British health authorities today announced that starting next fall, all 12- and 13-year-old girls will have to get the controversial shots to prevent the sexually transmitted virus that can lead to cervical cancer.
Merck and Sanofi-Aventis are partners on the vaccine Gardasil and the UK-based GlaxoSmithKline makes a similar one Cervarix.
Can you imagine the firestorm stateside if the U.S. federal government ever handed down a similar edict?
GSK is waiting for the Food and Drug Administration to approve Cervarix. The agency okayed Gardasil last year and despite all of the socio-political controversy over the vaccine it has become an overnight sensation. Merck reported earlier this week that in the first nine months of this year it has sold $1.1 billion worth of Gardasil, more than $400 million worth in the third quarter. It is a major driver of the company's rebound from Vioxx.
GSK only recently won European approval of Cervarix, so it's just beginning to sell it there, including the UK. Reuters is quoting a British Department of Health vaccine official as saying the agency hasn't yet decided whether the government will buy Gardasil or Cervarix, but he indicated it's unlikely it'll go with both of them. Let the marketing battle begin, but you have to think Glaxo will have the inside track being the home team and all.
The UK Secretary of Health says, "Prevention is always better than cure and this vaccine will prevent many women from catching the human papillomavirus (HPV) in the first place, potentially saving 400 lives a year." Health officials at the state level have been arguing that here, but they've encountered a significant amount of pushback from politicians and parents who say the decision whether to vaccinate should be left up to them and not mandated by any government or school district.
Some parents also claim they're fearful of finding out years from now about potential long-term side effects from the shots. The three injections, which are given over a six-month period aren't cheap--around $300-$400.
Earlier this week I interviewed GSK CEO JP Garnier (video below) following the release of his company's earnings and I asked him how Glaxo will compete with Merck, which has gotten a tremendous head start, if or when it wins FDA approval of Cervarix. "It's not a question of eating into Merck's business. Merck has done a very good job," he said. "But frankly, there's only nine percent of the target audience that has been vaccinated. There is a huge opportunity out there…huge…that we have never seen with any vaccine ever before and there will be plenty of opportunity with Merck and with us. The most important thing to understand is that there is a mass opportunity in front of us and both companies will do well in the future," Garnier told me.
The FDA is expected to make a decision on Cervarix by around the end of next January.