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The "Vaccine Shock" of the Year

June 01, 2010 | 211,742 views
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Barbara Loe Fisher is the founder of the National Vaccine Information Center, www.NVIC.org, which is, unquestionably, the best resource for vaccine safety and efficacy information on the Internet.

If you need to make a decision about whether or not the risk benefit ratio of a specific vaccine is appropriate for you or someone in your family, this is the go to site you need to review before you make your decision. It will provide you with loads of objective unbiased information that you simply will not get from the media, the CDC or your doctor.

In this interview, we discuss her participation in the May 7th FDA Vaccine Advisory committee, which focused on the rotavirus vaccine and the newfound issues of broad contamination with two different types of pig viruses.

This meeting produced amazing revelations that have profound and important implications for the whole concept of vaccination and vaccine safety that you need to know about.

 

Dr. Mercola's Comments:

The National Vaccine Information Center (NVIC) is clearly the leading Internet resource, providing objective, unbiased information that you will need to make intelligent, informed decisions about which vaccines you may want to administer for yourself, or your family member.

In this interview, I’m talking to Barbara Loe Fisher, founder of the NVIC, about a common childhood vaccine that’s used to treat and prevent diarrheal infection and illness from the rotavirus.

For those of you who are not familiar with this virus, the rotavirus is the leading cause of diarrhea in infants, not only in the United States but in the developing world. A number of trials have shown that this vaccine has been useful in reducing the death rate from rotaviral infection in the developing world, and that’s the key.

In the United States, prior to the introduction of this vaccine, about 50,000 infants required hospitalization each year as a result of this infection. However, in the US, where we have an advanced healthcare system, this infection is very rarely fatal.

In fact, prior to the introduction of the rotavirus vaccine, about 40 infants per year died from this infection. This is because it’s diagnosed early on, and simple intervention – usually with the administration of intravenous fluids to rehydrate the child – is quickly implemented.

Interestingly, since the introduction of the vaccine, the death rate from rotavirus infection in infants has not decreased at all; in fact, it’s risen slightly!

So, the major argument in the US is: Does the rotavirus vaccine decrease hospitalizations, and at what cost?

We elaborate on this issue in this interview, because an interesting development has occurred that you need to beware of, which has tremendous implications for all other vaccines as well, as it brings into question the very integrity and safety of the entire vaccine system.

Hopefully, the evidence of the potential dangers inherent with this vaccine will compel you to join us, and take action to force the primary manufacturer of this vaccine to take it off the market.

Background on the Rotavirus Vaccine

The rotavirus vaccine was initially recommended in the 1990s but was removed from the market in 1999 when it was found to cause intussusceptions, a condition where a part of your intestine folds into another part. This can cause potentially serious complications. Within the last 10 years, two other rotavirus vaccines were brought to market to replace it.

The justification for giving this vaccine is that it saves 50,000 babies from going to the hospital each year. However, as I just explained, it’s extremely rare for American babies to die from this virus. Once they receive some intravenous fluids to rehydrate them, they recover marvelously. So it is NOT a dangerous disease in the US. Yet the hospitalization rate is used as justification to give this vaccine to millions of children.

If it was safe, effective, and inexpensive, this wouldn’t be an issue. But it’s none of those things.

Newfound Dangers in Rotavirus Vaccines

On May 7th, the FDA called a special meeting of the Vaccines and Related Biological Products Advisory Committee to discuss the fact that a DNA from a porcine circovirus (PCV1), a pig virus, was found in Glaxo SmithKline’s rotavirus vaccine.

Previously, on March 22nd, they had announced they were recommending the suspension of the use of GlaxoSmithKline’s Rotarix vaccine due to contamination with PCV1 DNA.

PCV1 is a pig virus that does not appear to cause any clinical disease in pigs or humans.

There is, however, another virus called porcine circovirus 2 (PCV2). This is a DEADLY pig virus that causes very severe disease in infant pigs, including:

  • Wasting and failure to thrive
  • Immune suppression
  • Respiratory problems
  • Kidney, brain and reproductive problems
  • Death

A general description of PCV2-associated disease can be found on the Iowa State University College of Veterinary Medicine website.

There’s also a study published in May 2004 in the journal Xenotransplantation, which looked at whether PCV1 and PCV2 can infect human cell lines. The conclusion of this study was that PCV gene expression and replication did take place in human cells but was non-productive.

Even so, there appears to be human cell disruption of some kind that has to do with proteins.

Two days before the May 7th meeting, it was announced that the more dangerous PCV2 had been found in Merck’s RotaTeq vaccine...

Interestingly, on March 22nd, FDA Commissioner Dr. Margaret Hamburg advised that “Anyone who has already received a dose of [GSK’s] Rotarix should switch to the Merck product for the next two doses,” because “preliminary testing of the Merck product has found no evidence of the porcine circovirus 1 DNA.”

So PCV1 was “dangerous enough” to recommend switching to Merck’s product. Now that Merck’s RotaTeq has been found to be potentially more dangerous, well that puts the FDA in quite a pickle…

This is a clear illustration of the challenge the FDA has when it comes to having any definitive insights as to what the reality of the situation is, seeing how the head of the agency issued the absolute wrong recommendation as little as two months ago.

One Vaccine Suspended while the More Dangerous Vaccine is Still on the Market

While Merck did not attend the FDA’s May 7 meeting, GlaxoSmithKline did show up and pledged to reformulate their vaccine to remove the (non-lethal) PCV1 virus.

However, Merck’s RotaTeq vaccine, which contains DNA from a lethal pig virus, could not be properly addressed at the meeting since they were not in attendance.

Barbara Loe Fisher says:

“So, the problem we have is that babies are swallowing basically parts of a lethal pig virus, and that’s why we believe Merck should voluntarily take RotaTeq vaccine off the market until they can clean the vaccine up, and put a vaccine on the market that is not contaminated.”

It’s quite shocking that these vaccines are not guaranteed to be free from contamination with DNA from animal viruses or any other kind of virus, especially when you consider that the technology currently available could have been used to screen for this pig viral DNA.

Yet the reality is that there is no such guarantee, and although the technology is there, it’s apparently not being used or not being used properly to ensure that this kind of contamination does not occur.

NVIC Calls for Stricter Decontamination Rules and Labeling Requirements

Now, what’s so important about the discovery of these DNA fragments?

“It could be important because, at the May 7th meeting, it was discussed that they don’t know whether this DNA is infectious or not,” Fisher says.

“When you have DNA that contaminates vaccines from animal viruses or other insect viruses -- they’re trying to make vaccines now using insect cells -- you can have a problem with it being infectious.

You can have a problem with it becoming part of our own DNA, or recombining and creating hybrid viruses. For example, the pandemic H1N1 swine flu was a hybrid virus, a human-pig-bird hybrid virus.

It is possible for animal viruses to recombine with human viruses and create new viruses that could be quite lethal.”

Similarly, the early polio vaccines that came out in the late 50’s, early 60’s, were found to be contaminated with a monkey virus, SV40, because kidney tissue cells from monkeys were used to produce the polio vaccine.

Once the contamination was discovered, one researcher began testing it and found that the SV40 virus caused cancer in hamsters. It took awhile for people to recognize that that could potentially cause cancer in humans, but eventually independent researchers confirmed that indeed SV40 is associated with human cancers – even though government health agencies still deny it..

SV40 DNA has since been found in people with brain, bone and lung cancers.

So, when you give your child the RotaTeq vaccine, a live virus vaccine that is taken orally, they are ingesting parts of a dangerous pig virus that causes wasting disease in infant pigs. How do we know that this will not cause immune suppression in susceptible babies or their children down the road?

Might it cause the same kind of wasting disease?

No one knows!

And that’s why the precautionary principle must prevail. Interestingly enough, a 2008 drug review by the FDA determined that GSK’s Rotarix vaccine is associated with a significant increase in convulsions and pneumonia-related deaths, compared to a placebo.

Rotarix, as mentioned earlier, was found to contain PCV1, believed to be harmless compared to PCV2, which is known to cause respiratory disease and death in pigs, and yet Rotarix can increase your child’s risk of pneumonia-related death…

Is it a coincidence? Or do we simply not know enough about what swallowing foreign viral DNA can do in certain vulnerable children?

“When in doubt, you take it out,” Fisher says. “You have to have high standards at the FDA for proof of safety and efficacy of these vaccines.

At public comment time on May 7th, my organization called for the FDA to raise its standards for screening these vaccines and legally requiring vaccine manufacturers to take this contamination out of their vaccines – if they’re using cell substrates that could possibly be infected with viruses – and also to label the vaccines.

If they’re going to allow DNA contamination in these vaccines, then at least they have to let the people know how much of it is in the vaccines.

It’s a problem because there are many, many vaccines that are going to be created in the future using animal cell substrates, insect cell substrates, and potentially even cancer cell substrates. And if they’re going to do that, the public needs to know.

We need to have informed consent. We need to understand what we’re putting into our bodies or the bodies of our children.”

Vaccines are Not “Pure” Products

We made this point quite clear last year when we exposed the massive swine flu fraud, but many people still refuse to accept the fact that vaccines are actually not pure products. Many still hold onto the idea that vaccines are purified extracts that will improve your immune response.

Unfortunately, nothing could be further from the truth, as this recent finding indicates.

Rather, vaccines are frequently grown in cultured media that can be contaminated, not only with viral particles but also with other proteins. Once these proteins are injected or squirt into your body, they could cause significant complications.

In the case of the rotavirus vaccine, contamination may not be quite as hazardous since it’s swallowed rather than injected. However, there’s no GUARANTEE of safety. The truth is that no one knows whether or not swallowing these DNA fragments might pose a health risk to infants now or in the future.

Now, one of the central issues here is the advancement of technology. The PCV contamination was not discovered by the vaccine manufacturers themselves, but rather by an independent lab, funded by the most prestigious government authority, the National Institutes of Health (NIH), using more sophisticated technology. Hence their findings are both objective and reliable.

It stands to reason that as technology advances, we should, indeed must, implement the precautionary principle by using the more sophisticated technology now available to LOOK for potential problems and contaminations. And once they’re identified, action must be taken to remove the contamination.

Fisher says:

“What we need is to have Merck be a good corporation and adhere to the precautionary principle, like other corporations whose products have been found to be contaminated for one reason or another. They voluntarily withdraw the product from the market.

This should be the case with a vaccine that is contaminated with DNA from a lethal pig virus, when we don’t know what that could mean down the road.”

… That should be the commitment of every vaccine manufacturer. And if they can’t make a vaccine that is free from contamination using the process that they are using currently, then they need to find a different way to make vaccines that are not contaminated.”

A Call to Action!

We’re hoping that with pressure from you, your family, and your friends, Merck can be motivated to voluntarily withdraw the RotaTeq vaccine from the market until they can guarantee that it is not contaminated with foreign viral DNA fragments.

The FDA is not doing it for you.

Instead of admitting they made a mistake in recommending the use of a potentially more dangerous vaccine and suspending Merck’s RotaTeq as well, they made a complete turnabout and withdrew the suspension of GSK’s Rotarix instead!

It’s important at this point for parents to realize that the rotavirus vaccine is not a mandated vaccine. It’s a vaccine that you can opt to use if you want, but it’s not required. So the choice is yours.

Is the risk of giving your child a known contaminated vaccine higher than the risk of her being one of the 50,000 Americans a year suffering the generally non-fatal consequence of having to go to the hospital and get an I.V.?

Once you have the facts, it’s your responsibility to discern what you want to do for yourself and your family.

Also understand that you can request one brand over another. In this case, Rotarix is actually likely the lesser evil of the two, even though it was the one initially suspended by the FDA.

“What we do now to draw the line in the sand on contamination in vaccines is going to have a profound effect on the future,” Fisher says.

“We have to make it clear to the government health agencies, to the corporations that are producing these vaccines, and to the doctors who are giving them, and to the legislators that often pass laws to require them, that we do not want these vaccines contaminated.

We want them clean. We want the manufacturers to clean them up. We want the government to require the manufacturers to clean them up.

We want doctors to tell us what the information is. We want them to be truthful with us about the vaccines they are giving to our children. And ultimately as we always say, we must have voluntary informed consent to the use of vaccines.”

We need your help to accomplish this, and it starts with raising awareness about these contamination issues.

“You could certainly get involved by contacting your local media and making them aware,” Fisher says. “Take some of the information that we have on www.Mercola.com and www.NVIC.org and make your local media aware that you care about this issue in your community and you want them to investigate it.

The doctors who give these vaccines must become aware that we care about vaccines being contaminated. You could raise awareness in the medical community and at the American Academy of Pediatrics who advise pediatricians in this country.

You can also make your legislators, the people who you elect to public office, aware that you don’t want vaccines contaminated. If the government wants us to use vaccines it would be smart for them to require these companies to produce clean vaccines.

…If we want to use these vaccines, then we have to make sure that they are safe as possible.”

NVIC.org has an entire web page outlining specific action steps you can take.

It includes an additional video commentary by Barbara Loe Fisher, along with Action Step Instructions and sample letters you can send to:

Please take a moment to visit NVIC.org, and Take Action now!

National Vaccine Advisory Committee Also Needs Your Input

In addition, I want to alert you of an important meeting of the National Vaccine Advisory Committee (NVAC) on June 2-3, 2010 and the need for public comment.

The NVAC's Vaccine Safety Working Group (VSWG) is currently charged with reviewing the current federal vaccine safety system and developing a White Paper describing different options for what can be done to improve the system.

Different options for improving effectiveness, accountability and transparency will be discussed, including whether changes in the infrastructure and governance are needed.

The White Paper will be sent to the Secretary for the Department of Health and Human Services (DHHS) for action.

Public comment is urgently needed to reinforce the consumer voices on the Committee. It is important that NVAC receive many public comments during this critical June 2-3 to evaluate whether or not there should be independent oversight of vaccine safety activities.

The June 2-3 meeting will be held in Washington, DC. at the Hubert H. Humphrey Building - Room 800, 200 Independence Ave S.W. from 9-5 PM EST and 9-3 PM EST. Meetings of the NVAC are open to the public and pre-registration is required to physically attend and/or comment and the agenda has been posted.

I join the NVIC in urging you to provide your written comments. Please send them to nvpo@hhs.gov.

The meeting will also be broadcast via webinar if you cannot attend the meeting in DC. You must register for each day's webinar separately. Click on each day to register for the webinar:

It is vitally important that government hear from the public on important issues like improving the vaccine safety infrastructure. We encourage you to participate by making your voice heard.


[+] Sources and References