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The HPV vaccine, which prevents cancer of the cervix and other malignancies, is now approved for men and women between the ages of 27 and 45, the Food and Drug Administration said Friday.
The vaccine is Gardasil 9, manufactured by Merck, which had already been approved for minors and people under 26 years old.
It works against the human papillomavirus, HPV, which can also cause genital warts and cancers of the vulva, anus, penis and certain parts of the throat. The virus has a lot of strains. It is sexually transmitted and most adults encounter at least one strain at some point in their lives. The vaccine protects against nine strains, including those that are most likely to cause cancer and genital warts.
"Today's approval represents an important opportunity to contribute to the prevention of HPV-related diseases and cancers in a broader age group," said Dr. Peter Marks, Director of the Center for Evaluation. and biology research at FDA, in a statement.
The approval is based on a study in women aged 27 to 45 years, showing that an earlier version of the vaccine was very effective in preventing persistent HPV infection, genital warts, vulvar and vaginal precancer, cervical precancers and cervical cancers related to the types of viruses covered. by the vaccine.
The efficacy of the vaccine in men aged 27 to 45 is inferred from the data for women, its efficacy in younger men, and the evidence that it created immunity in a study of men between 27 and 45 years old.
The most common side effects of the vaccine include injection site pain, swelling, redness, and headache.
If a person has previously been exposed to a particular strain of HPV, the vaccine will not work against that strain. For this reason, vaccination has been highly recommended to young people before they become sexually active.
But even someone who has already been exposed to a few strains – but not to the nine people in the vaccine – can still get protection against strains she has not encountered.
"It's great," said Dr. Lois M. Ramondetta, an instructor of gynecologic oncology at the MD Anderson Cancer Center in Houston. "It's a preventative vaccine. The best time to get it is before you are 13 years old and having an intimate activity. That said, it protects against nine types of HPV. Therefore, if you have one, you can still be protected against other types of HPV. "
She added, "There is a whole generation of people who went missing without knowing it. Doctors were not good at talking about it. "
She and Dr. William Schaffner, an infectious disease specialist at Vanderbilt University, said people over the age of 26 had started asking the doctor for information about the vaccine. Some left weddings or monogamous relationships, hoped to start dating and realized that they might be exposed to the virus.
"They want to feel protected to a certain extent," said Dr. Ramondetta. "Now, they have the opportunity."
The youngest need two injections, but the older ones will have three, spaced a few months apart.
Dr. Ramondetta noted that tumors affecting part of the throat – called oropharyngeal cancers – caused by HPV were increasing, especially in men. The vaccine is thought to help prevent them.
Dr. Schaffner said that a group of experts who advise disease control and prevention centers has already discussed data on the use of vaccine in the elderly and should make a recommendation on this subject. The recommendation may be universal, which means that anyone in this age group should receive it, or it may be permissive, which means that the decision belongs to the physician and the patient.
Once this group, the Advisory Committee on Immunization Practices, recommends a vaccine, insurers usually cover it.
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