Coronavirus Vaccine Could Be Ready in Six Months from Sarah Gilbert at Oxford University

By Olivia Konotey-Ahulu

A vaccine against the coronavirus could be ready by September, according to a scientist leading one of Britain’s most advanced teams.

Sarah Gilbert, professor of vaccinology at Oxford University, told The Times on Saturday that she is “80% confident” the vaccine would work, and could be ready by September. Experts have warned the public that vaccines typically take years to develop, and one for the coronavirus could take between 12 to 18 months at best.

In the case of the Oxford team, however, “it’s not just a hunch, and as every week goes by we have more data to look at,” Gilbert told the London newspaper.

Gilbert’s team is one of dozens worldwide working on a vaccine and is the most advanced in Britain, she told the Times. As the country looks set to begin its fourth week under lockdown, a vaccine could be fundamental in easing the measures and returning to normal life. Gilbert said human trials are due to start in the next two weeks.

Her remarks came as the death toll from the virus pushed past 100,000 globally. On Friday, the U.K. reported 980 fatalities, taking the total count from the virus to 8,958, and the government has repeatedly pleaded with the public to obey lockdown rules during the long Easter holiday weekend. As Prime Minister Boris Johnson begins his recovery after a spell in intensive care, Patrick Vallance, the government’s chief scientific adviser, warned he expects the number of deaths to increase for “a few weeks” yet.

Manufacturing the millions of vaccine doses necessary could take months. Gilbert said she’s in discussions with the British government about funding, and starting production before the final results are in, allowing the public to access the vaccine immediately if it proves to work. She said success by the autumn was “just about possible if everything goes perfectly.”

China approves first homegrown COVID-19 vaccine to enter clinical trials

By Elise Ma

One day after the U.S. began the first human trial of an mRNA vaccine candidate for COVID-19 on March 16, China said Tuesday evening that it had approved the first clinical trial of a vaccine candidate developed by domestic researchers.

The vaccine candidate, known as Ad5-nCoV, is a recombinant novel coronavirus vaccine. It was jointly developed by Tianjin-based Cansino Biologics Inc. and the Institute of Biotechnology of the Academy of Military Medical Sciences. The clinical trial will enroll 108 subjects and take place at Tongji Hospital in Wuhan, the epicenter of COVID-19.

Cansino said Ad5-nCoV is a genetically engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express SARS-CoV-2 spike protein. The vaccine candidate is intended to be used to prevent the disease caused by the novel coronavirus infection.

Backed by the state, the company has also obtained support from the Tianjin Science and Technology Bureau through the Project on Emergency Prevention and Control of COVID-19 Infection to develop the vaccine.

On March 17, the company said it has started to prepare for clinical trials of Ad5-nCoV and the pre-screening of healthy volunteers.

Cansino CEO Xuefeng Yu said the company and the academy have been collaborating closely since late January to develop Ad5-nCoV and generate sound scientific data to support its IND filing. “Having committed to providing unconditional support to fight against the global epidemic, Cansino is determined to launch our vaccine product candidate as soon as possible, with no compromises in quality and safety,” he added.

According to the Chinese Clinical Trial Registry, it is a single-center, open and dose-escalation phase I trial testing safety and tolerance of Ad5-nCoV in healthy adults, ages 18 to 60. The low-, middle- and high-dosage groups will each see 36 patients, who will receive 5e10vp, 1E11vp and 1E11vp of Ad5-nCoV, respectively.

The primary indicator is to see whether there are adverse reactions seven days after injection, and the secondary indicators are whether adverse reactions are observed 28 days after injection or severe adverse reactions six months after the injection.

Researchers will also look for anti-S antibody immunoglobulin G, neutralizing antibodies against SARS-CoV-2, neutralizing antibodies against Ad5 and specific T-cell responses as secondary indicators.

Ad5-nCoV is developed with Cansino’s adenovirus-based viral vector vaccine technology platform, which utilizes adenoviruses as viral vectors to deliver vaccine antigens to the human cell. Previously, the technology platform was key in enabling Cansino to translate its Ebola virus disease vaccine, Ad5-EBOV, from a concept to an approved product in merely three years.

A forerunner in China’s vaccine space, Cansino came to the industry’s attention when its Ad5-EBOV became the first approved Ebola virus vaccine in China for emergency use and as part of the national stockpile in October 2017.

Leveraging the existing technology platform, Cansino said results from preclinical animal studies of Ad5-nCoV show that the vaccine candidate can induce strong immune responses in animal models. The preclinical animal safety studies demonstrated a good safety profile.

“We have completed the necessary preclinical steps for vaccine R&D. To date, the GMP clinical batches have passed quality testing and are ready for the phase I clinical trial,” the company said.

Stepping carefully

A cautious scientist, Yu stressed the importance of safety in vaccine development and warned that there is more to think of than just the speed of development.

“We need speed, but we still need quality. We d

on’t want to introduce a second harm to people. It is critically important to check every step,” Yu said in a webinar organized by Chinese CRO Wuxi Apptec last month.

He said although the existing technology platform can speed up the development of a vaccine, there are issues to address before applying any vaccine to a human. Animal models should be available before moving any vaccine candidates into human trials so as to produce a vaccine that will eventually work without concerns such as disease enhancement.

“Even though we have learned from MERS and SARS, COVID-19 is still a new virus that behaves very differently, so we should really get some basic understanding,” Yu said.

And in developing a vaccine for emergency response, Yu said it would be ideal to require just one dose, and developers need to consider the manufacturability of the vaccine in order to benefit more people.

On March 16, the NIH said a phase I trial has begun in Seattle. The vaccine candidate, known as mRNA-1273 and co-developed by NIH and Moderna Inc., encodes viral spike (S) protein for prevention of COVID-19.

Regeneron and Sanofi speed Kevzara into coronavirus trials

Dive Brief:

Rheumatoid arthritis drug Kevzara will be used in an international study of patients infected with the new coronavirus and suffering from acute respiratory distress syndrome, Regeneron Pharmaceuticals and Sanofi announced Monday.

The trial will kick off in disease hotspot New York City, expanding to a total of 16 U.S. sites and enrolling 400 patients. The companies aim to study whether Kevzara can reduce fever and the need for supplemental oxygen in patients severely affected by COVID-19, the illness caused by the virus.

Roche’s Actemra, which has a similar mechanism of action, has been tested in Chinese patients and led to a decrease in fever and oxygen use, prompting the country to include it in treatment guidelines. The drug’s use shows the speed with which global public health officials are willing to consider using drugs off-label in order to address the coronavirus pandemic.

Dive Insight:

A vaccine to prevent infections of the novel coronavirus SARS-CoV-2 is likely a year or more away — at best — and treatments specifically designed to fight this virus or its complications are similarly far off.

Possible treatments, however, could already be available in the form of marketed or existing experimental drugs. Global public health officials, eager for a weapon to use in the midst of a global pandemic, are showing a willingness to be flexible in terms of the clinical trials and the evidence needed to prove treatments’ effectiveness.

Earlier this month, China OK’d the use of Actemra in patients with lung complications and high levels of interleukin-6, or IL-6, a protein that mediates inflammatory and immune response. High levels of IL-6 have been associated with a greater risk of death in patients with community-acquired pneumonia.

Actemra and Kevzara both block IL-6 and are prescribed for rheumatoid arthritis, a disorder in which an overactive immune system creates joint-damaging inflammation and pain. Actemra is similarly approved in conjunction with cancer cell therapy, which can sometimes trigger an immune reaction known as cytokine release syndrome.

The U.S.-based Kevzara trial is a two-part design that will initially evaluate fever and oxygen use in patients with acute respiratory distress syndrome, or ARDS. Two different dose levels will be used and compared to a placebo.

Longer-term, the trial hopes to measure prevention of death, use of ventilation, supplemental oxygen or hospitalization, but the design will be “adaptive” to determine the number of patients that will be followed and the endpoints to be used. ARDS often causes permanent lung damage and can lead to early death.

The trial aims to enroll 400 patients in the U.S. Regeneron’s partner Sanofi will handle international trial sites, naming Italy as one likely location for testing in coronavirus patients.

To get the trial underway quickly, Regeneron and Sanofi worked closely with the Food and Drug Administration and the Biomedical Advanced Research and Development Authority, the division of HHS involved in preparing for natural and man-made biological threats.

Hong Kong researchers make major progress in developing coronavirus vaccine

By David Ho and Cornelia Zou

HONG KONG – As drug developers are racing to find a cure for the new coronavirus, researchers in Hong Kong claim to have made major headway in the development of a vaccine for the virus that has so far killed 132.

Yuen Kwok-yung, the chair of infectious diseases at the University of Hong Kong’s (HKU) department of microbiology, said in a press briefing at Hong Kong’s Queen Mary Hospital that his team had successfully isolated the novel virus from the first imported case in Hong Kong.

But he said the vaccine still needs months to be tested on animals and an additional year for human trials before it is fit for use.

The vaccine is based on a nasal spray influence vaccine invented by Yuen, a severe acute respiratory syndrome (SARS) expert, and his team.
The race to find a cure is on.

“It will normally take 15 to 18 months to go from obtaining the DNA of a virus to getting an IND for neutralizing antibodies,” Chris Chen, CEO of Wuxi Biologics Cayman Inc. (HK: 2269), told BioWorld. “Because of the possibilities of unexpected mutations, we cannot afford to follow the normal procedures, so we decided to compress the process to four or five months, while complying to all the international standards.”

The company said on Jan. 29 that it has stepped up its efforts in enabling the development of multiple neutralizing antibodies for the novel coronavirus.

Having respectively completed all preclinical CMC for the world’s first yellow fever antibody and the worlds’ first Zika virus antibody in a record timeline of seven and nine months previously, the company is aiming at a five-month mark for the development of new antibodies for the 2019 coronavirus.

“We obtained the virus DNA this week, we will produce the first batch of sample antibodies in the next few weeks, then we’ll ask authorized institutes to test the efficacy of our antibodies before communicating with the National Medical Products Administration and the Chinese Academy of Inspection and Quarantine regarding moving the antibodies forward into clinical study,” said Chen. “And in March, hopefully we’ll be able to start the mass production for human use.”

HKU’s Yuen told media that the coronavirus in SARS and Middle East Respiratory Syndrome (MERS) are in the same family of virus as the new strain.

Consequently, previous drugs used to battle those indications, such as the protease inhibitor Kaletra [lopinavir/ritonavir for HIV-1] and interferon beta, may be tested to see if they are effective treatments.

He added that they would investigate whether the antiviral ribavirin may also be added to those two candidates to improve them.

“We hope we can tell everyone if the drugs are effective in the laboratory after several weeks,” he said.

Yuen recently warned that the virus is entering its third wave of transmission, which would be human-to-human.

The first wave of transmission is believed to be from animal-to-human while the second wave spread from a seafood market in Wuhan to neighboring areas.

“Unlike the 2003 SARS outbreak, the improved surveillance network and laboratory capability of China was able to recognize this outbreak within a few weeks and announced the virus genome sequences that would allow the development of rapid diagnostic tests and efficient epidemiological control,” wrote Yuen and team in a recently published article in The Lancet.

“Our study showed that person-to-person transmission in family homes or hospitals, and intercity spread of this novel coronavirus are possible, and therefore vigilant control measures are warranted at this early stage of the epidemic.”

Global development work underway

Yuen’s HKU team is not the only one in the rush to develop a coronavirus vaccine.

The University of Queensland (UQ) in Australia is also aiming to develop one at an unprecedented speed.

“The team hopes to develop a vaccine over the next six months, which may be used to help contain this outbreak,” said Paul Young, the head of UQ’s school of chemistry and molecular biosciences, in a statement.

“The vaccine would be distributed to first responders, helping to contain the virus from spreading around the world.”

The speedy development is credited to a novel ‘molecular clamp’ technology invented by UQ researchers.

“The University of Queensland’s molecular clamp technology provides stability to the viral protein that is the primary target for our immune defense,” said Keith Chappell, a senior research fellow at UQ’s school of chemistry and molecular biosciences, in a statement.

“The technology has been designed as a platform approach to generate vaccines against a range of human and animal viruses and has shown promising results in the laboratory targeting viruses such as influenza, Ebola, Nipah and MERS coronavirus.”

Oslo, Norway based-public private coalition The Coalition for Epidemic Preparedness Innovations (CEPI) is supporting UQ’s development efforts. It is also working with biotech firms like Inovio Pharmaceuticals, Inc. and Moderna, Inc. on vaccines.

Rockville, Maryland-based Novavax Inc. is also working on one.

Others like Salt Lake City-based Co-Diagnostics Inc. claims to have finished the principle design work for a diagnostic.

Some expect that the health care system in China will bear the economic brunt of the virus.

“There is a risk that China’s health care system will not have sufficient resources to control the outbreak, which would mean that economic disruption could spiral further. Health care costs will also increase,” Imogen Page-Jarrett, a research analyst for the Access China division of the Economist Intelligence Unit, told BioWorld.

“The government added drugs used to treat the virus to the drug reimbursement list on January 21st, although patients will still face some out-of-pocket costs. Consumers may be forced to cut their spending, especially on non-essential items, in order to afford treatment or to save money as part of contingency planning,” she added.

Despite the dire situation, there is a silver lining for the pharmaceutical industry: “More positively, pharmaceutical companies will see strengthened demand for vaccines and antibiotics,” said Page-Jarrett.

Scientists Have Discovered a Brand New ‘Micro-Organ’ in The Human Immune System: subcapsular proliferative foci


Researchers have identified a brand new ‘micro-organ’ inside the immune system of mice and humans – the first discovery of its kind for decades – and it could put scientists on the path to developing more effective vaccines in the future.

Vaccines are based on centuries of research showing that once the body has encountered a specific type of infection, it’s better able to defend against it next time. And this new research suggests this new micro-organ could be key to how our body ‘remembers’ immunity.

The researchers from the Garvan Institute of Medical Research in Australia spotted thin, flat structures on top of the immune system’s lymph nodes in mice, which they’ve dubbed “subcapsular proliferative foci” (or SPFs for short).

These SPFs appear to work like biological headquarters for planning a counter-attack to infection.

Immune cells gathering at the SPF, with the purple band showing the SPF surface.

These SPFs only appear when the mice immune systems are fighting off infections that have been encountered before.

What’s more, the researchers detected SPFs in human lymph nodes too, suggesting our bodies react in the same way.

“When you’re fighting bacteria that can double in number every 20 to 30 minutes, every moment matters,” says senior researcher Tri Phan. “To put it bluntly, if your immune system takes too long to assemble the tools to fight the infection, you die.”

“This is why vaccines are so important. Vaccination trains the immune system, so that it can make antibodies very rapidly when an infection reappears. Until now we didn’t know how and where this happened.”

Traditional microscopy approaches analyse thin 2D slices of tissue, and the researchers think that’s why SPFs haven’t been spotted before – they themselves are very thin, and they only appear temporarily.

In this case the team made the equivalent of a 3D movie of the immune system in action, which revealed the collection of many different types of immune cell in these SPFs. The researchers describe them as a “one-stop shop” for fighting off remembered infections, and fighting them quickly.

Crucially, the collection of immune cells spotted by the researchers included Memory B type cells – cells which tell the immune system how to fight off a particular infection. Memory B cells then turn into plasma cells to produce antibodies and do the actual work of tackling the threat.

“It was exciting to see the memory B cells being activated and clustering in this new structure that had never been seen before,” says one of the team, Imogen Moran.

“We could see them moving around, interacting with all these other immune cells and turning into plasma cells before our eyes.”

According to the researchers, the positioning of the SPF structures on top of lymph nodes makes them perfectly positioned for fighting off infections – and fast.

They’re strategically placed at points where bacteria would invade, and contain all the ingredients required to keep the infection at bay.

Now we know how the body does it, we might be able to improve vaccine techniques – vaccines currently focus on making memory B cells, but this study suggests the process could be made more efficient by also looking at how they transform into plasma cells through the inner workings of an SPF.

“So this is a structure that’s been there all along, but no one’s actually seen it yet, because they haven’t had the right tools,” says Phan.

“It’s a remarkable reminder that there are still mysteries hidden within the body – even though we scientists have been looking at the body’s tissues through the microscope for over 300 years.”

The research has been published in Nature Communications.

New heroin vaccine offers promise for treatment

Scientists at The Scripps Research Institute (TSRI) have achieved a major milestone toward designing a safe and effective vaccine to both treat heroin addiction and block lethal overdose of the drug. Their research, published today in the journal Molecular Pharmaceutics, shows how a new anti-heroin formulation that is safe in animal models remains stable at room temperature for at least 30 days. As a result, the vaccine is close to being ready for human testing.

“The heroin vaccine is one step closer to clinical evaluation,” says Candy S. Hwang, PhD, first author of the study and a research associate at TSRI.

According to the National Institute on Drug Abuse, 15,446 Americans died from heroin overdose between 2000 and 2016, and the mortality rates are increasing. Heroin abuse has been further fueled by a rise in prescription opioid abuse—studies show that opioid pain reliever users are 40 times more likely to abuse heroin.

The first formulation of the heroin vaccine was developed in 2013 by a team led by Kim D. Janda, PhD, the Ely R. Callaway Jr. Professor of Chemistry and member of the Skaggs Institute for Chemical Biology at TSRI. It has been shown to be effective—and safe—in both mouse and non-human primate models.

The vaccine works by training the immune system antibodies to recognize and bind to heroin molecules, blocking the drug from reaching the brain to cause a “high.” Researchers believe that blocking the high of heroin will help eliminate the motivation for many recovering addicts to relapse into drug use.

The heroin molecule does not naturally prompt an antibody response, so researchers attach it to a carrier protein that alerts the immune system to start making antibodies. Scientists also add an ingredient called an adjuvant to the vaccine, which boosts the immune response and makes the vaccine more effective.

Hwang says, “Our goal was to prepare a vaccine that could be advanced to clinical trials. As such, we were looking for the best combination of ‘hapten’ (the heroin molecule), carrier protein and adjuvant to keep the vaccine both stable for transport and storage but still efficacious.”

For the new study, the researchers investigated how 20 different carrier protein/adjuvant combinations worked, including shelf stability based on temperature and storage time and whether the formulation was a liquid or powder.

Their experiments in rodent models showed that the best vaccine formulation contained a carrier protein called tetanus toxoid (TT) and adjuvants called alum and CpG ODN. The discovery that alum worked best as an adjuvant was especially significant since alum is one of the few adjuvants used in vaccines already approved by the U.S. Food and Drug Administration. The researchers also found that there was no difference in how well it worked between the liquid and powder versions of this formulation.

Hwang notes that the best vaccine formulation showed protection against lethal doses of heroin. This is particularly important as many heroin addicts have succumb to overdose and death during their attempts to quit the drug.

With this new study, the researchers have shown that the vaccine is safe and effective in animal models, stable under clinical conditions and reliant on an already-approved adjuvant. The next step is to find a producer to make the vaccine on a large scale.

“We believe that a heroin vaccine would be tremendously beneficial for people who have a heroin substance use disorder but have found difficulty in trying to quit,” says Hwang.

In addition to Hwang and Janda, authors of the study, “Enhancing Efficacy and Stability of an Anti-Heroin Vaccine: Examination of Antinociception, Opioid Binding Profile, and Lethality,” were Paul T. Bremer, Cody J. Wenthur, Beverly Ellis and Bin Zhou of The Scripps Research Institute; and Sam On Ho, SuMing Chiang and Gary Fujii of Molecular Express, Inc.

The study was supported by the National Institutes of Health (grants UH3DA041146, F32AI126628, F32DA043323, R42DA040422 and R44AI094770).

Julius Youngner, Polio Vaccine Pioneer, Dies at 96


Julius Youngner, an inventive virologist whose nearly fatal childhood illness destined him to become a medical researcher and a core member of the team that developed the Salk polio vaccine in 1955, died on April 27 at his home in Pittsburgh. He was 96.

His death was confirmed by his son, Dr. Stuart Youngner.

Dr. Youngner was the last surviving member of the original three-man research team assembled by Dr. Jonas Salk at the University of Pittsburgh to address the polio scourge, which peaked in the United States in the early 1950s when more than 50,000 children were struck by it in one year. Three other assistants later joined the group.

Dr. Salk credited his six aides with major roles in developing the polio vaccine, a landmark advance in modern medicine, which he announced on April 12, 1955.

The announcement — that the vaccine had proved up to 90 percent effective in tests on 440,000 youngsters in 44 states — was greeted with ringing churchbells and openings of public swimming pools, which had been drained for fear of contagion. Within six years, annual cases of the paralyzing disease had declined from 14,000 to fewer than 1,000.

By 1979, polio had been virtually eliminated in developed nations.

“I think it’s absolutely fair to say that had it not been for Dr. Youngner, the polio vaccine would not have come into existence,” Dr. Salk’s son, Peter L. Salk, president of the Jonas Salk Legacy Foundation and a visiting professor at the University of Pittsburgh Graduate School of Public Health, said in an email.

While Dr. Youngner, who was 34 at the time, remained at the university and made further advances in virology, he and other members of the team remained embittered that Dr. Salk had not singled them out for credit in his announcement speech.

The printed version was prefaced with the phrase “From the Staff of the Virus Research Laboratory by Jonas E. Salk, M.D.,” and a United Press account quoted him as crediting his original three assistants, who had joined him as early as 1949 — Dr. Youngner, Army Maj. Byron L. Bennett and Dr. L. James Lewis — as well as three others.

“The really important thing to recognize is that the development of the polio vaccine at the University of Pittsburgh was a team effort,” Dr. Peter Salk wrote.

He added, “There is no question that my father recognized the importance of the team, and if there were circumstances in which that wasn’t adequately expressed, I would feel that it needs to be expressed now and very clearly so.”

In 1993, Dr. Youngner crossed paths with Dr. Salk for the first time since Dr. Salk left for California in 1961. According to “Polio: An American Story” (2005), by David M. Oshinsky, Dr. Youngner raised the 1955 announcement speech in confronting Dr. Salk.

“Do you remember whom you mentioned and whom you left out?” the book quoted him as saying to Dr. Salk. “Do you realize how devastated we were at that moment and ever afterward when you persisted in making your co-workers invisible?”

Asked later, though, whether he regretted having worked for Dr. Salk, Dr. Youngner replied: “Absolutely not. You can’t imagine what a thrill that gave me. My only regret is that he disappointed me.”

Dr. Youngner’s contribution to the team was threefold.

He developed a method called trypsinization, using monkey kidney cells to generate sufficient quantities of the virus for experiments and production of the vaccine. He also found a way to deactivate the virus without disrupting its ability to produce antibodies. And he created a color test to measure polio antibodies in the blood to determine whether the vaccine was working.

He later contributed research to understanding interferon as an antiviral agent in the treatment of cancer and hepatitis; to the development (with Dr. Samuel Salvin) of gamma interferon, which is used against certain infections; and to advances that resulted in vaccines for Type A influenza and (with Dr. Patricia Dowling) equine influenza.

“As a direct result of his efforts, there are countless numbers of people living longer and healthier lives,” Dr. Arthur S. Levine, the University of Pittsburgh’s senior vice chancellor for the health sciences and dean of its medical school, said in a statement.

Julius Stuart Youngner was born on Oct. 24, 1920, in Manhattan and raised in the Bronx, where he survived lobar pneumonia, a severe infection of the lungs. His father, Sidney Donheiser, was a businessman. His mother was Bertha Youngner. He took her surname when his parents divorced.

After graduating from Evander Childs High School in the Bronx at 15, he earned a bachelor’s degree in English with a minor in biology from New York University in 1939 and a master’s and doctorate of science in microbiology from the University of Michigan.

Drafted into the Army in World War II, he worked on the Manhattan Project at Oak Ridge, Tenn., and at the University of Rochester, testing the toxicity of uranium salts. He said he learned of the project’s goal of building an atomic bomb only when it was dropped on Japan.

He was working at the National Cancer Institute, part of the National Institutes of Health, when the University of Pittsburgh hired him as an assistant professor in 1949 to assist Dr. Salk. He was a professor of microbiology and medical genetics at the university School of Medicine and chairman of the department of microbiology (biochemistry and microbiology were added later) from 1966 until his retirement in 1989.

His first wife, the former Tula Liakakis, died in 1963. Besides their son, Stuart, a psychiatry and bioethics professor at Case Western Reserve University in Cleveland, Dr. Youngner is survived by his wife, the former Rina Balter; a daughter, Lisa, an artist, also from his first marriage; three grandchildren; and a half brother, Alan Donheiser.

Dr. Youngner’s infectious curiosity, as a colleague characterized it, generated hundreds of scholarly papers and more than 15 patents. He was president of the American Society for Virology from 1986 to 1987.

When he was 7, Dr. Youngner nearly died from the pneumonia he had contracted when bacteria ate through his chest and infected a rib. An effective vaccine for pneumonia and antibiotics would not be invented for nearly two decades.

“So they strapped my legs to a table, and two nuns held my arms and another held my head and they prayed while they operated on me,” he recalled in an oral history interview in the early 1990s with the National Council of Jewish Women. “To this day I can remember the feeling of the saw on that rib.

“Later in life, when I had to have some minor surgery,” he said, “I put it off for years because I was so affected by this episode.”

NewLink Genetics in Ames, Iowa is closing in on human trials for Ebola vaccine

The biotech company NewLink Genetics in Ames, Iowa is closing in on human trials for an Ebola vaccine.

“From the laboratory to moving these first human trials has moved faster than I’ve ever seen anything move before in my professional career,” said Charles Link, CEO of NewLink Genetics.

Link said they are just a few days away from human testing. During Phase 1 of testing, healthy volunteers will be given the vaccine. Researchers will test to see how safe the vaccine is and what dosage is necessary for an immune reaction.

“With a dangerous virus, you don’t ever use the dangerous virus. You basically use a little snippet of it,” said Link.

Link said that snippet is a surface protein you get from Ebola and assures us there is no Ebola is in the vaccine.

“If you get an immune reaction to the surface protein an then it sees the real Ebola, it will attack it,” said Link.

Once those tests are complete, the company will move into Phase 2 where tests focus on how effective and useful the vaccine is. Those tests will be done in West Africa.

Link said he’s hoping it’ll take less than a year, but there’s no real way of telling when the vaccine will be ready for distribution until test results start coming in.

“We want to shorten the process as much as humanely possible within the bounds of safety and the ethics that’s required to conduct these sorts of studies in healthy volunteers,” said Link.

The Phase 1 of the tests will be conducted at the National Institute of Allergy and Infectious Disease and the Walter Reed Army Medical Center.
Ames Company Close to Ebola Vaccine Trials