The two companies that make vaccines against cervical cancer announced Thursday that they would cut their prices to the world's poorest countries below $5 per dose, eventually making it possible for millions of girls to be protected against a major cancer killer.
Thanks to Pap tests, fatal cervical cancers are almost unknown today in rich countries. But the disease kills an estimated 275,000 women a year in poor countries where Pap tests are impractical and the vaccine is far too expensive for the average woman to afford, so the price cut could lead to a significant advance in women's health.
The World Health Organization, which has been pressing for faster progress in maternal health, greeted the news as "a great step forward for women and girls."
When the new price was described, Dr. Paul Blumenthal, a professor of gynecology at the Stanford University School of Medicine who has pioneered cervical cancer prevention techniques in poor countries, said, "Mazel tov! " As long as there is enough affordable vaccine for the ever-growing populations of poor countries, he said, "this is good news for girls, women and their families."
The lower prices $4.50 for Merck's Gardasil vaccine and $4.60 for GlaxoSmithKline's Cervarix were negotiated through the GAVI Alliance, which was created in 1999 with a grant from the Bill and Melinda Gates Foundation to deliver more vaccines to the world's poor.
The low price will initially apply to a few million doses for demonstration projects in Kenya, Ghana, Laos, Madagascar and elsewhere, but Dr. Seth Berkley, the alliance's chief executive officer, said he hoped that by 2020, 30 million girls in 40 countries would get the vaccine at that price or less.
The vaccines must be kept refrigerated, and the three doses are normally given over six months requirements that add to the difficulty of deploying them in poor countries.
The vaccines cost about $130 a dose in the United States, and each girl needs three doses. The lowest price that any other agency or government has negotiated, Berkley said, is the $13 paid by the Pan American Health Organization, which negotiates a bulk price for Latin American countries.
Since Latin America includes both poor and middle-income countries, the manufacturers do not offer rock-bottom prices there, he said. The alliance subsidizes vaccine costs for the poorest countries in Africa, Asia and elsewhere, with the subsidies shrinking as the countries get richer.
The vaccines protect against the strains of human papillomavirus, or HPV, that cause 70 percent of cervical cancers. The Merck one also prevents genital warts, which are caused by related viral strains.
Gardasil and Cervarix, given to girls as young as 9, have caused controversy in the United States, where many parents fear side effects and worry that girls will see the vaccines as condoning sex at a young age. The vast majority of girls in the United States have not been inoculated.
In Australia, where the vaccines have been readily accepted, a recent study found a striking drop in cervical abnormalities, which are cancer precursors, among young women. In the five years after the vaccine was introduced there, cases of warts dropped by 93 percent among women and girls under age 21.
Despite the excitement among global health agencies, the charity Doctors Without Borders called the news "disappointing," arguing that the prices should be even lower.
"Why are the pharmaceutical companies still making profits off the backs of the poorest countries?" asked Kate Elder, a vaccines policy specialist at the charity.
HPV vaccines were developed with taxpayer money, largely from the National Institutes of Health, she said, and Glaxo and Merck have already reaped billions in profits from theirs.
Measles vaccines, invented 50 years ago, cost as little as 25 cents to produce, and Elder said she believed HPV vaccines could be made for as little as $1 a dose.
She acknowledged, however, that her only evidence of that was an unofficial estimate by Pan American Health Organization experts.
A spokeswoman for the organization declined to discuss its assessment of manufacturing costs because its price negotiations are continuing.
Dr. Julie Gerberding, a former director of the Centers for Disease Control and Prevention who is president of Merck's vaccine division, said $4.50 was Merck's manufacturing cost, with no previous research, marketing or other costs built in.
"The price is what we calculate to be our cost of goods we could be off by a few cents but not more," she said. "As we expand volumes, the cost per unit can go down. Our intent is to sell it to GAVI at a price that does not bring profit to Merck."
Glaxo declined Wednesday to disclose its manufacturing costs, but noted that it had always been in first place on the Access to Medicines index, which was introduced in 2008 as a measure of how well pharmaceutical companies get their goods to the poor. A company representative said it would not make a profit on the vaccine at the new price.
Dr. Peter Hotez, president of the Sabin Vaccine Institute, said the vaccine should cost more to make than, for example, measles vaccine because it contains "viruslike particles" made through recombinant DNA technology rather than a virus simply grown in cells and then killed. Also, it protects against several HPV strains, while there is only one measles strain.