Benefit and Doubt in Vaccine Additive

Are Americans obligated to use an unproven vaccine to help protect people in other countries from the flu pandemic?

That is the crux of a debate over adjuvants — a class of substances that somewhat mysteriously increase the potency of vaccines. Early studies suggest that adjuvants (pronounced AD-joo-vants) could allow four times as many people to be immunized against the H1N1 pandemic influenza with a given amount of vaccine. So with the world facing possibly severe shortages of vaccine, the World Health Organization and some health experts have been calling for the use of adjuvants to stretch the vaccine supply.

“We have always argued that using adjuvanted vaccine would leave more vaccine for poor people,” said Marie-Paule Kieny, director of the World Health Organization’s initiative for vaccine research.

Wealthy nations have contracted for much of the expected pandemic vaccine production, leaving little for poorer countries. But while Canada and some European nations will use vaccines containing adjuvants, American officials have decided against it for now. They say that they have enough vaccine and that the safety of the additives has not been proved.

“These are products that potentially can be given to millions of healthy people,” said Dr. Jesse Goodman, chief scientist at the Food and Drug Administration. “There is not a known, specific safety danger or issue” with the adjuvants, Dr. Goodman acknowledged. “There’s just more uncertainty.”

http://www.nytimes.com/2009/09/22/health/22vacc.html?th&emc=th

Dodged the bullet for now. The safety has NOT been proved.

The Novartis site (fluvirin) shows the manufacturing process DOES include MF59.

Inspection of a syringe containing H1N1 vaccine during filling process. The white color is due to the addition of the adjuvant MF59.

MF59 ready for use in influenza vaccines
http://www.novartis.com/newsroom/multimedia-library/vaccines-production.shtml


Don't expect them to tell you if/when something changes.

The information in the press releases on these pages was factually accurate on the date of publication. These press releases remain on Novartis website for historical purposes only. Novartis assumes no duty to update the information to reflect subsequent developments. Readers should not rely upon the information in these pages as current or accurate after their publication dates.

http://www.novartis.com/newsroom/media-releases/en/2008/1241557.shtml

Portion of package insert.
NO COPYRIGHT

Influenza A (H1N1) 2009 Monovalent Vaccine

DOSAGE FORMS AND STRENGTHS
Influenza A (H1N1) 2009 Monovalent Vaccine, a sterile suspension for intramuscular injection, is supplied in two presentations:
•
Prefilled single dose syringe, 0.5-mL. Thimerosal, a mercury derivative used during manufacture, is removed by subsequent purification steps to a trace amount (≤ 1 mcg mercury per 0.5-mL dose) (3, 11)
•
Multidose vial, 5-mL. Contains thimerosal, a mercury derivative (25 mcg mercury per 0.5-mL dose). Thimerosal is added as preservative. (3,11)

They can remove mercury but not egg proteins.

4 CONTRAINDICATIONS
4.1 Hypersensitivity
Influenza A (H1N1) 2009 Monovalent Vaccine should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), or to any component of Influenza A (H1N1) 2009 Monovalent Vaccine, or who has had a life-threatening reaction to previous influenza vaccinations .

5.1 Guillain-Barré Syndrome
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give Influenza A (H1N1) 2009 Monovalent Vaccine should be based on careful consideration of the potential benefits and risks.
5.2 Altered Immunocompetence
If Influenza A (H1N1) 2009 Monovalent Vaccine is administered to immunocompromised persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained.
5.3 Preventing and Managing Allergic Reactions
Prior to administration of any dose of Influenza A (H1N1) 2009 Monovalent Vaccine, the healthcare provider should review the patient’s prior immunization history for possible adverse events, to determine the existence of any contraindication to immunization with Influenza A (H1N1) 2009 Monovalent Vaccine and to allow an assessment of benefits and risks. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
5.4 Limitations of Vaccine Effectiveness
Vaccination with Influenza A (H1N1) 2009 Monovalent Vaccine may not protect all individuals.
Vial and Syringe leaflet text Page 5

5.3 How sure are you that your Safeway store employees are trained to do this?

Adverse events described here are included because: a) they represent reactions which are known to occur following immunizations generally or influenza immunizations specifically; b) they are potentially serious; or c) the frequency of reporting.
•
Body as a whole: Local injection site reactions (including pain, pain limiting limb movement, redness, swelling, warmth, ecchymosis, induration), hot flashes/flushes; chills; fever; malaise; shivering; fatigue; asthenia; facial edema.
•
Immune system disorders: Hypersensitivity reactions (including throat and/or mouth edema). In rare cases, hypersensitivity reactions have lead to anaphylactic shock and death.
•
Cardiovascular disorders: Vasculitis (in rare cases with transient renal involvement), syncope shortly after vaccination.
•
Digestive disorders: Diarrhea; nausea; vomiting; abdominal pain.
•
Blood and lymphatic disorders: Local lymphadenopathy; transient thrombocytopenia.
•
Metabolic and nutritional disorders: Loss of appetite.
•
Musculoskeletal: Arthralgia; myalgia; myasthenia.
•
Nervous system disorders: Headache; dizziness; neuralgia; paraesthesia; confusion; febrile convulsions; Guillain-Barré Syndrome; myelitis (including encephalomyelitis and transverse myelitis); neuropathy (including neuritis); paralysis (including Bell’s Palsy).
•
Respiratory disorders: Dyspnea; chest pain; cough; pharyngitis; rhinitis.
•
Skin and appendages: Stevens-Johnson syndrome; sweating; pruritus; urticaria; rash (including non-specific, maculopapular, and vesiculobulbous).
6.4 Other Adverse Reactions Associated with Influenza Vaccination
Anaphylaxis has been reported after administration of FLUVIRIN. Although FLUVIRIN and Influenza A (H1N1) 2009 Monovalent Vaccine contain only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis .

13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Neither FLUVIRIN nor the Influenza A (H1N1) 2009 Monovalent Vaccine have been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Fortunately, it has not been found "effective" in children <4 years old.

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182242.pdf

I have been trying since then to find out if all the vaccines have this in them and I see where you have listed the single-dosage has Thimerosal being filtered out. I just wonder how good that is. I have hypothyroid problem and my immune system is low because of it.
:hi:

I truly understand what you are feeling.

In all past years, the insert that the public health nurses hand out stated quite clearly that anyone who ever had a bad reaction to a previous flu shot (as well aas though with egg sensitivites) shoud avoid the flu shot.

But this time they really want all of us vaccinated.

And as the Powers that Be lie about everything, I wouldn't believe them any more no matter what they say.

My faith is shot.

(25 mcg mercury per 0.5-mL dose).

Reactions will vary depending on sensitivity.
Follow the link. There is additional information for those who are immune-compromised. Someone taking drugs to lower the immune system (as in immune disorder treatments) are warned not to take the shots.

Are "they" trying to find something else that can do the same thing as mercury? And if not I wonder when they will ever be able to get rid of it?

If I understand correctly, they have stopped using mercury in childhood vaccines. But if a child gets a flu shot, they are exposed. If they can do it at all, I don't know why it isn't done across the board.

Are you aware of precautions to take to avoid the flu? The CDC reports that the worst will be over by mid October. They also report it is "mild" and does not have a high mortality rate.

http://health.usnews.com/articles/health/infectious-diseases/2009/09/24/with-rapid-swine-flu-spread-will-h1n1-vaccine-come-too-late.html

Just hope I can weather it again this year. I did get it a couple of years ago but managed to just be ill for about 4 days. Luck of the draw actually. I have found that the drug store is one of the worst places to be around in flu season. I think I caught it once when I was checking out from a cashier at CVS. Makes sense I guess. Everyone who is ill would go there.

Will the vaccine be available with and without a preservative?

Yes. As with the seasonal influenza vaccines, the Influenza A (H1N1) 2009 Monovalent vaccines will be available in formulations that contain thimerosal, a mercury-containing preservative, as well as preservative-free formulations.

http://www.hhs.gov/news/press/2009pres/07/20090713b.html

It keeps costs down and enables the vaccine to reach more people more easily. This is a good thing.

has made it a *level 6*. That means that, at least on paper, they are driving the bus. Not "US officials".

It's their program. Maybe you were talking about the adjuvant? I'm pretty sure if the WHO decided they needed to spare the vaccine, they could order the adjuvant be used. It is being used in the UK.

The WHO is not deciding whether or not to put adjuvant in vaccine distributed throughout the US. Do you have any proof otherwise?

There is no "proof" that the manufacturers won't be putting it in. Did you see the links cited with pictures taken at the manufacturing site?

No one approved Baxter to put Avian flu in it's HIV vaccines. But they did.

http://www.who.int/csr/disease/swineflu/frequently_asked_questions/vaccine_preparedness/production_availability/en/index.html

What is the global manufacturing capacity for a potential influenza A (H1N1) pandemic vaccine?

Based on a global survey made by WHO on 15 May 2009, a maximum of 4.9 billion doses potentially could be produced in 12 months, but only if several assumptions are met. First, full global manufacturing capacity is devoted to this production. Second, production yields for influenza A (H1N1) vaccine are similar to those usually obtained for seasonal vaccines. Third, each manufacturer uses the vaccine formulation that is most "dose-sparing" (i.e. using a smaller quantity of active principle). A more conservative estimate of global capacity is at least 1 to 2 billion doses per year. The numbers of persons who might be vaccinated will not be known until it is determined whether one or two doses of the vaccine will be needed to achieve protection.

They don't find any "safety concerns" with the adjuvant.

http://www.who.int/csr/disease/swineflu/frequently_asked_questions/vaccine_preparedness/safety_approval/en/index.html

Will new pandemic influenza A (H1N1) vaccines be safe?

Licensed vaccines, including influenza vaccines, are held to a very high standard of safety. Likewise, all possible precautions will be taken to ensure safety of new pandemic vaccines and results from clinical trials, currently ongoing or soon to be initiated, will be taken into consideration by the regulatory authorities in their decision to license pandemic vaccines. In early June, WHO held a consultation of experts which reviewed the safety of adjuvants, or substances added to vaccines to make them more effective; no significant safety concerns were identified. Vaccine safety will be carefully monitored through post-marketing surveillance.

Do you honestly believe that the WHO could make a vaccine manufacturer put adjuvants in a vaccine to be distributed in the US in complete disregard for the FDA's explicit instructions?

Novartis may not even need the WHO.

http://www.flu.gov/professional/federal/pandemic-influenza.pdf

Published: June 12, 2009
Novartis is suggesting that their vaccine will be used with their proprietary adjuvant MF59, which has been licensed in Europe for several years but is not approved in the U.S.

Dr. James said a vaccine against a novel strain of the flu would usually need two doses several weeks apart.

"With a potent adjuvant this might not be needed," he said, "and that would significantly decrease the time and complexity of the vaccination process."

One possible hurdle, Dr. Schaffner said, is the FDA's response to the use of MF59. "How will FDA handle an adjuvanted H1N1 vaccine? So far, no clear answer has appeared," he said.

The adjuvant could be quickly used in Europe and in resource-poor countries, according to Gregory Poland, M.D., of the Mayo Clinic in Rochester, Minn.

In the U.S., though, it will probably have to go through clinical trials, he said, "unless an emergency use authorization is granted."

Dr. Poland's concern was echoed by Donald Henderson, M.D., of the University of Pittsburgh Medical Center.

"The use of an adjuvant has much to recommend it," he said, "but the U.S., to date, has steadfastly refused to license any adjuvant other than aluminum hydroxide." (...)
http://www.medpagetoday.com/InfectiousDisease/SwineFlu/14684



July 29 (Bloomberg) -- Swine flu vaccine makers may rely on a U.S. emergency declaration to use experimental additives made by GlaxoSmithKline Plc and Novartis AG to boost a limited supply of shots that will be available to fight the pandemic.

The ingredients, known as adjuvants, may be added for the first time to flu shots in the U.S. health officials today are meeting to discuss the additives at the U.S. Centers for Disease Control and Prevention in Atlanta, and to recommend who should receive the limited amount of vaccines drugmakers say they will begin delivering in September or October.

The U.S. Health and Human Services Department declared a public health emergency over swine flu in April, and the Food and Drug Administration has the power to allow the use of unapproved medical products during such a crisis. The U.S. has been slow to approve the use of adjuvants because of safety concerns, and for fear of giving Americans an excuse to avoid getting the shots, said John Treanor, a University of Rochester researcher.

“The question is, do you really feel comfortable throwing this new thing into the mix and do you really need to?” said Treanor, a professor of medicine, microbiology and immunology at the school in Rochester, New York. “I myself, if I had to do it, would really wrestle with that decision.”

The CDC agreed to pay London-based Glaxo and Novartis, based in Basel, Switzerland, more than $415 million for adjuvants that could be added to the swine flu vaccines, according to a July 13 statement.

Early Production

Adjuvants may not be necessary if enough shots can be produced without them, according to Health and Human Services. That possibility got a boost today from authorities at the CDC, who said 40 million shots of unadjuvanted vaccine may be available in September, earlier than previously reported, with 80 million more doses ready in October.

A safety concern was raised in 2004 when researchers at the University of Florida in Gainesville reported that mice injected with oils used in the adjuvants developed conditions of the type that occur when the body’s immune system produces an excessive protective reaction. Similar reactions haven’t been seen in humans.

MF59, made by Novartis and sold in Europe, has been given to more than 40 million people, mostly adults, to prevent seasonal flu, according to the company. Glaxo’s adjuvant has proven safe and effective in clinical trials with 39,000 people, said Lisa Behrens, a spokeswoman for the company, in an e-mail. Glaxo will conduct more studies and continue to monitor safety after the vaccines are in use, she said.

Emergency Authorization

Under the U.S. health emergency, the FDA may authorize the use of unlicensed vaccines, according to Peper Long, an agency spokeswoman. The FDA convened an advisory committee July 23 to consider what trials are necessary for the vaccines’ approval. Advisory committees consist of medical experts who provide guidance to the agency. (...)
http://www.bloomberg.com/apps/news?pid=20601103&sid=alZncUEvwtIM

what I think. All I can do is pay attention.

is from a professional journal. I had to look a long time to find the stories. The public probably would be informed, if they're paying attention. But will they know it was an emergency approval and that MF59 destroys mice?

Thanks. :hi:

:kick: