Swine Flu Vaccination

What is Swine Flu?

Genetically, this virus appears to contain a combination of swine, avian, and human influenza virus genes.  Technically, this  is why it is being referred to as a novel human flu virus. So while intensive farming of pigs, poultry and other animals have the potential to be fertile production grounds for new strains of pathogenic disease organisms, you can’t help feeling that, given the media hype about ‘swine flu’, pigs are in this case being unfairly maligned.

Historically, human transmission of swine flu from birds or pigs may often have gone undetected due to them yielding mild or even no symptoms at all, or assumed to be normal seasonal flu. Subsequent human to human transmission has happened before too, although this has been limited to close contacts or closed groups of people. As with seasonal flu, deaths would occur, particularly among those with poor immunity, and among the vulnerable such as the very old, the very young or the already sick.

The particular strain or subtype of the H1N1 virus associated with the current concern could of course also cross to pigs, something the pig industry is justifiably concerned about. But for the time being it has found a way of transmitting readily between humans, mainly cause it binds to tissues in the nose and throat where it can easily be passed on by coughing or sneezing. In contrast, the much more virulent H5N1 bird flu virus, although it has not yet found ways of sustainable ways of human to human transmission—and may never mutate to do this—binds to tissues in the lung. There it causes much more serious disease, notably viral pneumonia, and creates a massive imbalance in the immune system referred to as a 'cytokine storm'.

When looking at ways of reacting to the current situation we should particularly draw from the lessons of the past.

What is the Swine Flu vaccine?

The Swine Flu vaccine is a vaccine made to protect against influenza A virus subtype H1N1, more commonly known as swine flu.

Two vaccines have been produced within a matter of months, GlaxoSmithKline’s Pandemrix and Baxter’s H1N1 jab, have been tested and are in the process of being approved and licensed.

As of the 24 September 2009, regulatory authorities have licensed pandemic vaccines in Australia, China and the United States of America, and these are soon to be followed by Japan and several countries in Europe. The length of the approval process depends on factors such as each country's regulatory pathway, the type of vaccine being licensed, and the stage of manufacturers' readiness to submit appropriate information to regulatory authorities. (WHO, 2009)

How proportionate is the pandemic response?

 No one doubts the suffering that some have experienced due to the current outbreak of new influenza A(H1N1), formerly referred to as ‘swine flu’. But in the context of many other human diseases, the media reaction to the disease, as well as the international coordination of responses by governments, the pharmaceutical industry and vaccine manufacturers seems somewhat disproportionate.

To put it in context, in the tropics, particularly in sub-Saharan Africa, at least a million people die each year from malaria — the mortality figures average out at around a staggering 3,100 people each day. Worldwide, common-or-garden seasonal influenza causes 3 to 5 million cases of severe illness each year and kills between 250,000 and 500,000 people annually.

In contrast as of 1 May 2009, the US Government has reported 109 confirmed cases of swine flu, with just a single death. Over the same period, Mexico has reported just nine deaths, and 156 confirmed cases. Sixty six further cases have been reported in a further nine countries—with no deaths. None.

The World Health Organization (WHO) was able to confirm by 29 May 2009 some 15,510 cases— but just 99 deaths (0.6%) had occurred, and as of 3 June 2009, in the most recent WHO Influenza A(H1N1) update, the figures are reported as 66 countries officially reporting 19,273 cases of influenza A(H1N1) infection, including 117 deaths. In the case of the vast majority of confirmed infections of ‘new influenza’, the symptoms have been mild and present no threat to life whatsoever.

When you look at the pattern of deaths as compared with the spread of the virus, it’s clear that the virus is spreading, yet causing a declining death rate, which appears to have settled, at least for the time being, at a around half a percent of those infected (Fig 1 above). This is a common pattern in epidemics; the greatest virulence often occurs in the early stages — then it tends to peter out. While the majority of infected persons have so far suffered only mild ‘flu symptoms, one shouldn’t become complacent. A mutation or reassortment of the virus may yet cause significant death and distress. However, there is no evidence yet of any such change to the virus. We shouldn’t forget that this virus’ close relative, the avian-derived H1N1 virus that causes mostly non-lethal seasonal influenza, originally caused between 25-50 million deaths during the ‘Spanish flu’ of 1918-19. With around 90 years of opportunity, its virulence has never returned to the levels found in the early waves of infection in humans. Will it be any different for the new subtype?

Overdependence on vaccines and drugs

What’s perhaps most disturbing is the reliance placed on pharmaceuticals and vaccines by the WHO, governments and the ‘healthcare system’ generally. The primary means of ‘dealing’ with the infection is currently the dispensing of antiviral drugs and, in particular, Tamiflu (made by Roche) and Relenza (GlaxoSmithKline).

Sales of Tamiflu in the first quarter of 2009 skyrocketed to $347 million worldwide, while those for Relenza were $324 million (see Zacks Investment Research report). Most of the sales were generated through government stockpile orders, as the WHO’s Pandemic Phase 5 alert triggers international, pandemic preparedness. This penultimate level in WHO’s pandemic rating scale has absolutely no bearing on the virulence of the virus, and is characterised simply “by human-to-human spread of the virus into at least two countries in one WHO region”. Even the highest pandemic level, Phase 6, “the pandemic phase, is characterized by community level outbreaks in at least one other country in a different WHO region in addition to the criteria defined in Phase 5.” One can’t help feeling this rating system, which completely ignores the virulence and actual harmfulness of a pathogen, is a very convenient tool for the drug companies. The last pandemic scare was three years ago, when governments then upped their stockpiles in readiness for another pandemic that never unleashed itself fully. Now the drug companies get to have another bite at the cherry, with very little evidence that their drugs are effective or are warranted in relation to the risks caused by current strains of the virus.

Vaccine manufacturers, which collaborate closely with the WHO, have also been triggered into producing a vaccine for the new strain of influenza. One only needs look at the media to see just how much pressure has been brought to bear on the general public around the world to receive this new cocktail vaccine.

Non-drug measures 

Unfortunately, there’s been far too little talk about non-drug measures such as social distancing and hygiene as means to reduce infection, while nothing has been said officially about measures to enhance the effectiveness of the best viral control system known to humankind: the human immune system, with which each one of us is endowed. Enlightened governments (none come to mind) should have been talking more about combining social distancing, ‘open-air treatment’ and specific nutritional and botanical approaches (eg. boosting vitamin D levels) that are known to facilitate a better modulated, immune response. Sadly, these are things about which we must learn for ourselves because we are unlikely to hear about them from our drug-dependent governments.

What happened the last time around (1976) 

This is not the first time swine flu fears have caused a nationwide panic.

The swine flu epidemic of 1976 is of particular relevance and is a good example of hype leading to catastrophe. In February of 1976 President Gerald Ford issued a warning in fear of an outbreak following the death of 20-year-old Army recruit David Lewis and the illness of several other soldiers who contracted swine flu.

In response to his concern of an impending epidemic, a nationwide vaccination programme was initiated. More than 40 million Americans received swine flu immunisations and in the weeks that followed, reports surfaced that the vaccine appeared to increase the risk for Guillain-Barre Syndrome, a rare disease that causes paralysis from the legs upward as a result of a response in the immune system, which attacks the nerve sheaths. The condition may be fatal while some may be left permanently paralysed. Click here to read the CDC’s reflections on the events of 1976. It is estimated that some 500 vaccinated people developed GBS, and of these, 25 died. This means that vaccinated persons were between 4 and 8 times more likely to get GBS. Are you prepared to trust vaccine companies and governments this time around?

In this epidemic more people were harmed by the efforts to deal with the virus—notably vaccination—than they were by the virus itself, which remained fairly non-virulent.

Who benefits from the hype? 

This swine flu pandemic scare is very timely indeed for the pharmaceutical industry, which has not been enjoying, in the recent years, the easy ride it had in previous decades. The hype has already seen share prices in the pharma companies Roche and GSK, makers of the anti-viral drugs Tamiflu and Relenza, soar. Even if a pandemic does eventuate, the companies will have some difficulty making a killing (excuse the pun…[ed]) from immediate sales because of the significant lead-time required to prepare for large-scale manufacture. But the pharma companies are already gaining from sales to countries to replace or even increase country-held stockpiles of anti-virals that will be approaching the end of their shelf life. You’ll remember how countries built up their stocks following the bird flu scare of 2006? Well, now it’s three years on and, yes—you’ve guessed it— the shelf life of Tamiflu is 36 months, and around the same for Relenza.

Hogwash or hog hoax? The maligned swines?

You can see how GSK is gearing people up by checking out its Pandemic Planning webpage, which is nothing short of a commercial.

There’s also a lot of money to be made from countries that decide they want stockpiles held by the drug companies ready for use. The drug companies themselves manage these stockpiles on behalf of individual countries, being paid a fat retainer for the privilege, allowing them to rotate stocks keeping them in date. But certainly in the case of Roche and its anti-viral drug Tamiflu, when a country wants the stock because of an imminent pandemic, it will be shipped within 48 hours and the drug company receives in exchange a fat cheque from selling the drug at wholesale price. Not a bad business arrangement if you can ensure a pandemic from time to time so you get your cash prize on top of your retainer!

So, saying that the current epidemic is convenient for the pharma companies is a bit of an understatement. The vaccine companies will also be major beneficiaries of 'swine flu 2009'; they are already increasing their sales of seasonal flu vaccines to countries, knowing full well that that they will have little effect on a mutated form of H1N1. In due course, they will also be able to 'upgrade' their future seasonal flu vaccines by incorporating swine flu, and governments will no doubt try to persuade or force ever more people to be vaccinated. For example, Maryland-based Novavax Inc. and Illinois-based Baxter are are gearing up to fast-track a human vaccine for this particular strain, while increased use of vaccines in the pig industry is also likely.

Is the swine flu vaccine safe? 

Putting it in perspective, statistically, 3,000 subjects are needed to have 95% probability of detecting an event that occurs at a rate of one in 1,000. That means around 6,500 subjects being needed to detect 3 cases. So, what about possible rare effects? What about impacts on fertility? What about neurological effects that might be delayed, such as those that occurred following the development of Guillian-Barre Syndrome following the 1976 swine flu vaccination program? On this basis, at the ANH, we argue that government’s are on a very weak wicket claiming that the vaccines have been evaluated as safe.

On top of this, are the findings from the first published trial, in the New England Journal of Medicine, that shows that 45%—nearly one in two persons—vaccinated, suffered systemic effects (e.g. headache) following vaccination. Headache is a common symptom of a massive immune response from the adaptive side of our immune system, in which immune signaling chemicals, called cytokines, are released in large quantities. An hyper-response of such cytokines, commonly referred to as a ‘cytokine storm’, can be enough to kill someone, as we have seen back in 2006 in the lethal cases of avian influenza (H5N1 virus) which was transmitted to humans.

While it’s disturbing enough to find that there are not nearly enough data to verify safety of the vaccines, what if governments decide to make swine flu vaccinations mandatory?

Mandatory vaccination – is it a possibility?

There is huge speculation at the moment as to whether the swine flu vaccine will be made mandatory in the UK, and a lot of talk about France already having made that decision. It is difficult to find accurate information with a lot of scare stories circulating but we have looked at the French Health Ministry web site and found there is no evidence to say that the vaccination is mandatory in France, despite all the speculation. Ontario has also stated that it will not make the vaccine mandatory for health workers or anyone else. However, in Ottawa the military's surgeon general has said “the Canadian Forces reserves the right to order its soldiers deployed in Afghanistan to take the vaccine meant to prevent swine flu.”

Hajj pilgrims from Russia wishing to travel to Saudi Arabia will have to have the vaccination and will have to provide certification to prove they have had it. The certificate will have to show that they were vaccinated two weeks before the visa issue date.

Many countries have said that they may make the vaccine mandatory but saying it and actually enforcing it are completely different things. Here at the ANH we are very pro freedom of choice and we would hate to see the choice be taken away from the public on this matter. In an ideal world we would have liked to have seen longer test periods but are very pleased that the parents of the children in the trial seem to at least have been warned of the possible side effects or negative outcomes. As these are their precious children they are handing over to medical research, this is the least they deserve.

What to do? 

When you look at the bigger picture and see the facts and figures in context, the present situation does look to be massively overblown by the media, by governments and by the drug companies.

Here’s what we advise for the time being:

• Keep a watchful eye on reliable media sources informing you of the spread of the new strain of 'swine flu'
• In particular, watch out for evidence of its virulence. If the virus is decreasing rather than increasing in virulence, there is really nothing to worry about
• To see official figures about confirmed cases, go to the WHO's swine influenza pages and read its regular updates
• Keep your immune system in tip-top shape (see ANH's Food4Health campaign page and the recommendations about natural products given in our 2006 avian influenza report)
• Watch this space for more information!