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A certified medical assistant holds the needles filled with HPV medication Gardasil before administering them to children at a community health center in Texas. (Matthew Busch for the Washington Post)
The Food and Drug Administration has extended HPV vaccine approval to men and women between the ages of 27 and 45 to protect more people from many types of cancer caused by the human papillomavirus.
The vaccine, called Gardasil 9, was previously approved for people aged 9 to 26 years. The vaccine is usually given in two doses spaced several months apart for people aged 9 to 14 years and in three doses for people aged 15 to 26 years. 26, the recommended regimen will be three doses.
In the United States, most sexually active people will be infected with HPV in their lifetime. In most cases, the virus is eliminated by the body's immune system, but when this does not happen, HPV infections can cause cancers of the cervix, anus, vagina, penis and throat.
The approval "represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age group," said Peter Marks, director of the Center for Biologics Evaluation and Research.
Experts say the vaccine, which protects against nine different strains of HPV, is more effective when it is administered before the onset of sexual activity. But the data also indicates that the vaccine can benefit the older group. Although many adults have been exposed to certain types of HPV, most have not been exposed to the nine types covered by the vaccine.
Merck, the manufacturer of the vaccine, has asked for the extension of the age bracket this year. In June, the FDA granted the priority review of the application.
The original version of the vaccine, called simply Gardasil, was approved by the FDA in 2006 and covers four strains of HPV; it is no longer available in the United States. Gardasil 9 was approved in 2014. Both versions are manufactured in the same way and cover four identical types of HPV.
The agency said it had based its expanded approval on data from the original Gardasil vaccine, which involved 3,200 women between 27 and 45 years old. lesions and cancers related to the types of HPV covered by the vaccine. The FDA said that the effectiveness for men had been deduced from women's data, from a small trial for men aged 27 to 45 years and from the experience of younger men.
The Advisory Committee on Immunization Practices of Centers for Disease Control and Prevention, composed of experts in medicine and public health who make recommendations on the use of vaccines, should review the slice. of enlarged age at its meeting later this month and decide on it is next year. If the CDC committee recommends that the older group receive the vaccine, insurance companies are much more likely to cover the costs.
But HPV-related cancers are also increasing. More than 43,000 people developed HPV-associated cancer in 2015, up from about 30,000 in 1999, the CDC said.
Read more:
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