Don't Rush Your Vaccines

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Published online 17 May 2007 | Nature | doi:10.1038/news070514-15

Column

Don't rush your vaccines

The ethical debate about a vaccine for a sexually transmitted disease

has been premature, says Apoorva Mandavilli; we don't even know howell it works.

Apoorva Mandavilli

Here's a good lesson: before you start pushing for a controversial vaccine to be made compulsory

best wait for the research and I mean all the research to come up with results.

For more than a year, we've been hearing that there is a vaccine that is 100% safe and effective in

protecting young girls and women from the deadly viruses that cause cervical cancer.

Merck's Gardasil, a vaccine against human papilloma virus (HPV), has been hailed as perhaps the

biggest boon for women since the contraceptive pill. Across the world, including many American

states, politicians and activists have proposed laws to make Gardasil mandatory for girls in their

early teens or younger. Australia has already started a national programme of free vaccines for

young girls.

All that sounds a bit premature and rightly so. As we find out more about this vaccine, includin

new studies in last week'sNew England Journal of Medicine1,2, it's clear we simply don't know

enough about it to be giving it to young girls en masse.

It's not that I think vaccinating young girls will encourage them to become promiscuous, as some

conservative groups have argued. And I'm not going to question Merck's motives in pushing this

vaccine because, well, what else do we expect pharmaceutical companies to do with their product

I'm also not contesting that the vaccine is great at what it sets out to do: in trials, it was nearly

100% effective at preventing infection with the two strains of HPV (16 and 18), which cause abou70% of cervical cancers. It also seems to protect from two other strains that cause genital warts.

But that's not all we need to know.

Good for the young?

For example, because the initial trials tested the vaccine in women aged 16-26 over five years, we
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don't know for sure that the vaccine is effective in girls younger than 16, nor whether its effect

and safety will last longer than five years (see 'Controversy over cervical cancer vaccine

spurs safety surveillance ').

Another important piece of fine print: the vaccine is most effective before women are sexually

active.

When scientists tested the vaccine in more than 18,000 women in two further trials, most of

whom were already sexually active, the vaccine's effectiveness fell to less than 20% a modest

protection at best1,2.

That's at least partly because some of those women were already infected with the virus strains

that the vaccine is designed against. It might also be because the vaccine, by blocking four strains

allows other strains to flourish which could negate the vaccine's benefit.

When we don't know the answers to so many questions, why are we in such a rush to make the

jabs mandatory?

Good for the rich

Let's leave aside for the moment that only a fraction of cervical cancer cases in the world occur in

countries where the debate is ongoing (that is developed nations), thanks in part to Pap smears,

which can detect pre-cancerous conditions before they develop into full-blown cervical cancer.

More than 80% of cervical cancer cases expected to increase to 90% by 2020 are in

developing countries, which can't afford the pricey jab or the pap smear.

At the moment, the vaccine costs US$360 for the three required doses. Having governments

provide the vaccine for free to millions of women and girls would add up to an enormous amount

That money might be better spent providing Pap smears to the women who can't afford them or a

least diverted to more urgent health needs.

In the meantime, I do think the vaccine should be

given but with caution and perhaps only in girls and

women who we know are not yet infected with two

deadliest strains. Merck and GlaxoSmithKline, whichalso has a HPV vaccine in the works, are working on

adding more of 20 known strains to their vaccines.

Merck is also tracking Gardasil's long-term effects in

the 40,000 women who have received it.

To be fair, the latest studies have only tracked three
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years of data, and after a longer follow up the vaccine

might well prove to be worth all the hype. Then again,

it might not. But until we have enough information to

decide, let's admit we just don't know.

Visit our rushyour_vaccines.html">newsblog to read and post comments about this

story.

References

1. The FUTURE II Study Group.N. Engl. J. Med., 356 . 1915 - 1927 (2007).

2. The FUTURE II Study Group.N. Engl. J. Med., 356 . 1928 - 1943 (2007).

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Don't Rush Your Vaccines