The FDA’s approval of a new HIV-prevention vaccine has prompted questions about whether the agency is trying to cover up its past efforts to make condoms more widely available.
In a letter to the CDC, the FDA said it has been aware of “the concerns raised by the Office of Inspector General about the agency’s handling of the importation of vaccine materials prior to September 26, 2009.”
In the letter, the CDC’s Inspector General said “the OIG received information indicating that certain materials imported into the United States from China and other foreign countries have been adulterated or misbranded” and said “we are taking appropriate action to ensure that all imported materials are properly labeled and properly labeled vaccines are properly administered to all individuals, including those with HIV/AIDS.”
The letter, dated Sept. 24, 2009, was sent to CDC Administrator Dr. Stephen M. Anderson and Dr. William L. Frieden, director of the CDC.
It said “there is substantial evidence that vaccines and other materials imported from China, and others, have been mislabeled and have been falsely reported as containing the active ingredient in the vaccine or other vaccine material.”
Anderson responded by saying the FDA’s handling is “based on the best scientific information available at the time of importation.”
The CDC’s new vaccine, the vaccine for ZMapp, is designed to be injected into the body through the nose.
CDC officials say the vaccine has been tested on a large number of volunteers, and the agency says it has “limited evidence of adverse effects or other problems.”
However, the agency has yet to conduct a clinical trial of the vaccine, and in a letter sent to the FDA on Friday, FDA Commissioner Julie A. Feighan said the agency was “still working with the CDC on this matter.”
“There are serious questions about the adequacy of the process for ensuring that the vaccine is safe and effective,” Feighaan said in the letter.
Frieden, who is now under fire for his handling of ZMamp, has denied the accusations.
He has also said that he has a great relationship with the Chinese government and believes they would approve the vaccine if it were made available in the country.
The FDA did not respond to a request for comment.