Don't thow away the condoms just yet......

Talking of vaccines, the vaccine topic de jour yesterday, more so than even the progress of the swine flu vaccines through the various regulatory hurdles, was that of the new HIV vaccine. And how the media lapped it up!

"New Vaccine reduces the risk of contracting HIV by 31%!!" trumpet the media! "Up yours, all you naysayers," you who said a vaccine against HIV could never be produced!

Eye - catching coverage, I am sure you will agree, but was it justified? Lets look at some of the background.

1. This was a blend of 2 previous vaccines (ALVAC and AIDSVAX), neither of which had been shown to work on their own. The vaccine manufacturers themselves appeared surprised at the seeming success of this latest trial.
2. Even should the figure of 31% prove reproducible, it is worth bearing in mind that this still falls significantly short of the widely accepted minimum target efficacy for vaccines of 50% population protection.So the figures, if confirmed, signal cautious optimism, but would still require much work.
3. The articles and reports so prominently featuring the relative success of this vaccine trial have been released in advance of publication of the actual data - never a good sign, in my opinion. In some instances, the absolute figures have not even been offered!
4. 31% is a great, eye catching, memorable headline figure, but do the absolute figures justify the optimism? This is where it starts to get interesting - Total volunteers for the trial, 16,000 or so, test period between 2003 - 2006. 8,197 randomised to vaccine arm and 8,198 to placebo arm. Number of confirmed infected individuals in the placebo arm - 74; in the vaccine cohort - 51.

So this relative protection of 31% is based upon the difference between only 74 and 51 individuals - and only just qualifies as being statistically significant. Should one less individual have become seropostive in the placebo cohort, then the result would have been classed as statistically insignificant.

What I find interesting is the triumphalist tone adopted by some of the media. Again,as with swine flu coverage, I found the BBC article factual in tone with little opinion colouring it. Compare and contrast with, yet again to my disappointment,The Independent article , which doesn't even provide the absolute numbers!

Over the last few decades, there has been a massive investment in the development of an HIV vaccine, probably in the billions of dollars. Such a vaccine has been imbued with the hope of being the best method of HIV prevention. The failure of the various trials to date has lead to increasing pessimism amongst the majority of researchers that a successful vaccine could ever be manufactured. So the cynic in me asks this - Was all the hype surrounding the news of this trial more to do with justifying the cost of the existing trial and procuring future funding?

I am also curious as to why the health editor at The Independent is so upbeat about reports of as yet unpublished data from this latest HIV vaccine trial despite the small absolute numbers and the borderline statistical significance? Why didn't the article mention the absolute numbers at all? How do they justify such an optimistic tone over this one trial, with such small numbers and borderline statistical significance, and on the other hand have such an alarmist tone over the negligible risk posed by adjuvants present in the swine flu vaccines?

I am rapidly going off The Independent, especially when it comes to health stories.And another example of why it is important that you look at more than one news outlet.

Just the facts Ma'am

Always check the facts, always check the source, always get a second opinion. Following this virtuous approach can lead to headaches though, as it was for me reading various articles yesterday over the upcoming licencing and release of swine flu vaccines from various favoured news outlets. This is the BBC version. Nothing controversial here, sticking firmly to established facts,with no editorial opinion colouring the article, and with some useful elaboration.
From the article, you would come away with the following facts;
Fact 1. European Drugs regulator has given the go ahead to one of the UKs swine flu vaccines.
Fact2. The vaccine given the green light is Pandemrix, from GlaxoSmithKline.
Fact3. The UK has bought 60 million doses of this vaccine.
Fact4. The UK has also ordered a second vaccine, as yet unapproved, called Celvapan, being produced by Baxter.
Fact6. This will give the UK provision for up to 132 million doses
Fact7. A second vaccine, Focetria, manufactured by Novartis, has also been approved by the european drugs regulator - but this is not planned for use in the UK.

The article then goes on to give additional detail about the accelerated approval process, especially relevant given that swine flu numbers are now rising rapidly again.They even go on to explain why we have contracts with 2 different vaccine manufacturers;

1. Having 2 contracts increases the number of doses available, and ensures we are not totally reliant on one manufacturer.
2. Pandemrix, from GSK, is made in eggs. Celvapan, from Baxter, is manufactured in a mammalian cell culture, meaning it can be offered to those individuals with an egg allergy. An interesting point, although I am not sure how important it is.
3.Then they point out another difference between the 2 vaccines, noting that Pandemrix contains an adjuvant, whereas Celvapan does not.

So far, so good, I would have said. Factual article, no axe to grind or bias that I noted.

On to the second article, in the Guardian . Again, nothing too controversial here - a briefer article, sticking closely to published fact. I was midly irritated that anyone not reading it carefully might go away with the impression that the 2 vaccines destined for the UK were Pandemrix from GSK, and Focetria, from Novartis, which is incorrect.

It was the 3rd article i read on this issue that gave me the headache though, from The Independent, here. This article differed markedly in tone from the other 2 articles,being coloured much more by an editorial mindset which i found particularly irritating, since it is from a favoured paper of mine, one I value because of its impartiality.

Given the level of hysteria amongst a small but vocal subset of the population over vaccine safety, which was ignited over a decade ago by the truly abysmal, thoroughly ill informed, wildly speculative and unduly sensalionalist coverage of the "MMR causes Autism" controversy, and further fuelled over the years by rabid speculation, conspiracy theorising, and latterly celebrity endorsement of the view that Autism is caused by toxins contained within vaccines ( intially thimerosal, a bacteriostatic, and latterly aluminium salt adjuvants,there to amplify the immune response and increase efficacy of the vaccine), The impression I came away with was that the Jeremy Laurance article was unduly alarmist.

From the very first line, the article raises the spectre of vaccine safety.

"The first swine flu vaccine was approved for use in the UK today - but it would not pass muster in America."

That line sets the tenor of the whole article.The inference is that we in the UK are being "fobbed off" with an inferior and possibly dangerous product,good enough for us, but not good enough for our more discerning american cousins. This is all because the vaccine contains, shock horror! adjuvants, the latest of the allegedly deadly toxins contained within vaccines, according to some of the more fervent anti-vaxxers. The author then goes on to explain that US regulators have ruled out adjuvants in vaccines destined for the US market.

One can argue about that decision all day, but one thing it isn't, and it isn't anything to do with evidence, as the regulators themselves admit.Rather,it has everything to do with political expediency,attempting to maximise vaccine uptake amongst a population sensitised to the "toxins" of western medicine in general and vaccines in particular,through generally anti-vaccine populist media coverage.

What this decision is then, is an example of the precautionary principle in action - Worthy of debate on its own perhaps, but not a reason to adopt such a cautionary tone in the article.
Many responsible commentators would claim that this is an unduly cautious and unneccesary approach given the safety information we have on the adjuvants. This position has been adopted by US regulators before - over the use of thimerosal in childhood vaccines. One could argue their use of the precautionary principle then achieved precisely the opposite of what they intended. Rather than giving additional reassurance to the general population, so hopefully increasing public uptake, it could be argued that it backfired instead, handing a propaganda victory to the anti-vaccine lobby and their unscientific,evidence - free, biologically implausible and conspiracy fuelled agenda, increasing public concern over vaccine safety and reducing public uptake.

The article also flatly contradicts the BBC report in at least one, important factual detail, given the focus of the The Independents article, stating that both of the vaccines destined for the UK market contain an adjuvant. According the the BBC report, Celvapan from Baxter does not. So which one is correct?

So here is the thing. Who do i believe, the BBC or the Independent? My own research suggests the BBC has the right of it, but I would appreciate additional clarification.One can expect factual inaccuracies, sensationalism and bias in red tops and other populist outlets, but broadsheets should do better - And the alarmist tone adopted in The Independent does little to aid public uptake of the vaccine in the UK when it is finally released.