Wednesday, February 27, 2019

Things I learned This Week About Ebola, and the Use of Untrialed Experimental Vaccines

NEWS ITEMS:

People who contract Ebola in some areas of Congo, have one thing "in common": local hospitals, which may not be correctly following recommended hygiene protocols. NPR reports:
" They had all recently visited a health clinic for treatment for some other disease such as a respiratory infection or malaria. They would say, 'I went to the hospital. They treated me. I got clear [of that illness]. And then a few days after, I start having fevers.' " Fevers that were the first of signs of Ebola. The surge of confirmed cases in Katwa and Butembo – 307 and rising — is now the largest flare-up during the course of this outbreak, which has infected nearly 900 people since August. And WHO officials estimate that in about one-fifth of these recent cases, the person contracted Ebola at health care facilities.
One of the saddest stories I've read about this: a woman who never even knew she had had Ebola, had a relapse more than a year later and transmitted it to several family members. Although this was known in 2015, it was not publicized until this year. WJLA published the AP report:
 "A Liberian woman who probably caught Ebola in 2014 may have infected three relatives a year after she first fell sick, doctors reported... The unusual cluster of cases in Liberia was identified after the woman's 15-year-old son was diagnosed with Ebola in November 2015. Scientists then tested the rest of his family: the woman, her husband and their three younger sons. The 15-year-old died a few days later. The father and an 8-year-old boy were positive for Ebola, but both recovered. The couple's 5-year-old son wasn't infected.
"Doctors found Ebola antibodies in the mother, her breast milk and her 2-month-old baby, suggesting a previous infection and the possibility she passed on protection to her infant son through breastfeeding.
"Researchers reported genetic similarities between the viruses taken from the father, the two boys and the strain circulating during the 2014-15 outbreak across Liberia, Guinea and Sierra Leone, which ultimately killed more than 11,000 people in the biggest Ebola epidemic in history.
"Scientists discovered the woman had cared for her brother in July 2014, who died after suffering Ebola-like symptoms but before being tested for the disease. The woman later experienced a similar illness, but never sought care
."
Perhaps knowing this danger, one of the CDC's Ebola experts took special effort to make sure no one else was infected when an American Ebola survivor was giving birth, as reported by STAT News in an article about a retiring virologist:
" If [Dr Pierre] Rollin was good with viruses, he was equally as good with people. Damon, his former CDC boss, recalled that when one of the nurses from Dallas who had been infected with Ebola in 2014 gave birth well after she had recovered from the virus, there were still niggling concerns about whether she could infect others. So Rollin flew out to be on site, just in case."
Ebola survivors, it turns out, can transmit the disease to others for up to two years - and can be sexually transmitted by females as well as malesDebora MacKenzie at The New Scientist reported:
" The Ebola virus can persist in a man’s semen for much longer than we thought. A man in Guinea who survived Ebola in 2014 is now known to have carried it for at least 531 days. Earlier this year, he transmitted the virus sexually, causing it to spread to at least 10 people, and killing 8 of them. .... "In January, 470 days after he initially fell ill, this man had sex with the woman who became the first known case in this year’s outbreak. She then spread the virus to nine more people, one of whom carried it to Liberia."
 The CDC has recommended that male survivors of Ebola use condoms "indefinitely", but this suggests that both sexes risk infecting their partners.

Survivors who had latent, non-fatal, or mild infections and recovered but remained infectious, resulting in transmission of the disease, are now being recognized as the source of new outbreaks. CIDRAP , The Center for Infectious Disease Research and Policy. reports that a new outbreak in the town of Beni, Congo, is likely due to survivor transmission:
"The group conducted the study in June and July of 2017, enrolling 237 participants ... They found that illnesses were more widespread than the 11 cases originally reported from the area, which includes a 2-year-old boy thought have been the first case and to have been exposed to the virus by a bat.
"Researchers identified two more probable deaths and eight previously unrecognized IgG-positive survivors, including one person who had mild illness and another who was asymptomatic, for a case fatality of 55.6% for adults, much lower than originally reported 100%."
Victims of Ebola who die, are not to be embalmed, according to CDC guidelines, and if buried, must have a "closed casket" service - the body will not be available for viewing. The CDC recommends cremation for those who die of Ebola, but says if they are to be buried, funeral home personnel must not even open the body bag that the remains arrive in, and must transfer it to a casket which is then hermetically sealed.  More information is available at "The CDC’s “Guidance for Safe Handling of Human Remains of Ebola Patients in U. S. Hospitals and Mortuaries

It is not yet known whether other mammals such as dogs and cats can contract or carry Ebola. Everyday Health reports:
"“At this time, there is no evidence that dogs or cats can carry Ebola nor are they at risk for contracting Ebola in the United States,” says Angela Vassallo, PMH, MS, director of infection prevention and epidemiology at Providence Saint John’s Health Center in Santa Monica. ....The U.S. Centers for Disease Control and Prevention (CDC) also stated that there were no cases of dogs or cats getting sick from Ebola, nor of these pets spreading Ebola to others.
 ...."Julio Lopez, DVM, of Studio City Animal Hospital in Los Angeles, says that what little we know about Ebola and dogs comes from a single study. Published in Emerging Infectious Diseases in 2005, after an Ebola outbreak in Gabon, the study included data on blood tests of 439 dogs, some from Ebola-affected villages. “Dogs consuming infected meat developed antibodies against the Ebola virus, but did not show signs of sickness,” says Dr. Lopez. “None of the dogs in this study died from this disease.” Researchers found no cases of dogs passing on Ebola, neither to animals nor people.
..."While there are no known cases of an infected pet transmitting Ebola to a person, pets can infect people with other more common zoonotic diseases. “Leptospirosis, hookworms and roundworms, and toxoplasmosis are a few common examples,” says Lopez.  ... "We can also transmit diseases to our pets. In 2009, a cat and some ferrets contracted H1N1, commonly called the swine flu, from their owners,” Lopez says." 
Additional info about animals and Ebola in this Time article (from 2014 so perhaps out of date). 

Finally, as we all know, researchers are working ceaselessly to develop a vaccine for Ebola. With the latest outbreak, companies are setting up clinical trials of new medicines in-country, often at great risk from violence in the area.  But of interest was this article about giving the vaccine to young children without benefit of any clinical trial to determine its safety for that age group.
As reported by StatNews, in an article that could have been headlined 'Doctors Without Borders Supports Giving Untrialed Experimental Vaccines To Pregnant Women and Babies En Masse'
"Women who are pregnant and lactating, as well as children under the age of 1, will be offered access to an experimental Ebola vaccine in the Democratic Republic of the Congo, officials said Wednesday, marking the reversal of a controversial policy that had drawn fire from public health experts. .... 
"Proponents of the earlier policy argued that the vaccine, which goes by the provisional name V920, might harm the fetus or trigger a miscarriage. They noted that there were no data to show the vaccine was safe to use in this very vulnerable population.
"But critics countered that unless the vaccine is used in pregnant women there would never be data to determine whether it was safe. And they noted that while there may be some risk involved in vaccinating pregnant and lactating women, the risk to them from Ebola is greater. ....
"The decision to exclude lactating women stemmed from concerns the vaccine viruses might be transmitted via breast milk. Children under the age of 1 were excluded from vaccination because the vaccine’s safety and effectiveness in this group hasn’t been tested. (An earlier decision to lower the threshold for those eligible for vaccination from 6 years old to 12 months old was made without the benefit of a clinical trial.)
"...As of Tuesday nearly 82,000 people in North Kivu and Ituri — the provinces where the outbreak is occurring — have been vaccinated. The vaccine, which has yet to be licensed, is being developed by Merck.
"Carleigh Krubiner, a policy fellow at the Center for Global Development, welcomed the news. Krubiner said the policy reversal will not only offer pregnant women the protection of the vaccine, but also provide a critical chance to see how the vaccine works in these women. That knowledge will be of benefit in future outbreaks, she said. ...
"The decision was also applauded by Doctors Without Borders, which had opposed the exclusion of pregnant women. Dr. Séverine Caluwaerts, a Belgian gynecologist who volunteers with MSF —the acronym is based on the organization’s name in French — said in reality some pregnant women have already received the vaccine, because they were vaccinated before they knew they were pregnant. MSF has heard reports of at least 20 such cases in this outbreak, Caluwaerts said."
"Reluctance to offer the vaccine to pregnant and lactating women is based on the fact it is a live-virus vaccine. The virus it contains is not Ebola; it is a livestock virus called vesicular stomatitis virus that can infect, but does not sicken people. A key protein from the Ebola virus has been fused to the VSV virus, which then prompts the immune system to develop a protective response to Ebola. Traditionally there has been concern about using live-virus vaccines in pregnant women.
"It was not immediately clear whether all children — even newborns — could be vaccinated. Nor is it clear how the WHO feels about this part of the decision.... The WHO did not immediately respond to a request for an interview." 
The article continues with information about other vaccines that do not use live viruses and are being recommended for trials.

Are the families - husbands and fathers as well as women and mothers - being made fully aware of the risks of these untrialed, experimental vaccines?  What kind of responsibility will these organizations bear who made the "outcry" demanding use of the experimental vaccines on vulnerable people?

The global health organizations are using the third world as their unregulated playground, taking advantage of people with no experience to use as human guinea pigs for testing their science-fair projects. Who is going to hold them to account when they make a fatal error?  Or half a million fatal errors?



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