Johnson & Johnson Covid-19 vaccine enters Phase 3 trial in U.S.
S E E D E D C O N T E N T
A fourth Covid-19 vaccine candidate has gone into the final stage of clinical trials in the U.S., with Johnson & Johnson announcing the start of its Phase 3 trial Wednesday.
The drugmaker follows Pfizer and Moderna, whose Phase 3 trials began in late July. AstraZeneca also started its Phase 3 vaccine trial this month, but it remains on pause in the U.S. after a participant in the U.K. was reported to have developed a spinal cord injury.
The Johnson & Johnson trial is not expected to yield preliminary results for at least two months.
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President Donald Trump has repeatedly pressed for faster work on vaccine research — even suggesting that there could be some kind of approval before the Nov. 3 election. That timeline would be impossible, at least for Johnson & Johnson, whose interim results are not expected until late November at the earliest.
Johnson & Johnson's vaccine candidate, which is being developed in partnership with Janssen Pharmaceuticals, differs in several ways from the others that have reached the final stage of trials.
Unlike Pfizer's and Moderna's vaccines — which require two doses about a month apart — the Johnson & Johnson vaccine can be administered fully in one dose, avoiding the complicated coordination to require that people return in time for the second dose.
In addition, the Johnson & Johnson vaccine requires basic refrigeration for storage. Pfizer's vaccine must be stored at minus 94 degrees Fahrenheit. (For comparison, that's colder than the South Pole's average winter temperature: minus 76 degrees.)
Moderna has aimed to enroll 30,000 participants, and Pfizer expects to sign up 44,000 in U.S. Phase 3 trials. Johnson & Johnson's enrollment will be much larger, aiming for 60,000 people.
The larger study is "notable and commendable," said Dr. Gregory Poland, an infectious diseases expert who directs the Mayo Clinic's Vaccine Research Group in Rochester, Minnesota. He said a single dose of vaccine in a pandemic provides an opportunity to fully vaccinate more people more quickly.
The Johnson & Johnson vaccine was made using a technique used in previous vaccines, including the one the company developed for the Ebola virus. It combines genetic material from SARS-CoV-2 (the virus that causes Covid-19) with an adenovirus, which causes the common cold but has been genetically altered to be harmless in this case.
Using the genetic material from the coronavirus, the disarmed adenovirus is able to teach the immune system to generate antibodies to attack SARS-CoV-2's spike protein, which is what allows the virus to enter human cells.
The accelerated efforts to find a safe and effective Covid-19 vaccine are part of Operation Warp Speed under the departments of Defense and Health and Human Services. The Johnson & Johnson vaccine trials are sponsored in part by the National Institute of Allergy and Infectious Diseases.
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The agency's director, Dr. Anthony Fauci, called the latest vaccine trial launch a "very important advance" during a call with journalists Tuesday. He attributed the speed of the vaccine's research and development to longtime working partnerships among NIAID, Johnson & Johnson and Janssen.
"These things don't just happen overnight. What you're seeing now is the result of the fruitful relationships that have been developed over literally several years," Fauci said.
The Food and Drug Administration has said an effective vaccine needs to protect at least 50 percent of people to be considered effective. Companies are working toward a higher percentage, at 60 percent.
That is key for scientists to determine whether a vaccine is working. Investigators need to log 154 infections, or "events," among study participants to see whether more of the infections were in the groups getting the actual vaccine or a placebo shot.
"From the statistical construction of the trial, in order to get to an efficiency target of 60 percent, you would need 154 events. Now, it could be that you have a much more effective vaccine" than 60 percent, Fauci said. "We're hoping that that's actually the case."
The first shots are expected to be administered Wednesday. Johnson & Johnson's chief scientific officer, Dr. Paul Stoffels, said the company is targeting "high-risk areas and specific populations" that are at greater risk for infection and complications of the virus.
A diverse study group is key for safety and efficacy, said Poland, who is not involved with the Johnson & Johnson trial.
"It's fine to tell me that in healthy 18- to 55-year-old that the vaccine was safe and 70 percent effective, for example," he said. "But also tell me what it would be in grade school kids. Tell me what it will be in pregnant women, in people 75 or 80 and older with diabetes and obesity."
A varied study population is necessary to figure out who should or should not get a vaccine. "You don't just complete the trial and say, 'Well, nobody died,'" Poland said. "You want to carefully analyze and parse the data to say, 'Are there any surprises here?'"
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So... we may have a partially effective (60%) vaccine early in 2021.
Should we rejoice?
We can rejoice 60%. Not a full rejoicing. But maybe a little more than half rejoicing.
I have a bad heart. I am a "person at risk". This crap is giving me a 60% shot at living?
That doesn't really thrill me....
I'll take 60%. Shoot, we have flu shots that are only 35% effective some years
I don't think anyone will force you to take it if the odds and science aren't to your liking.
Still better than nothing.
Keep in mind that vaccines usually give you the disease... in attenuated form. I'll wait for confirmation.
Absolutely. I will get my flu shot every year even if they tell me it's 0.01% effective. Not that I have a choice. I have to get a flu shot where I work
60% is better than 0%.
Your comment reads as though you would have a 40% chance of dying if you took the vaccine. Is that what you meant to connote?
Seems to me that if one takes the vaccine, one reduces the likelihood of getting infected if exposed from 100% to 40% (assuming one has no natural immunity, etc.).
I don't know. All vaccines have some side effects. These are being fast-tracked awfully powerfully.
It should work as you say... but all the hype worries me. Covid would very likely be fatal to me, so the idea of having it injected, even, in attenuated form... kinda bothers me...
You did not mention side-effects. I agree, I would be very cautious based on the side-effects once we know what they might be.
That depends on the biochemistry of the vaccine. I fully agree with checking out the empirical results of the vaccine. If people are acquiring active COVID-19 due strictly to the vaccine I certainly would opt out of taking it.
Attenuated vaccines give you a "live" form if the virus. But they are usually non-virulent or highly weakened. Another type of vaccine are inactivated, "dead" vaccines, which do not contain the live virus.
I got mine already.
I get mine in 2 weeks. They schedule us.
I hope they can develop a covid vaccine from a "dead" virus. They're gonna want high risk people to get this shot and an attenuated virus could turn out to be deadly for some
That would be good. But it would also require booster shots to remain effective.
It's possible. Certainly more study is warranted when the vaccine is released to determine its effectiveness and potential side effects. But it might also be indicated for high risk populations, much like the pneumonia and flu vaccines are for the elderly or those at high risk of exposure.
Progress is good.
Don't worry. It won't be available until probably some time next spring
That is such crap, Greg.
No one is trying to postpone the vaccine. You know that.
Trump may be trying to put it on the market before anyone knows if it is worthwhile...
I got a letter from one of the hospitals here to volunteer for the trials. They pay money!
I hope you are not a "person at risk"...
Hmmmm.....I'm old, fat, and a smoker. Any risk there?
Anyway...Mr Giggles has forbidden me to participate in any of these trials.
Mr. Giggles is right. You are at high risk.
Well, I didn't really need that 25 bucks anyway
Someone at the hospital where I work, the Radiology Coordinator, I spoke with the other day and he said he wasn't going to get a vaccine. It shocks me when intelligent people, who should know better, flat out admit that they won't get the vaccine when it becomes available.
My husband won't get any kind of vaccine. He had to get all of his shots when he was in the military (so did I, but I still get my shots) and he says he won't get the flu or the covid shot. He did get a shingles vaccine, tho. I'm not sure how they talked him into that one
The vaccine is being rushed out under very powerful political pressure. The risk of cutting corners, either in its definition or in its evaluation, is significant. Prudence seems reasonable.
PROVE IT
Why?
Im definitely not going to be first in line , keeping in mind a vaccine usually can take up to 2 years in development , 7 months in , , my opinion is something likely has been overlooked with trials , not worth risking my health or life with unknown side effects , especially in my case of what i consider being low risk.
get a few million to take it before me and i might think about it.
Mark, I'll tell you what I'm goin to do. As soon as that vaccine is available I'm going to take it.
After that I will no longer wear a mask.
Nothing personal, my friend, but after that I am not going to worry about those who don't get vaccinated.
i understand , and thats where it should be left for anyone , personal choice after they look at whats going on as it pertains to them.
Correct...You & I can leave it at that.
LOL yes you and i can , others .... cant and wont.
I think this is something people will have to evaluate for themselves , based on the individual risks they have .
Based on my own individual risks , i wont be getting it.
Risks i will use pertaining to me . age , health history , social interaction , and general geographic likelihood of infection.
My actual biggest risk i think is social interaction from and with individuals whom are either from out of state or people whom live here and go out of state and come back. and those are things i have little to no control over.
So some quick facts about the differences in live vs dead vaccines
Dead or Alive: What’s the Difference?
Live…
Stability— The live attenuated vaccines are more unstable than their dead counterparts, comprised of weakened bacteria or viruses. To maintain their effectiveness they must be stored via refrigeration to ensure they don’t gain strength and mutate into a virulent form.
Strength— Strength is the key advantage for live vaccines due to their powerful immune response. This is why a single dose lasts a lifetime.
Immune System Response—The strength and instability of the live vaccines means they should not be given to people with compromised or damaged immune systems due to the risk of the resurrection of the disease you’re trying to prevent. This includes people undergoing chemotherapy treatments and AIDS patients
Dead…
Stability—These vaccines are very stable and the risk of mutating dead microbes is minimal. Refrigeration is not required for their storage. Therefore they can be stored without refrigeration.
Strength— The weaker response of the dead vaccine requires an occasional memory refresher for the immune system in the form of booster shots.
Immune System Response— The advantage here is that dead vaccines are 100-percent safe no matter how compromised the immune system of the recipient
Which Vaccinations for What Diseases?
Following are some of the diseases held at bay by live viral and bacterial vaccines:
—Viruses such as rubella, mumps, measles, varicella, polio (oral vaccine) and influenza (nasal spray)
—Bacterial live vaccines also include oral polio vaccine, oral typhoid vaccine and BCG.
—Dead inactivated whole viral vaccines protect against hepatitis A, rabies and influenza.
—Diseases like cholera, typhoid, pertussis, and plague should receive vaccinations of dead inactivated whole bacterial vaccines.
Keep in mind, that COVID comes from the same class of disease as rubella, mumps, measles, varicella, polio, influenza, (RNA viruses) so probably live would work the best, but comes with some risk.
They didn;t have the oral typhoid when I had to get one. It was a painful shot and I actually got ill from it
Good recap. Thanks.
Alex Jones the nut case from Austin, Texas is selling a cure for COVID. Cheap and ineffective.
And I'll bet there are those out there dumb enough to buy it too.