-believer.

    • Referencing your 3rd world countries because they do not have the same medical attention–look at Uganda. Uganda is an impoverished nation with major issues of disease and poor living conditions. They have had less than 10,000 cases. Why?…because most of the population takes Hydroxychloroquin to prevent Malaria. Amazing…an inexpensive effective drug that can prevent deaths is blocked by the radical left from being administered in a country with such “sophisticated treatments”. This is not about a virus. It is about profits from another unnecessary vaccine. Believe what you want. This isn’t about anti-vax vs. vax….its about common sense and the American sheep being used for profits. Adverse events will happen as they do with all vaccines and it is not worth it. A vaccine is not needed for this virus and that’s the bottom line.

    • Plain and Simple
      Hydroxychloroquin pills are not going to stop/prevent COVID-19 infection any more than contraceptive pills – viruses don’t reproduce like single celled or multi-celled organisms. Viruses don’t have a “living” cell structure like the parasites that cause malaria. Malaria parasites react to their host and environment.
      Most antibiotics and anti-parasitic drugs don’t work against viral infections(this should be common sense and common knowledge). Using them too frequently for the wrong reason allows microscopic organisms to develop resistance against them or the human body to eventually reject them – after which they become useless, and the work that went into their development pointless.

    • “Uganda is an impoverished nation with major issues of disease and poor living conditions. They have had less than 10,000 cases.”
      Uganda is a land-locked country with few travelers to or from the country, it is for the most part isolated from the rest of the world. Unlike the US, EU, China, Brazil, Russia, or Mexico where ‘normally’ millions of people travel to and from these countries per year and there is frequent internal mobility(public transportation) of populations contributing to the spread of disease. Not to mention overcrowding of major cities(NYC, Hong Kong, Mexico City, Tokyo, Rio de Janeiro, Moscow) also leads to more people becoming infected. Poor people normally don’t buy medications and there is likely under-reporting or underestimating of sick individuals(mainly from under-developed healthcare) from COVID-19 in some African and Asian countries.

  • This article is clearly whitewashing the dangers of this and other vaccines. With an herb if someone gets sick while using it the herb can be completely banned as happened in the US with Ephedra. Never any proof the herb was causative in the person’s collapse during a marathon race but the FDA banned it despite the herbs safe history of use for 100’s of years! But with a vaccine seizures, neurological spinal damage, visual decay, and other serious effects in young and healthy subjects gets whitewased as nothing deserving serious concern. In this case the ‘pause’ is expected to be lifted after a pro-forma look into the injured subject’s health. Ho Hum?

    It seems to me that such an extreme reaction would be a major red alarm to cease the study–period! It is not acceptable to create toxic drugs that will knowlingly cause serious harm to 1000’s of people with less serious harm to millions. Just because a lot of $$$ was spent is no excuse for approving the poison! Perhaps the real lesson is to cease all these toxic drugs and cease the supression of study and use of natural means for building health and healing.

    • Ephedra was effective and cheap, there was no way to really make $$$ from it, that’s why it got banned.
      That and the meth addicts. :/

  • Thank you for the info please keep it up and let us know what’s going on thank you again Florida

  • The only thing that’s paused is the intake of participants. The study continues. They just stopped taking in new Guinea pigs. One unexpected situation in 60,000 is not bad at all and certainly not unusual. It’s just Marxist Socialist Media cleverly wording a nothing burger in a desperate attempt to create fear and confusion. Unfortunately, all this really accomplishes is permanently eroded media credibility.

    • The intake and the second dose of the vaccine for those who have not yet received it. The “unexpected situation” is unknown
      despite the fact that we, the taxpayers, are paying for the trial.

  • It is sad to have to defend the use of vaccination as a preventive measure in the XXI century. This is a big problem. It calls for a stronger science curriculum in elementary school. If there are problems for any vaccine, existing or under development, for any illness, the potential benefits need to be fully understood through a good (not perfect) understanding of the biology. To use internet postings without real knowledge of a vaccine’s way of action, to inspire fear and distrust through ignorant comments is unbecoming of a well informed modern society. This is not religion. Any judgment should be based on an understanding of quantifiable risks and weighing the consequences of NOT having a vaccine versus having one that undergoes peer review and strong scrutiny of the experts. Are you an expert or just a misinformed person?

    • This is one of the most coherently written and pointed comments I’ve ever read in a comments section. I wholeheartedly agree with the point you are trying to get across and appreciate the manner in which you communicated it. Thank you!

    • Vaccines aren’t safe, if you read the insert, which virtually noone does, you would see that the safety and efficacy have not been proven. A well informed public would reject vaccines as the trials are flawed, side effects aren’t fully disclosed, and many ingredients are either toxic or shouldn’t be injected into anyone for any reason.

    • Don’t you mean indoctrination of our children when they are at their most vulnerable? This type of thought reasoning is a REALLY good reason why any parent with any amount of intelligence should home school their children. Laws have been passed prevent us litigation if we are harmed at all through these vaccines. Any type of program which we, the American public cannot litigate is a big red flag. There are hundreds of thousands of people who have had issues after receiving some type of vaccination. Very few of them have been able to recover anything from the companies that profit in the billions of dollars from these vaccines. Check the ingredients that are used. Human fetus particulates, animal particulates, “preservation materials” of various sorts, they are all in these vaccines to one degree or another and are foreign to each individual. No wonder some people have hyper immunity responses to them.

      Also, why not give people the option to choose whether they have a vaccine or not? To force people to have a vaccine is unconstitutional. If YOU have a vaccine and are protected, why should you care if I don’t have a vaccine? Me getting some type of virus or flu should not affect you if you are supposedly protected.

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