What does the science say: H1N1
It seemed like a good idea to do a quick entry addressing the H1N1 “swine flu” strain as well as the vaccine for it. A friend of mine suggested adding it to my previous entry on vaccines, but I thought I’d do a separate one instead so people’s eyes don’t glaze over from an already over-long article.
I have no intention of promoting the quack H1N1 claims that are floating around the Internet, so I won’t be linking to them. What you will find here is the official information that is available about the disease and the vaccine. As usual, if you are convinced that the government is lying to us about the flu, then you may as well stop reading now, as I am really just summarizing CDC and FDA data.
As always, I welcome comments on my blog (https://whatdoesthesciencesay.wordpress.com) or to my email address (josh at 40two org). If anything in here seems factually inaccurate to you, please let me know, but cite your sources. I’m truly not interested in what “Mr. Fit” or any number of random Internet flu scare sites have to say unless they have any genuine science to back them up.
- The H1N1 virus
- The Vaccine
- Was the vaccine rushed?
- But I heard that I might get Guillain-Barré?
- But what about the crazy ingredients?
- Is it safe for pregnant women?
- Further Resources
This virus was originally referred to as “swine flu” because laboratory testing showed that many of the genes in this new virus were very similar to influenza viruses that normally occur in pigs (swine) in North America. But further study has shown that this new virus is very different from what normally circulates in North American pigs. It has two genes from flu viruses that normally circulate in pigs in Europe and Asia and bird (avian) genes and human genes. Scientists call this a “quadruple reassortant” virus.
The symptoms of 2009 H1N1 flu virus in people include fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills and fatigue. Some people may have vomiting and diarrhea. People may be infected with the flu, including 2009 H1N1 and have respiratory symptoms without a fever. Severe illnesses and deaths have occurred as a result of illness associated with this virus.
In seasonal flu, certain people are at “high risk” of serious complications. This includes people 65 years and older, children younger than five years old, pregnant women, and people of any age with certain chronic medical conditions. About 70 percent of people who have been hospitalized with this 2009 H1N1 virus have had one or more medical conditions previously recognized as placing people at “high risk” of serious seasonal flu-related complications. This includes pregnancy, diabetes, heart disease, asthma and kidney disease.
With seasonal flu, we know that seasons vary in terms of timing, duration and severity. Seasonal influenza can cause mild to severe illness, and at times can lead to death. Each year, in the United States, on average 36,000 people die from flu-related complications and more than 200,000 people are hospitalized from flu-related causes. Of those hospitalized, 20,000 are children younger than 5 years old. Over 90% of deaths and about 60 percent of hospitalization occur in people older than 65.
- First, states are not required to report individual seasonal flu cases or deaths of people older than 18 years of age to CDC.
- Second, seasonal influenza is infrequently listed on death certificates of people who die from flu-related complications.
- Third, many seasonal flu-related deaths occur one or two weeks after a person’s initial infection, either because the person may develop a secondary bacterial co-infection (such as a staph infection) or because seasonal influenza can aggravate an existing chronic illness (such as congestive heart failure or chronic obstructive pulmonary disease).
- Also, most people who die from seasonal flu-related complications are not tested for flu, or they seek medical care later in their illness when seasonal influenza can no longer be detected from respiratory samples. Influenza tests are most likely to detect influenza if performed soon after onset of illness.
- For these reasons, many flu-related deaths may not be recorded on death certificates.
The viruses in the vaccine change each year based on international surveillance and scientists’ estimations about which types and strains of viruses will circulate in a given year. About 2 weeks after vaccination, antibodies that provide protection against influenza virus infection develop in the body.
- seasonal A (H1N1)
- seasonal B
Vaccines used in the United States must be licensed by FDA. FDA approved these vaccines as a strain change to each manufacturer’s FDA-approved seasonal influenza vaccine. Each of the manufacturers will make the Influenza A (H1N1) 2009 Monovalent vaccines using its well-established, licensed egg-based manufacturing process that is used for seasonal influenza vaccine.
There is considerable experience with seasonal influenza vaccine development and production and influenza vaccines produced by this technology have a long and successful track record of safety and effectiveness in the United States. The safety and effectiveness demonstrated for seasonal influenza vaccine also support the licensure of the Influenza A (H1N1) 2009 Monovalent vaccines produced using the same process as for seasonal vaccine.
The Influenza A (H1N1) 2009 Monovalent vaccines will undergo the same rigorous testing and lot release procedures that are in place for seasonal influenza vaccines.
Every year, it takes approximately 6 months to make the current season’s batch of flu vaccine. The pandemic H1N1 strain (an earlier version of which circulated in 1976) vaccine is being produced using the same process as the seasonal flu. To call it rushed is to also claim that every year the seasonal flu vaccine is “rushed”. I see no evidence of truth in that claim.
Guillain-Barré syndrome (GBS) is a rare disorder in which a person’s own immune system damages the nerves, causing muscle weakness and sometimes paralysis. GBS can cause symptoms that last for as little as a few weeks, or go on for several months. Most people recover fully from GBS, but some people have nerve damage that does not go away. In rare cases, people have died of GBS, usually from not being able to breathe due to weakness of their breathing muscles.
A key item in there is the fact that “most people recover fully”.
In very rare cases, someone may develop GBS in the days or weeks after getting a vaccination. In 1976, there was a small increased chance of GBS after getting a flu (swine flu) vaccination. This means about 1 more case per 100,000 people who got the swine flu vaccine
Since 1976, many studies have been done to see if other flu vaccines may cause GBS. In most studies no link was found between the flu vaccine and GBS. However, two studies did suggest that about 1 more person out of 1 million people vaccinated with seasonal flu vaccine may develop GBS. This continues to be studied. For the most part, the chance of getting very ill from flu is far higher than the chance of getting GBS after getting the flu vaccine.
During the 2009-2010 flu season, CDC and FDA will be closely looking at reports of serious problems, including GBS, which may be linked to the use of the 2009 H1N1 flu vaccine and to the seasonal flu vaccine. These systems already include some vaccination safety systems, such as the Vaccine Adverse Event Reporting System (VAERS), and new systems, such as the CDC Emerging Infections Program and a partnership with the American Academy of Neurology, which includes doctors who are most likely to see people with GBS. None of these systems existed in 1976.
In view of the potential risks of and likely exposure to flu infection as a health care professional, the lack of relapse of the syndrome in a sizable number of people who have had the flu vaccine, and the lack of a persistent causal association, my current view is to consider “having the jab” when it becomes available.
The scientific connection between a relative risk of 2.0 and specific causation is doubtful. Large relative risks argue for general causation, while small ones argue against. If the relative risk is near 2.0, problems of bias and confounding in the underlying epidemiologic studies may be serious, perhaps intractable. Problems created by individual differences may be equally difficult. Bias and confounding affect the estimation of relative risk from the underlying data. By contrast, individual di fferences affect the interpretation of relative risk:namely, the application to any specific individual.
In short, when the relative risk indicates an increased risk, but that relative risk is still low, then it is not necessarily indicative of an actual association.
Guillain-Barré Syndrome is rare to get and generally a person recovers fully. Guillain-Barré appears to be triggered from many illnesses (including the flu) as well as other factors that affect the immune and nervous system. In rare causes (1/1,000,000) the flu vaccine itself can be this cause (as obviously the intent of the vaccine is the trigger an immune reaction). During the 1976 swine flu vaccination program, there appeared to be a 1/100,000 extra cases for those who were vaccinated. The health risks (as well as the incidence) of H1N1 itself is much higher and easily outweighs the risk of Guillain-Barré.
Because people are unnecessarily scared, none of the US approved vaccines have adjuvants (basically they help to “annoy” the immune system into producing more antibodies) such as aluminum in them. But for some of the more “controversial” ingredients (for all US vaccines, not just flu), the FDA has produced a nice FAQ.
They specifically cover formaldehyde, preservatives, amino acids, sugars, etc.
I’ll quote from a portion of the section on formaldehyde (emphasis mine):
Although high concentrations of formaldehyde can damage DNA (the building block of genes) and cause cancerous changes in cells in the laboratory, formaldehyde is an essential component in human metabolism and is required for the synthesis of DNA and amino acids (the building blocks of protein). Therefore, all humans have detectable quantities of natural formaldehyde in their circulation. In addition, quantities of formaldehyde at least 600-fold greater than that contained in vaccines have been found to be safe in animals.
Additionally, some of the sugars, proteins and amino acids:
These materials may be added as stabilizers. They help protect the vaccine from adverse conditions such as the freeze-drying process, for those vaccines that are freeze dried. Stabilizers added to vaccines include: sugars such as sucrose and lactose, amino acids such as glycine or the monosodium salt of glutamic acid and proteins such as human serum albumin or gelatin. Sugars, amino acids and proteins are not unique to vaccines and are encountered in everyday life in the diet and are components that are in the body naturally.
You can see this same list at the FDA’s “2009 Monovalent Descriptions and Ingredients” site.
- sodium chloride (4.1 mg)
- monobasic sodium phosphate (80 mcg)
- dibasic sodium phosphate (300 mcg)
- monobasic potassium phosphate (20 mcg)
- potassium chloride (20 mcg)
- calcium chloride (1.5 mcg)
- sodium taurodeoxycholate (≤ 10 ppm),
- ovalbumin (≤ 1 mcg),
- neomycin sulfate (≤ 0.2 picograms [pg]),
- polymyxin B (≤ 0.03 pg),
- beta-propiolactone (< 25 nanograms)
- 15 mcg hemagglutinin per 0.5-mL dose of the influenza A/California/7/2009 (H1N1)v-like virus.
- Thimerosal, a mercury derivative, is added as a preservative. Each dose contains 25 mcg mercury.
- egg proteins (≤1 mcg ovalbumin)
- formaldehyde (≤25 mcg)
- sodium deoxycholate (≤50 mcg)
No doubt the first thing you will notice is the use of Thimerosal, which has absolutely not been found to be linked to Autism. However, this vaccine is still only used for adults over 18 years of age. I repeat, children do not receive this vaccine.
- 0.188 mg/dose monosodium glutamate
- 2.00 mg/dose hydrolyzed porcine gelatin
- 2.42 mg/dose arginine
- 13.68 mg/dose sucrose
- 2.26 mg/dose dibasic potassium phosphate
- 0.96 mg/dose monobasic potassium phosphate
- <0.015 mcg/mL gentamicin sulfate.
- 15 mcg hemagglutinin (HA) per 0.5-mL dose of the following virus strain: A/California/7/2009 (H1N1)v-like virus.
- egg proteins (≤ 1 mcg ovalbumin)
- polymyxin (≤ 3.75 mcg)
- neomycin (≤ 2.5 mcg)
- betapropiolactone (not more than 0.5 mcg)
- nonylphenol ethoxylate (not more than 0.015% w/v)
Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain:
- formaldehyde (not more than 100 mcg),
- polyethylene glycol p-isooctylphenyl ether (not more than 0.02%) [Note: this is not anti-freeze, or even related to anti-freeze. Antifreeze is made from propylene glycol or ethylene glycol. It is non-toxic. It’s also in laxatives!]
- sucrose (not more than 2.0%)
No, these vaccines are manufactured according to the same processes as the licensed (approved) seasonal influenza vaccines, which do not contain adjuvants.
As usual, let’s go straight to the CDC’s statements about pregnant women and the flu vaccine[12 ]
Additionally, because the vaccine cannot be given to babies less than 6 months old, the antibodies will protect the baby after it is born until they can get themselves vaccinated.
Yes. Besides protecting her from infection, the shot may also help protect her infant. Flu shots are only given to infants 6 months of age and older. Everyone who lives with or gives care to an infant less than 6 months of age should get both the seasonal flu and 2009 H1N1 vaccines. A woman can get either the shots or the nasal spray after she delivers.
No study to date has demonstrated an increased risk of either maternal complications or adverse fetal outcomes associated with inactivated influenza vaccination. Moreover, no scientific evidence exists that thimerosal-containing vaccines are a cause of adverse events among children born to women who received influenza vaccine during pregnancy. In this article, we review the evidentiary basis for the recommendation of vaccination of all women who will be pregnant during the influenza season and safety data of influenza vaccination during pregnancy.
Among 7183 eligible mother-infant pairs, only 252 pregnant women (3.5%) received the influenza vaccine. Women with medical insurance were more likely to be vaccinated, although the rates for women with chronic underlying conditions were similar to those of healthy women, regardless of insurance status. The mean gestational age at the time of influenza vaccination was 26.1 weeks (range, 14-39 weeks). No serious adverse events occurred within 42 days of vaccination, and there was no difference between the groups in the outcomes of pregnancy (including cesarean delivery and premature delivery) and infant medical conditions from birth to 6 months of age.
CDC’s “key facts” about the flu vaccines: http://www.cdc.gov/flu/protect/keyfacts.htm
1 “CDC: Seasonal Influenza Key Facts”. http://www.cdc.gov/flu/protect/keyfacts.htm Visited 11/26/2009
2 US Food and Drug Administration. “Influenza A (H1N1) 2009 Monovalent Vaccines Questions and Answers.” http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm182335.htm. Published September 15, 2009. Visited 11/28/2009
3 http://www.cdc.gov/h1n1flu/vaccination/factsheet_gbs.htm CDC. “Fact Sheet: Guillain-Barré Syndrome”. Published 11/2/2009. Visited 11/27/2009.
4 Breman, Joel G. “GUILLAIN-BARRÉ SYNDROME AND ITS RELATIONSHIP TO SWINE INFLUENZA VACCINATION IN MICHIGAN, 1976–1977”. American Journal of Epidemiology Vol. 119, No. 6: 880-889 http://aje.oxfordjournals.org/cgi/content/abstract/119/6/880
5 Marks, James S. “Guillain-Barré Syndrome in Recipients of A/New Jersey Influenza Vaccine”. JAMA. 1980;243(24):2490-2494.http://jama.ama-assn.org/cgi/content/abstract/243/24/2490
6 Stowe, Julia et a. “Investigation of the Temporal Association of Guillain-Barré Syndrome With Influenza Vaccine and Influenzalike Illness Using the United Kingdom General Practice Research Database”. American Journal of Epidemiology 2009 169(3):382-388; doi:10.1093/aje/kwn310 http://aje.oxfordjournals.org/cgi/content/abstract/169/3/382
7 Lasky T, Terracciano GJ, Magder L, Koski CL, Ballesteros M, Nash D, Clark S, Haber P, Stolley PD, Schonberger LB, Chen RT. The Guillain-Barré syndrome and the 1992-1993 and 1993-1994 influenza vaccines. N Engl J Med. 1998 Dec 17;339(25):1797-802. PubMed PMID: 9854114. http://content.nejm.org/cgi/content/full/339/25/1797
8 Price, Laura C. “Should I have an an H1N1 flu vaccination after Guillain-Barré syndrome?”. BMJ 2009;339:b3577. http://www.bmj.com/cgi/content/full/339/sep09_1/b3577. Visited 11/27/2009
10 “Common Ingredients in U.S. Licensed Vaccines”. fda.gov. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm187810.htm. Visited 11/27/2009
11 US Food and Drug Administration. “Influenza A (H1N1) 2009 Monovalent Vaccines Descriptions and Ingredients”. FDA.gov. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm186102.htm Visited 11/27/2009
12 Center for Disease Control. “2009 H1N1 Influenza Shots and Pregnant Women: Questions and Answers for Patients”. http://www.cdc.gov/h1n1flu/vaccination/pregnant_qa.htm Updated November 2, 2009. Visited November 28, 2009.]:
13 ClinicalTrials.gov. “H1N1 Vaccine in Pregnant Women”. http://www.clinicaltrials.gov/ct2/show/NCT00963430?term=NCT00963430&rank=1 Updated 11/25/2009. Visited 11/28/2009
15 Flor M. Munoz, MD et al. “Safety of influenza vaccination during pregnancy”. American Journal of Obstetrics and Gynecology (2005) 192, 1098–106. http://www.i-lumens.com/DOCUMENTS/VACCINATION%20ET%20GROSSESSE.pdf