Kaiser’s first trial of a drug that protects against HIV in HIV-positive people has been delayed after the company’s lawyers argued the drug was “not an effective treatment for the condition.”
Kaiser says the delay is in response to a complaint from the National HIV Vaccine Advisory Committee (NIVAC) filed in federal court, which claimed the trial of an HIV vaccine in the United States would be unethical.
The NIVAC argues that the trial will cost the government $100 million and that there will be no way to determine whether the vaccine is safe and effective.
The drug is now in clinical trials in Canada, Germany, Japan, Spain, South Africa, and the United Kingdom.
The company says it has already spent more than $10 billion to develop HIV drugs.
The vaccine, called LPS2, is designed to block the virus’ ability to replicate.
It was tested in a trial in Canada in 2014 and was found to be 98 percent effective.
Kaiser’s CEO, Dr. Michael Schoenfeld, was in a meeting with NIVACA on Tuesday when he said that it was important for Kaiser to make a decision that “reflects the strong public interest in ensuring that the vaccine we’re developing is not only safe, but also effective and that we have an informed and transparent discussion with stakeholders.”
The drug has been approved in the U.S. and other countries, and Kaiser says it expects to start selling it in Europe later this year.
The US government has said that the drug should be available within five years.
In Europe, where HIV-AIDS is relatively rare, the drug has had a tougher time getting through the approval process.
The FDA has said it has been studying LPS1, which has been used in Europe since 2014.
The agency has said the new vaccine will be 100 percent effective against the virus.
Schoenfeld said the company has made some progress, and has already begun to distribute LPS vaccine to people in other parts of the world, including the U, UK, and Japan.
But the company also needs to address concerns from its European customers.
“I think the first step is to be patient,” Schoenfeld said.
“We know that there’s a lot of work that needs to be done to get the vaccine out there and we’re confident that the FDA will do that.”