The Democratic Republic of Congo is
planning to use a second Ebola vaccine to help control an outbreak that has
killed more than 2,100 people.
In July, former Health Minister Oly
Ilunga opposed the vaccine use saying it had not been proved effective.
However, DR Congo health officials
say the vaccine, developed by Johnson & Johnson, is safe.
This outbreak, in the east of DR
Congo, is the second largest on record.
The largest was the epidemic that
ravaged parts of West Africa from 2014 to 2016, killing more than 11,000
people.
According to a government statement,
the Johnson & Johnson vaccine will complement the vaccine manufactured by
Merck which has been administered to 225,000 people in the past year.
However, DR Congo’s Ebola response
team have not yet said when it will be introduced.
Leading health experts have said
that the second vaccine is safe and could be an important tool in holding back
the spread of the virus.
Earlier this year, Johnson & Johnson said it had 1.5 million doses
available to be deployed.
The current Ebola vaccine, which is in short supply, is only being given to
health workers and people who might have been exposed to the virus.
The new vaccine could create a protective wall, vaccinating people outside
the immediate outbreak zone.
The Congolese authorities intend to use the second vaccine outside the
infected areas in Ituri and North Kivu provinces. They first want to protect
the small Congolese traders who regularly cross into Rwanda.
There have been concerns that the new vaccine – which requires two
injections at least 25 days apart – may be difficult to administer in a region
where the population is highly mobile, and insecurity is rife.
DR Congo has struggled to get the outbreak under control.
Insecurity in the east of the country and people’s suspicions of treatments
have hampered efforts.
About 200 health facilities have been attacked in the country this year,
causing disruption to vaccinations and treatments. In one incident, family
members assaulted health workers who were overseeing the burial of their
relative.
A 2018 study published in the Lancet
medical journal says “belief in misinformation was widespread”
concerning the Ebola outbreak.
In a statement in August, the World Health Organization (WHO) called on
countries and NGOs that have offered help to “increase their presence in
the field to stop Ebola and to address one of the largest and most complex
humanitarian crises in the world”.
The current outbreak in eastern DR Congo began in August last year and is
the biggest of 10 to hit the country since 1976, when the virus was first
discovered.
In July, the WHO declared the Ebola crisis in the DR Congo a “public health emergency of international concern”.
The World Health Organization (WHO) has announced that a highly effective vaccine against the deadly Ebola virus could be available by 2018.
Trials conducted in Guinea, one of the West African countries most affected by an outbreak of Ebola that ended this year, show the vaccine offers 100% protection.
The vaccine is now being fast-tracked for regulatory approval.
Manufacturer Merck has made 300,000 doses of the rVSV-ZEBOV vaccine available for use should Ebola strike.
GAVI, the global vaccine alliance, provided $5 million for the stockpile.
Photo Flickr
The trial’s results, published in The Lancet medical journal, show of nearly 6,000 people receiving the vaccine, all were free of the virus 10 days later.
In a group of the same size not vaccinated, 23 later developed Ebola.
Only one person who was vaccinated had a serious side effect that the researchers think was caused by the jab. This was a very high temperature and the patient recovered fully.
It is not known how well the vaccine might work in children since this was not tested in the trial.
The trial was led by the WHO, working with Guinea’s health ministry and international groups.
WHO Assistant Director-General for Health Systems and Innovation Dr. Marie-Paule Kieny, who is the lead author of the study, said the results could help combat future outbreaks: “While these compelling results come too late for those who lost their lives during West Africa’s Ebola epidemic, they show that when the next Ebola outbreak hits, we will not be defenseless.”
Other drug companies are developing different Ebola vaccines that could be used in the future too.
The Ebola virus was first identified in 1976 but the recent outbreak in West Africa, which killed more than 11,000 people, highlighted the need for a vaccine.
The Ebola outbreak began in Guinea in 2013 and spread to Liberia and Sierra Leone.
Gavi, the Vaccine Alliance, has signed a $5 million deal for an Ebola vaccine, to protect against future outbreaks of the deadly disease.
The deal commits pharmaceutical company Merck to keeping 300,000 vaccines ready for emergency use or further clinical trials.
It will also submit an application to license the vaccine by the end of 2017, which would the next step towards enabling Gavi to prepare a global stockpile.
More than 11,000 people have died in the latest Ebola outbreak in West Africa.
The sheer scale of the outbreak – the largest in history – led to an unprecedented push on vaccines, which condensed a decade’s work into less than a year.
Merck has led trials of the VSV-EBOV vaccine – which combines a fragment of the Ebola virus with another safer virus in order to train the immune system to beat Ebola.
Early evidence from studies in West Africa suggest it may give 100% protection, although more data is still being collected.
Gavi CEO Dr. Seth Berkley said: “The suffering caused by the Ebola crisis was a wake-up call to many in the global health community.
“New threats require smart solutions, and our innovative financing agreement with Merck will ensure that we are ahead of the curve for future Ebola outbreaks.”
Gavi is an alliance of public bodies and companies committed to saving lives through vaccination.
It announced the advanced-purchase commitment at the World Economic Forum held at Davos in the Swiss Alps.
The $5 million paid to Merck will be offset against any vaccines Gavi orders once the shot is licensed.
The World Health Organization declared West Africa Ebola-free last week, after all of the affected countries had gone 42 days without a case.
However, just hours later, a death in Sierra Leone was confirmed to be from Ebola.
Ebola vaccine VSB- EBOV has led to 100% protection and could transform the way the virus is tackled, preliminary results suggest.
There were no proven drugs or vaccines against Ebola virus at the start of the largest outbreak of the disease in history, which began in Guinea in December 2013.
The World Health Organization (WHO) said the findings, being published in the Lancet, could be a “game-changer”.
Experts said the results were “remarkable”.
This trial centered on the VSV-EBOV vaccine, which was started by the Public Health Agency of Canada and then developed by the pharmaceutical company Merck.
It combined a fragment of the Ebola virus with another safer virus in order to train the immune system to beat Ebola.
A unique clinical trial took place in Guinea. When a patient was discovered, their friends, neighbors and family were vaccinated to create a “protective ring” of immunity.
One hundred patients were identified in the trial between April and July and then close contacts were either vaccinated immediately, or three weeks later.
In the 2,014 close contacts who were vaccinated immediately there were no subsequent cases of Ebola.
In those vaccinated later there were 16 cases, according to the results published in the Lancet medical journal.
The WHO says it is so far 100% effective, although that figure may change as more data is collected.
Close contacts of Ebola patients in Guinea will now be vaccinated immediately. Since the vaccine has been shown to be safe the process will also be extended to include children.
Médecins sans Frontières (MSF) is involved with this research, and is part of a parallel trial for frontline healthcare workers.
Medical director Bertrand Draguez said the Lancet results should spur instant action.
“With such high efficacy, all affected countries should immediately start and multiply ring vaccinations to break chains of transmission and vaccinate all frontline workers to protect them.”
Ebola experimental vaccine first large-scale trial is due to begin in Liberia.
The potentially preventative medicine was taken under strict security to a secret location in the West African country.
Scientists aim to immunize 30,000 volunteers, including front-line health workers.
More than 8,500 people have died in the Ebola outbreak, the vast majority in Guinea, Liberia and Sierra Leone.
The total number of reported cases is more than 21,000. In Liberia alone, more than 3,600 people have died from the disease.
The trial beginning on February 2 will involve injecting a small amount of the strain of the Ebola virus into 12 volunteers in order to trick the body into producing an immune response.
However, it is not yet clear whether this will really offer protection against the disease.
Community nurses are being trained in how to monitor volunteers in the months after they have had their injections.
In the meantime, parts of the largest Ebola treatment centre in the world, on the edge of Monrovia, are being knocked down.
The number of Ebola cases in Liberia has been steadily decreasing – in recent months, there have only been five confirmed cases across the country.
The World Health Organization (WHO) says the epidemic has entered a “second phase” with the focus shifting to ending the epidemic.
The survival rate of the current Ebola outbreak is around 40%.
The first batch of GSK’s Ebola experimental vaccine is on its way to Liberia.
The shipment will be the first potentially preventative medicine to reach one of the hardest hit countries.
However, experts say that, with Ebola cases falling, it may be difficult to establish whether the jab offers any protection against the virus.
The vaccine has been produced by British company GlaxoSmithKline (GSK) and the US National Institutes of Health.
GSK said a plane carrying some 300 initial doses of the vaccine was expected to arrive in Monrovia on January 23.
The company hopes the first volunteer will be immunized in the next few weeks.
GSK CEO Andrew Witty said the pace of development was almost unparalleled and was comparable to only the development of a pandemic flu vaccine or new medicines for HIV.
Photo AP
Scientists aim to involve 30,000 volunteers in the trial in total, including frontline health workers.
If all regulations are met, 10,000 volunteers will be given the GSK vaccine.
A matching number will get a placebo, dummy vaccine. And there are plans for a further 10,000 people to get a separate experimental jab.
The results will be compared to see if either vaccine offers any meaningful protection against the virus.
A version of the vaccine has already been tested on 200 healthy volunteers across the UK, US, Switzerland and Mali.
GSK says it has been found to have an acceptable safety profile so far.
However, it is only in affected countries that experts can determine whether it provides adequate protection against the virus.
Dr. Moncef Slaoui, of GSK said: “Shipping the vaccine today is a major achievement and shows that we remain on track with the accelerated development of our candidate Ebola vaccine.
“The initial phase one data we have seen are encouraging and give us confidence to progress to the next phases of clinical testing.”
GSK stresses the vaccine is still in development and the World Health Organization, and other regulators, would have to be satisfied the vaccine is both safe and effective before any mass immunization campaigns could be considered.
Field trials of other promising vaccines – for example one involving the company Merck – are planned in Guinea, Liberia and Sierra Leone in the months to come.
There are reports that a trial of an experimental drug called Zmapp might start in the next few weeks.
However, experts say with the number of Ebola cases falling opportunities to test vaccines and drugs could be limited.
A new Ebola vaccine is being tested on healthy volunteers at Oxford University.
In September 2014, a separate trial of another Ebola vaccine got under way in Oxford.
This latest trial involves 72 volunteers aged 18-50.
Initial tests in monkeys showed the vaccine, developed by Janssen Pharmaceutical Companies of Johnson and Johnson, gave complete protection against Ebola.
The volunteers in Oxford are the first humans to receive the vaccine.
Dr. Matthew Snape, from the Oxford Vaccine Group, part of the University of Oxford Department of Paediatrics, said: “We aim to immunize all participants within a month.
“The main aim is to understand the safety profile of the vaccines.”
The trial involves volunteers receiving an additional booster dose one or two months after the initial injection.
Similar small trials will also get under way in the US and three African countries unaffected by Ebola.
The first dose is designed to prime the immune system with the second booster dose to enhance the immune response.
The two doses contain different components, but both include genes for a protein from the Zaire strain of the Ebola virus.
The trial organizers stress the vaccine cannot cause anyone to be infected with Ebola.
The immune response the vaccine generates – both antibodies and T cells – will be measured over the course of a year.
Johnson and Johnson said it hoped to begin a larger Phase II trial in Africa and Europe within three months and then to have the vaccine available for use in Liberia, Guinea and Sierra Leone by the middle of 2015.
The pharmaceutical company says it could have 2 million doses of the vaccine available in 2015.
The health crisis triggered by the Ebola outbreak has led to a huge acceleration in the pace of vaccine research.
In September a separate team at the Jenner Institute in Oxford began a trial of an Ebola vaccine.
GSK and the National Institutes of Health in the US developed the vaccine.
Results of that trial are due shortly and there are plans for the vaccine to be offered to health workers in Ebola affected countries of West Africa later this month.
The study led by the Jenner Institute has now been modified to include a booster dose.
Merck has recently bought the rights to a third Ebola vaccine being developed by the biotech company NewLink Genetics.
That vaccine is being tested in Switzerland.
The trial, in Geneva, was halted in December 2014 after some volunteers complained of joint pain.
It resumed this week, with participants being given a lower dose.
Ebola vaccines are also being developed in Russia.
Dr. Matthew Snape said: “The fact that there are at least three Ebola vaccines entering these early safety trials is good news.
“We are not playing first past the post here. Having multiple vaccines progressing through clinical trials increases the likelihood of vaccine manufacturers having the capacity to meet production demands should mass immunization be required.
“The more vaccines and more manufacturers there are working on this, the better.”
An Ebola vaccine clinical trial in Switzerland has been interrupted after some patients complained of joint pains in their hands and feet.
The trial was stopped one week early in all 59 volunteers “as a measure of precaution”, the University of Geneva Hospital said.
The vaccine being tested is one developed by NewLink Genetics, and recently bought by Merck.
There is currently no vaccine licensed for use to protect against Ebola.
Two vaccines are currently being tested in humans in a number of countries.
The side-effects in the Geneva trial were experienced by four volunteers.
The hospital said human safety trials would resume on January 5 in up to 15 volunteers after checks had taken place to ensure the joint pain symptoms were “benign and temporary”.
“They are all fine and being monitored regularly by the medical team leading the study,” the hospital said.
Four trials of another Ebola vaccine developed by GSK, in collaboration with the US National Institute of Allergy and Infectious Diseases, are also underway.
The experimental vaccine against Ebola is safe and may help the immune system to combat the virus, the first human trial results suggest.
Twenty volunteers were immunized in the US. Scientists at the US National Institutes of Health (NIH) described the results as “promising”.
The research is published in the New England Journal of Medicine (NEJM).
None of those immunized suffered major side-effects and all produced antibodies.
The volunteers were divided into two groups, receiving either a low or high dose. The antibody response was stronger among those receiving the higher dose.
The investigators found that seven of the high dose and two of the lose dose volunteers produced T-cell immune responses, which may be important in protection against Ebola viruses.
The vaccine uses a chimpanzee cold virus which has been genetically engineered to carry a non-infectious Ebola protein on its surface.
There are four trials underway of this experimental vaccine.
The US vaccine is bivalent – aimed at giving protection against the Sudan and Zaire strains of Ebola. It is the latter which is responsible for the current outbreak.
Trials of a monovalent vaccine – against the Zaire strain – are also underway in Oxford, Mali and Switzerland.
If these also yield positive results then the monovalent vaccine will be offered to thousands of health workers in West Africa.
If the vaccine does work, it is unclear how long the protection would last.
These kinds of questions are usually settled during the early stages of human trials.
In an editorial in the NEJM Dr. Daniel Bausch said that while the trial left many questions unanswered, an Ebola vaccine was “one step closer”.
The experimental vaccine is being manufactured by the British drugs giant GlaxoSmithKline (GSK).
GSK says it can produce one million doses a month by the end of 2015.
The World Health Organization (WHO) has announced that one million doses of an Ebola vaccine will be produced by the end of 2015.
The WHO said “several hundred thousand” would be produced in the first half of the year.
Vaccines could be offered to health workers on the frontline in West Africa as soon as December 2014.
However, the WHO cautioned that vaccines would not be a “magic bullet” for ending the outbreak.
There is no proven cure or vaccine for Ebola.
In response to the largest epidemic of the disease in history, the WHO is accelerating the process of vaccine development
It normally takes years to produce and test a vaccine, but drug manufacturers are now working on a scale of weeks.
One million doses of an Ebola vaccine will be produced by the end of 2015
Two experimental vaccines, produced by GlaxoSmithKline (GSK) and the Public Health Agency of Canada, are already in safety trials.
The GSK vaccine is being tested in Mali, the UK and the US. Research on the Canadian vaccine is also under way in the US with further trials expected to start in Europe and Africa soon.
The results are expected in December. After that, trials will move to countries affected by Ebola, probably starting with Liberia.
That will allow researchers to assess how effective the vaccine is and what dose is needed to provide protection.
Healthcare workers, who place themselves at risk when treating patients, will take part in the first trials in West Africa.
The WHO says we should have the first hints of how effective these experimental vaccines are by April.
There are no plans for mass vaccination before June 2015 but the WHO has not ruled it out.
The WHO says vaccines are likely to be key to ending the outbreak, even if cases fall in the next few months.
Dr. Marie Paule Kieny, a WHO assistant director-general, said: “While we hope that the massive response, which has been put in place will have an impact on the epidemic, it is still prudent to prepare to have as much vaccine available as possible if they are proven effective.
“If the massive effort in response is not sufficient, then vaccine would be a very important tool.
“And even if the epidemic would be already receding by the time we have vaccine available, the modeling seems to say vaccine may still have an impact on controlling the epidemic.”
As well as the two vaccines already in trials, there are a further five in the pipeline which could yet play a role in the outbreak.
The World Bank and the charity Medecins Sans Frontieres will help finance the vaccine.
There are also suggestions that an “indemnity fund” could be set up in case people have a serious adverse reaction to a vaccine being rushed through.
Scientists say that vaccinated monkeys have developed “long-term” immunity to the Ebola virus, raising a prospect of successful human trials.
The experiments by the US National Institutes of Health (NIH) showed immunity could last at least 10 months.
Human trials of the Ebola vaccine started this week in the US and will extend to the UK and Africa.
The World Health Organization (WHO) says more than 2,000 people have now died in the outbreak in West Africa.
Several experimental treatments are now being considered to help contain the spread of Ebola.
Human trials of the Ebola vaccine started in the US and will extend to the UK and Africa
This includes a vaccine being developed by the US National Institute of Allergy and Infectious Diseases and pharmaceutical company GlaxoSmithKline (GSK).
It uses a genetically modified chimp virus containing components of two species of Ebola – Zaire, which is currently circulating in West Africa, and the common Sudan species.
The viral vaccine does not replicate inside the body, but it is hoped the immune system will react to the Ebola component of the vaccine and develop immunity.
Animal research, on which the decision to begin human trials was based, has now been published in the journal Nature Medicine.
It shows four crab-eating macaques all survived what would have been a fatal dose of Ebola virus five weeks later.
However, only half survived an infection 10 months after immunization.
For now this is the best evidence available on how successful such a vaccine would be in people.
The first patient, a 39-year-old woman, was given the vaccine last week as human trials got under way.
There will also be separate trials of the vaccine against just the Zaire Ebola species.
These will take place in the US, the University of Oxford in the UK as well as in Mali and Gambia.
The WHO said safety data would be ready by November 2014 and, if the vaccine proved safe, it would be used in West Africa immediately.
Healthcare workers and other frontline staff would be prioritized for vaccination.
The number of doses currently available is between 400 – if a lot of vaccine is needed for immunity – and 4,000 if smaller amounts are sufficient.
As with all experimental therapies, the WHO has warned hopes of a vaccine must not detract from the proven methods of infection control which have defeated all previous outbreaks.
The first human trials for an Ebola vaccine have begun in Maryland.
Researchers are studying how human immune systems respond to the vaccine.
Twenty healthy adult volunteers are being tested at the National Institutes of Health (NIH) in Maryland.
The trial has been brought forward amid an outbreak of the Ebola disease in West Africa that has killed at least 1,500.
No volunteers will be infected with the Ebola virus but the vaccine has performed well in primate trials.
There is no cure for Ebola but a separate experimental drug, ZMapp, was 100% effective in studies on monkeys, according to researchers who published their data in Nature last week.
The first human trials for an Ebola vaccine have begun in Maryland
ZMapp has not been officially studied in humans, but it was used on seven people infected with Ebola in West Africa, mostly health workers.
Two of them later died and it is unclear if the drug helped the others to recover. The fatality rate during this outbreak has been about 50%, according to the World Health Organization (WHO).
At least 3,000 people have been infected with the virus. On August 29, a fifth country, Senegal, had its first confirmed case.
WHO has warned it could get much worse and infect more than 20,000 people.
“There is an urgent need for a protective Ebola vaccine, and it is important to establish that a vaccine is safe and spurs the immune system to react in a way necessary to protect against infection,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which helped develop the drug.
Researchers in Bethesda, Maryland, will be looking for any adverse reactions and how each volunteer’s immune system responds to the vaccine.
NIH is also partnering internationally with the Wellcome Trust and others for a similar trial in the UK, the Gambia and Mali.
Canada will donate up to 1,000 doses of an experimental Ebola vaccine to help battle the disease’s outbreak in West Africa.
The announcement comes after the World Health Organization (WHO) said it was ethical to use untested drugs on Ebola patients.
However, experts say supplies of both the vaccine, and experimental drug ZMapp are limited and it could take months to develop more supplies.
More than 1,000 people have been killed by the current outbreak.
Canada says between 800 and 1,000 doses of the vaccine, which has only been tested on animals, will be donated to the WHO for use in West Africa.
However, it will keep a small portion of the vaccine for research, and in case it is needed in Canada.
The current outbreak has infected people in Guinea, Sierra Leone, Liberia and Nigeria.
Canada will donate up to 1,000 doses of an experimental Ebola vaccine to help battle the disease’s outbreak in West Africa (photo WHO)
Dr. Gregory Taylor, deputy head of Canada’s Public Health Agency, said he saw the vaccines as a “global resource”.
He said he had been advised that it would make sense for health care workers to be given the vaccine, given their increased risk of contracting the disease.
Even if Canada releases most of its existing doses, experts warn it could take four to six months to make a quantity large enough to have any real impact at preventing the illness.
On Tuesday, the WHO said that in light of scale of the outbreak and high number of deaths, it was “ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.”
Last week the WHO declared the Ebola outbreak was a global health emergency.
Liberia says it is getting an experimental drug, ZMapp, after requests to the US government.
However, the WHO said there were only 12 doses.
ZMapp maker Mapp Biopharmaceutical said on Tuesday: “The available supply of ZMapp has been exhausted. We have complied with every request for ZMapp that had the necessary legal/regulatory authorization.
“Drug has been provided at no cost in all cases.”
ZMapp has been used on two US aid workers, Dr. Kent Brantly and Nancy Writebol, who have shown signs of improvement, although it is not certain what role the medication played in this.
A Roman Catholic priest, infected with Ebola in Liberia, who died after returning home to Spain is also thought to have been given the drug.
Ebola’s initial flu-like symptoms can lead to external hemorrhaging from areas like eyes and gums, and internal bleeding which can lead to organ failure. Patients have a better chance of survival if they receive early treatment.
There a handful of Ebola drugs that have been shown to work well in animals.
One is ZMapp – the drug requested by the Liberian government to treat infected doctors. This contains a cocktail of antibodies that attack proteins on the surface of the virus.
Only one drug has moved onto early safety testing in humans. Known as TKM-Ebola this interrupts the genetic code of the virus and prevents it from making disease causing proteins.
There a handful of Ebola drugs that have been shown to work well in animals
TKM-Ebola was trialed in healthy volunteers at the beginning of 2014 but the American medicines regulator asked for further safety information. The manufacturer says human studies may soon resume.
Another option would be to use serum from individuals who have survived the virus – this is a part of the blood that may contain particles able to neutralize the virus.
Vaccines to protect against acquiring the Ebola disease have also been shown to work in primates.
The US authorities are considering fast-tracking their development and say they could be in use in 2016. Trials are likely to start soon, according to the World Health Organization.
However, experts warn ultimately the only way to be sure a drug or vaccine is effective is to see if it works in countries affected by Ebola.
Clinical trials of a preventative vaccine for the Ebola virus made by pharmaceutical company GlaxoSmithKline may begin next month and made available by 2015, the WHO said on Saturday.
“We are targeting September for the start of clinical trials, first in the United States and certainly in African countries, since that’s where we have the cases,” Jean-Marie Okwo Bele, the WHO’s head of vaccines and immunization, told French radio.
Jean-Marie Okwo Bele said he was optimistic about making the vaccine commercially available.
Clinical trials of a preventative vaccine for the Ebola virus made by GSK may begin next month and made available by 2015
“We think that if we start in September, we could already have results by the end of the year.
“And since this is an emergency, we can put emergency procedures in place … so that we can have a vaccine available by 2015.”
There is currently no available cure or vaccine for Ebola, a virus that causes severe fever and, in the worst cases, unstoppable bleeding.
It has claimed close to 1,000 lives in the latest epidemic to spread across West Africa this year. Fatality rates can approach 90 percent, although the latest outbreak has killed around 55 to 60 percent of those infected.
Several vaccines are being tested, and a treatment made by San Diego-based Mapp Biopharmaceutical, ZMapp, has shown promising results on monkeys and may have been effective in treating two Americans recently infected in Africa.
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