There are two primary reasons behind the shortage of H1N1 vaccine in the U.S. The first involves the fact that the science used to make the vaccine is really old-fashioned. The second is the fear-mongering caused by the Anti-Vaccine Activists (“AVA’s”).
Making Vaccines Bocky Style
My daughter’s favorite stuffed toy is a (female) chicken named Bocky. Imagine thousands of real Bockys sitting in their cages waiting to meet a Mr. Bocky to be able to lay an egg so that a strain of H1N1 can be injected into it. The virus reproduces inside the egg and, several months later, retrieved. Voilá! That’s how vaccines are made.
In a normal flu season, all those Bockys need to lay several million eggs. Ever worse, this year we have both the H1N1 and the regular flu strain to deal with. So that means a whole lot of extra lovin’ is needed to meet egg demand.
Now, despite using the antiquated Bocky Method, drug manufacturers have still produced the actual vaccine in 3 months – much faster than the normal 7 month timetable. They even managed to complete this process after being told the regular flu strain had to be the one completed first! One vaccine provider has maxed out its manufacturing capacity, even devoting their entire UK site to the vaccine. They are literally doing the best they can with what they are required to work with.
Natural question: Why is the U.S. still using the Bocky Method when the European Union is producing it using mammalian cell cultures – a much faster and cheaper process, that also eliminates risks such as allergic reactions to eggs? After all, polio vaccine is already produced under this method.
Faster, Adjuvant, Faster!
There’s yet another method to speed up production. There is an additive that can be put into the vaccine called an adjuvant, which stimulates the immune system to respond more vigorously to the vaccine. It makes the vaccine more efficient, because you need to inject about 25% as much of it. In Europe, an H1N1 vaccine with adjuvant can be used on 4 times as many people as the same H1N1 vaccine used in the U.S. without the adjuvant.
The World Health Organization has no problem with adjuvants, either. As reported in the Nov. 2 NY Times, W.H.O.’s director of vaccine research confirms that 14 other countries use the H1N1 vaccine with adjuvants and all appear to be safe. One adjuvant, MF59, has been used for 12 years in European seasonal flu vaccines.
The Commission on the Prevention of WMD Proliferation and Terrorism has noted that, while H1N1 isn’t a bioterrorism event, when one does occur, wouldn’t we all rather have those vaccines made as quickly as possible?
Despite the fact that demand for H1N1 vaccine exceeds supply, the FDA only recently approved the use of adjuvants in vaccines…and yet federal health officials still won’t use them.
Natural question: why isn’t the U.S. using adjuvants to stretch the vaccine supply?
Anytime something bad happens, it is human nature to seek out a scapegoat. We need to put a face on evil. We need a place to direct our anger, frustration, and anguish – particularly when these bad things happen to children. Our inability to control when and where bad things will strike, and fear associated with our lack of control, runs so deep that they are mirrored in many fairytales: The Pied Piper of Hamelin, The Norwegian Troll Myth, The Boogeyman – dozens of cultures create a monster that kidnaps or kills children. It’s our way of trying to explain the unexplainable, the hurtful, the unthinkable – that something bad can happen to a child.
A neurological disease (“ND”) is one such terrible thing. And ND’s boogeyman is vaccination.
The result is an anti-vaccination movement that has spread over the years, and become so vocal that it has affected U.S. policy and impacted the country’s response to H1N1. The Feds are understandably skittish – they’ve been sued once already over vaccine additives. So the AVA propaganda has created needless fear and limited options. They can be blamed for the fact that demand currently exceeds supply.
Behind the Fear – Lack of Evidence
Have you ever seen the Boogeyman? I haven’t. Nobody has. Because he isn’t real.
Fear is, by nature, irrational. As the incidence of disease decreases from immunization, concern naturally shifts from adverse disease effects from lack of immunization to adverse effects from immunization.
For example, there is not a shred of evidence that autism is, in any way, linked to immunization.
This study found no evidence.
Neither did this one.
And for those concerned about other bad things happening from vaccines, here’s another
40-odd studies that also showed no linkage between vaccines and various bad things.
However, there is a difference between Bocky Littles – who insist that vaccines cause neurological disorders -- and those who feel enough anecdotal evidence exists to seek more data. There is no reason not to call for a well-funded, comprehensive study with well-defined methodology. After all, it is our children we’re talking about.
As a parent, you must distinguish between proper scientific studies such as those listed above, and random anecdotal stories of something bad happening “about the time my kid got vaccinated”. Any number of factors that had nothing to do with the vaccination may have contributed to this unfortunate event.
We don’t know what causes autism, period. It is very likely to be a complex variety of factors. As a parent, do you want to risk your child contracting any number of awful diseases because of an unproven link between vaccination and autism, or any other neurological disorder?
The Blame Game
November 17th’s Homeland Security hearing was filled with finger-pointing regarding the shortage. As expected, nobody took responsibility. Sen. Claire McCaskill (D-MO) and HHS Secretary Kathleen Sibelius passed the buck, claiming drug manufacturers overpromised and under-delivered. Well, thanks to the antiquated Bocky Method, the virus grew slower than expected. This wouldn’t have happened if – say it with me – the vaccines were produced with faster processes.
Sibelius also copped to going public with overly optimistic estimates. By doing so, she created expectations. That gaffe put unfair further pressure on the already-limited manufacturers.
At the hearing, Sen. Susan Collins (R – Maine) specifically asked about adjuvants. Dr. Nicole Lurie, the assistant secretary for Preparedness and Response at HHS had no good answer, but did say that public confidence in vaccines with adjuvant is low, “and we didn’t really want to rock the public confidence in a new vaccine with adjuvant”.
So there you go. Fear – promulgated by the AVA’s. Mix it with unrealistic expectations promulgated by Sibelius, and you have an impatient populace unfairly blaming the drug manufacturers.
Enough is enough. It’s time to take the blame off drug manufacturers for any vaccine shortage. The blame must fall first on the anti-vaccination movement. Next, the Obama administration needs to import its message of CHANGE to both HHS, and the FDA. We are in the midst of a pandemic, and it’s time to put science first.
How is this actionable?
I believe the swine flu pandemic has made it apparent that it's time for the U.S. to move vaccination science into the 21st century. Novartis (NVS) has built a lab capable of using mammalian cell methods here on U.S. soil, so it's only a matter of time before it is approved for use. I think we'll see a bigger push by health advocates, including doctors, to roll out this science. It means a company like Novartis stands to gain because it can produce more vaccines each year. This may help increase Novartis revenues in the years to come, and I don't think this has yet been reflected in the stock price.
Full Disclosure: No position in any stocks mentioned
Disclosure: Full Disclosure: No position in any stocks mentioned