The US Food and Drug Administration (FDA) should consider adding vaccines to its Ebola vaccine, according to a senior health official in the US government, as well as a former director of the CDC.
The comments came after the agency approved the first of three doses of the vaccine for use in the United States.
The first dose, given in the early hours of April 4, is designed to be administered through an IV catheter and is expected to contain the full number of doses needed to cover the epidemic.
However, some officials are concerned that the second dose, which was distributed last week, may not contain enough material to ensure full coverage.
The second dose contains a different strain of the Ebola virus and will be administered as an IV-substitute.
“We are very concerned about the lack of preparation of the second vaccine,” said Dr. James Fagan, the acting commissioner of the US Department of Health and Human Services (HHS).
“We don’t want to give people a false sense of security that this vaccine is safe.
We want people to get it.”
Fagan, who is also the chief science officer at Merck & Co., the US drug giant, said he believed the vaccine would have to be manufactured in China or another country that would be able to ensure the safety of its material.
In addition to concerns about the vaccines safety, Fagan said the agency has not yet determined whether the US should use the second or third dose of the vaccines.
“We’re waiting on those determinations to see if there’s any additional data that could help us make a decision,” he said.
“But I would imagine that if the first dose was OK and there’s a possibility of the third dose going through, we should be in the market for the third vaccine,” Fagan added.
While the vaccine could be made at a factory in China, Fagen said the US was not in a position to build the factory in the current climate.
“I think it’s too early to say that the CDC is going to build that factory, but I think that is a possibility,” he added.
“That is not an issue we can really address right now, as we are dealing with an active pandemic in this country, which is really a national security issue.”
Fagen noted that the FDA is still evaluating the effectiveness of the first and second doses of both vaccines.
The agency is also working on a vaccine that would contain the same type of Ebola protein that caused the pandemic.
Fagan described that vaccine as being more likely to contain a virus that was resistant to the first two vaccines.
“That’s what we’re working on,” he told Fox News.
“And there are other factors that we are not talking about.”
Farens comments come after the US Food &!
Co. on Wednesday said it was delaying the second and third doses of its vaccine until at least April, after the CDC had provided assurances that the vaccines would be made in China.
The first two doses of vaccines were expected to be given on April 6.
“The FDA is not making this decision lightly, but it is not in the best interest of the public,” the agency said in a statement.
“As soon as the data and the safety profile are in, we will determine if we will continue to use the third and first doses.”
Ferguson, the CDC director, said that although the second batch of vaccines would not have a higher proportion of the virus in it than the first, it would still contain enough virus to cover an Ebola outbreak.
Fagan said he had not seen any data on the second phase of the drug that was being used.
“The CDC has not been able to say for sure how much virus is in the second stage,” he noted.
“If we get a second dose of that, we may have a slightly higher proportion.
We’ll have to see.”
The third and fourth doses of either vaccine have not been scheduled for distribution.
However on Wednesday, Farens office said it planned to announce that the fourth dose would be given by April 7.
The agency did not elaborate.
“This is a difficult decision,” said Fagan.
“I’m not going to go into any detail, because we have a lot of work to do.”
The first and third vaccines were approved by the FDA on April 4.
The third was approved on April 5.
The vaccine is being developed by Merck and AstraZeneca.
The second and fourth vaccines were developed by GlaxoSmithKline and Pfizer.