An expert group that provides guidance on U.S. vaccine policy on Wednesday recommended that decisions on the use of two vaccines — one against bacteria that cause pneumonia and one against human papillomavirus — be left to patients and their doctors, stopping short of blanket recommendations from the panel itself.
The decisions by the Advisory Committee on Immunization Practices came as a disappointment to the vaccine manufacturers. But they also keep both products on the official vaccine schedule and covered by health insurance.
The vaccines in question are Pfizer’s Prevnar 13, which protects against pneumococcal disease, and Merck’s Gardasil, which protects against human papillomavirus. In both cases, the recommendations related to the use of these vaccines in adults; the votes do not affect the recommendations for their use in children and teens.
ACIP, as the committee is known, had previously recommended that all adults over the age of 65 receive a dose of Prevnar 13. That recommendation was adopted in 2014.
But at the time the committee agreed that it might need to revisit the advice because of the effect the vaccine was having in children, who also receive it. In short, older adults were benefiting from the use of the vaccine in small children. With fewer kids sick with pneumococcus, fewer cases in older adults were being seen as well.
Several of the committee members who voted against continuing to recommend Prevnar 13 for all adults 65 and older pointed to what Dr. Peter Szilagyi, vice-chair for pediatric research at the University of California, Los Angeles, described as “the remarkable success of the pediatric program.”
The vote was close, however, with eight members voting to remove the recommendation and six voting to continue it. In a 13-1 vote that followed, the committee recommended what’s known as a “shared clinical decision making” — in effect leaving it up to doctors and their patients aged 65 and older to decide whether they should get a single dose of Prevnar 13.
In a press release, Pfizer (PFE) acknowledged the decision, and said it will continue to develop its pneumococcal vaccine pipeline.
“Direct vaccination remains the best available tool to help prevent against pneumococcal disease and the revised recommendation emphasizes the importance of the health care professional and patient relationship in shared decision regarding vaccination,” said Luis Jodar, chief medical and scientific affairs officer for Pfizer Vaccines.
The committee also took two votes on Gardasil, the HPV vaccine. The first turned previous — and differing — recommendations for men and women on who qualify for catch-up vaccination into a single policy. With Wednesday’s unanimous vote, catch-up vaccination with the HPV vaccine is recommended for young women and men up to the age of 26 who have not previously received three doses of the vaccine.
Although the Food and Drug Administration recently extended the age indication for the vaccine to allow people aged 27 to 45 to be vaccinated, ACIP did not recommend all people in that age group get the three-dose vaccine. Instead, the committee voted to leave the choice to patients and their doctors.
The HPV vaccine protects against viruses that cause cervical, anal, and other cancers. The primary recommendation for its use is in young people before they become sexually active; the viruses are transmitted sexually.
ACIP recommends that the vaccine be given between the ages of 11 and 12 (though it can be started as early as 9 years old) in both girls and boys. Catch-up vaccination programs were recommended for young women up to the age of 26 who were not vaccinated earlier. The catch-up program for young men was to the age of 21; the vaccine was also recommended for males between the ages of 21 and 26 who have sex with men and those who are immunocompromised.
On the issue of whether to recommend catch-up vaccination for people aged 27 to 45, the committee voted 10-to-4 to leave that decision to patients and their doctors. There would be some people in that age group that would benefit from getting vaccinated, a number of the members noted. A working group that advised the committee noted that recommending vaccination of all adults 27 to 45 would not be a reasonable use of resources.
Several members of the committee also questioned expanding the recommendation to such a large population demographic at a time when there is a global shortage of the vaccine that is slowing its roll out in low and middle income countries which could benefit from its use in young women.
Correction: An earlier version of this story misstated the nature of the vote that panel took on catch-up HPV vaccination for those aged 27 to 45.