The Wall Street Journal reports Johnson & Johnson Begins Final-Stage Testing of Covid-19 Vaccine.
Key Details
- J&J aims to enroll adult volunteers in the U.S. and several other countries, including Brazil and South Africa.
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A vaccine that Moderna Inc. codesigned with the National Institute of Allergy and Infectious Diseases started Phase 3 testing in July and has enrolled nearly 26,000 people toward a goal of 30,000.
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AstraZeneca PLC, which licensed a vaccine from the University of Oxford, started a 30,000-person Phase 3 trial in the U.S. in August but that study is on hold while an independent committee reviews a safety matter.
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Pfizer Inc. and partner BioNTech SE also started a Phase 3 trial of their vaccine in July and have enrolled nearly 32,000 toward a goal of 44,000. Interim results of the Moderna and Pfizer studies could come as soon as October, but possibly later, according to company executives.
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J&J’s vaccine is known as a viral vector shot because it uses a modified adenovirus—a virus that can cause the common cold—to deliver genetic instructions teaching the human immune system to build a defense against the coronavirus
The J&J trials begin shortly after the Number of US Covid-19 Deaths topped 200,000.
Counts are again on the rise nationally and internationally but the death rate is headed the other way.
The number of deaths and cases is very suspect in some countries.
Question of the Day
Would you take the vaccine?
Mish
Nope
Already been innoculated by the real thing
I’m thinking that I don’t want to be genetically modified at this stage in my life, particularly with a vaccine that has NOT been exposed to long term testing. Who the hell knows what will happen as a result a few years down the road.
While vaccine makers have a liability shield from adverse effects of their vaccines (which has been upheld by the Supreme Court), I’m concerned to see Moderna insiders dumping their shares (Forbes; Sept 4 2020) at a staggering pace over the past year, with virtually no insider purchases. Very bizarre behavior for a company that could potentially hit the mother load if their vaccine proves successful.
I’ll wait 5 years and see.
H*ll no on the mRNA vaccines. Not gonna be in the early cohorts till some decent data is out there. Plus I’m pretty d@mn sure I had it already back in December.
I agree that the mRNA vaccine sounds like it has some risks for longer term side effects. Most of the vaccines, including J&J, Oxford, China, and Russia are based on an inactivated Adenovirus.
No. I don’t trust the drug companies. Social distancing, wearing a mask and washing my hands frequently are working just fine.
I will, because J&J is a pretty decent company, and because their vaccine is a single shot deal, not a two shot vaccine.
For those above who think you do not need immunity from this as long as you are young and healthy that is what a lot of people thought until they got sick and died. It is true that this harms older people and people with health issues more, but that does not mean you are safe from Covid.
A lot of younger people are living through it, some without ever going to the doctor or a hospital, only to go on to develope long term disabilities afterwards. Extreme life changing fatigue in as many as a 1/3 of covid survivors, along with debilitating headaches, shortness of breath, sinus problems, heart rhythm problems, permanent loss of taste or smell, organ problems, permanent lung damage leading to pneumonia, damage to the T lymphocytes paralleled that caused by HIV, and many more. In fact Covid may leave us with a population permanently debilitated by it’s effects for many who survive it.
If you get any opportunity at all to avoid getting it you must at least try.
Exactly. This thing is an autoimmune virus waiting to happen for those who get Covid.
Hell no. Not one developer under this administration.
Hell no. Not one developed under this administration.
Yes absolutely. I estimate the risk of getting covid over the next year is 5%. As someone 60+ my death risk from covid is 4%. The vaccine would have to be problematic for more than 1 in 500 to be worse. Even incomplete testing will prove it less harmful than that.
Finally a comment by someone who understands risk.
Can you teach me how to use the Black-Scholes equation?
Do you really want to understand options prices? 😉
No, Just kidding. 🙂
I learned everything I need to know about options in the school of hard knocks. No Black-Scholes needed.
What if Covid-19 is man made, and it is not found in nature as the Australian team determined? What if it could be slightly modified every year to avoid the current vaccine and reintroduced? Just asking.
The correct answer to your question is that it really doesn’t matter at all if it was man-made. The likelihood of mutations is high either way, and whether a vaccine works has a lot to do with the precise mechanics of HOW the vaccine works (what part of the virus it targets) as to whether it confers long term immunity.
The reason so much is unknown about the vaccines is that there is no good way to predict efficacy in a case like this. Only time will tell. There are no shortcuts.
A vaccine won’t stop the virus spread. COMMON SENSE does. If you are concerned that you might be in the category of ‘suspetible’,…wear a mask.
The coronavirus out there (which has mutated so no vaccine can remedy the mutation) that in my research is no worse than any other virus we have championed before. Stay healthy,..eat good fresh food and your body’s immune system will kick any virus out. IT is stronger than any virus.
The marketing of how (alledgedly) dangerous this virus is has taken off more virually then the virus itself. Long story behind all of that I suspect.
I would not take any vaccine period. Especially one that has been rushed through with no long standing science and trials to prove its effectiveness .
I’ve never taken a flu shot and have never been sick from the flu of any type. I’m 68,…I eat correctly,…exercise,…meditate,..and keep a positive mindset. Some might think that has no affect,..I will take issue with that as I am proof.
We need a medication for the paranoia and totally inaccurate infomation that Fauci, Gates have spewed out. Nothing they have said has come to pass regarding the people affected and deaths.Total fear mongering.
Follow the money. It’s that plain and simple.
Unlike some viruses, the Coronavirus should be fairly easy to develop a vaccine for, precisely because they can target a critical area, the spike. Mutations can take place, but if there is a mutation that affects the spike, it will no longer be able to infect, so that part will remain stable.
As for the virus itself, it’s a race between the body and the virus. Can your body eliminate it before it shuts down the immune system? A strong immune system “should” win, while a weak immune system might not, but that’s not the only factor. As with any infection, the severity of the infection also depends on the size of the initial dose, the innoculum. The larger the initial dose, the less time the body has to react before the immune system is compromised.
That’s why masks have been so much more effective in real life than expected. Even when they don’t completely protect you, they significantly reduce the initial dose, resulting in far more asymptomatic cases. That’s why Fauci and Robert Redfield have changed position on masks since February; it turns out they do work.
“News of the vaccine’s success was first made public on April 12, 1955.[6] Salk was immediately hailed as a “miracle worker”, and chose to not patent the vaccine or seek any profit from it in order to maximize its global distribution.[1] An immediate rush to vaccinate began in both the United States and around the world. Many countries began polio immunization campaigns using Salk’s vaccine, including Canada, Sweden, Denmark, Norway, West Germany, the Netherlands, Switzerland, and Belgium. Less than 25 years later, domestic transmission of polio had been completely eliminated in the United States.”
ordinarily yes but trump and his political appointees have corrupted fda, cdc and our health regulators that i’ll be counting on my doctor and his health network to independently review the data
…..”There’s lots of agendas at play here, not just public good,” said Naor Bar-Zeev, PhD, of the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health.
“It’s extremely optimistic to think you will be able to deploy a vaccine by the election or even by the end of the year,” he added. “Deployment fully will be at least another year.”
Bar-Zeev and other experts detailed production and distribution cycles. Research challenges aside, they cited many obstacles to meeting the time frame offered by the Trump administration’s Operation Warp Speed.
“You need to do things sequentially,” said Paul Offit, MD, who directs the Vaccine Education Center at Children’s Hospital of Philadelphia.
Once the trials theoretically yield results demonstrating a vaccine’s efficacy and safety, experts said manufacturing doses should be the easiest part of the whole process. Investments in production capacity have substantially increased, Bar-Zeev said, and RNA vaccines especially are easier to replicate reliably. He estimates doses will be available for 20% of the global population by the end of next year and the U.S. will have a large amount of doses by then. Several manufacturers have promised to have hundreds of millions of doses ready in 2020 alone.
There are manufacturing challenges, said David Aronoff, MD, director of the Division of Infectious Diseases in the Department of Medicine at Vanderbilt University. One is producing at scale, given regulatory issues associated with inoculating otherwise healthy people.
“The task remains daunting to scale up manufacturing capacity to levels never seen before,” according to a technical sheet from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). “Now the focus is on reducing the number of steps it takes to manufacture the vaccine as well as the amount of equipment and range of different skills needed.”
Manufacturers are employing single-use technologies, for example, to streamline the process, according to IFPMA. These technologies are especially helpful sparing operators from having to sterilize bioreactors between batches.
Distribution figures to be an even bigger obstacle. The leading vaccine candidates would have to be shipped and stored at temperatures ranging from -20 to -70 °C. These conditions are not readily available at the scale needed, Bar-Zeev said. According to the IFPMA technical sheet, “This could be a challenge going forwards in terms of distribution.”
And even with those problems solved, vaccines can’t be administered quickly to millions of people, Bar-Zeev noted, if only because of the need to maintain social distance; dozens of people can’t be crowding into pharmacies or doctors’ offices at once.
Qualified, trained people will also be needed to help administer the vaccine, he said, and they will need oversight.
The bigger medical supply chain is also being tested, Aronoff said, as a worldwide campaign will require billions of individual vials, syringes, labels, and other mundane items.
Realistic Timeline
But that may be putting the cart before the horse. Accumulating sufficient safety and efficacy data will extend through 2020 and probably into next year, said Offit, who sits on the FDA’s vaccines advisory committee. The best-case scenario is that participants complete phase III trials by mid-November. “If we were lucky we’d have clear information by early next year,” he said.
Still, he added, “I’m open minded to the fact it may come out earlier.”
Offit, citing a CDC Advisory Committee on Immunization Practices presentation, said the first wave of U.S. vaccine recipients could number 150 million — healthcare workers, other essential workers, people with pre-existing conditions, and the elderly. With two doses needed, that would require 300 million just for those high-risk individuals.
“It’s going to be a real challenge to vaccinate that many people that quickly,” Offit said, noting they would all have to return a month later for their booster doses. (Last week, however, a National Academies panel recommended a much smaller group for the first wave — limited to healthcare workers and first responders — such that only 10-15 million doses would be needed initially.)
The prevalence of anti-vaccine sentiment is also a significant issue. “It’s going to be hard to convince people to get these vaccines. People generally don’t trust the government, they don’t trust the government about this virus,” Offit said. “It’s just not a government you can trust with science.”
Interesting comments.
I see that it isn’t just in investing where people tend to screw themselves by misjudging risk.
50 percent of the population say “no”.
Threshold of 50% is defined as “success” for vaccine.
50% of 50% is 25%
Is 25% enough to stop the virus spread?
how is that HIV vaccine coming?
nope. I’ve never had a flu shot and don’t plan to start now. The flu and covid are both RNA viruses which mutate constantly. The covid vaccine could be obsolete by the time it’s available to the public, just as the flu vaccine is often obsolete. Besides, getting a flu shot WEAKENS a person’s immunity. How else to explain this outcome of one test? Group A received a flu shot. Group B did not get a flu shot. The next year neither group got a flu shot. Which group had a higher incidence of flu the second year? That’s right, Group A! How else to explain that than Group A getting the shot the year before weakened their immune system? There are other studies that show that getting a shot every year is not healthy. Moreover, the vaccine companies won’t tell us what’s in the vaccine. Why would I want to inject something directly into my muscles without know what that something is? And finally, if vaccines are so safe, why did Congress feel it necessary to shield vaccine manufacturers from liability lawsuits?
From the folks who brought us asbestos laden talcum powder, nope.
No. Not before tRump and cohorts take the vaccine.
Another interesting data point is whether you are out in the world or in some form of sheltering in home.
No
We will. 6+months after Tony tells us it is effective and safe.
And, for us, there is no point in taking a vaccine before:
Given the time frame of development, I’d test fly a 737 Max before I took that vaccine and I don’t have a pilot license. Boeing doesn’t have arbitration for product liability like the vaccine industry has either. The whole covid 19 pandemic is tainted beyond belief. Lies. lies and coverups.
There is a blind spot with the information pertaining to covid. It could be many people have been infected and it’s most swept though the population or some people are naturally immune to it.
I don’t know what I don’t know but I know we are missing key information.
A vaccine is the least of country’s problems.
The Atlantic is trash!
No. If one is healthy there is no need to take a intervention with no long term, or even medium term effects understood.
Would I take the vaccine? Of course.
But I am skeptical about most of the vaccines as far as whether they can confer long term immunity. I wish somebody would do an article that had a spreadsheet with all the vaccines currently in trial, that showed how each vaccine was supposed to work…that is…..what part of the virus the vaccine is supposed to affect.
I am particularly skeptical of anything that is supposed to affect the spike protein, because that approach was tried without success on HIV, from what I’ve read. Several of the vaccines in trial target the spike protein, I believe. For HIV the vaccine stopped working after about a month..and the trial ended.
No successful vaccine has ever been made in the past for any Coronavirus…and there are some reasons for that…that might apply here.
I think the shotgun approach of throwing big money directly to Big Pharma, and bypassing some of our best virologists and ignoring their input was not a wise way to go, and that is what happened. So hopefully we get lucky. I think there are some interesting approaches being tried.
But would I be worried about side effects from taking the vaccine? Nope. For somebody my age and in my occupation (dentistry) the potential benefits far outweigh the tiny risk,