when are they going for EUA? What is expected date for 1st vaccine?

On February 4th, they applied for emergency use authorization. The FDA is going to finish reviewing the request and data by February 26th. Availability to the public would be shortly after that and is expected by early March.

DadHammer said:

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You would think the government agency would have been working side by side with JJ so 3 dang weeks wouldn't be needed for approval? Just seems like a waste of two weeks to me.

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LOL, I admire your optimism.

On Feb 4th J&J announced that they were applying for the EUA. They didn't actually apply that day. Some of that 3 weeks is waiting on J&J to actually give FDA the data.

A lot of focus has been on the approval timeline, but the more critical timeline for J&J will be the actual manufacturing of doses.There have also been reports that J&J has notified the government that they are behind on manufacturing the vaccine and won't meet their commitment to the federal government.

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But the encouraging prospect of a third effective vaccine is tempered by apparent lags in the company's production. In the company's $1 billion contract signed with the federal government in August, Johnson & Johnson pledged to have 12 million doses of its vaccine ready by the end of February, ramping up to a total of 100 million doses by the end of June.

Federal officials have been told that the company has fallen as much as two months behind the original production schedule and won't catch up until the end of April, when it was supposed to have delivered more than 60 million doses, according to two people familiar with the situation who were not authorized to discuss it publicly. Carlo de Notaristefani, lead manufacturing adviser for Operation Warp Speed, the federal vaccine development program, acknowledged a delay, but said the company might be able to catch up with initial production goals by March.

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Quote:

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But at a Tuesday news conference, Dr. Slaoui said that instead of 12 million doses envisioned in the contract by the end of February, the company was likely to have in the "single-digit" millions. He also said the company was "trying to make that number get as close to a double-digit number as possible, and then a larger number in March and a much larger number in April." Another person familiar with the company's progress said it was poised to deliver only perhaps three million or four million doses of its vaccine by the end of next month.

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We asked the same questions on the previous two vaccines as well.

I can't remember the poster and I paraphrase: There are hundreds of thousands of pages of documentation, data, etc. and it has to be gone through in as unbiased a way as possible to ensure not only effective it is but how safe it is as well.

I agree that it would be nice if they had been in there a bit more real time but not sure if that is actually the best course of action given the importance of this to getting us back to normal.

Just to drive home the importance of the manufacturing -- it wouldn't matter if the J&J vaccine got approved today if there were no doses to be put into arms available. 3-4 million doses total by the end of February isn't very much when you considering we're giving 1.5MM shots per day right now of Moderna and Pfizer.

I thought a lot of that was the supply chain. I thought pfizer was making them as fast as they could but the glass and some reagents were the rate limiters.

They are making them as fast as the can now. They were supposed to be doing that starting in September, way before they knew if it would be approved.

I'm sure there are some honest explanations about logistics and raw materials, but my guess is that they decided not to fully commit until after they knew it worked.

And I don't necessarily blame them. I'm not sure any company would feel good about the risk of having to throw away a billion dollars of vaccine, or the potential bad press of getting paid to do so by the government.

I think there a number of factors at play. Multiple large pharma companies abandoned their vaccine projects because of ineffectiveness so even in a scenario where the government is fronting lots of money, there's still reputational risk if it gets thrown away (plus isn't government waste everyone's favorite punching bag?).

The other piece I'm curious about would be opportunity cost - if JNJ buys up 100 million glass vials and loads them with a vaccine that ultimately fails, that's 100 million vials not available for moderna/Pfizer. Even if you're burning money to get a vaccine in place, there are still physical bottlenecks you have to overcome (look at mask production rates and how long it took to get N95 production up to a reasonable level).

It's also possible that JNJ has been working for months to get the manufacturing right but there have been screwups or maybe this vaccine is more difficult to manufacture than they expected.

I don't think anyone is lying. But it's clear that no one fully bought into the idea of manufacturing at full scale at risk. That was the plan sold to the public last summer. They were supposed to be making a million doses a day before they knew that it worked. That didn't happen.

I don't know why it didn't happen. Big pharma culture being conservative? Government not fully committing the funds? Mistrust between pharma and government? Look, I'm fully aware that any plan to intentionally set 10 billion dollars on fire is going to make a lot of the people responsible really uneasy, but that's what should have been done. Any amount of money that could have been thrown at the problem is insignificant compared to the cost of the pandemic.

In private companies, missing deadlines, running over cost is not unusual -- even with billions of dollars at stake. If I recall correctly, at the Downstream conference two years ago they shared a statistic that 80% of the mega-projects (>$5B) in the Gulf Coast were at least 20% over cost and 20% over schedule.

We know why these things happen -- overly optimistic projections by management, unforeseen shortages in supply/labor, unforeseen delays in some portion of the critical path, etc.

In this case, it sounds like they're behind, but not as much as you're making it sound like. Back in August when they signed the contract with the government they were supposed to deliver 12mm vaccines by the end of february and 60mm by the end of April. They still believe they can be on track by the end of April, but they may only deliver 3-4MM in February instead of 12. That doesn't suggest to me a systemic hedging of bets or risk calculation. It just seems like they had a slip in their timeline that they're aggressively trying to recover.

A couple thoughts on that. We know from the Pfizer dust up a couple of months ago that the government didn't initially order as much as they could, because they were worried about it not working. That never should have even been a consideration. Set the money on fire.

The scientific achievement on this is astounding, and I hope we see some Nobel Prizes for the mRNA folk. But it looks like the bureaucrats both in government and pharma could have been bolder. The EU ones are certainly kicking themselves right now.

amercer said:

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A couple thoughts on that. We know from the Pfizer dust up a couple of months ago that the government didn't initially order as much as they could, because they were worried about it not working. That never should have even been a consideration. Set the money on fire.

The scientific achievement on this is astounding, and I hope we see some Nobel Prizes for the mRNA folk. But it looks like the bureaucrats both in government and pharma could have been bolder. The EU ones are certainly kicking themselves right now.

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Pondering setting money on fire is one thing, but also pondering the liability for producing a product that doesn't pass FDA good manufacturing practices reproducibility and testing standards is another.

I think you are oversimplifying it for a couple of reasons. The FDA over 15 years ago moved away from a mere 'test what you produce to make sure it works, and throw it out if it doesn't pass' philosophy for medical devices/products, to a 'test what you produce, how you produce it, and validate the process/ingredients so that it always works, and if it doesn't, at any time, stop and figure out why not.' This was a huge change.

Abbott, for instance, with their istat cartridges (blood gas/chemistry in a little fluidic chip basically), used to discard something like 70 percent of what they produced as failing QC checks ('supposedly.') That had to stop, immediately. So did innumerable other processes/products (not intended as a slam on Abbott).

I am not trying to say it is wrong but it is ISO9000 on steroids to those of you in quality manufacturing, but with a huge regulatory/liability risk behind it's back. It's very, very difficult to just move to 'hit the go button to produce a billion of these things.' It's not just the money or approvals etc., it's the whole system being absolutely engineered around a consistent product/production/regulatory compliance.

Back to my point, I've seen a lot of indications the manufacturers (and their contractors who do the manufacturing for them) did move forward with due haste, and no evidence that they took their time (let alone in an interest to preserve profit/margins). Dust ups, and delays in ramp up are related to my points above, imho.

There will be plenty vaccine available soon.

"The Trump administration bought 200 million doses of each of the Pfizer-BioNTech and Moderna vaccines with 100 million of each due by the end of March and the balance by summer and spent nearly $1.5 billion helping J&J develop its vaccine and produce 100 million doses. "

200 million by the end of March and 200 more by summer. That's 400 million total by summer. With the people already immune from recovery this thing is over soon. What a modern miracle.

I just wanted the JJ to start sooner to end this sooner.

J&J vaccine, COVID: One-shot Johnson & Johnson is safe, 66% effective (usatoday.com)

Trying to find the JJ time line for delivery.

Found It

"J&J said it would have some vaccine ready to ship if the FDA allows emergency use of the shot, but it didn't reveal how much. The pharmaceutical giant said it expects to supply 100 million doses to the U.S. by the end of June."

J&J asks US regulators to OK its one-shot COVID-19 vaccine (nbc29.com)

Add 100 million by end of June to the 400 million end of summer we have 500 million. That should pretty much kill this thing for good.

Minor point -- Each person requires two doses of Moderna/Pfizer, so you shouldn't add the number of doses for those with the JJ vaccine which only requires one dose.

Still more doses than Americans approved to take them

GAC06 said:

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Still more doses than Americans approved to take them

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Especially in places like NY where you have to be in a strict class of persons approved by the governor to receive them.

DadHammer said:

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You would think the government agency would have been working side by side with JJ so 3 dang weeks wouldn't be needed for approval? Just seems like a waste of two weeks to me.

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WSJ has a great podcast on the story behind scientific collaboration to expedite the vaccine process for COVID. So many institutional norms were sidestepped or walked over to get data from China to the research teams, who then worked alongside competitors, worked for no profit (Astrazeneca/Oxford), and published data outside the normal peer review process. I'm a scientist/engineer but not in the medical field, so I can't verify the data in the podcast, but as a guy who also works in government contracting, I can believe that the FDA would stick to the old tried & true authorization processes.

It's garbage because there are TONS of federal "regs" that aren't complied with and subsequently not enforced.

All this to say, I agree with you Dadhammer! Government collaborating hand in hand with J&J to speed this up a week or two might help stop mutations, etc.

GAC06 said:

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Still more doses than Americans approved to take them

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I just remembered there are 260 million adults in the US.

Children are not approved for, nor do they need, the vaccine.

Heck, if I already had COVID I wouldn't get the vaccine.

That's what I mean. 200 million moderna and 200 million Pfizer and 100 million JJ is enough for 300 million adults. More than we will need

I heard that the US has contracted for enough doses of vaccines to inoculate our entire population twice over. My guess is that once everyone who wants a vaccine gets one, we'll probably give the excess doses to other countries or we'll save them if booster shots become necessary.

I am guessing we give them away.

DadHammer said:

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I am guessing we give them away.

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Could be a good negotiation tactic with countries later down the road