Thumbs Up for Cervical Cancer Vaccine
FDA Advisory Panel Recommends Approval of Vaccine Called Gardasil
WebMD News Archive
FDA scientists said their analysis showed that vaccination of unscreened
women in doctors’ offices would likely cut the rate of precancerous lesions by
40%, since many are likely to already carry infections with one or more HPV
While praising its potential, several experts expressed concern that
overconfidence in the vaccine could undo years of progress in promoting cervical
cancer screening in women using Pap tests. The tests are the only
reliable way to detect the presence of abnormal cervical cells that may be
cancerous or precancerous.
Eliav Barr, MD, Merck’s senior director for vaccines and biologics, pledged
that the company would not promote Gardasil as an alternative to Pap testing.
“This vaccine is not a replacement for cervical cancer screening, and I
think that that’s clear,” Barr said.
Experts also urged Merck and the FDA to conduct longer-term studies on
Gardasil, because researchers still don’t know how long immunity will last.
“There are going to be questions of what lays down the line in the way of
boosting requirements,” said Pamela McInnes, director of the Center for
Integrative Biology and Infectious Diseases at the National Institutes of
Health and a member of the FDA panel.
Barr said that the company planned to track thousands of Norwegian women who
received the vaccine.
Merck is seeking to market the drug for HPV prevention in girls as young as
9 years old. The Advisory Committee on Immunization Practices, which advises
the federal government on vaccination policies, is set to meet next month. The
panel will likely consider whether HPV vaccine should be added to list of
recommended and required childhood immunizations, Barr said.
News of the vaccine’s development has also prompted conservative Christian
groups to question its potential to undermine abstinence messages by making sex
Peter S. Sprigg, vice president of the Family Research Council, called the
potential marketing of Gardasil a “positive development.”
“But we would be concerned if this were administered with a message that,
‘Hey, it’s now save for you to have sex,’” he tells WebMD.