What to Know About Flu Vaccines Before You Get One
What to Know About Flu Vaccines Before You Get One

Starting this year, around 150,000 school-age children in New York City will be required to get a flu shot. The Epoch Times spoke with the president of the National Vaccine Information Center, Barbara Loe Fisher, about how flu vaccines were different last year, and what you can do to learn more about any vaccine you or your child may choose—or are required—to get. Answers have been edited for clarity and length.

Epoch Times: 2013 saw some changes in the influenza vaccines available to Americans. Can you explain?
Barbara Loe Fisher: Yes, there were more vaccines, different influenza vaccines, made in different ways, on the market this year [2013] than ever before, at least here in the United States.There are many more manufacturers who have come into the influenza vaccine market.

Epoch Times: Why are there more vaccines being manufactured?
Ms. Loe Fisher: The market has really opened up in the U.S., certainly since passage of the National Childhood Vaccination Injury act of 1986, which gave manufacturers a partial liability and the doctors’ liability protection for vaccine due losses.

Then in 2011, the U.S. Supreme court eliminated all remaining liability in the civil courts in this country for vaccine injuries and death in terms of suing the manufacturer for product liability. So as of 2011, there is no liability attached for the manufacturers of vaccines, including the influenza vaccines, when someone is injured or dies.

As a result we have more and more vaccines—in this case, influenza vaccines, that are being put on the market. 

Epoch Times: Can you explain the new ingredients that appeared in some influenza vaccines in 2013?
Ms. Loe Fisher: This last year [2012] the FDA, which licenses the vaccines for our country, they approved several new ways of making vaccines, so this year [2013] we have two new influenza vaccines, one that is using army worm caterpillar cells for production and the other is using dog kidney cells for production instead of eggs

The use of chicken eggs has been the way all manufacturers have made influenza vaccines, both the live virus vaccine, which is the nasal spray vaccine that you inhale, but also the injectable, inactivated influenza vaccine. 

You have to use a lot of chicken eggs in order to produce influenza vaccines, and so the manufacturers got approval from the FDA to use these new cell substrates for production. 

Epoch Times: What is the advantage of dog kidney and army worm cells? 
Ms. Loe Fisher: They allow the manufacturers to produce more vaccine more quickly. Several years ago, in 2009, when you had the H1N1 pandemic the manufacturers were very upset and the CDC [Centers for Disease Control and Prevention] was upset that they couldn’t produce a pandemic influenza vaccine more quickly, and they all agreed that they had to move away from chicken eggs and they had to use cell substrates that allowed the virus to grow more quickly and these army worm and dog kidney cells allow the virus to be replicated more quickly.

Epoch Times: Is there any disadvantage to using the dog and insect cells?
Ms. Loe Fisher: There has been some controversy about these new cells. With the insect cells, insects have viruses as well as humans and there has been a concern that there may be insects cell viruses that are not detected because infection can be harder to detect and sometimes difficult to eliminate, as the World Health Organization, the CDC, and the FDA admit.

The dog kidney cells, the controversy there has been tumorigenic cells, if there [will be] some kind of an issue with cancer down the road. FDA says the advantages of using the cell line outweigh its tumorigenic concerns. But still the jury is out. Are the use of these dog kidney cells to produce influenza vaccines, down the road, going to cause some increases in tumors or in cancer?

The question becomes, how much evidence is enough evidence to give the green light to the manufacturers. 

Our organization has wanted a raising of the standards for proof of safety. However, the FDA and the CDC, and the manufacturers, claim that it is more important to get the vaccines out on the market and prevent influenza. 

Epoch Times: What are the risks associated with influenza? If we did not have these vaccines, how many people might die each year? Is there data on this? 
Ms. Loe Fisher: There is controversy about that figure. The CDC, had been saying, after about 15 years, that there are 36,000 people in our population of about 316 million people who die from influenza. They have backed off from the 36,000 per year figure. Their now saying it fluctuates from 3,000 to 49,000 depending upon the year. 

One of the problems of that is the only reportable influenza cases are people under 18 years old. The other suspected cases of influenza are not [kept on record]. The CDC doesn’t really keep records, what they do is make estimates based on influenza like illness, (ILI), which of course includes other kinds of respiratory illnesses that are not caused by influenza type A or type B influenza [the ones prevented by flu shots].

The CDC does admit that 80 percent of flu-type illness is not caused by type A or type B influenza. So about 80 percent of all flu like illness, respiratory illness, that looks like flu when you have a cold, a cough, a headache, body aches, etc. is not actually influenza. Only about 20 percent is influenza. People don’t realize that when they get sick in the winter, they can’t assume that it’s influenza. 

And that of course starts to muddy picture here, in terms of the effectiveness of the vaccine versus the risks associated with the vaccine because there are risks associated with every vaccine. And those risks can be greater for some than for others because of course we are not all the same biologically and genetically. 

Epoch Times: How can people make more informed choices about the vaccines they plan to take?
Ms. Loe Fisher: My advice is to get the product manufacturer insert and take a look at it before you go into the doctor. Find out what vaccines your doctor is carrying, and then based on your research, make a decision. 

You can go to our website, nvic.org, we have all the product manufacturer inserts posted there, and you can read about the vaccine because the FDA requires the manufacturers to publish product package inserts that list the ingredients of the vaccines, that list the pre-licensure clinical trials, what they found in the clinical trials regarding effectiveness and reactions reported, the contraindications, (reasons why the manufacturer feels the person might not be a candidate for vaccination).

The pregnancy category is also there. The FDA pregnancy category for these [influenza] vaccines is B or C, which women who are pregnant may want to look at. 

Editor’s Note:
The FDA pregnancy category B means that studies on pregnant animals showed no harm to their fetus, but that there are “no adequate and well-controlled studies in pregnant women.” Pregnancy category C means studies on pregnant animals showed “an adverse effect on the fetus” and that there are “no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.”

  • Dorit Reiss

    One of the reasons Barbara Loe Fisher is a bad source on vaccines is that she inevitably overstates their risks and understates their benefits. In this case, there are other inaccuracies in her statements.

    A. Claiming that the protection from liability led to more vaccine has no support. Why not connect it instead to advances in technologies? In addition, it is incorrect that manufacturers have no lability. Manufacturers can still be sued for design defects, which is important, since the last wide scale problem related to vaccines – the Cutter Incident in the 1950s – was a manufacturing defect. Also, the way Ms. Loe fisher presented it may make someone think there’s no compensation for vaccine injury – where in reality, there is a no-fault scheme that is actually more plaintiff friendly than our courts. http://shotofprevention.com/2013/11/08/congressional-briefing-attempts-to-discredit-vaccine-injury-compensation/

    B. When addressing the move to other places to produce viruses, Ms. Loe Fisher is ignoring an important reason: to use something other than eggs so that even someone with severe egg allergies can get the vaccine.

    Her claims about dangers from the new modes of production have no support, as far as I know. The technologies have been tested before being put on the market, and by hypothesizing on unsupported dangers, she is hardly doing people a favor.

    C. It is true that the number of influenza deaths is estimated, but an estimate is not a guess. It’s based on data and the best available knowledge. Here is an explanation: http://www.cdc.gov/flu/about/disease/us_flu-related_deaths.htm. As pointed out, there is also good reason to think deaths are under-estimated, because not all deaths will be reported as influenza.

    We do know 171 children died from this last year. The vast majority of them unvaccinated.

    D. Finally, Ms. Loe Fisher recommends the insert, though that has serious limitations as a source of information: it does not include later studies, and it lists things not caused by the vaccine under “adverse events”. http://www.skepticalraptor.com/skepticalraptorblog.php/vaccine-package-inserts-debunking-myths/

    In short, Ms. Loe Fisher – and her organization, like most anti-vaccine organizations – are not a good source of information about vaccines.

    • Vaccine Calculator

      Dorit Reiss purports to be knowledgeable about vaccines but time and again demonstrates that she is not. She consistently overstates the benefits of vaccines and denies risks while insisting that everyone be forced to use government recommended vaccines or face legal sanctions. (Listen to Ms. Reiss explain her views: http://www.scpr.org/programs/airtalk/2013/08/21/33359/should-anti-vaccination-parents-be-held-liable-if/ ) Although Ms. Reiss touts the benefits of influenza vaccines using a Facebook post by a pediatrician as her reference, the fact remains that the U.S. Food and Drug Administration (FDA), which licenses and regulates the “purity and potency” of vaccines, has placed influenza vaccines in either a B or C pregnancy category, depending upon the evidence base. The National Institutes of Health Chemical Hazards Emergency Medical Management website features an easy-to-read chart that describes the FDA’s Pregnancy Categories ( http://chemm.nlm.nih.gov/pregnancycategories.htm ):

      Category B: Animal reproduction studies have failed to
      demonstrate a risk to the fetus and there are no adequate and well-controlled
      studies in pregnant women.

      Category C: Animal reproduction studies have shown an
      adverse effect on the fetus and there are no adequate and well-controlled
      studies in humans, but potential benefits may warrant use of the drug in
      pregnant women despite potential risks.

      Following are inaccuracies in the statements Dorit Reiss makes in her
      personal attack on Ms. Loe Fisher in this article:

      A. Ms. Reiss alleges that the
      partial civil liability shield, which Congress gave drug companies in the
      National Childhood Vaccine Injury Act of 1986 that the U.S. Supreme Court
      expanded in 2011, has not had any effect on the proliferation of new vaccines
      being marketed in the U.S. Apparently she has not studied the legislative history
      of the 1986 National Childhood Vaccine Injury Act during which time drug
      company and American Academy of Pediatrics’ officials repeatedly testified
      before Congress that unless vaccine manufacturers were given a liability
      shield, research and development of new vaccines would stop and the childhood
      vaccine supply would be threatened. In fact, the 1986 Vaccine Injury Act was
      passed with the justification that it would secure the vaccine supply and
      stimulate the development of new vaccines. This legislative history is
      recounted in an amicus brief filed in a DPT vaccine design defect product
      liability case that came before the U.S. Supreme Court, which can be read
      here: http://www.scotusblog.com/wp-content/uploads/2010/02/09-152_Amicus-brief-of-the-National-Vaccine-Information-Center.pdf.

      Unfortunately, Ms. Reiss demonstrates a lack of knowledge about or
      failure to understand the 2011 U.S. Supreme Court decision in Bruesewitz v
      Wyeth, in which the 6-2 majority opinion (with Justices Ginsberg and
      Sotomayor dissenting) stated that FDA licensed vaccines are “unavoidably
      unsafe.” That ruling effectively barred product liability lawsuits based on
      design defect for vaccines sold and administered in the U.S. that result in
      injury or death. (See NVIC press release and links to the Supreme Court
      decision: http://www.businesswire.com/news/home/20110223005581/en/National-Vaccine-Information-Center-Cites-%E2%80%9CBetrayal%E2%80%9D-Consumers#.Uy8Kxl5AJgM)

      It is logical
      to conclude that elimination of product liability during the past three decades
      has facilitated a substantial increase in the numbers of vaccines on the market
      in the U.S. today and provided substantial profits for the pharmaceutical
      industry. (See: “Vaccine Markets a Refuge for Pharma:” http://www.dddmag.com/news/2011/01/vaccine-markets-refuge-big-pharma
      ) The U.S. has become one of the most lucrative and predictable markets for
      liability-free vaccine products in the world in no small part due to the fact
      that government officials recommend and mandate vaccines for universal use by
      316 million Americans. Pro- forced vaccination proponents like Ms. Reiss and
      her friends advocate that parents be criminally prosecuted and fined or charged
      with manslaughter if they refuse to buy and use all government recommended
      vaccines and their child gets a vaccine preventable disease and transmits a
      disease to another person who dies. (Ms. Reiss makes the argument for criminal
      prosecution here: http://shotofprevention.com/2014/02/25/rights-of-the-unvaccinated-child-criminal-law/ )

      B. While the cell substrates using dog
      kidney and army worm cells to produce influenza vaccines have been licensed by
      FDA as safe to use for persons with egg allergies who are at risk for a serious
      allergic reaction to influenza vaccines using chicken eggs for production,
      again Ms. Reiss demonstrates a lack of subject matter expertise when professing
      that the “new modes of production” are entirely risk-free. In fact, for the
      past two decades there has been plenty of discussion at the FDA about the
      potential risks of adventitious contamination of vaccines when using animal and
      insect cell substrates. (Read an FDA transcript of a Nov. 19, 2009 VRBPAC
      meeting on insect cell vaccines here: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM197912.pdf. Read a Sept.
      19, 2012 FDA briefing document discussing cell lines derived from human tumors
      for vaccine manufacture, which has information on use of dog kidney cells in
      influenza vaccines here: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM319573.pdf. Read a 2011
      study on tumorigenic dog kidney cells here: http://www.ncbi.nlm.nih.gov/pubmed/21819694

      C. Ms. Reiss fails to support her allegation that the CDC’s annual influenza mortality
      “estimates” are anything more than a “guess.” CDC officials include cases of
      pneumonia and other influenza-like illness (ILI) in their “estimates” of
      influenza-related morbidity and hospitalizations. ILI is defined as fever of
      100 F or more and a cough and/or a sore throat without a KNOWN cause other than
      influenza (See CDC’s Overview of Influenza Surveillance here: http://www.cdc.gov/flu/weekly/overview.htm )

      CDC also admits that only 20 to 30% of cases of
      suspected influenza cases test positive for type A or type B influenza every
      year (Read FDA transcript of Feb. 20, 2003 VRBPAC meeting: http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3922t1.htm ) If CDC really wanted to
      know how many influenza deaths occurred every year, all suspected cases of
      influenza deaths would be reportable and lab tested, rather than only those
      occurring in persons under age 18.

      Ms. Reiss also fails to document the source of her
      categorical statement: “We do know 171 children died from this [influenza] last
      year. The vast majority of them unvaccinated.” According to the CDC’s website,
      as of Mar. 21, 2014 there have been 75 pediatric influenza-related deaths
      reported during the 2013/2014 influenza season: http://www.cdc.gov/flu/weekly/. For more
      evidence-based information on influenza-related deaths, read a 2005 British
      Medical Journal article “Are U.S. flu vaccine figures more PR than science?”
      here: http://thisbluemarble.com/showthread.php?t=21091 and check out the long
      list of references in the 2012 commentary by Barbara Loe Fisher
      “Influenza Deaths: The Hype versus the Evidence” here: http://www.nvic.org/NVIC-Vaccine-News/October-2012/Influenza-Deaths–The-Hype-vs–The-Evidence.aspx

      D. Finally, while Ms. Reiss
      may lament the fact that the FDA requires vaccine manufacturers to include
      detailed information about a vaccine’s benefits and risks in product
      information package inserts, U.S. law requires such public disclosure. The
      vaccine product insert includes a description of vaccine ingredients; the
      results of pre-licensure clinical trials evaluating vaccine safety and
      efficacy; precautions and contraindications (reasons for not giving the
      vaccine); post-marketing reports of vaccine adverse events and other important
      information that adults and parents of minor children should read before
      vaccination.

      To summarize, Dorit Reiss has shown her ignorance in these comments
      and has demonstrated that she is coming from an ideological position rather
      than an informed one when she engages in gratuitous personal attacks rather
      than sticking with the facts.

      • Dorit Reiss

        A. Flu vaccines and pregnancy: the link above summarizes the many, many peer reviewed studies that examined if the vaccine are safe in pregnant women. They examined them directly, in controlled studies, in pregnant women. And found them safe. Here is the link again, so that people can look at these numerous studies. https://www.facebook.com/notes/chillin-out-vaxin-relaxin-all-cool/studies-of-influenza-vaccine-in-pregnancy/494141367316459

        B. Shielding against liability: It is true that the 1986 act was passed to assure security of supply. That’s not the same as saying that the high increase in the number of vaccines was directly because of the liability shield. Manufacturers were leaving the market in 1986s, mostly because of lawsuits that had little causation evidence, and Congress was worried about children left exposed to diseases. That’s what the security of supply refers to.

        And the majority of the Supreme Court did not declare vaccines “Unavoidably Unsafe” – in fact, they rejected that claim. Here is what the court actually said:

        “We have no need to consider the finer points of comment k. Whatever consistent judicial gloss that comment may have been given in 1986, there is no reason to believe that §300aa–22(b)(1) was invoking it. The comment creates a special category of “unavoidably unsafe products,” while
        the statute refers to “side effects that were unavoidable.” That the latter uses the adjective “unavoidable” and the former the adverb “unavoidably” does not establish that Congress had comment k in mind. “Unavoidable” is hardly a rarely used word. ”

        By the way, the term unavoidably unsafe does not refer to a very dangerous product – see here for explanation: http://momswhovax.blogspot.com/2013/11/vaccines-and-unavoidably-unsafe-products.html

        • Dorit Reiss

          C. Nowhere did I say the new modes of production are “risk free” – nothing is 100% risk free, from spinach to seat belts. I did point out that Ms. Loe Fisher pointed to no evidence of actual risks – and neither did the commentator. The risks mentioned in the sources brought were raised as theoretical possibilities only. Is there actually any evidence these modes of production are dangerous or problematic?When there’s only a theoretical risk on one side, and a very real risk of influenza on the other, it’s not a hard choice.

          D. Estimates: I think the link above, explaining how estimates are done, show that they are not guesses. I will give the commentator the benefit of the doubt and assume he or she misunderstood the term last year, with which I was referring to the 2012-2013 flu season. You can find the data on pediatric deaths for that here: http://gis.cdc.gov/GRASP/Fluview/PedFluDeath.html, showing the numbers are accurate.

          E. The problem with the insert is not its availability: it is rightfully available. It’s that as a document explaining the features of the vaccine, it can be highly misleading, unless the user has been given some information about the legal framework. It is, after all, a legal document, and like all legal document, has specific meanings. For example, the “Adverse event” section is not the warning section: it does not tell you which problems the vaccine has actually been shown to cause. It just lists everything that happened after market – including, for example, deaths from car accidents, if reported. Without knowing that, a reader may wrongly assume that section demonstrates causation. This is one of the many errors people getting information from anti-vaccine sites tend to make.

          My favorite error about inserts was an anti-vaccine activist whose reading of the insert led her to conclude – wrongly – that vegetables are not allowed for six weeks after a certain vaccine.

          People deserve to know the meaning of terms in legal documents they read – and just sending them to the inserts does not do that. Here, again, is the missing information, explaining how to read inserts: http://www.skepticalraptor.com/skepticalraptorblog.php/vaccine-package-inserts-debunking-myths/

          F. I will let readers conclude, given the commentator’s content and tone, whether that commentator is in a position of accusing others of mounting personal attacks.

  • Dorit Reiss

    “The FDA pregnancy category B means that studies on pregnant animals showed no harm to their fetus, but that there are “no adequate and well-controlled studies in pregnant women.” Here is a list of studies examining the safety of the influenza vaccine in pregnant women, put together by a pediatrician: https://www.facebook.com/notes/chillin-out-vaxin-relaxin-all-cool/studies-of-influenza-vaccine-in-pregnancy/494141367316459. He concludes:

    “These studies have, in fact, been done. Influenza vaccine is safe in pregnancy (without a known medical contraindication), does not cause miscarriage, and protects the health of pregnant women and their babies.”

  • elizabeth

    Under consideration for vaccines PERC6

    I do have concerns that cell lines derived from the eyes of aborted foetuses transformed by an Adenovirus to become immortal (aka cancerous) and then tested on nude mice. If the nude mice do not develop tumours – we are good to go. No studies on humans – oh I guess that might be linked in 20 – 30 years time when people develop cancers – but no vaccines are not tested for carcinogenicity so just trust Pharma to look after us.
    http://www.ncbi.nlm.nih.gov/pubmed/16566451

    Abstract
    PER.C6, a cell line derived from human embryonic retinal cells transformed with the Adenovirus Type 5 (Ad5) E1A and E1B genes, is used to produce E1-deleted Ad5 vectors such as the MRKAd5 HIV-1 gag vaccine. While whole, live PER.C6 cells are capable of growing as tumours when transplanted subcutaneously into immunodeficient nude mice at a high dosage, the process for vaccine production includes filtration steps and other methods which effectively preclude contamination by intact viable substrate cells. However, because of the neoplastic nature of this cell line, we carried out a series of investigations to assess the tumorigenic risk posed by residuals from the cell substrate in a vaccine. To address concerns about transmission of oncogenic DNA, we demonstrated that purified PER.C6 cellular DNA does not induce tumours in newborn hamsters or nude mice. To address concerns about other potential residuals, including hypothetical adventitious tumour viruses, we demonstrated that a PER.C6 cell lysate and a MRKAd5 HIV-1 gag vaccine produced on PER.C6 cells do not induce tumours in newborn hamsters or newborn rats. These results, in conjunction with the wide panel of viral safety tests performed on these cells, support the safety of the PER.C6 as a cell substrate for vaccine production.

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