When the Food and Drug Administration assessed the safety risks and benefits of a vaccine for a skin condition, it concluded that it was uncertain that the risks outweigh the benefits.
The decision is an apparent departure from a precedent set in 2015, when the FDA ruled that a vaccine that prevents infection by a particular strain of the human papillomavirus was safe for girls ages 10 to 17.
But it is in line with a similar conclusion about a version of the HPV vaccine that is recommended for children ages 5 to 11. The FDA has warned that this version of the vaccine may sometimes trigger immune response that causes the immune system to produce allergic responses, and it is urging health providers to closely monitor children’s development.
The FDA said in a statement that its decision on whether to approve the Cervarix vaccine in girls ages 11 and 12 “is based solely on the safety and effectiveness of the vaccine for its intended uses.”
The agency said that the vaccine could be considered for use in children ages 15 to 18 because its safety risks and benefits have become clearer.
In addition to a recommended prophylactic measure against a disease such as HPV, the HPV vaccine blocks development of different cancer-causing strains, sometimes effective when they have not yet occurred in people.