Company Cleared To Test Swine Flu Vaccine Fighting Off Liquidation

[Robbien]

Source: WSJ

As a new White House report raises the possibility that up to 50% of the U.S. population could contract swine flu this season, one drug maker has come a step closer to distributing a vaccine. That is, if the involuntary bankruptcy filing against it doesn’t get in the way.

Protein Sciences Corp., of Meriden, Conn., is a privately held vaccine maker that last week won federal approval to kick off clinical trials of its vaccine for the H1N1, or swine flu, virus, the Hartford Courant reported. That means Protein Sciences’ PanBlok vaccine will be tested on humans as soon as the next few weeks. Such trials have already started in Australia, where winter - and flu season - are underway.

. . .

In the meantime, Protein Sciences is gearing up to launch the six-month clinical trials before the summer’s end, a target the company’s chief executive admitted to the Courant was “optimistic.” If the company hits that mark and the trials are successful, the earliest that Protein Sciences could win federal approval to sell the vaccine is mid-2010.

The government could, however, decide to expedite the testing process, as it’s done for other pharmaceutical companies. According to ABC News, the U.S. Centers for Disease Control and Prevention expects that 45 million doses will be ready by Oct. 15 - the date White House experts believe that H1N1 infections will peak. The estimate is a substantial reduction from the 120 million doses that were originally expected to be ready by that time. Those experts further predict that in a worst-case scenario, the outbreak will cause between 60 million and 120 million Americans to take ill - and between 30,000 and 90,000 deaths.

Read more: http://blogs.wsj.com/bankruptcy/2009/08/25/company-cleared-to-test-swine-flu-vaccine-fighting-off-liquidation/

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Didn't the CDC just put out a notice yesterday that it safe to get this vaccine?

If six month clinical trials are just starting and won't be finished until 2010, the CDC is pulling someone's leg.

[Ilsa]

1. My family has various neurological disease issues. The possibility of

developing Guillain-Barre Syndrome scares the crap out of me. They don't know the long term effects of this yet. Shit. My gut instinct is to refuse the vax for myself and my kids.

[Robb]

3. If you have had a flu shot before

...You have (probably) had the ingredients of the H1N1 shots, except for the strain being used.

Edited to add the word "probably," since I don't know when you might've had a shot.

[Ilsa]

20. I take a flu shot about every other year. I rarely get it any more. If I

get anything, it is fairly mild. On edit: thanks for taking the time to reply. I'll reconsider.

[northernlights]

6. you're as likely to develop GBS from the flu as from the vaccine

GBS has been linked to flu-like illnesses, as well as to flu vaccines. The highest risk is to people who get vaccinated a few weeks after being sick with something flu-like.

http://www.ncbi.nlm.nih.gov/pubmed/19033158?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_Discovery_RA&linkpos=2&log$=relatedarticles&logdbfrom=pubmed

http://www.ncbi.nlm.nih.gov/pubmed/15562126?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_Discovery_RA&linkpos=3&log$=relatedarticles&logdbfrom=pubmed

[Ilsa]

19. Good information. Thanks. I'll certainly consider it. nt

[Robb]

2. IIRC there are several companies making the vaccine

This company's problem is apparently they haven't made it before. Since the only thing "new" in the H1N1 vax is the strain (the rest of it is the same as, say, last year's flu shot), repeat manufacturers have an advantage, since they have years of testing on the remaining components they can use in the approval process.

[Robbien]

7. The CDC said that clinical trials just started this month

in this article the CDC said
http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2009/08/25/MN0P19DG5T.DTL&type=health

So far, clinical trials have shown the swine flu vaccine to be safe, but the CDC will be monitoring immunizations throughout the season. If there are side effects, CDC officials said, they'll probably be rare and won't show up until hundreds of thousands of people have been vaccinated. If serious side effects appear during clinical trials, the vaccine program will be halted immediately.


in this article the CDC said
http://www.nytimes.com/2009/08/26/health/26flu.html

Releasing some vaccine for high-risk people in September, even before clinical trials are finished.


and in this article
http://www.greenvilleonline.com/article/20090826/NEWS/908260321/1013/NEWS05


But human trials of the vaccine just began this month, . . .

“So far, there's been nothing more than you'd expect with any vaccine, and the preliminary safety data we've accumulated, with healthy adults and the elderly, prompts us to go ahead and get started with pediatric trials,” he said. “But there are some safety issues you'll never be able to determine with a clinical trial. You'd have to literally vaccinate millions before people see it.”

[Robb]

8. Correct, but not for this manufacturer. nt

[Robbien]

9. Right, all others just started this month. This mfger hasn't even started their trials yet. n/t

[Robb]

10. Yep

...Did I make it clear why it's such a short trial period? I'm trying to make sure because I only just understood in the past week or two. :hi:

[TZ]

14. Clinical trials started in Europe in late July as well

[caseymoz]

13. If they are using financially strapped companies, there might be a danger.

Under-capitalization. Has the company had the resources to put the right equipment, methods and procedures into place?

I'm afraid there may be a "gold-rush" mentality with this. There is a lot of money to be made fast from Swine Flu vaccines now. There is normally not the capacity to produce so much vaccine so fast.

The worst thing is, as they are straining the system to produce this vaccine, it means the seasonal flu will get a free-ride this year. I have heard that it looks to be an A-strain flu such as the Swine Flu, so we might be lucky.

[TZ]

15. If they manufacture vaccines they do.

There are certain processes for all types of manufacturing that are maintained from vaccine to vaccine. Including facilities and trained personal. Most likely even a cash strapped company has that.
FWIW, the FDA STILL has to approve their vaccine and if they are lacking in the resources, they won't get it onto the marketplace.
The FDA does a lot more than merely give greenlights on this

[CoffeeCat]

4. There are clinical trials underway...

...in several U.S cities. Here is an article that lays out the trials that
are under way. http://www.journal-news.com/news/hamilton-news/swine-flu-vaccine-trials-start-250883.html?cxtype=rss_local-news

Those trials were government led. It's also my understanding that the trials are not completed--but they're reporting that there
are no problems with the vaccine, so far. Which kinda boggles the mind, because if there are long-term, harmful effects--we can't
know those yet.

It's interesting that a vaccine company is doing their own clinical trials. The article you posted said that it takes this company
six months to do clinical trials, but the government could expedite that process. That probably means shortcuts. Is this really
a good thing? And if six months is typical for the completion of a clinical trials--then the government trials that are happening
now (that are outlined in the link I posted) are being "expedited". Gee...what could possibly go wrong? Isn't the H1N1 vaccine
a mixture of bird, human and swine flu?

Bottom line, sounds like we have various government and private institutions conducting clinical trials of the H1N1 vaccine.

[Robb]

5. Remember

Most of the ingredients in the H1N1 vaccine in this country -- in fact, all of them but the strain -- are considered "tried and true," in that they've been used for several years in the "standard" flu shot.

This company does not have the benefit of years of testing on those ingredients to stand upon, since they (apparently) have not made a flu vax before. The other companies are being "expedited" for this reason, in that the ingredients already being used do not need as exhaustive a test.

[caseymoz]

12. They don't normally have the capacity to turn out so much vaccine so fast.

So, this could be a problem. It worries me, too, that a financially strapped company that probably had inadequate resources to put the right equipment and procedures in place, is being allowed to produce flu batches. If this goes wrong, somebody will be brought up on criminal charges.

[TZ]

17. Yes they do.

Any company that does vaccine manufacturing has the capability to turn out mass quantities. Usually a whole freaking building is devoted to vaccine manufacturing and nothing else

[caseymoz]

23. That is for a normal flu season, not this one.

And if they do, why are they contracting with near bankrupt companies that have never done it before?

Any industry absolutely does not want to have that much idle production capacity. It's a bad thing, and that's simply basic macro-economics. For example, the major part of the problem with the auto industry right now is excess production capacity, which means either the capacity must be cut by whole companies liquidating, or the cuts must be spread out throughout the industry.

If the whole freaking building is devoted to vaccine manufacturing in a normal flu normal season, do they generally keep extra buildings around empty just in case there is a pandemic, with a temp agency on retainer to send in workers? No, it might be common sense, but they can't afford those expenses.

Maybe you mean the production could be ramped up to meet this challenge. Yes, and that's what they are doing.

[caseymoz]

11. They are rushing this because this flu will easily kill 100,000 people otherwise.

In 1977, the Gullian-Barre Syndrome killed 25. Let's see, 100,000 or 25, which is higher? Meanwhile, pregnant women are more susceptible to this flu than with other strains. That means birth defects. No long-term adverse effects there.

It isn't that this flu is more deadly. That hasn't been demonstrated yet. We can't tell how deadly it is. It is, however, demonstrated to be more aggressively contagious than most. If half the people in the US come down with it, the deaths could be in the hundreds of thousands over the next two years.

And, depending on the precautions people take otherwise, this flu may kill a 2-3 times more than I've stated. If you are not going to get the vaccine and you have to work in a public place, wear a mask.

I'm afraid it's standard for pharma companies to do their own clinical trials with the government only reviewing them. The FDA doesn't have the budget for any of its own clinical trials. That's not the big scandal in overseeing the industry. The big scandal are the studies the government will allow industry to throw out. I don't know of studies about safety that pharma companies were allowed to suppress, but I have heard that if a pharma company's study shows the drug is no more effective than a placebo, than the company is allowed to suppress it.

[TZ]

18. Your last statement is patently untrue

I work in the industry. If the study shows a drug is no more effective than a placebo, the drug DOES NOT get approved.
Lets not also forget that not only does the FDA review the data but they monitor the site and inspect both personelle and process. Its a lot more complex than you think.

[caseymoz]

22. I worked in the industry, too.

Now, maybe things have changed since I've been out (the mid-90s), but given what the food industry has been getting away with since, I doubt it. Also, I don't think I worked at the same level, and, of course, not in the same company as you did, but what I saw has always effected me.

Let me clarify my statement: variances are granted. I know that when a drug under trial isn't for a serious or life-threatening condition they will be granted pretty easily. Claritin was an example. It's effectiveness was really pretty narrow.

I know that the FDA also do quality control for experiments, and it does inspections, as you say, but I really think the major protection consumers have is the threat of lawsuits, and for the FDA, the threat is of agency embarrassment and scandal.

[TZ]

16. the FDA regulates ALL clinical trials

and looks at the data before approval is given. As for long term effects. LOL! You do realize that vaccines are cleaned out of the body in a couple of weeks by the spleen right? All it does it provoke the body into making antibodies to a virus without someone getting sick. Thats why vaccine trials can be relatively short. In other words, if you have a bad reaction to a vaccine, you are gonna have it in a day to a week after. This long term effects is bullshit pushed by anti-vaxxers

[percussivemadness]

21. what about the Mercury contained in this Vaccine?