Category: Corona Virus Vaccine

Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time. USA TODAY

The Seattle volunteers who got shots in the first trial of a possible coronavirus vaccine are now getting the second shot an indicator the early trial is progressing well.

While the doctors at Kaiser Permanente'sVaccine Treatment and Evaluation Unitin Seattle dont know the results of the first round of tests, the fact that it has continued and that the second round of injections are now being given is good news, said Lisa Jackson, who is leading the study.

The trial hasnt been stopped. We know from the study protocol that if adverse events had happened, the protocol would have required that, she said.Therefore we presume those things havent happened.

The volunteers are taking part in the first investigational vaccine study to fight coronavirus. The studylaunched on March 16.

U.S. researchers have given healthy volunteers the first shot of an experimental coronavirus vaccine as anxiously awaited testing opens. The Associated Press observed as the study's first participant received the injection inside an exam room. (March 16) AP Domestic

The vaccine, called mRNA-1273, was developed by scientists at the National Institute of Allergy and Infectious Diseases and at theCambridge, Mass.-based biotechnology company Moderna, Inc..

It is being given in two doses because the SARS-CoV-2 virus, which causes COVID-19, is new and no one had been exposed to it before it appeared in December, said Jackson.

Humans are a "naive" population when it comes to the virus. The first shot is a primer to set the immune system up, giving it a first look at the virus, Jackson said.

The second shot, administered 28 days later, builds on that protection so the body can more rapidly produce antibodies if it is later exposed to the virus.

After the first set of volunteers was enrolled in Seattle, the trial was expanded on March 27 to include volunteers at Emory University in Atlanta, Georgia. The initial group included 28 in Seattle and 17 at Emory.

The volunteers will be followed for 13 months to ensure they have no side effects or other reactions to the vaccine.

Jennifer Haller, left, smiles as the needle is withdrawn after she was given the first-stage safety study clinical trial of the potential vaccine.(Photo: Ted S. Warren, AP)

The experimental Moderna vaccine uses messenger RNA to get the bodys own cells to produce a protein found on the spikes on the surface of the SARS-CoV-2 virus it uses to infect human cells.

The hope is that the body will respond to those proteins by mounting a robust immune response to the virus.

The National Institutes of health is now expanding the trial to include 60 adults over the age of 56, Jackson said. Some will be tested in Seattle, some in Atlanta at some at the NIH in Bethesda, Maryland.

The test is part of Phase I trial of the possible vaccine. The goal is to test the safety of various doses and whether these doses produce an immune response.

Phase I trials dont study whether the vaccine is effective in preventing COVID-19 infection. That comes in Phase II.

There are no vaccines or treatments that have yet been approved for COVID-19. The Moderna vaccine was the first of more than 70 candidate vaccines currently being tested worldwide, according to the World Health Organization.

In terms of treatment, thus far the most promising but still not yetapproved as it's in the testing phase may be Remdesivir, an antiviral drug from Gilead Sciences. Leaked data from a test at the University of Chicago appeared to indicate it might help those infected. The company has cautioned that until all data is analysized, it's impossible to draw any conclusions from the trial.

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Doctors start giving second round of shots to volunteers in Seattle COVID-19 vaccine trial - USA TODAY

The chances of securing an effective vaccine or treatment for the coronavirus this year are "incredibly small," the UK's top medical adviser has warned.

Professor Chris Whitty, the chief medical officer, said on Wednesday that the UK would have no choice but to retain at least some of the social distancing measures currently in place.

"In the long run, the exit from this is going to be one of two things, ideally," Whitty said at the UK government's daily coronavirus press briefing.

"A vaccine, and there are a variety of ways they can be deployed ... or highly effective drugs so that people stop dying of this disease even if they catch it, or which can prevent this disease in vulnerable people."

He added: "Until we have those, and the probability of having those any time in the next calendar year is incredibly small, we should be realistic that we're going to have to rely on other social measures, which of course are very socially disruptive as everyone is finding at the moment."

Whitty said the government's focus should be on ensuring the so-called "R number" the average number of people one infected person transmits the virus to remains below one. If it rises above one, the number of people infected with the virus would rise exponentially and threaten to overwhelm the NHS.

The social distancing measures introduced by Boris Johnson in March brought the R number below one within the general population,the government believes. Ministers and scientific advisers are currently considering which measures they can lift without taking it above one again.

"What we are trying to work out is what are the things that add up to an R of less than one," Whitty said.

"That narrows our options quite significantly. We are going to have to do a lot of things for really quite a long period of time, the question is what is the best package. If you release more on one area you have to keep onboard more of another area so there's a proper trade-off, and this is what ministers are having to consider."

His comments came after the chief executive of the Swiss pharmaceutical giants Roche said this week that scientists would be unlikely to secure a vaccine before the end of 2020.

"I'm afraid that the most likely scenario is that we will not have a vaccine before the end of next year," Severin Schwan said on a Wednesday conference call, adding that an 18-month timeline is "very ambitious."

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Coronavirus: Chance of vaccine or treatment this year 'incredibly small' - Business Insider - Business Insider

Pharmacist Michael Witte, left, gives Neal Browning a shot in the first-stage study of a potential coronavirus vaccine at the Kaiser Permanente Washington Health Research Institute in Seattle. Browning is the second patient to receive the shot in the study.(Ted S. Warren/AP)

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Six coronavirus vaccines already being tested in humans - New York Daily News

Virus Vaccine May Be Ready for Mass Production By Autumn, Oxford Professor Says  Bloomberg

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Virus Vaccine May Be Ready for Mass Production By Autumn, Oxford Professor Says - Bloomberg

Updated April 23, 2020 06:37:18

With more than 115 coronavirus vaccines in development, one of the largest pandemic health innovation funding bodies has raised the alarm over equity of access if a vaccine finally arrives.

Jane Halton is the former head of the Australian Department of Health and the chair of the Coalition for Epidemic Preparedness Innovation (CEPI).

"We now have to think about issues around vaccine sovereignty," she told 7.30.

"How do we ensure that the vulnerable populations around the world will get access to a vaccine?"

The organisation is attempting to avoid what happened in 2009, when wealthy countries including Australia entered into contracts with big pharmaceutical companies, effectively monopolising the H1N1 swine flu vaccine at the expense of poorer nations.

"Everybody will want this vaccine, everybody will want to be vaccinated to reduce their risk," she said.

"So we have to negotiate this."

It echoes the concerns of Pulitzer Prize-winning science writer Laurie Garett.

"Without equity, pandemic battles will fail," he wrote.

"Viruses will simply recirculate, and perhaps undergo mutations or changes that render vaccines useless, passing through the unprotected populations of the planet."

CEPI is currently funding 10 vaccines for COVID-19 that Ms Halton said were not necessarily in the commercial interest of big pharmaceutical companies in recent years.

"A number of people were very worried that we weren't investing money in some potential disease causing pathogens, that no one was going to spend money on because there wasn't a commercial return." she said.

Some of these vaccine technologies were initially created to combat SARS (severe acute respiratory syndrome), although an effective, safe vaccine was never fully approved.

"We were lucky with SARS, we dodged a bullet," Ms Halton said.

"And I think many of us would say that the countries who experienced SARS have responded more quickly than others; they remember.

"But we tried to develop vaccines for SARS. And in one particular case, there was a vaccine that looked very promising.

"Sadly, it turned out not to be safe."

According to CEPI, there are six candidates in clinical development right now.

Two in the USA (mRNA-1273 and INO-4800), three in China (Ad5-nCoV, LV-SMENP-DC and a Pathogen-specific aAPC) and one in the United Kingdom.

According to the British Secretary of Health, the UK trial is expected to begin human testing today.

The Oxford University project, a collaboration between the university's Jenner Institute and Oxford Vaccine Group, hopes to produce a million doses of the vaccine by September.

The world's biggest pharmaceutical company, Johnson and Johnson, announced it would begin clinical trials of its vaccine this September with the view to producing 1 billion doses by next year, according to Paul Kershaw, head of the company's Asia Pacific Medical Affairs.

"We're accustomed to developing vaccines over a period of five, seven or even more years," he told 7.30.

"And so doing this in 12 to 18 months is an extremely compressed timeframe.

"It's basically an inactivated virus that allows us to deliver antibodies, creating the presence of antibodies which will fight the virus in patients.

"It's a very safe vector. It's something that we have experience with.

"We've used it extensively already to mount a campaign against Ebola in Africa."

But the process is long and extremely expensive, and companies will look to be the first to market and recoup costs.

"That is the nature of drug development. It's a risky business," Mr Kershaw said.

"We can't wait to finish the clinical trials and then start developing on manufacturing and distributing the vaccine. What we need to do is both of those activities in parallel."

It is possible that multiple vaccines might succeed, much like the way flu shots have different brands or ingredients in each country.

"It's entirely possible that there will be a couple of vaccines, possibly using different technology," Ms Halton said.

Mr Kershaw agrees.

"There will likely be a number of vaccines that become available," he said.

"And that's all the better. We're playing a part."

Topics:chemicals-and-pharmaceuticals,health,covid-19,epidemics-and-pandemics,medical-research,vaccines-and-immunity,australia

First posted April 23, 2020 04:57:42

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Trials for a coronavirus vaccine are underway, but will it be available to all? - ABC News

Hancock: UK human trials for coronavirus vaccine to begin on Thursday video  The Guardian

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Hancock: UK human trials for coronavirus vaccine to begin on Thursday video - The Guardian

At 70 least potential novel coronavirus vaccines are being developed by research teams across the globe, including in the U.S., U.K. and China, according to the latest report this month from the World Health Organization (WHO).

Several pharmaceutical companies and biotechnology firms have joined the race to find a vaccine for the COVID-19 virus, which has infected over 2.4 million people across at least 185 countries and regions, as of Tuesday, according to the latest figures from Johns Hopkins University.

The director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), Dr. Anthony Fauci, who is also a member of the White House COVID-19 task force, stated: "It will take at least a year to a year in a half to have a vaccine we can use."

Here we look at some of the main potential COVID-19 vaccine developments currently in the pipeline.

Rearchers at Inovio Pharmaceuticals have developed the INO-4800 vaccine, which is given as a skin-deep shot instead of the typical deeper shot. The vaccine is in phase one of its clinical trials in Kansas City, Missouri, being conducted among 40 participants. The company is also working with China to begin studies there.

Earlier this month, Novavax (a Maryland-based biotechnology firm) announced its NVX-CoV2373 vaccine will begin its first human trial on 130 participants in mid-May, with preliminary results expected in July.

Pre-clinical studies found the vaccine "produces high levels of neutralizing antibodies against SARS-CoV-2 in animal studies," said Gregory Glenn, the president of research and development at Novavax.

"This is strong evidence that the vaccine created by Novavax has the potential to be highly immunogenic in humans which could lead to protection from COVID-19 and helping to control the spread of this disease," said Matthew Frieman, associate professor at the University of Maryland School of Medicine.

Johnson & Johnson, in collaboration with Beth Israel Deaconess Medical Center (part of Harvard Medical School), has been looking at potential vaccine candidates since January this year.

Last month, the researchers identified a lead vaccine candidate, which could potentially see a vaccine be available for emergency use by early 2021. Clinical trials are expected to begin in September, with data on the safety and efficacy of the vaccine expected to be available by the end of the year, the company confirmed in a statement.

"Our goal is to enable the supply of more than 1 billion doses of the vaccine globally," vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, Paul Stoffels, told Yahoo earlier this month.

Johnson & Johnson previously developed the Ebola vaccine, while its vaccine candidates for Zika, RSV, and HIV are currently in the second and third phases of their clinical development stages.

Last month, the U.S. began the first human trial for a potential COVID-19 vaccine. Developed by the biotechnology firm Moderna, the first phase of the trial for the mRNA-1273 vaccine is being conducted at Seattle-based Kaiser Permanente Washington Health Research Institute (KPWHRI).

Emory University's VTEU (Vaccine and Treatment Evaluation Unit) in Atlanta, Georgia was added by the NIAID, which is funding the trial, as a second test site for the first phase of the study.

The trial will observe 45 participants over 14 months to test how various safe doses of the vaccine react and whether it kicks the immune system into action. The vaccine uses a segment of the virus' genetic code rather than a piece of the virus, which it is hoped will allow it to be developed more quickly.

"Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority. This Phase 1 study, launched in record speed, is an important first step toward achieving that goal," Fauci said in a NIAID statement last month.

Earlier this month, Sarah Gilbert, a professor of vaccinology at Oxford University, claimed that a vaccine for the novel coronavirus could potentially be ready by this September.

Gilbert and researchers at Oxford University's Jenner Institute and Oxford Vaccine Group have been developing the ChAdOx1 nCoV-19 vaccine since January.

Working with a base vaccine for other similar coronaviruses, Gilbert's team managed to speed up a development process that would normally take around five years to around four months.

Earlier this week, she confirmed that her team is waiting for final safety tests and approvals for the clinical trials, which she hopes could begin by the end of this week. But she urged millions of doses of vaccine would have to be manufactured even before these trials are concluded.

"What we need from the [U.K.] government is support to help us accelerate the manufacturing," she said speaking on BBC One's The Andrew Marr Show.

"There aren't any manufacturing facilities in this country that at the moment can make very large amounts of the vaccine," she added.

Gilbert previously stated that she gives the vaccine an 80 percent chance of being successful based on evidence that she has seen.

China is looking at three potential vaccines, including one by Chinese biopharmaceutical company CanSino Biologics, developed in collaboration with the Beijing Institute of Biotechnology. The first phase of clinical trials for the team's Ad5-nCoV vaccine was launched last month.

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Recruitment of volunteers for the second phase of clinical trials for the Ad5-nCoV vaccine has begun. "It's the world's first novel coronavirus vaccine to initiate Phase II clinical studies," Wu Yuanbin, an official from China's Ministry of Science and Technology, said at a press briefing earlier this month.

Another potential vaccine is being developed by Beijing-based Sinovac Research and Development Co., Ltd, while another is being studied by the Wuhan Institute of Biological Products and the Wuhan Institute of Virology. Both vaccine candidates were approved for the first phase of their clinical trials earlier this month.

The graphic below, provided by Statista, illustrates countries with the most confirmed COVID-19 cases.

Data on COVID-19 cases is from Johns Hopkins University unless otherwise stated.

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Coronavirus Vaccine Update as 70 Potential Treatments Being Rapidly Developed Across the Globe - Newsweek

Representative Bill Foster (DIL) is leading an effort to encourage U.S. regulators to allow volunteers to be infected with the pandemic coronavirus to speed vaccine testing.

By Jon CohenApr. 21, 2020 , 11:55 AM

Sciences COVID-19 reporting is supported by the Pulitzer Center.

Political support is building for regulators in the United States to embrace the controversial strategy of intentionally infecting volunteers with the virus that causes COVID-19 in order to test experimental vaccines. Such human challenge trials could greatly accelerate the development of an effective vaccine, 35 members of the House of Representatives argue in a letter sent yesterday to the heads of the U.S. Food and Drug Administration (FDA) and its parent agency, the Department of Health and Human Services (HHS).

[A] more risk-tolerant development process is likely appropriate in the case of a COVID-19 vaccine, write the group of lawmakers, which includes both Democrats and Republicans. The enormous human cost of the COVID-19 epidemic alters the optimization of the risk/benefit analysis.

The lawmakers also back the idea of parallel, simultaneous testing of different doses of a vaccineas opposed to the traditional practice of sequential testing that, for safety reasons, begins by giving trial participants the lowest dose first and then ratchets up. Parallel testing could more quickly move a candidate vaccine from small studies that look only at safety and immune responses to larger ones that actually assess efficacy, the letter notes.

The letter was spearheaded by Representatives Bill Foster (DIL), a physicist, and Donna Shalala (DFL), former HHS secretary. This is designed as much as anything to give the FDA political cover needed to approve challenge trials, Foster tells ScienceInsider. The FDA must be worried that theyre going to have these trials, something bad is going to happen, therell be a bad story in the newspaper about a sympathetic person who got unlucky in one of these trials and didnt survive. And then Congress is going to go and say: Lets have a hearing on this, and start dragging them in. One of my goals in here was to let them know that Congress understands that there are no risk-free paths here.

According to the latest tally by the World Health Organization (WHO), 76 vaccine candidates are already under development around the world. Five have moved into clinical trials. But public health officials have cautioned that, from start to finish, it takes at least 1 yearand more likely 18 monthsto prove whether a candidate is safe and effective. And thats if no problems surface.

Stanley Plotkin, a leading vaccine researcher at the University of Pennsylvania who has advocated human challenge studies for COVID-19 vaccines, welcomes the congressional show of support. It is urgent that authorities like FDA and WHO give challenge studies immediate consideration, as they could speed up the use of vaccines even before formal licensure that would depend on additional data, Plotkin says.

In theory, challenge trials could enroll volunteers who are at low risk of harm from the virus that causes COVID-19dubbed SARS-CoV-2such as young adults who rarely develop serious symptoms after becoming infected naturally. Our situation in this pandemic is analogous to war, in which there is a long tradition of volunteers risking their health and lives on dangerous missions for which they understand the risks and are willing to do so in order to help save the lives of others, the letter states. Every week of delay in the deployment of a vaccine to the seven billion humans on Earth will cost thousands of lives.

Critics of human challenge studies note that many unknowns remain about SARS-CoV-2. Conducting proper studies would require time to grow the viruses to be used in the challenges under sterile conditions and to determine the optimal challenge dose. Whats more, Sinovac, a Chinese company that began clinical trials of its COVID-19 vaccine last week, says it may complete the first two phases of testing by the end of June and seek regulatory approval for emergency use of their candidate in high-risk people like health care workers, which is another way to shortcut answers to whether a produce is safe and effective.

Foster counters that testing a vaccine in health care workers who are needed in a hot spot also has risks, as it might take them out of work for a time. He hopes the letter just makes the FDA a little less scared, stressing that its pretty clear that the only way were really finally going to get out of this [pandemic] is when we have an effective vaccine.

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United States should allow volunteers to be infected with coronavirus to test vaccines, lawmakers argue - Science Magazine

A coronavirus vaccine being developed by Oxford University will enter human trials as early as this Thursday, according to the U.K.s health secretary.

The U.K. government will provide 20 million ($24 million) to the universitys team and a further 22.5 million to Imperial College, where scientists are also working on a vaccine. Scientists at Oxford have previously said the aim is to produce a million doses of the vaccine by September.

Secretary of State for Health and Social Care Matt Hancock praised both teams for making rapid progress and said the U.K. will throw everything weve got at developing a vaccine.

He also said the government would invest in manufacturing capabilities so that if either vaccine was successful it could be available for British people as soon as humanly possible.

We are going to back them to the hilt and give them every resource that they need to get the best possible chance of success as soon as possible. The upside of being the first country in the world to develop a successful vaccine is so huge that I am throwing everything at it.

Read:These 21 companies are working on coronavirus treatments or vaccines

However, he insisted vaccine development was a process of trial and error and trial again.

The Oxford University project, a collaboration between the universitys Jenner Institute and Oxford Vaccine Group, opened recruitment for the clinical trial for healthy adults between 18 and 55 at the end of March, having begun research on a vaccine against the coronavirus-borne disease COVID-19 in February. Trials will now begin as soon as this Thursday, the health secretary revealed in the governments daily briefing on Tuesday.

Praising the team, Hancock said reaching this stage in normal times would take years.

Also:GSK, Sanofi to team up on COVID-19 vaccine

Speaking at the end of March, Adrian Hill, director of Oxford Universitys Jenner Institute, said: The Oxford team had exceptional experience of a rapid vaccine response, such as to the Ebola outbreak in West Africa in 2014. This is an even greater challenge.

Vaccines are being designed from scratch and progressed at an unprecedented rate. The upcoming trial will be critical for assessing the feasibility of vaccination against COVID-19 and could lead to early deployment.

Read on:Hydroxychloroquine as treatment for COVID-19 shows no benefit and more deaths in VA study

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Oxford University coronavirus vaccine to begin human trials on Thursday as U.K. throws everything at vital breakthrough - MarketWatch

Here are five things you need to know about the coronavirus outbreak this Tuesday evening. We'll have another update on Wednesday morning.

Health Secretary Matt Hancock, giving the daily briefing at Downing Street, has revealed that a potential coronavirus vaccine being developed by Oxford University will be trialled in people from Thursday. "The upside of being the first country in the world to develop a successful vaccine is so huge that I am throwing everything at it," he said. It comes as the number of hospital deaths from coronavirus in the UK has risen by 823 to 17,337 people.

New figures from the Office for National Statistics show deaths in England and Wales have hit a 20-year high, but experts also believe virus deaths could well have peaked. There were about 8,000 more deaths in the week up to 10 April than is normal at this time of year. But separate analysis by NHS England is being highlighted by experts which showed the number of deaths in hospitals has been falling since 8 April.

Capt Tom Moore, the 99-year-old war veteran who has raised more than 27m for the NHS, has appeared via video link to open a new Nightingale hospital in Harrogate. Social distancing rules meant a virtual ceremony had to be held for the opening of the 500-bed facility at Harrogate Convention Centre, which was converted into a hospital in less than three weeks.

Born eight weeks early and weighing just 3lbs 5oz (1.5kg), Peyton Maguire was diagnosed with Covid-19 at just three weeks old. "I think the doctor was trying to keep me calm but I was sobbing," her mum Tracy, from Lanarkshire, says. Peyton was given steroids to help strengthen her lungs and received "amazing" care from neonatal nurses in hospital. Fortunately she has now recovered, with mum and baby leaving hospital on Monday.

Imagine you've been sailing around the world, blissfully unaware of the global pandemic changing our lives. That's what happened to Elena Manighetti and Ryan Osborne, who asked their loved ones to keep in touch - but not to share bad news. So after 25 days at sea, they attempted to dock on a small Caribbean island in mid-March. There, they found all the island's borders were closed and discovered the world had been suffering from a pandemic they'd heard nothing about.

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Coronavirus: Evening update as human vaccine trials to start this week - BBC News