Johnson & Johnson is cutting the size of its pivotal U.S. Covid-19 vaccine trial — the only major study testing a single dose of a Covid vaccine — from 60,000 volunteers to 40,000 volunteers.
The change is being made possible by the fact that Covid-19 is so pervasive across the country, according to a person familiar with the matter. The more virus there is in the U.S., the more likely it is that participants will be exposed to it, meaning researchers will be able to reach conclusions based on a smaller trial.
Changing the size of the study does not indicate that results will come on a different timetable, or anything about whether they will be positive or negative.
During a press briefing on Wednesday, Moncef Slaoui, the head of Operation Warp Speed, made brief mention of the change.
“We have already recruited more than 38,000 subjects in the study,” Slaoui said. “With J&J, we decided to cap the recruitment to around 40,000 subjects, which will happen by the end of this week, so in the next two [or] three days.”
In a statement, J&J said: “We continue to anticipate that interim data from the ENSEMBLE trial will be available by the end of January. If the vaccine is safe and effective, an emergency use authorization application could be submitted to the FDA in February.”
The J&J study, started Sept. 23, was the largest Phase 3 trial of a Covid-19 vaccine. The vaccine J&J has developed uses an adenoviral vector, a type of genetically modified virus that leads the body to produce a protein to which the immune system then reacts, in theory inoculating the recipient against the virus.
Like other Covid-19 trials, the goal is to follow the volunteers enrolled in the study until 154 of them have contracted the virus that causes the disease. In the case of the J&J study, in order to be counted, a case of Covid-19 must be severe or moderate and occur at least two weeks after vaccination.
Because Covid-19 cases are skyrocketing in the U.S., J&J will reach this milestone while enrolling fewer patients. That leaves the J&J study as about the same size as that run by Pfizer and BioNTech, which included 44,000 volunteers in their study of the first vaccine to deliver positive results, and somewhat bigger than the 30,000-patient study run by Moderna, which developed the second vaccine to show positive results.
Johnson & Johnson is also conducting a second study using two doses of the same vaccine in Europe and the U.S. That study plans to enroll 30,000 volunteers.
Lev Facher contributed reporting.
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I’m interested in vacine study in Lake Worth, Fla
I don’t like to comment on public blog, but this may help someone. I am a vaccine trial volunteer and got my j&j trial vaccine or placebo few days ago, the first night I was a bit tired and my arm, injections area was a bit sore for 3 days. Had no notice adverse side effects. I may be on placebo or may be that’s all I am supposed to feel. I am in my early 40s, my tolerance for vaccine is very high. I had the same symptoms when I had the flu shot.
Anyhow, waiting on the next visit. Nothing exciting to report so far. I am wondering to hear from my other vaccine volunteers, if they had a different experience.
My husband and I are both in the trial,we had our injection in Nov. I felt very tired the next day my husband not so much. Like you said we don’t know if we had the vaccine or the placebo. But so far so good.
Received the shot on 12/10 only hurt on the injection no side effects-sore arm but nothing like the shingles vaccine-it did hurt more than the flu? So 50/50
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Matching the JNJ trial size to that of Pfizer, Moderna and AstraZeneca makes a lot of sense. And with Covid explosive Covid spread the data from the placebo arm will be even more telling in the upcoming JNJ trials. With the devastating skyrocketing increase in Covid cases and deaths (now more than 9/11 every day, and totalling already far more than in any war) we desperately need more vaccines and faster effectiveness. JNJ’s is based on the same vector as AstraZeneca’s (that is already deemed safe) and its one-shot and far less cumbersome delivery would seriously speed up immunization .
I am in the ENSEMBLE study and believe I received the placebo. Can I move over to the ENSEMBLE 2 study in hopes of receiving the actual vaccine? It seems to me that J&J would be better off giving actual vaccines to study instead of placebos. I just feel my “contribution to society” would be better served that way. Just a thought.
I am in the study however because of my age and morbidity factors, if I am approved to get another vaccine before Jannsen is approved- I expect to be told if I had the placebo or the vaccine- PLEASE RESPOND AS THIS IS IMPORTANT –
Pls advise on how to volunteer to participate in the Phase 3 trials of the J & J COVID vaccine
I was tested positive on November 6th. I had to self quarantine. Is this good for people that tested positive?
I am deathly allergic to DPT vaccine, which vaccine should I take?
Did your physician say you are deathly allergic to the DPT vaccine?
I am not a doctor but… I would avoid the DPT shots.
I would try to identify the specific substance in the vaccine that you are allergic to and avoid anything containing that ingredient