In my recent Diary: Kicking Ebola :: A new serum ready-to-go AND two new vaccines in January. I discuss two new vaccines currently in human trials that are scheduled to show up in Africa in January.
Although these are not the type of trials and testing that would get FDA approvals -- they are meant to demonstrate safety (no adverse effects). For ethical reasons, there will be no placebos or control groups in the initial trials. Researchers really can't show efficacy until the human subjects are exposed to the Ebola virus.
But, it looks like that moment has arrived.
In September, the Ebola vaccine developed by the National Institute of Health (NIH) was tested in Mali, where Ebola had not yet occurred. In theory, the idea was to give it to Mali health care workers, first.
And today, Mali has reported its first serious cross-border Ebola case -- a two-year-old girl. Mali has become the sixth West African country with an Ebola infection. The current cases are contained in just three countries: Liberia, Sierra Leone, and Guinea, where infections are still rising exponentially.
bevenro has a Diary on the Mali case here: Ebola: Excellent reporting from the Mali-Guinea border
Health authorities in Mali are monitoring 43 people known to have been in contact with the Ebola-infected 2-year-old girl. The child was brought to Mali by her grandmother to to be given to relatives in the Mali town of Kayes after the child’s mother died of Ebola in Guinea.
Ten Mali health workers who treated the child are among the 43 being observed.
“As soon as the case was confirmed, local authorities began tracing everyone who had contact with the little girl and her grandmother,” said WHO spokeswoman Fadela Chaib at a Geneva news conference Friday.The child died on Friday.“She saw a healthcare worker on Oct. 20 when she had a fever of 39 degrees Celsius [102 degrees Fahrenheit], blood in her stools, was coughing and had a nosebleed,” Chaib said. “They tested for malaria or typhoid and she was admitted to hospital on Oct. 21.”
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Aside from the two promising vaccines I discussed in my earlier Diary, I also mentioned one new antiviral from China that can be used to treat the disease in its early stages by blocking viral replication until the body develops its own antibodies. Antivirals have been used in all the Ebola cases treated in the US. Although not approved yet, China has sent 10,000 doses of its new Ebola antiviral to Africa for consideration.
Now, Japan has also announced a new antiviral medication targeted to Ebola.
Fujifilm Holdings Corp. said Monday it is preparing to manufacture up to 300,000 new courses of treatment of its anti-influenza drug, Avigan for use in people with Ebola virus disease. The company already has provided the flu drug to several infected Ebola patients in Europe, in response to emergency requests from governments and medical groups. Fujifilm said some research papers report that Avigan was efficacious against Ebola virus in mice.::
One announcement for an Ebola diagnostic device has me particularly intrigued:
France's Atomic Energy Commission has developed a test that could allow doctors to diagnose a patient with Ebola in 15 minutes, compared with almost 3 hours presently, Radio France Internationale (RFI) reported yesterday.This could be a real game changer in controlling the disease. Not unlike a pee-strip pregnancy test, it could be used at airports and borders, and also included in home health kits that WHO is creating to distribute to citizens of the affected Africa nations.The test is expected to be available for clinical trials in Ebola outbreak countries by the end of October. It uses monoclonal antibodies to detect the virus in a small sample of blood, plasma, or urine. Results show up in the window of a handheld device, similar to an over-the-counter pregnancy test. RFI said two other companies are also working on rapid diagnostic tests for Ebola: Primerdesign, based in Britain, and Corgenix Medical Corp. in the United States.
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Don't like needles? In another new development, a South San Francisco pharmaceutical company, Vaxart, has announced the first Oral Vaccine for Ebola. The tablet is expected to be available for human trials at the first of the year, although extensive trials are being attenuated during this epidemic, if the risk seems reasonably low.
Vaxart's vaccine contains a disabled adenovirus that delivers an Ebola virus gene and a gene for a molecule that serves as an adjuvant. The vaccine showed promise in preclinical challenge studies in nonhuman primates conducted at the US Army Medical Research Institute of Infectious Diseases (USAMRIID).::The company said the tablet vaccine can be held at room temperature for more than a year, reducing or eliminating the need for cold storage, an advantage for settings like West Africa that have limited infrastructure.
One of the more exotic approaches comes from a secretive high security lab. Tekmira Pharmaceuticals often works with the Department of Defense -- no doubt in biological warfare, given the hedging and discretion surrounding its operations. Their approach to Ebola is novel. They have developed a drug that genetically alters the Ebola virus RNA inside the patient's body. It turns off the Ebola viral gene that causes the disease in humans. It is designed to work with only one strain of Ebola -- the Guinea strain that is the basis of the current epidemic.
Tekmira Commences Manufacture of New RNAi Therapeutic for Ebola - Guinea VariantIt's a tad above my pay scale, but I'm certain that there are plenty of folks here who grasp it.Tekmira Pharmaceuticals Corporation (TKMR) (TKM.TO), a leading developer of RNA interference (RNAi) therapeutics, provides an update on its Ebola program. The Company is reporting it has commenced limited GMP manufacture of a new therapeutic specifically targeting the Ebola -- Guinea variant, which is the viral variant responsible for the Ebola epidemic currently prevalent in West Africa. Supply of this new product will be available in early December, 2014, for potential use by various collaborators. As definitive agreements are established we will provide updates accordingly.
The genomic sequence of the Ebola virus responsible for the current outbreak in West Africa has been determined from several viral isolates. The Company has completed the design of a modified RNAi therapeutic specifically targeting this viral variant, now termed 'Ebola-Guinea.' The ability to rapidly and accurately match the evolving genetic sequences of emerging infectious agents is one of the powerful features of RNAi therapeutics.
Theoretically, the lab can produce an adequate supply of the drug by the first of the year for use in the West African epidemic, assuming there is leeway on full human trials.
Things are definitely moving.
Thanks to Strong Central Governments, which can underwrite monumental efforts and extraordinary outcomes that the free-market cannot even conceive of. Especially if the effort is beneficial to others and is not outrageously profitable to the private owners.
