HPV: Britain switches to new product for vaccination

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    Britain is to stop using GlaxoSmithKline’s cervical cancer vaccine Cervarix from next September and will instead offer girls Merck & Co’s rival product Gardasil.

    The move underscores Gardasil’s lead in a $1 billion-plus worldwide market for vaccines that protect against the sexually transmitted human papillomavirus (HPV), which can cause cervical cancer.

    The health ministry said on Thursday the decision followed a competitive tendering exercise. GSK, however, said it had opted not to bid in the process because the government had made clear it wanted a vaccine offering broader protection.

    While both shots are effective, Gardasil targets four strains of HPV — two responsible for cervical cancer and two causing the less serious condition of genital warts — while Glaxo’s product addresses only the two cancer strains.

    Following a review of the various conditions caused by HPV, British health authorities placed additional emphasis on genital warts in the 2011 tender, effectively knocking Cervarix out of the competition.

    David Salisbury, the government’s director of immunisation, said experts had weighed up both the cost and clinical benefits before deciding to switch to Gardasil.

    “We have reflected the changes in scientific knowledge that has become available since last time,” he told reporters.

    “They are not huge changes — we still prioritise the prevention of cancer — but based on all these things the winner is Gardasil.”

    Gardasil protects against the two strains of HPV virus that cause more than 70 percent of cervical cancer and two types that cause 90 percent of genital warts.

    GIRLS AGED 12-13

    Under the British programme, HPV vaccination is offered routinely to girls aged 12 to 13 years, with a catch-up programme for those up to 18.

    Cervarix, from British-based GSK, has been the vaccine of choice since the programme it was started in 2008 — but a number of critics said at the time that the decision was based on cost and Gardasil should have been chosen from the start.

    Tony Falconer, president of the Royal College of Obstetricians and Gynaecologists said he was delighted about the decision to switch to the quadrivalent vaccine.

    “Not only will it provide immunity against cervical cancer caused by HPV, it will also protect against the strains of HPV that cause genital warts, which are unpleasant and the cause of much psychological distress for sufferers,” he said in a statement.

    Gardasil is sold in Europe by Sanofi Pasteur MSD, a joint venture between U.S.-based Merck and French drugmaker Sanofi . A spokesman for Sanofi Pasteur MSD declined to comment on the price it was charging the British government.

    Globally, Gardasil outsells Cervarix, with revenues of $988 million last year and sales expected to reach $1.25 billion by 2015, according to Thomson Reuters Pharma data. Cervarix sales last year were 242 million pounds ($375 million) and are forecast to reach $848 million in 2015.

    GSK said at least 5 million doses of Cervarix had been administered in Britain up to July 2011 and the company remained committed to making the vaccine available around the world.

    Significant new demand for HPV vaccines could soon open up in the poor nations, following a decision last week by the GAVI international immunisations group to fund their roll-out in developing countries — provided it can reach a deal on pricing with the manufacturers.

    The group has agreed to fund the roll-out of vaccines against cervical cancer in developing countries, offering protection against a disease that kills one woman every two minutes.

    Nearly 90 percent of the 275,000 deaths every year occur in poor nations,
    where cervical screening programs that are routine in rich nations are virtually
    non-existent.

    The Global Alliance for Vaccines and Immunisation said up to two million girls in nine developing countries could be protected from cervical cancer by 2015 under the program, which still depends on negotiating a final price deal with manufacturers.

    Nina Schwalbe, its managing director for policy and performance, said
    discussions were ongoing with the makers of the world’s two approved HPV
    vaccines, Merck & Co Inc and GlaxoSmithKline Plc .

    Human papillomavirus, or HPV, is a sexually transmitted virus that causes most cases of cervical cancer.

    Adolescent girls are commonly vaccinated against HPV in Europe and the United States but the greatest need for the vaccine is actually in the developing world, where the burden of disease is far higher.

    “For women in developing countries this is the only option,” Schwalbe said in a telephone interview from Dhaka, where a GAVI board meeting gave the green light to the initiative.

    “The introduction of an HPV vaccine is a major public health breakthrough — but to date this vaccine has only been available for women who live in developed countries.”

    For GAVI, which was set up a decade ago with backing from governments and Microsoft Corp co-founder Bill Gates, the decision to endorse HPV vaccination marks a step change, since until now it has been focused on vaccinating infants.

    Merck’s Gardasil and GSK’s Cervarix are designed for use in girls aged between 10 and 13 years.

    The first developing countries could be up and running with vaccination programs from 2013, with Rwanda and Vietnam — both of which have conducted pilot vaccination programs — likely to be among the first.

    U.S. drugmaker Merck said earlier this year it would offer GAVI its Gardasil shot at a deeply discounted price of $5 per dose, implying a cost of $15 for a three-dose course. Schwalbe described this as “a good starting offer.”

    Mark Feinberg, a senior Merck vaccines executive, on Thursday said Merck is holding for now to those prices, which afford no profit to the drugmaker. But he said the price could come down if the vaccination programs generate considerable demand for Gardasil, and thereby create economies of scale in manufacturing the product.

    “Our goal is to make the vaccine as affordable as possible and bringing the price down as low as possible,” he said.

    Britain’s GSK has not made a public price offer but Jean Stephenne, head of the group’s vaccines business, said he looked forward to discussing how to
    provide Cervarix in a sustainable way to GAVI.

    GAVI’s move to close inequalities in access to HPV vaccination was welcomed by UN Secretary-General Ban Ki-moon, who also praised a separate plan by the Geneva-based group to open a funding window for vaccines against the rubella virus, which can lead to birth defects and miscarriages.

    MALARIA NEXT?

    The go-ahead for the HPV and rubella projects follows a successful meeting in
    London in June, when international donors pledged $4.3 billion to help the group
    with its work.

    GAVI says it has prevented more than 5.5 million child deaths in the last decade by bulk-buying vaccines against diseases such as pneumococcal pneumonia,
    Haemophilus influenzae type b, or Hib disease, diphtheria, pertussis or whooping cough, tetanus, measles and rotavirus.

    With the move into HPV it will be buying a more complex and expensive vaccine than those used in existing programs, paving the way for other similarly price-sensitive decisions in future.

    In a few years, GAVI will have to decide whether to buy the world’s first malaria vaccine, also developed by GSK and designed exclusively for use in the developing world.

    The vaccine, known as RTS,S or Mosquirix, halved the risk of five- to 17-month-olds getting the mosquito-borne disease in a recent clinical trial but
    the shot is no panacea, since it is less effective than vaccines against common infections such as polio and measles.

    Schwalbe said the RTS,S results to date were very encouraging but GAVI was waiting to see the outcome of using the vaccine in babies aged six to 12 weeks, expected in a year’s time, before taking any decisions. If all goes well, GSK believes the vaccine could reach the market in 2015.