Pfizer strikes global licensing deal for Covid pill

Yahoo – AFP, Robin MILLARD, November 16, 2021 

Pfizer's Covid pill showed an 89 percent reduction in hospitalisation and
death in clinical trials. (AFP/Don EMMERT)

US pharmaceutical giant Pfizer on Tuesday announced a deal to make its prospective antiviral Covid-19 pill available more cheaply in the world's least wealthy countries. 

Pfizer will sub-licence production of its promising Paxlovid pill to generic drug manufacturers for supply in 95 low- and middle-income nations covering around 53 percent of the world's population. 

Under the deal struck with the global Medicines Patent Pool (MPP), Pfizer -- which also produces one of the most widely-used Covid vaccines with German lab BioNTech -- will not receive royalties from the generic manufacturers, making the treatment cheaper. 

The agreement is subject to the oral antiviral medication passing ongoing trials and regulatory approval. 

The Pfizer drug is to be taken with the HIV medicine ritonavir. 

Interim data from ongoing trials demonstrated an 89 percent reduction in the risk of Covid-19-related hospitalisation or death compared to a placebo, in non-hospitalised high-risk adults with Covid-19 within three days of symptom onset, said Pfizer. 

Similar results were seen within five days of symptom onset, it added. 

The Geneva-based MPP is a United Nations-backed international organisation that works to facilitate the development of medicines for low- and middle-income nations. 

If approved, the pill could be on the market in "a matter of months", MPP policy chief Esteban Burrone told AFP. 

HIV drug mix

Pfizer will forego royalties on sales in all countries covered by the agreement while Covid-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization. 

Last month, the WHO maintained the highest level of alert over the spread of the SARS-CoV-2 virus that causes Covid-19. 

Paxlovid, or PF-07321332, is an investigational antiviral therapy designed to block the activity of the SARS-CoV-2-3CL protease -- an enzyme that the coronavirus needs to replicate. 

Taking it together with a low dose of ritonavir helps slow the breakdown of PF-07321332. It therefore remains active in the body for a longer period at a high concentration, to help combat the virus. 

The pill could potentially help patients avoid severe illness, which can lead to hospitalisation and death, Pfizer said. 

"We believe oral antiviral treatments can play a vital role in reducing the severity of Covid-19 infections, decreasing the strain on our healthcare systems and saving lives," said Pfizer chairman and chief executive Albert Bourla. 

While a multitude of vaccines have been rolled out in the pandemic, the hunt for treatments for those who have already caught the disease has not been as fruitful. 

Agreement follows Merck deal 

The MPP was founded by Unitaid, which works on innovations to prevent, diagnose and treat major diseases in poorer countries. 

"During a pandemic, saving time means saving lives. This agreement could help us to reach more people more quickly as soon as the medicine is approved," said Unitaid executive director Philippe Duneton. 

Potential sublicensees have until December 6 to register an expression of interest. 

The announcement comes after the MPP signed a similar voluntary licensing deal with Pfizer's US rivals Merck & Co last month for its investigational oral antiviral medicine molnupiravir. 

Subject to regulatory approval, the deal will help create broad access to molnupiravir in 105 low- and middle-income countries. 

Pills are easier to make than vaccines, do not require a cold chain for delivery and can be self-administered by the patient. 

In terms of relieving health systems by preventing hospitalisations, "it's a game changer", said Burrone. 

He said pricing for the Pfizer pill had not yet been set, but said that "in a competitive environment... the prices tend to come down" to a low level. 

Doctors Without Borders (MSF) meanwhile suggested it might cost around $700 per Pfizer treatment course, in line with molnupiravir. 

The medical charity said it was disheartened by the deal, saying restrictive voluntary licences were no substitute for guaranteed global access to Covid tools to bring the pandemic under control.

Last century's epidemics more deadly than today's

Yahoo – AFP, Jean-Philippe CHOGNOT, Olivier THIBAULT, February 5, 2020

The deadliest epidemic of the haemorrhagic fever Ebola broke out in West Africa
in December 2013 and lasted more than two years (AFP Photo/CELLOU BINANI)

Paris (AFP) - Before the emergence of the new coronavirus, which has sparked worldwide panic, other epidemics had struck earlier in the 21st century, but were less deadly than the previous century's pandemics.

An overview.

21st century epidemics

2013-2016: Ebola

The deadliest epidemic of the haemorrhagic fever Ebola broke out in West Africa in December 2013 and lasted more than two years, killing more than 11,300, mainly in Guinea, Liberia and Sierra Leone.

First identified in 1976, Ebola is less contagious than other viral diseases, but is particularly lethal, killing around 40 percent.

The virus re-emerged in August 2018 in the eastern Democratic Republic of Congo where it has so far killed more than 2,200.

The World Health Organization (WHO) says 18,500 died of so-called "Swine flu", 

or H1N1, which was first uncovered in Mexico and the United States in March 

2009 (AFP Photo/LUIS ACOSTA)

2009-2010: Swine flu

The World Health Organization (WHO) says 18,500 died of so-called "Swine flu", or H1N1, which was first uncovered in Mexico and the United States in March 2009.

The Lancet medical review, however, puts the toll at between 151,700 and 575,400.

The pandemic alert was launched on June 11, 2009 and lifted on August 10, 2010 but the virus turned out to be not as deadly as first feared.

Vaccines were rushed out, but in hindsight, the West, particularly Europe, and the WHO were criticised for overreacting at a time annual influenza epidemics every year kill between 250,000 and 500,000, according to the Geneva-based UN health agency.

Severe Acute Respiratory Syndrome first emerged in Guangdong in southern 

China in November 2002 before sparking a health crisis in mid-2003, in particular

traumatising Asia (AFP Photo/SAMANTHA SIN)

2002-2003: SARS

Severe Acute Respiratory Syndrome first emerged in Guangdong in southern China in November 2002 before sparking a health crisis in mid-2003, in particular traumatising Asia.

It killed 774, four fifths of whom were in China and Hong Kong. It was transmitted to man from horseshoe bats, eventually spreading to around 30 countries. It had a mortality rate of 9.5 percent.

2003-2004: Bird flu

The deadly H5N1 strain of bird flu killed more than 400 people, mainly in Southeast Asia, after appearing in 2003. It first ravaged poultry farms in Hong Kong, before being transmitted to humans. The WHO declared a global health emergency, but the toll remained limited.

20th century's big pandemics

AIDS, by far the most deadly epidemic of modern times: according to UNAIDS 

some 32 million people around the world have died of the disease (AFP Photo/

Dibyangshu SARKAR)

1981-to date: AIDS

By far the most deadly epidemic of modern times: according to UNAIDS some 32 million people around the world have died of the disease which affects the immune system and leaves people vulnerable to opportunistic infections.

Today around 24.5 million people have access to retroviral drugs which when taken regularly efficiently stop the illness in its tracks and heavily reduce the risk of contamination.

1968-1970: The Hong Kong flu

Around one million people died of this disease, according to the US Centers for Disease Control and Prevention (CDC).

Transmitted around the world between mid-1968 and early 1970, it in particular killed many children. It first started in Hong Kong, spread through Asia and reached the United States in late 1968. After lying low for several months it then hit Europe in late 1969.

For epidemic experts, this flu went down in history as the first of the modern era, due to the advent of high-speed air travel.

1957-1958: Asian flu

Around 1.1 million people died of Asian flu, according to the CDC.

The pandemic hit in two aggressive waves. The virus first appeared in southern China in February 1957. Several months went by before it reached America and Europe.

The disease, which results in serious lung complications, in particular affected the elderly.

Spanish flu hit the world's population in the wake of WWI, killing up to 50 million, 

according to the CDC, and is considered the most deadly in history over such 

a short period (AFP Photo)

1918-1919: Spanish flu

Spanish flu hit a large part of the world's population in the wake of World War I, killing up to 50 million people, according to the CDC.

Striking between September 1918 and April 1919, it is considered the most deadly in history over such a short period.

Five times more people died of it than did in World War I. The first victims were recorded in the United States, before it spread to Europe and then around the world.

Its mortality rate was estimated at more than 2.5 percent, according to the CDC.

New implant, vaccine trial offer fresh HIV hope

Yahoo – AFP, July 23, 2019

The findings were unveiled during the 10th International AIDS Society (IAS)
Conference in Mexico City (AFP Photo/RODRIGO ARANGUA)

Paris (AFP) - A matchstick-sized implant could revolutionise HIV prevention regimes after early trials suggested the device could stop at-risk people contracting the virus for up to a year at a time, new research showed Tuesday.

Unveiling their findings from a clinical trial at the 10th annual International AIDS Society conference in Mexico City, developers said the device could eventually offer a novel approach to HIV suppression.

It uses a molecule called MK-8591, which is roughly 10 times stronger as an HIV inhibitor than medicines currently on the market, and which has a very high barrier against resistance.

"It slowly releases the drug and maintains a very consistent level of the drug in your body and taking this prophylactically it can actually prevent you from getting infected," Mike Robertson, director global clinical development for virology at MSD research, told AFP.

Currently, individuals at high risk of contracting HIV have to take a pill every day in order to guarantee their protection.

In its annual report on the disease, the United Nations this month said that global AIDS deaths had fallen one third since 2010 to roughly 770,000 in 2018.

But it warned that the decline in new infection rates was slowing worldwide, and in some regions including Eastern Europe and the Middle East, rates were increasing dramatically.

Robertson said that the implant, or even a monthly pill containing the same active ingredient could provide more options for at risk communities.

"The people that are at highest risk are different populations -- for example men who have sex with men still remain in the US and Europe the group that has the highest rate of new infections," he said.

"But globally the highest incidence rate is in young women in sub-Saharan Africa and this is another group where most the new infections are occurring."

Anton Pozniak, International AIDS Society president, said that the implant "offers another choice for those who might in the future also have pills and injectables available" to prevent infection.

Tuesday also saw fresh analysis unveiled on a recent clinical trial into the safety and tolerability of a HIV vaccine.

The Phase 2 trial took place in Kenya, Rwanda and the United States among healthy, low-risk, HIV negative adults. The initial results showed that the vaccines were well-tolerated among subjects.

A Phase 3 trial is now in planning.

"These are very promising times in HIV vaccine research, with multiple efficacy clinical trials ongoing, new approaches in development, and a growing sense that we may be getting closer to an effective vaccine," said Global HIV Vaccine Enterprise Director Roger Tatoud.

Second HIV remission patient rekindles cure hope

Yahoo – AFP, Marlowe HOOD and Patrick GALEY, 5 March 2019

Ten years after the first confirmed case of an HIV-infected person being rid of the
deadly disease, a man known only as the 'London patient' has shown no sign of the
virus for nearly 19 months

For just the second time ever an HIV patient is in sustained remission from the virus in what was hailed by experts Tuesday as proof that the AIDS-causing condition could one day be curable.

Ten years almost to the day since the first confirmed case of an HIV-infected person being rid of the deadly disease, a man known only as the "London patient" has shown no sign of the virus for nearly 19 months, doctors reported in the journal Nature.

Both patients underwent bone marrow transplants to treat blood cancers, receiving stem cells from donors with a genetic mutation present in less than one percent of Europeans that prevents HIV from taking hold.

"It is a landmark. After 10 years of not being able to replicate (the first case), people were wondering if this was a fluke," said lead author Ravindra Gupta, a professor at the University of Cambridge.

"I think it is important to reaffirm that this is real and it can be done," Gupta told AFP.

The findings will be presented later Tuesday at a medical conference in Seattle, Washington.

Graphic on how HIV attacks white blood cells

Millions of people infected with HIV around the globe keep the disease in check with so-called antiretroviral therapy (ARV), but the treatment does not rid patients of the virus.

Close to 37 million people are living with HIV worldwide, but only 59 percent are receiving ARV. Nearly one million people die every year from HIV-related causes.

A new drug-resistant form of HIV is also a growing concern.

The first sustained remission survivor, announced in 2009 as "the Berlin patient" and later named as American Timothy Brown, was given two transplants and underwent total body irradiation to treat leukaemia -- a process that nearly killed him.

Gupta said that while a second successful transplant did not constitute a generalised cure, it showed that even milder forms of treatment can achieve full remission.

"There are a number of learning points here," he said. "Radiation has a lot of side-effects and leads to a delayed recovery of the bone marrow, so it's really good that we've shown you don't need radiation.

"The Berlin patient also had two rounds of chemotherapy because the first one didn't work. We've done ours just once, and it was also a milder form, which is important," he added.

Close to 37 million people are living with HIV worldwide, but only 59 percent 

are receiving treatment

'HIV is curable'

Both patients received stem cell transplants from donors carrying a genetic mutation that prevents expression of an HIV receptor, known as CCR5.

The London patient was diagnosed with HIV infection in 2003 and had been on antiretroviral therapy since 2012.

Later that year, he was diagnosed with advanced Hodgkin's Lymphoma, a deadly cancer.

He underwent a stem cell transplant in 2016 from a donor with two copies of a CCR5 gene variant, which is resistant to most HIV-1 virus strains.

"CCR5 is something essential for the virus to complete its life-cycle and we can't knock out many other things without causing harm to the patient," said Gupta.

"We know that CCR5 can be knocked out without any serious consequences because people are walking around without that gene."

Map showing the latest data on HIV infections for adults between 2010 to 2017

CCR5 was the target in the genome of the controversial gene-edited twins born last year in China, whose father is HIV-positive.

Experts cautiously welcomed Tuesday's announcement.

The International AIDS Society said in a statement Tuesday that results from the second patient "reaffirm our belief that there exists a proof of concept that HIV is curable".

Sharon Lewin, director of the Peter Doherty Institute for Infection and Immunity, told AFP that the second case showed a cure was "feasible".

"We can try to tease out which part of the transplant might have made a difference here, and allowed this man to stop his anti-viral drugs," she added.

New communities

After the bone marrow transplant, the London patient remained on ARV for 16 months, at which point treatment was stopped.

Regular testing has confirmed that the patient's viral load remained undetectable since then.

But scientists were keen to stress that the technique is likely only viable among a tiny percentage of sufferers.

The first sustained remission survivor, announced in 2009 as "the Berlin patient" and 

later named as American Timothy Brown, was given two transplants and underwent 

total body irradiation to treat leukaemia -- a process that nearly killed him

"Due to the rarity of suitable donors, this precise approach will not be available to all HIV patients," said Aine McKnight, professor of Viral Pathology at Queen Mary University, London.

"However, this work has the potential to stimulate research into more generally applicable therapies."

Gupta said he hoped to expand research on the stem-cell transplant technique to focus on communities in Africa, where the HIV-beating mutation does not naturally occur.

"Expanding remission to populations that are affected disproportionately is quite important," he told AFP.

China eyes bans for rogue scientists after gene-editing uproar

France24 – AFP, 27 Feb 2019

Chinese scientist He Jiankui has been placed under police investigation and the
government ordered a halt to his research work AFP/File

Beijing (AFP) - China has drafted new rules for biotechnology research, including fines and bans for rogue scientists, after a Chinese researcher caused a global outcry by claiming that he gene-edited babies.

Scientist He Jiankui's shock announcement that his experiment led to the birth of the world's first genetically-modified babies in November put a spotlight on China's lax oversight over scientific research.

He claimed to have altered the DNA of the twins to prevent them from contracting HIV by deleting a certain gene under a technique known as CRISPR.

The new rules unveiled on Tuesday propose to classify technology used for extracting genetic materials, gene editing, gene transfer and stem cell research as "high risk".

Health authorities under the central government would manage such research.

The State Council, China's cabinet, would be responsible for "the supervision and administration of clinical research and applications throughout the country," according to the rules.

The new draft proposes fines of between 50,000 and 100,000 yuan ($7,500 and $15,000) for scientists or institutions that carry out research without proper authorisation, and the government can halt and confiscate the work.

A scientist who earns "illegal income" from unauthorised research would be fined 10 to 20 times the amount of the illicit earnings.

Depending on the severity of the violation, a scientist can be banned from their field of work for six months to one year.

"If the circumstances are serious, their medical practice licence shall be revoked and the individual shall not engage in clinical research for life," the rules say.

He Jiankui has been placed under police investigation and the government ordered a halt to his research work.

A government probe found that He had "forged ethical review papers" and "deliberately evaded supervision", according to state media.

He had recruited eight couples for the gene-altering trial, and the investigation confirmed that a second woman became pregnant.

It is unknown if she has given birth yet.

Gene-editing for reproductive purposes is illegal in most countries, but China does not have a law banning it.

A brief regulation issued by the health ministry in 2003 prohibits gene-editing of human embryos, but does not stipulate any punishments for violators.

Following the storm sparked by He's announcement, scientists have called for an international treaty on gene-editing.

Chinese hospital denies approving gene-edited babies experiment

Yahoo – News, 27 November 2018

A group of 122 Chinese scientists have signed a joint statement condemning
the experiment as 'crazy'

The Chinese hospital linked to a controversial experiment purporting to have created the world's first genetically-edited babies denied its involvement Tuesday.

Shenzhen Harmonicare Women and Children's Hospital said in a statement that it suspected the signature on a document approving the experiment, specifically its adherence to ethical standards, was falsified.

It has also asked police to investigate.

"We have always firmly opposed the development of genetic experiments that violate human ethics and morality," the hospital said on its website.

The experiment, which was led by Chinese professor He Jiankui, claims to have altered the DNA of twin girls born a few weeks ago to prevent them from contracting HIV, and has prompted a heated debate among the scientific community.

Some warned that exposing healthy embryos and children to gene editing was irresponsible, while others denounced He's experiment as premature and dangerous.

Chinese scientists and institutions have also criticised the experiment, with 100 scientists in China issuing a joint statement calling for better state legislation.

"It is a great blow to the global reputation and development of biomedical research in China," said the statement posted on the Twitter-like platform Weibo.

The university where He works has also distanced itself from the scientist's experiment.

"This research work was carried out by Professor He Jiankui outside of the school," the Southern University of Science and Technology said in a statement Monday.

He has been on unpaid leave since February and his research is a "serious violation of academic ethics and norms", it said.

The Shenzhen Harmonicare Women and Children's Hospital too has denied any involvement with He.

In interviews with Chinese media, Cheng Zhen, the general manager of the hospital, said the hospital had not partnered with He, and that he had never even met the man before.

He's experiment -- if it had been carried out -- is prohibited under Chinese laws and regulations, according to state media CCTV in a report citing remarks at a Tuesday event by the deputy minister of China's Ministry of Science and Technology, Xu Nanping.

Specifically, Chinese laws limit in vitro human embryonic stem cell research to a maximum of 14 days, said Xu.

#UPDATE The Chinese hospital linked to a controversial experiment purporting to have created the world's first genetically-edited babies has denied its involvement. https://t.co/pvybblDOCm #CRISPR #geneediting pic.twitter.com/nj8GwQA60X

— AFP news agency (@AFP) November 27, 2018

Elton John and Prince Harry launch bid to 'smash' AIDS stigma

Yahoo – AFP, July 24, 2018

Elton John and Britain's Prince Harry launched a new initiative to break the
cycle of HIV transmission (AFP Photo/Robin Utrecht)

Amsterdam (AFP) - Elton John joined forces with Britain's Prince Harry to launch a $1.2 billion initiative on Tuesday to "break the cycle" of HIV transmission by targeting young men, among whom infections are on the rise.

On the second day of a major international AIDS conference in Amsterdam, the two lent their mega-wattage star power to calls for action to end the lingering stigma around the virus and protect generations to come.

"Young people are the only age group where HIV infections are rising, not falling," warned rock star and veteran AIDS campaigner Elton John as he announced the launch of the MenStar Coalition.

"We have to do much, much more to bring men, especially younger men more fully into the fold," he insisted.

The coalition brings together different partners, including the UN's Unitaid and the US fund PEPFAR, as John warned that 24- to 35-year-old men were accessing HIV testing and treatment at "unacceptably low rates".

Much work has been done to protect women and girls but "we can't solve the whole problem if we are only addressing half the situation," John said.

"If we want to win this fight, if we want to end AIDS once and for all, we must make men part of the solution" and teach them to protect themselves, "not only their wives and girlfriends, their sisters, and daughters, but also critically their brothers and their sons."

The countries with the highest rates of new HIV infections (AFP Photo/Cecilia SANCHEZ)

'Dangerous complacency'

Some 15,000 delegates -- researchers, campaigners, activists and people living with the HIV virus which causes AIDS -- have gathered for the five-day war council, amid dire warnings the AIDS epidemic could yet spiral out of control.

"The progress we have fought so hard for is at risk from a dangerous complacency," Prince Harry told conference delegates.

"Too many around the world are still ignoring the damaging knock-on effects on education and other community services for not prioritising HIV prevention and treatment."

The new initiative was focused on "the tough but essential work of truly changing mindsets," the Duke of Sussex said.

"Inspired by the growing alarm of the rate of new HIV infections among young women, this campaign is bravely tackling the root of this problem -- the lack of awareness of HIV prevention amongst hard-to-reach young men."

He urged people to unite around the "smashing of a deadly stigma" surrounding HIV, "and calling out the prejudice that is still there".

South African actress Charlize Theron agreed as she addressed the day's opening plenary session entitled: "Breaking the barriers of inequity".

"We have come a long way as a global community from that moral panic that defined early stages of this epidemic," she told the audience.

But she warned that "most of us now know and understand that HIV is not just about sex or sexuality... We know it is linked to the second-class status of women and girls worldwide."

Britain's Elton John and Prince Harry launch a $1.2 billion initiative to fight AIDS transmission by targeting the education of young men, during a major international AIDS conference in Amsterdam pic.twitter.com/wCizRktKBI

— AFP news agency (@AFP) July 24, 2018

Pharma Bro' Shkreli gets seven years jail for defrauding investors

Yahoo – AFP, March 9, 2018

Pharmaceutical executive and hedge fund manager Martin Shkreli was
sentenced to seven years prison for defrauding investors (AFP Photo/Drew Angerer)

New York (AFP) - Infamous "Pharma Bro" Martin Shkreli, once dubbed the most hated man in America for ratcheting up the price of an HIV drug, was sentenced to seven years prison Friday on charges of defrauding investors.

The disgraced former pharmaceutical executive and hedge fund manager was convicted last August of conspiracy to commit securities fraud and two counts of securities fraud.

Shkreli is best known for suddenly raising the price of the drug Daraprim by 5,000 percent -- from $13.50 a pill to $750 -- in 2015.

Although that incident had nothing to do with his trial before a federal court in New York, so great was the 34 year-old's notoriety that it was initially difficult to find an impartial jury for the trial.

His bail was revoked in September over a threat aimed at Hillary Clinton -- which he insists was a joke.

Shkreli's high-profile attorney, Ben Brafman, described his client as a mildly autistic self-taught genius and asked Judge Kiyo Matsumoto to limit the prison sentence to a maximum of 18 months.

Prosecutors were seeking 15 years prison, arguing that Shkreli had showed no remorse for his actions and pointing to his provocative and bizarre statements posted on social media.

Shkreli's high-profile attorney, Ben Brafman, had described his client as a mildly autistic self-taught genius and asked Judge Kiyo Matsumoto to limit the prison sentence to a maximum of 18 months https://t.co/yPMOKAyPgf

— AFP news agency (@AFP) March 9, 2018

Africa gets generic version of most effective HIV drug

Yahoo – AFP, June 28, 2017

A nurse takes a blood sample on March 8, 2011 in a mobile clinic set up to test
students for HIV at Madwaleni high school near Mtubatuba in Kwazulu Natal,
South Africa (AFP Photo/STEPHANE DE SAKUTIN)

Nairobi (AFP) - The generic version of the most advanced drug against HIV has been introduced in Kenya, a first in Africa where more than 25 million have the disease, the NGO Unitaid said Wednesday.

The drug, Dolutegravir (DTG) is the anti-retroviral drug of choice for those living with HIV in developed countries, but its high price has put it out of reach for most struggling with the disease in Africa.

"The generic DTG has two advantages: on the one hand, it is very good from a pharmaceutical point of view. On the other hand, it is much cheaper," said Robert Matiru of Unitaid, which works to reduce the costs of medicines treating AIDS, tuberculosis or malaria.

He described the drug as "the most effective HIV treatment currently on the market."

A box of 30 pills of DTG, which lasts a month, costs between $25 (21 euros) and $50. The generic version only costs $4.

Kenya has already started rolling out the new drug, which will initially be provided for free to 27,000 people living with HIV who are intolerant to the side effects of the current best drug used in the country.

It will become available nationwide later in the year, and will also be rolled out in Nigeria and Uganda.

The drug is easier to take than those currently on the market, requiring only one pill a day, causing fewer side effects, and patients are less likely to develop resistance, said Matiru.

Around 37 million people live with HIV/AIDS around the world, 70 percent of them in Africa, according to 2015 statistics from the World Health Organisation (WHO). 

Ebola vaccine may be 'up to 100% effective': WHO

Yahoo – AFP, Marlowe Hood, December 23, 2016

In a major clinical trial, nearly 6,000 people in Guinea were given the test vaccine
last year, at the tail end of a lethal epidemic of Ebola and non of them contracted
the disease (AFP Photo/CELLOU BINANI)

Paris (AFP) - A prototype vaccine for Ebola may be "up to 100 percent effective" in protecting against the deadly virus, the World Health Organization (WHO) said Friday.

If all goes well, the vaccine could become available in 2018 under a fast-track approval process, it said.

In a major clinical trial, nearly 6,000 people in Guinea were given the test vaccine last year, at the tail end of a lethal epidemic of Ebola.

Not one of the 6,000 contracted the disease.

But in a control group of volunteers that did not receive the vaccine, 23 Ebola cases occurred, researchers reported in The Lancet medical journal.

"If we compare zero to 23, this strongly suggests that the vaccine is very effective, that it could be up to 100 percent effective," Marie-Paule Kieny, WHO's assistant director-general and lead author of the study, told AFP.

Her team of three dozen researchers calculated a 90-percent likelihood during a full-fledged epidemic that the vaccine, dubbed rVSV-ZEBOV, would work in more than 80 percent of cases.

"After 40 years, we appear to now have an effective vaccine for Ebola virus disease to build upon," Thomas Geisbert, a scientist at Galveston National Laboratory in Texas who did not take part in the study, wrote in a commentary, also in The Lancet.

Factfile on how the Ebola virus attacks (AFP Photo/John Saeki/Adrian Leung)

'Compassionate use'

First identified in 1976 in what is now the Democratic Republic of Congo, the Ebola virus erupted periodically in outbreaks of up to a couple hundred cases, mainly across west and east Africa.

In early 2014, however, a handful of infections in southern Guinea mushroomed rapidly into an epidemic.

Over the next two years, more than 28,000 people fell ill, mainly in Guinea, Liberia and Sierra Leone. Some 11,300 died.

With a mortality rate above 40 percent, the disease -- one of a category of so-called haemorrhagic fevers -- has an incubation period of up to three weeks. It causes violent and painful symptoms, including vomiting, diarrhoea, organ failure and internal bleeding.

The new vaccine was initially developed in Canada by public health authorities before being taken over by pharmaceutical giant Merck.

It is slated to be submitted by Merck to health authorities in the United States and Europe sometime next year under a fast-track approval process.

"We may have a vaccine which is registered in 2018," Kieny told journalists at a press conference Thursday, noting that the standard approval process for a new drug takes a decade, if not more.

In the meantime, Merck has committed to ensuring that 300,000 doses of the vaccine are available for emergencies under a protocol called "compassionate use".

"They will be able to produce a million in very short period of time," Kieny noted.

Of the more than 6,000 people injected with the Ebola vaccine only two showed 

serious adverse effects, the study reported, both recovered fully (AFP Photo/

CELLOU BINANI)

Unanswered questions

There are still questions to be resolved concerning the vaccine, including side effects.

Initial tests last year did not include children, while the most recent trials covered those over six years old.

Of the more than 6,000 people injected with the Ebola vaccine only two showed serious adverse effects, the study reported. Both recovered fully.

But it is still unknown if the vaccine is safe for children six and under, pregnant women, or people with the AIDS virus -- all groups that were excluded from the most recent trials.

Another unknown is how long innoculation lasts.

"With the Canadian Merck vaccine, you have a protection very early after vaccination, but we don't know if it will last after six months," Kieny said.

Other Ebola vaccines under development -- some of which have been tested in humans -- could prove more effective over a longer period.

British firm Glaxosmithkline and Johnson & Johnson, based in the United States, each have experimental products in the pipeline.

China and Russia have also developed vaccines, with the Russian one having just finished the second phase of three-step clinical trials.

Some of these vaccines require two doses three weeks apart, and may confer a longer immunity.

"That might be better suited to immunise health workers in advance of an outbreak," Kieny said.

Health officials also point to the fact that other strains of the virus -- including one in Sudan -- will require the development of separate vaccines.

Health workers assist a patient suspected of having Ebola on their way to a

 treatment centre run by the French Red Cross in Patrice, Guinea, on

November 21, 2014 (AFP Photo/Kenzo Tribouillard)

Related Articles:

Sierra Leone's first Ebola-hit community reconsiders its traditions

WHO declares Ebola outbreak over

"Revelations of Darkness" - Oct 1, 2014 (Kryon Channelling by Lee Carroll) - (Text version)

“ .. The Role of Gaia in Human Consciousness

One of those times might be frightening for you to know about, since it was a full cooperation with Gaia for your termination, and a pandemic almost wiped humanity off the map. A pandemic! Now, you say, "What has that got to do with Human consciousness, Kryon?" Pay attention, dear ones, because this is the day where the teaching was given by my partner, and he put together the Nine Human Attributes. One of the attribute sets included three Gaia attributes and one of them was the consciousness of the planet. Gaia is related to Human consciousness!

Are you starting to connect the dots? You are connected to this planet in a profound and spiritual way. As goes humanity goes the planet's consciousness. Gaia, Mother Nature, whatever you want to call it, cooperates with Human consciousness. If you spend 1,000 years killing each other, then Gaia will do its best to cooperate with your desires! Gaia will look at Human consciousness and try to help with what you have shown you like to do! Did you know this role of Gaia with you? It's a partner with you, fast tracking what you give to it. You may wish to review what the indigenous of the planet still understand. Gaia is a partner!

Pandemic: Don't you find it odd that in the last 50 years, when you have a population of seven billion Human Beings, with up to 2,000 airplanes in the air at any given moment, going between almost every conceivable place, that there has not been a pandemic in your lifetime? There have been five starts of potential pandemics over the last 20 years, yet none became serious. Did any of you put this together? Dear ones, when the world was far less populated a few hundred years ago, with no mass travel to spread a virus, there were still millions wiped out by a pandemic. With the increased population and mass travel, there is far more danger today than before. It doesn't make sense, does it? What happened to stop it?

When you know humanity's relationship to Gaia, it makes sense. Gaia is a life-force that is your partner, watching you change the balance of light and dark and reflecting what Humans want. It has polarity, too! Perhaps it's time to start your meditations with thanking your planet Earth for supporting you in the spirituality of your Akash, for always being with you, a life-force that is always present. The ancients started their ceremonies in that way. Have you forgotten?

Ebola

Now, I've just set the stage for the next subject, haven't I? Ebola. Are you afraid yet? Gaia is a life-force that is a part of Human consciousness. My partner put it on the screen today so you could see the connections [during the lecture series]. Now it's time to connect the dots. Dear one, Gaia is in the battle, too, for here comes something scary that you haven't had in your lifetime and you're afraid of it - the potential of a pandemic on the planet.

There's a very famous film that has some dialogue that my partner will quote. Some of you will know it and some of you won't, but here it is: "Have a little fire, scarecrow?" What are you afraid of? Darkness? Gaia is in the battle with you and is actively pursuing solutions through light. The energy of the planet is with you in this fight! The ebola virus is a shock and a surprise. It is propelled by ignorance and fear, so it can flourish. Look at where it started and look at how it gets its ability to continue. It expands its fear and power easily with those who believe it's a curse instead of those who understand the science.

Villages are filled with those who refuse to leave their family members because they believe the disease is a curse! FEAR! Instead of understanding that they should be in isolation from the virus, the family dies together through ignorance and fear. This represents how darkness works. Are you going to become afraid also? Dear ones, ebola will be conquered. Know this and be at peace. Pray for light for those in the villages who are afraid, that they can know more about how to keep the spread of this disease and live to see their families. .”