Skip to Main Content

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. 

advertisement

“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.

advertisement

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.

  • In any event, this new vaccine should NOT be mandatory. Aluminum, mercury, aborted fetal tissue, etc. are in vaccines. That truth is suppressed because the people making the money from vaccines don’t want us to know (they are also immune from liability when you get hurt by it). You want that poison injected into you? Go ahead but leave me out. I’ll fight germs and viruses the way the human body was made to do so: the body’s NATURAL immune system (which vaccines also damage). Stop being afraid of dying and live life!!

    • Ignorant, ill-informed people like you, and comments like yours, are the source of untold suffering in the world. You have no idea what you’re talking about. Vaccines, like this one being studied, and annual flu vaccines, inter alia, SAVE LIVES. EVERY DAY. They are safe because of the immense precautions taken during their development and approval, as this article clearly demonstrates.

    • Call me what you will, RM, but those in the know and those that have personal experience with vaccine damage agree with me. You want the vaccine? Have at it!! As for me, I want the option to make my own informed decision of ‘no’. Does that affect you? Not if the vaccine actually works, right? Now go find sources other than the ones bought and paid for by those who only pretend to care about us commoners.

    • Jennifer
      Until 100 years ago the average person with their “natural immune system” was lucky to live to the “ripe old age” of 35. Infectious diseases used to be the main cause of death. Smallpox, typhoid fever, malaria, bubonic plague, tetanus, and influenza used to cause hundreds of millions of deaths. Most people didn’t live long enough to suffer from Alzheimer’s disease. At first inoculations, then vaccines, after that antibiotics, and later anti-viral drugs led to near eradication for many diseases(smallpox and typhus).

  • To : me again
    You stated that the survival rate of 99.9 % was wrong.
    Then you stated that 210,000 have died and 25,000,000 have contracted Covid.
    210,000 of 25,000,000 is LESS than 1%. How is the math RIDICULOUS as you state ???

    • Couple of things: I don’t know about your denominator. The total number of cases in US is approx. 7,800,000. Numerator=215,000. Case-fatality ratio =o.o28=2.8%. There are different ways to calculate survival rate, but if we take it as inverse of latter: 97.2%

    • You’re accepting the number of deaths reported by the media as correct? The CDC itself has now admitted (albeit in footnote fashion) that only about 6% of those deaths were from Covid-19. Truly, dying with does not equate to dying from. Even then, one must accept the test results which have been proven faulty to those who are looking only for the facts.

  • Vaccines are notorious for causing serious health damage, you only have to look at the side effect lists or ask the parents, and this rushed experimental vaccine will be no exception. Since all viruses are known to leave some sufferers with long term fatigue and other ills this latest virus in no different. The idea that the global economy and countless millions of lives should be trashed in favour of a failed experimental game of hide and seek is idiotic in the extreme. And if that isn’t bad enough we are set to lose forever the freedoms a whole generation of young men and women gave their lives fighting for. We need to take a breath and stop this runaway train before it’s too late. Natural herd immunity is the only way we have ever survived viruses with the vaccines coming after the event and that has not changed because a pile of compromised politicians and power crazy billionaires say so.

    • You cant be serious. Vaccines are far safer than the actual disease. Have you payed attention to the issues that those with COVID are suffering? There are a number of long term/permanent conditions arising from COVID and are seen in as many as 80% of those hospitalized. Trying for herd immunity will only unnecessarily debilitate and kill people. BTW, the influenza vaccine alone saves millions of lives EVERY year, so your last sentence is garbage.

    • No one is losing freedoms (there will always be alarmists but they lack a measured view). We are preserving our freedoms by agreeing to take tiny, short term measures (no different than curfews during blackouts, stopping at stop signs, not driving while drunk) as preventatives so that conditions don’t escalate, which would require larger, more consequential measures to preserve our health and the economy. Americans have always sacrificed tiny freedoms voluntarily (speed limits) to safeguard the larger freedoms and our quality of life.

  • I am a phase 1/2a volunteer in this study. Survived first shot ( not placebo, as fever over 102). Due for second shot in trial on 21st. Please let me know when you have further info. Since their phase 3 has barely begun, wondering if the adverse evenr was from that study or mine ( phase 1/2a). You don’t even get the shot on your first 2 visits

  • Yea you better stop all the studies permanently!!
    All kinds of illness- death &
    side effects will happen from these vaccines!! And a signed waver that was “forced” isn’t going to save any of these companies from a law suite!!

  • There are folks who, primarily because they are obese or have conditions relating to being obese, will not fare well if they get Covid. However to shut down the economy or force vaccines on the rest of the population (99%) is unfair and unjust. If you’re worried about getting sick you need to take better care of yourself.

    • It’s just not that easy. First off, 80% of America has a preexisting condition. We shouldn’t be willing to play Russian Roulette with people’s lives based on the fact that they’re obese, have diabetes, or heart disease, or lung conditions. Secondly, even healthy people are dying, or being left with chronic conditions CAUSED by the virus. One (otherwise healthy) 40yo man I know had to have esophageal surgery to repair the rupture caused by the coughing fits – he has limitations for life now. One (otherwise marathon-runner healthy) 37 yo woman I know spent 2 weeks too sick to eat and her pancreas stopped producing insulin. She’s now diabetic. Permanently. They are followed the rules. They wore masks and isolated. Doesn’t matter if we all don’t work together. Also: Stop parroting this idea that the old and/or already infirm among us are expendable. Are you willing to tell your grandparents that you are okay with them dying? What about cancer patients? Diabetics? Fat people?

    • Your assertion that if you take better care of yourself, you wont get COVID is absurd. Your age is a primary morbidity factor and there are plenty of young healthy people dying or suffering long term/permanent disability from this disease. People refusing to vaccinate is selfish and make things less safe for everyone. If you refuse to vaccinate, please remove yourself from society so the rest of us don’t have to suffer your poor choice.

  • Time to buy Moderna, people. Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, said by email that “Everybody is on the alert because of what happened with AstraZeneca,” adding that it could take a week to gather information.
    “It would have to be a serious adverse event. If it was something like prostate cancer, uncontrolled diabetes or a heart attack – they wouldn’t stop it for any of those reasons. This is likely to be a neurological event,” he said.

  • Covid19 has never been isolated and proven to be contageous (Koch’s nor River’s Postulates).

    Iceland did dna analysis and found 291 versions of covid19, so its mutating just like the common colds. So which version of the 291 will this vaccine prevent?

    Why do we need to spend billions upon billions for a bug with a 99.97% survival rate?

    Just another big pharma con.

    • Coronaviruses are slow to mutate, unlike HIV and the flu. 291 variants does not mean a single vaccine won’t prevent it, unless these mutations make it differ so much that the T-Cell/antibody response will not alleviate it, which has yet to occur, per a senior life sciences exec I know who has made vaccines around the world.

      And where did you come up with a 99.97% survival rate? Please don’t make up numbers and pretend they are facts. Estimates are that 210,000 have died and 25-million to 50-million Americans have been infected, so your math is ridiculous.

    • To the comment about coronavirus not mutating as fast as something like the HIV virus, sars-cov2 is basically sars with a little bit of the HIV virus. I’m a cpa and somehow know more than people in the medical profession. So for everyone reading this, take vitamin d because no one will discover that until next year. Wear a mask. If everyone wore mask, many people would be infected with such a small viral load their body will most likely be able to fight off before developing symptoms or severe case of covid19.

    • Like we spent billions in making common cold vaccines … it’s a cocktail of different mutated viruses that changes every year in composition. Due to the virulent nature of viruses (generally speaking including the C-19), there is no vaccine per se.

    • Lets see, you say they did a DNA analysis of a virus you say has never been isolated. Both Koch’s & River’s Postulates are obsolete largely because they fail in many diseases, modern nucleic-acid-based microbial detection have taken over. Of course SARS-CoV2 is an RNA virus so doesn’t contain DNA only the instructions to make it. Mutations are common in all genomes but its only mutations that persist in the viral population that are important. There are some parts of the genome that are essential for life, obviously any change there leads to death. In immunology the interest is in the genes responsible for the immunogenic proteins on the viral capsule and in the case of this virus the only ones that offer protection are the spike proteins. This is what’s used to infect cells so mutations here would probably be more likely to interfere with its infectivity, unfortunately this appears to be a fairly stable area. So far no one has suggested any variants that might be able to avoid neutralising antibodies.
      There is no such thing as a fixed survival / fatality rate, this varies for all sorts of reasons. Early in the pandemic some areas reported infection fatality rates of between 7 – 10%, however as the most vulnerable die or are protected the numbers fall. At the moment the majority of infections in the west are in young fit adults who are far less at risk and those who do become ill have access to better treatments and good care. The numbers give us a reasonable estimate of people currently dying, in a particular area and with particular resources.
      Globally we are approaching 1,100,000 deaths after around an estimated 50,000,000 infections, using the very best estimates and then lowering risks even further, we could be looking at around another 2 million premature deaths that’s not a trivial number when every point you make is wrong.

Comments are closed.