By Sherri Tenpenny, DO, AOBNMM, ABIHM
The new Zika vaccine is roaring onto the market. We’ve seen this before. Think about it. We’ve had: SARS (2002); Bird flu – H5N1 (2005); Pandemic swine flu – H1N1 (2009); Ebola (2014); and now, Zika.
Shouldn’t everyone be saying, “Fool me once (or twice or four times), shame on you. Fool me in 2016, shame on me”?
In the rush to create another pandemic scare – and another pandemic vaccine – blaming the Zika virus is the Perfect storm. The Vaccine Industry can once again pull out their proven recipe known as the Hegelian Principle: Problem-Reaction-Solution. What if behind the scenes they’re saying something like this:
- Problem: Oops. We created a vaccine-induced disaster, using the MMR and toxic pertussis vaccines together in young women who were pre-pregnant and pregnant. Coupled with Monsanto’s pesticides in the water, we have to find something to blame. We need a diversion, a cover-up.
- Reaction: How about blaming a common mostly-benign virus! We’ve done that before, and it works. The Zika virus is found widely across the world, so we’ll have an immediate and huge market share. Let’s get the Hype Machine going now. Create the fear in everyone – especially pregnant women – so they will demand the vaccine. We’ll expand the hysteria as we get the vaccine ready for launch.
- Solution: Let’s get General Director Margaret Chan at the WHO to declare Zika Infection to be an international emergency. That way, we can get billions from the U.S. and other governments to make the vaccine. EVERYONE will want to protect pregnant women. We’ll get a tropical disease voucher then get the FDA and HHS to issue an Emergency Utilization Authorization (EUA) so we won’t need years to test the vaccine. Oh! And we’ve got the Olympics coming!! We can get the airlines to require Zika vaccination for international travel, not only to Brazil but to every country where Zika has been reported. We’ll maximize our ROI on the sale of vaccine – and resale of the voucher. Such a deal, since we’ll have minimal out-of-pocket to manufacture it! Pure profit! And we’ll make a killing on all the drugs we sell when people get sick from the (untested) vaccine! And best of all, we’ll have 100% liability protection even if the mom or fetus dies – at least in the U.S. – thanks to the PREP Act. Our shareholders will love it. <high-five> What a plan!
Sound far-fetched? Let’s examine how this science fiction scenario is far from fantasy. It’s the scary truth…
Vaccines On The Way
Until now, Zika hasn’t had any interest for vaccine developers. The infection is mild, consisting of a transient fever and a rash. More than 80% of those affected have no symptoms at all. Now, with absolutely no proof that Zika causes birth defects or that it is associated with microcephaly, the Big Boys in the vaccine industry are chomping at the bit to get in the game. Why? As the Wall Street Journal reported, “Zika’s rapid spread could provide biopharma companies with a blockbuster opportunity.” It appears they overlooked the fact that among the 404 confirmed cases of microcephaly, only 17 have an association with the Zika virus.
On February 1, 18 “experts and advisors” met with the Director-General of the WHO, Margaret to discuss Zika. Even the experts agreed that a causal relationship between Zika infection during pregnancy and microcephaly is “strongly suspected, though not scientifically proven.” Nonetheless, Dr. Chan moved forward and declared the Zika/microcephaly problem in Brazil to be a “Public Health Emergency of International Concern.” It’s a handy designation. The emergency declaration allows the WHO to mobilize resources – money, people, and power – for surveillance and rapid vaccine development.
It seemed the Big Boys of the industry couldn’t get into the race fast enough, and up to the money trough, fast enough. Right on cue, the manufacturers stepped up to the plate:
- Feb 2: Sanofi became the first major pharmaceutical company to commit to Zika vaccine R&D, launching a program to develop a jab just after receiving the first regulatory approvals for its dengue shot.
- Feb 3: Pfizer, Merck, Johnson & Johnson and Takeda all announced that they’d look into their existing vaccines and technologies for the potential to create a vaccine against Zika.
- Feb 3: Bharat Biotech in India is developing two inactivated vaccines for Zika that will enter animal trials within a few weeks.
- By Feb 8, twelve groups had tossed their hat in the ring to be the first to develop a Zika vaccine.
On the same day the WHO declared Zika infection to be an international emergency, a bipartisan bill was quickly submitted to add drugs and vaccines Zika infection to the FDA’s Priority Review Voucher Program. Initiated in 1992 under the Prescription Drug User Act (PDUFA), the program allows manufacturers to buy vouchers to move their product to the head of the line, shortening the approval time from 10 to 6 months. The vouchers are not inexpensive. Since October 1, 2015, the FDA tropical disease priority review user fee was $2,727,000, confirming drug companies really can buy their way to the rapid release of their products. If the bill is passed, Congress has added another windfall line-item for drug companies through the resale market for the vouchers.
In 2014, Knight Therapeutics paid the user fee to obtain a tropical disease voucher to seek approval of a drug for a parasitic disease called leishmaniasis. After the medication was approved, the voucher was sold to Gliead Science that same year for $125 million. In March 2015, a voucher was granted to Asklepion Pharmaceuticals research and fast track a drug for a rare pediatric disease. After it was approved, the voucher was sold in May 2015 to Sanofi for $245 million.
Congresswoman Susan W. Brooks (R-IN) jumped into further launch Zika vaccines by sending a letter on February 5th to the FDA’s Acting Commissioner Dr. Stephen Ostroff, asking him to “fast-track the development of vaccines or treatments for Zika virus helping save lives and prevent infections.” Even President Obama chimed in, requesting $1.8B from congress to defend American against a non-threatening infection and encouraging the FDA to fast track approval of a Zika vaccine.
Confirming the fast-tracking would be possible, Dr. Anthony Fauci, director of the US National Institute of Allergy and Infectious Disease (NIAID) stated:
“We can use the technologies from other flaviviruses to get the product made by the end of 2016. Testing the efficacy of the drug could take a year or more but if you were in an emergency situation you could do this at the same time as the testing and make it available as soon as it shows efficacy. So you could get something out in 2017, on an accelerated emergency basis.”
“As soon as it shows efficacy” means as soon as Zika vaccine is shown to induce an antibody response, they will plow ahead. The FDA and the Secretary of HHS can then release the unapproved vaccine through an Emergency Use Authorization, or EUA. The EUA process was part of Project BioShield, legislation signed into law in 2005 by then-president G.W. Bush. Project BioShield was initially funded with $5.6B, with an additional $1.4B added in 2013. The allocations allow the government to purchase non-FDA approved drugs and vaccines as soon as experts believe the product is “safe enough.”
Complete Liability Protection – Even If It Kills You
As far as the drug companies are concerned, there is no reason to delay: they can even through together a fast, sloppy product because they have on fear product liability. After the passage of Project BioShield in 2005, an even more nefarious bill was signed into legislation: The Public Readiness and Emergency Preparedness Act or the PREP Act of 2006.
The PREP Act, provides, at least, four sweeping provisions:
- Immunity from liability for a faulty product. Courts are required to dismiss any and all claims against drugs, vaccines and/or biological products used in the event of a declared an emergency. If the product doesn’t protect the patient from illness or causes serious side effects? Oh well. The company has no liability. The language is so broad it could even apply to medications such as acetaminophen and ibuprofen.
- Immunity from property damage. Courts are required to dismiss any and all claims of property damage or business interruption that may occur during a declared emergency.
- Immunity from accountability. Even if the Company’s dirty facility created a batch of contaminated vaccines that resulted in death or injury to thousands of people, the drug company will remain immune from liability. Persons and entities protected by the PREP Act include, well, everybody: Manufacturers, distributors, healthcare personnel, employees and agents of the manufacturer, and the United States government.
- Immunity from malpractice lawsuits of any kind. A person who suffers any physical, mental or emotional loss will be legally prohibited from suing…anyone. Any person or entity that has in any way been involved with the production, distribution or administration of the emergency countermeasure has immunity from all liability. They could essentially even get away with murder.
In simple terms, a claim can go forward only if the injured party can prove willful misconduct. In other words, the injured party has to prove the vaccine maker intentionally caused them harm, either by an act of omission or commission. Unbelievably, even if you somehow caught them red-handed and had unequivocal proof of misconduct, the manufacturer is still immune from legal prosecution unless the U.S. Attorney General agrees with you and your evidence, and agrees to prosecute. This means the U.S. government would have to side with you and go to bat for you against the drug company. How likely is that?
According to the American Trial Lawyers Association the PREP Act contains language “never before seen in any proposal.” Susan Sherman, senior attorney from the Office of the General Counsel for the U.S. Department of Health and Human Services (HHS) applauded the protection saying, “We’ve made commitments through the PREP Act to various folks, the manufacturers, the distributors, and everyone in the chain, so they will have liability protection.”
Zika Vaccine – For Pregnant Women
For decades, doctors admonished pregnant women to not take any medications while pregnant, not even a Tylenol or antihistamine. Currently, the flu shot and the pertussis vaccine (Tdap) are routinely given to pregnant women at around 26 weeks of fetal development. The other vaccines currently recommended DURING pregnancy are Hepatitis A, hepatitis B, meningitis, pneumococcal (Prevnar), and tetanus shots. Currently, under investigation are human papilloma virus (Gardasil/Cervarix), Respiratory Syncytial Virus (RSV), malaria, and group B streptococcus. And many more vaccines targeting pregnant women will no doubt be coming soon.
Keep in mind there is NO proof that Zika virus causes birth defects or that it is in any way associated with microcephaly. In fact, researchers say that to conclusively determine a benign, mosquito-borne virus is to blame could take years. And remember, of the 404 children with confirmed microcephaly, only 17 tested positive for Zika virus. Nonetheless, the vaccine is on its way…and it will no doubt be protected – and targeted – toward pregnant women.
They say truth is stranger than fiction. Unfortunately, the Problem-Reaction-Solution scenario mentioned at the beginning of this article is not fiction. It’s fact. Let the consumer beware – and remember to exercise your right to refuse this vaccine, while you still have the chance.