By Christopher Cousins The Journal of Infectious Diseases September 13, 2019 05:15:10Health officials are warning that there is a risk of serious side effects when people receive a Gardasil vaccine, the latest step in the process to start distributing the vaccine in the United States.
The Advisory Committee on Immunization Practices, a federal panel that advises the Food and Drug Administration on vaccine safety, released its recommendations Friday.
The recommendations do not apply to the vaccine that was approved in Europe and Japan, and is currently being tested in a number of countries.
But they could have implications for people who get the vaccine from an unlicensed source in the U.S., including those who are married to a woman who has HPV and live in areas where the virus has been found in at least one person.
In a statement, the committee’s chair, Dr. John S. Miller, a professor of medicine at Johns Hopkins University, said the recommendations are designed to provide guidance to healthcare providers and parents to protect the public and minimize vaccine-related side effects.
“While we cannot say for certain that vaccines will prevent all infections, we can predict that they are unlikely to be the cause of serious adverse effects,” Miller said.
The committee, which is led by FDA commissioner Dr. Julie Smith, said it believes Gardasils are safe and that most people who receive them should be protected from any potential side effects from the vaccine.
The recommendation from the advisory panel came after a review of nearly 1,000 vaccine-preventable infections that the Centers for Disease Control and Prevention reported in 2017.
It also came after more than 300 studies and other data from more than 100 studies showed that Gardasls did not cause any serious side-effects, including a reduction in the risk of cervical cancer or other cancers, the study said.
Researchers also reported that Gardus was safe in studies of healthy people and people with weakened immune systems, which might help explain why some vaccinated individuals reported feeling better.
But Miller said the committee believes there are other potential side-effect risks.
He noted that the committee did not address the risk that Gardaix could be a more effective vaccine than the one that is being tested at this time.
“In other words, it’s possible that there are a few people who may be less susceptible to GardasIL and may respond more favorably to Garda, and GardasILS effectiveness could increase with the introduction of a new vaccine,” Miller wrote.
In addition, the vaccine is now being tested on humans who have a weakened immune system and have not been vaccinated before, and the committee noted that other studies have found the vaccine to be safe for people with weak immune systems.
In another sign that the panel is recommending caution, Miller said in the statement that Gardavac is a more efficient vaccine than Gardasllis.
The new vaccine is less effective at preventing infection than the old one, but it’s still effective, he wrote.
The committee noted it has not yet evaluated whether the new vaccine will be as effective in preventing infection as the old vaccine.
It also said the safety of Gardasillin was “robust,” with no serious side reactions reported.
The vaccine was approved for use in the USA in January 2018, and in Europe in March 2018.
“Given the recent reports of adverse events related to Gardavax in Europe, the FDA should review this recommendation to determine if it is appropriate to include Gardasillil in Gardasix for the United State,” the committee said.
Miller did not specify how the recommendation would affect Gardasild, the Gardasylactive, the generic version of the vaccine made by Pfizer.
The company said in a statement that it was reviewing the advisory committee’s recommendation and will consider it.
“As we work with the Advisory Committee, we remain focused on making sure that the vaccine will provide patients and the world with the safest and most effective vaccine available,” Pfizer spokesman Patrick Bresch said.
A Pfizer spokeswoman declined to comment further on the committee recommendation.
In Europe, Pfizer is in talks with the European Medicines Agency to develop a generic version that would be easier to obtain, and that could be used to distribute Gardaslax in the EU.