Coverage concerns The vaccines are likely to be pricey, with estimates ranging between $150 and $500 for the three-dose vaccine; analysts are
expecting good coverage. "Cost is going to be a major factor, but you've had more expensive vaccines like Prevnar that have
shown good uptake," says Decision Resources analyst John Lebbs. "If you have the clinical justification and the public health
issue and rationale—which you do for these vaccines—there's a very good likelihood that the vaccine will be integrated into
the [CDC's Advisory Committee on Immunization Practices] immunization schedule." The ACIP is supposed to vote on this in June.
Getting onto the schedule—and obtaining that "universal vaccination" recommendation—is critical. "It means they feel the intervention
is important enough for the public health of this country that everyone should get it, and there should be funds available
for those children without insurance to get the vaccine," says Barr. "When universal vaccinations are made, uptake is quite
a bit more robust because people expend the efforts to make sure the people who need it have access."
One of the convincing arguments for coverage is one based on cost effectiveness. PAP smear screening costs between $4 and
$6 billion annually. However, much of that cost can be eliminated—GSK says 40 percent, or $2.4 billion—by using HPV vaccines
to prevent the likelihood of abnormal PAP smears in the first place.
Understanding long-term protection Both Merck and GSK have pledged to conduct large-scale studies that follow women throughout their lives to definitively assess
how the vaccines act in real-world populations. Such undertakings will take time and immense resources, but are necessary
in creating the foundation of data to ensure maximum uptake of the vaccines. Already, some physicians have voiced their wish
for this data. "If we vaccinate 12-year-old girls, will it still offer protection at age 25?" asks Myers. "A lot of follow-up,
at least from Merck, is going to be in Denmark, Norway, and Iceland, which have electronic records that can link people and
allow them to study how long the protection from the vaccine lasts, and if a booster is needed."
THE IMPACT FACTOR
Cervical cancer tends to strike women in their later years because it is so slow growing. And given that Merck and GSK plan
to target the 9-15 year-olds, the benefits of vaccination won't be seen for some time. But the industry will see their impact
in other areas.
First, Gardasil and Ceravix both rely on, and thus have validated, the use of "virus-like particle" technology, which stimulate
immunity to the viruses by mimicking only the surface proteins of the viruses, but don't contain any genetic information.
Some say the technology will be applicable for other viral infections with relatively small, simple viruses.
The use of adjuvants is also validated. Says Dubin, "Adjuvant technologies can make a difference. One example, beyond HPV,
is a malaria vaccine in development where we have convincing evidence that the reason it appears to be effective is due to
the adjuvant being used."
Still others view the introduction of these cancer vaccines in a much broader context, such as helping spark renewed interest
in vaccines to treat viral infection or helping lay down needed physician and educational infrastructure that might one day
be needed for an AIDS vaccine.
It is for this last point that Barr and Dubin envision more busy nights. "The greatest burden of disease lies in countries
with undeveloped medical structures," says Dubin. "The more 'developing' the country, the more cases of cervical cancer. We
have been gearing up for this. It requires a huge amount of manufacturing capacity—not to mention working with governments
and NGOs, and dealing with the political environment in different countries. These are implementation issues, and where a
majority of the challenges for us now lies."
OUT IN FRONT
As per FDA regulations, drug companies must wait until launch to market a product. And PhRMA guidelines advise waiting at
least six months after launch to market to consumers. But Digene, a diagnostics company which has had an HPV test on the market
since 1999, has already rolled out a glossy consumer advertising campaign to educate women about HPV. "You want to first educate
physicians," says Digene's Pamela Rasmussen. "We have a huge amount of data, we're in all the guidelines, we had the thoughtleaders,
yet some doctors told us they weren't going to change their habit [and use the HPV test] unless women were asking for it."
Rasmussen also said that doctors, surprisingly, were forgoing the test because they didn't feel comfortable educating patients
about HPV from scratch. "The DTC ads do a little bit of that job already for the doctors, so women are already aware when
they go into the office." It also makes vaccine manufacturers' marketing efforts easier, in that a baseline of knowledge among
the public is currently being established.