Category: Covid-19 Vaccine

Leaders in the health tech industry are skeptical that a COVID-19 vaccine will be available by 2021.

Thats one of the takeaways from the latest Healthcare Prognosis Report, an annual 300-person survey published by venture capital firm Venrock that gathers opinions from members of the health tech industry on what to expect in the upcoming year. As the firm was working on the 2020 survey, COVID-19 landed in the United States and dramatically altered the course of the healthcare industry. Venrock subsequently decided to do three surveys over the course of eight weeks to get a more accurate reading of how industry leaders were feeling about the pandemic and to chart their changing perspectives. The list of contributors skews toward entrepreneurs, those working on healthcare delivery software, and health industry investors.

The first survey was sent out at the end of February, right as the first U.S. cases were discovered. The second survey was sent out four weeks later, by which point 1,500 Americans had died of COVID-19. At that point, 45% of participants believed a COVID-19 vaccine would become broadly available by 2021. By the third survey, optimism about a vaccine waned. That one went out at the end of April, when at least 90 vaccine candidates for COVID-19 were in development, seven of which had advanced to phase I trials. Despite this, only 31% of those surveyed thought a vaccine would be broadly available by 2021.

Respondents expressed similar doubts about the rapid development of treatments for COVID-19. By the time the second survey was issued, both remdesivir, an antiviral once tested as a possible treatment for Ebola, and chloroquine and hydroxychloroquine, which have been used to guard against and treat for malaria respectively, were being tested as potential treatments for COVID-19. The survey shows respondents were hopeful about them: Slightly more than half thought a good treatment would become available by 2021. In a subsequent survey, only 39% were positive a treatment would emerge within 18 months.

According to Bryan Roberts, a partner at Venrock whose portfolio includes 10X Genomics, Devoted Health, Doctor on Demand, and Lyra Health, the people who take his firms survey are predisposed to thinking about innovation in terms of its ability to scale quickly, which is inherently difficult for vaccines.

I think that between survey two and survey three it became clear that there was not a silver bullet that somebody could pull off the shelf that would be an awesome therapy, Roberts says of COVID-19. I would argue the same thing is true of vaccines.

It became clear that there was not a silver bullet that somebody could pull off the shelf that would be an awesome therapy.

Given the challenges of biomedicine, there are no guarantees that a vaccine candidate will succeed. One study found that over a 20-year span, an average vaccine had a 6% chance of making it to market. Notably, HIV still does not have a vaccine 30 years after it rose to prominence in the U.S., though it does have lots of treatments, including ones capable of suppressing the worst effects of the disease and mitigating its spread.

Development is not the only cumbersome aspect of making a vaccine thats accessible to everyone. Building up vaccine production facilities traditionally takes years. Companies that are working on COVID-19 vaccines are already discussing how to scale manufacturing infrastructure for candidates that are still in an early stage of development. Even with significantly crunched timelines, it could take a long time before a vaccine is widely available. However, biomedical companies, the government, and philanthropists are working to scale up vaccines quickly. Moderna, a company with an mRNA vaccine in clinical trials, says that it will have tens of millions of doses of its yet-to-be-approved vaccine by 2021, thanks to funding from the Biomedical Advanced Research and Development Authority. Johnson & Johnson, meanwhile, has announced a partnership with a manufacturer to supply 1 billion doses of its proposed vaccine. There is no guarantee that either Moderna or Johnson & Johnsons vaccine will ultimately work.

Venrocks survey is less an indicator of when a viable vaccine or treatment for COVID-19 will actually emerge and more reflective of the tech industrys expectations. The survey also indicates areas where health tech businesses might be investing, such as big data platforms and in-home care. COVID-19 and social distancing restrictions have pushed patients online, away from the doctors office and into video sessions and text chats with health professionals. The survey respondents expect that until a vaccine for COVID-19 is available, people may prefer to go online for their healthcare needs when possible.

As for big data, there is still a lot to learn about COVID-19. The virus has highlighted the importance of more open data in healthcare. One reason biomedical companies have been able to rally vaccine and drug development for COVID-19 is because Chinese researchers sequenced the genome of the coronavirus and published their findings early on in the outbreak. That kind of rapid scientific sharing has allowed researchers around the world to get to work developing medicines to combat the virus. While information about the coronavirus is being shared right now, disease research has not traditionally been so open. Medical research is often distributed across a web of publications and proprietary company databases in ways that are inaccessible to scientists broadly. There isnt a single platform researchers can easily access to search and analyze all past researcha major hurdle for biomedical innovation. Companies that use artificial intelligence to discover drugs were already thinking about how to amass and leverage big data before the coronavirus outbreak. However, the conversation around building big data repositories and analytics for health research has become more urgent.

Its important to remember that investors and health tech experts are not soothsayers, though they enjoy pontificating and placing big bets on the future. In the first survey, the vast majority of participants predicted deaths from the coronavirus in the U.S. would total less than 10,000. As of this writing, deaths related to COVID-19 in the U.S. have topped 100,000.

It reinforced for me how hard it is for any of us to quantify dramatic changes in existential risk, Roberts says.

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Will a COVID-19 vaccine arrive by 2021? Health tech leaders are skeptical - Fast Company

This week, the UK hosts the Global Vaccine Summit which brings together the global health community to celebrate the power of vaccines and pledge to support immunisation for everyone, everywhere, by funding the next five years of work by Gavi, the vaccine alliance.

Since it was set up 20 years ago, Gavi has made sure the worlds poorest communities have had access to vaccines, and prevented more than 13 million deaths through routine immunisation. COVID-19 presents a major risk to their work.

In the early days of the COVID-19 pandemic, mass vaccination campaigns were paused to reduce the risk of spreading the virus. As well as official restrictions on peoples movements, some parents understandably worried and uncertain have been reluctant to take their children out to get vaccinated. This has been compounded by the new challenges facing health workers, including restrictions on travel, redeployment to the COVID-19 response, and a lack of protective equipment.

A recent statement from the World Health Organization, UNICEF and Gavi lays bare the immediate and quite staggering effects of this the biggest of which are being felt by children in low-income communities. It showed that routine immunisation services have been substantially hindered in at least 68 countries, affecting approximately 80 million children under the age of 1.

A further 24 million people in Gavi-supported lower-income countries are at risk of missing out on vaccines against polio, measles, typhoid, yellow fever, cholera, rotavirus, HPV, meningitis A and rubella. It is in these communities, that often have poor access to health care and treatments, that vaccines are of the highest importance. By providing protection against infection in the first place the vaccines can mean the difference between life and death.

Even in countries where COVID-19 transmissionremains high, the argument for keeping up routine immunisation is persuasive. New analysis has shownthat in Africa, for each death caused by COVID-19 acquired from an immunisation visit, there could be more than 100 childrens deaths prevented by continuing routine immunisation. A difficult and delicate balance must be struck between lockdown measures that reduce the risk of COVID-19 and maintaining safe immunisation that will prevent other devastating outbreaks in the months and years to come.

Mass immunisation not only saves lives, it also givesvital insights into the health of communities around the world. The fewer vaccines that are given, the fewer interactions there are between health care workers and communities. This effectively leaves local health systems blind to the spread of disease and whatthey need to doto prevent further infections. Without this insight that immunisation systems provide, it will be evermore difficult to target the most at-risk communities with the vaccines they need to stay healthy.

Keeping immunisation systems and structures active throughout this time also means that they will be ready and resourced to deliver a COVID-19 vaccine when one is developed. Billions of doses will be required to stop the spread of the virus. This enormous undertaking will require the support of regional and national immunisation systems to get the vaccine to everyone that needs one.

The COVID-19 pandemic has shown us the importance of a single vaccine for our health, for our connection to family and friends, and for economies around the world. During this crisis we must not develop tunnel vision and forget the importance of our existing vaccines or the dangers of the diseases they protect us from.

We need governments to continue to champion and invest in immunisation systems in every country, starting today. Supporting Gavi to deliver life-saving vaccines in the worlds poorest countries is a great way to do this. The world has never faced a problem like the one we are facing. We need short-term action as well as long-term thinking to balance getting control of the pandemic bydeveloping vaccines, tests and treatments,with maintaining essential routine immunisation. If we can do this, we can reach a world where everyone, everywhere has access to lifesaving vaccines.

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While we wait for a COVID-19 vaccine, let's not forget the importance of the vaccines we already have | News | Wellcome - Wellcome Trust

On the heels of the Food and Drug Administration (FDA) creating the Coronavirus Treatment Acceleration Program (CTAP)an emergency initiative aimed to support clinical trials that are testing new treatments for COVID-19Honeywell has introduced a technology package that can help accelerate the production of vaccines.

Last week, Honeywell announced Fast Track Automation. Using a combination of its proprietary automation and process technologies for the life sciences industry, Fast Track Automation enables vital vaccines, treatments, and therapies to move from regulatory approval to full production in as little as two months, depending on process requirements, the company said.

The offering brings together the cloud, virtualization, batch software, remote asset management from a data center, and the flexible assignment of computing power. The technology combination prepares manufacturing automation designs in parallel with clinical trials to ensure production is ready to go once a medical therapy is approved.

Specifically, the set up incorporates process automation elements that can be configured in a virtual environment, then implemented rapidly once a therapy is approved and ready to be produced for public distribution. Manufacturers can even use the system to digitize manual steps during clinical trials to better consolidate and analyze data and more seamlessly prepare electronic submissions for regulatory body review and approval, using this data to prepare final production automation design.

Fast Track Automation is a direct response to the global COVID-19 outbreak. According to the company, at the point in time when clinical trials are nearing completion, the ability to rapidly pivot and scale up to meet production demand will severely test existing technology infrastructures.

Our solution allows for end-to-end manufacturing process and data visualization, providing real-time visibility and predictive insights while offering benefits like enhanced audit-readiness and data integrity, minimized regulatory risk, increased operational efficiencies and reduced rejects and waste, said Cynthia Pussinen, vice president and general manager, Life Sciences, Honeywell Process Solutions.

Fast Track Automation, available now, can be quickly scaled up or down depending on needed changes and demand.

Click here for more on Automation Worlds COVID-19 coverage.

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Using Automation to Fast Track COVID-19 Vaccine Production - Healthcare Packaging

A nurse prepares a vaccine to be given to a child. A revolutionary mRNA vaccine is hoped to provide an antidote for COVID-19 and against a whole new class of pathogens, or infectious agents, for which no vaccine exists yet. The traditional vaccine industry usually takes time to get themselves organised and develop a shot for a new infectious disease, averaging of 16 years. mRNA could potential speed up this process. In many ways, it digitises vaccine development, using nano technology, to enhance the human bodys own machinery to do exactly what the body does once infected. Image Credit: Reuters

Dubai: The world has reopened, but we're all still waiting for a vaccine. A COVID-19 jab is considered the key to lifting social-distancing measures, reopening schools, markets and events around the globe.

Among the front-runners in vaccine development, there are several methods being used: live-attenuated, inactivated, subunit, toxoid, DNA and mRNA.

Today, the most advanced method is the mRNA (messenger ribonucleic acid).

This relatively new platforms remains unproven, but holdsmuch promise.This technology, if it delivers, is hoped to speed up revolutionise vaccine development.

What do vaccines do?

In general, vaccines train and strengthen the bodys immune system to develop resistance against pathogens and illnesses by imitating an infection to kick up a natural immune response specific to the infectious agent (such as COVID-19 virus).

Why is an mRNA vaccine being dubbed 'revolutionary'?

Nucleic acids are the basic building blocks of life. An RNA (ribonucleic acid) vaccine or mRNA (messenger RNA) vaccine is a new type of vaccine.

mRNA vaccine is seen as the new hope for the world, now among the most advanced in human trials (Phase-2) to screen a safe and effective COVID-19 shot that will be used on the world's healthy population.

Developing immunity to SARS-CoV-2 would render the virus no worse than the seasonal flu.

There are four phases in vaccine trials, the first 3 being the most crucial.

At the end of the Phase-1 trial of mRNA-1273, involving 45 volunteers, the company said the results were "encouraging", moving it closer to getting the licence for the first mRNA vaccine for human use.

On May 12, Moderna received fast-track approval from the USFood and Drug Administration (FDA) for mRNA-1273. On May 18, the company announced positive interim Phase 1 trial data.

On May 29, the first volunteer under Phase 2 testing of the vaccine was dosed, this time withan estimated 600 participants including adults below and above age 55.

Phase-3 study (involving thousands of volunteers) begins in July 2020 for Moderna.

Can mRNA vaccines be used to speed up vaccine trials against other infectious diseases?

Yes. mRNA is seen as the advanced biopharma industry's answer to a whole new class of pathogens or infectious agents for which no specific vaccines exist yet.

Vaccines are great, and have kept many infectious diseases at bay, saving tens of millions of lives.

However, the traditional vaccine industry usually takes time to get themselves organised and develop a vaccine, typically an average of 16 years.

mRNA speeds up this process. In many ways, it digitises vaccine development to enhance the human bodys own machinery to do exactly what the body does once infected.

mRNA vaccines are intended to kick up the production of antibodies within the human body, which will bind to fight (disable) potential pathogens when they enter the human body.

The mRNA sequence codes for antigens (disease-fighting agents), proteins that are identical or resemble those of the pathogen. Upon the delivery of the vaccine into the body, this sequence is translated by the host cells to produce the encoded antigens, which then stimulate the bodys adaptive immune system to produce antibodies against the pathogen.

Basically, an mRNA vaccine provides acquired immunity through an RNA-containing vector, such as lipid nanoparticles.

How does mRNA-vaccine technology work?

The mRNA sequence codes for antigens (disease-fighting agents), or proteins that are identical or resemble those of the pathogen.

Upon the delivery of the vaccine into the body, this sequence is translated by the host cells to produce the encoded antigens, which then stimulate the bodys adaptive immune system to produce antibodies against the pathogen.

Nature reports that thebiggest advantage of mRNA technology is rapid manufacturing of vaccines.

In theory, using mRNA as the basis of therapeutics and vaccines is characterised by a flexibility with respect to production and application.

"Any protein can be encoded and expressed by mRNA, in principle enabling the development of prophylactic and therapeutic vaccines fighting diseases as diverse as infections and cancer as well as protein replacement therapies," according toRNAbiology.

How many mRNA vaccines are on trial for COVID-19?

Among the top 10 front-runner candidate vaccines for COVID-19, there are currently two based on mRNA technology: one each by Moderna (US) and another by Pfizer/BioNTech/Fosun (US-Germany-China).

In total, there are 18 mRNA-based candidate vaccines in development globally for COVID-19, according to GlobalDatas Pharma Intelligence Center Drugs Database.

WHAT IS AN ANTIGEN?

The presence of antigens in the body normally triggers an immune response.

When was mRNA first used?

mRNA as a therapeutic was first promoted in 1989 after the development of a broadly applicable in vitro transfection technique. A few years later, mRNA was advocated as a vaccine platform.

It was deemed ideal as it brings together the immunological features of live "attenuated" vaccines such as endogenous antigen expression and T-cell induction with those of "killed" (or subunit vaccines_ like defined composition and safety.

What's the different between 'attenuated' vs 'inactivated' vaccine?

An attenuated vaccine is a vaccine created by reducing the virulence of a pathogen (disease-causing agent), but still keeping it viable (or "live"). Attenuation takes an infectious agent and alters it so that it becomes (theoretically) harmless or less virulent.

In contrast, an inactivated vaccine (or "killed" vaccine) is a vaccine consisting of virus particles, bacteria, or other pathogens that have been grown in culture and then lose disease-producing capacity.

Examples of inactivated vaccines include: inactivated poliovirus (IPV) vaccine, whole cell pertussis (whooping cough) vaccine, rabies vaccine and the hepatitis A virus vaccine.

Are there mRNA vaccines approved for use by humans for COVID-19?

No. Or not yet. But there are mRNA vaccines on trial as antidote to the coronavirus.

What are the leading mRNA vaccine candidates?

There are two, among the leading 10:

What are the advantages of mRNA vaccine over DNA or other traditional ones?

mRNA vaccines offer multiple advantages over DNA vaccines in terms of the following:

mRNA vaccines are also thought to have the potential to be used for cancer in addition to infectious diseases.

Multiple companies, including CureVac and Moderna, Pfizer/BioNTech/Fosun work on the development of mRNA vaccines to combat the COVID-19 pandemic.

If the mRNA vaccines pass rigorous trials proving they're safe and efficacious following trials on thousands of subjects/volunteers one key advantage hinges on rapidity of manufacture. This is because the process is cell-free and scalable.

A key advantage in mRNA technology is that the production facility could theoretically manufacture vaccines rapidly against multiple targets, with minimal adaptation to processes and formulation.Within weeks, clinical batches can be generated after the availability of a sequence encoding the immunogen.

In addition, new targets requiring multi-antigen approaches will benefit from the speed in which mRNA can render multiple constructs, according to Nature.

Who will approve the vaccine, and review the trials?

They will go through approvals in different jurisdictions. The Who keeps an online database of all the trials and their status. In the US, the vaccine must be approved the FDA (US Food and Drug Administration).

For Europe, its the EMA (European Medicines Agency). Every country has its own drug and vaccine regulatory body who also must approved the vaccine.

Who are the major vaccine developers?

Other major pharma giants in various stages of vaccine development include: AstraZeneca/Oxford GlaxoSmithKline/ Sanofi, Johnson & Johnson/US Biomedical Advanced Research and Development Authority (BARDA). In addition, there are Chinese, Indian, Italian biotech firms as well as Mexican, Japanese, Danish and Thai vaccine developers, among others.

What are the results of mRNA vaccine trials in human volunteers?

On May 18, 2020, Modern said its vaccine trials showed early signs of viral immune response. Moderna injected the first mRNA-based vaccines on human volunteers in March 16, 2020.

In the Moderna trial, researchers looked at blood samples taken from volunteers to check whether the vaccine helped them generate antibodies that could fight off an infection.

What they found: At two lower dose-levels used in the study, levels of antibodies found after getting a second booster shot of the vaccine either equaled or exceeded the levels of antibodies found in patients who had recovered from the virus.

Its an early sign that an antibody was made and can stop the virus from replicating. The company said that safety profile appeared to be good, and the reactions were typical of vaccines. They included injection site pain and redness, as well as temporary fever or chills that quickly go away on their own, said officials.

Meanwhile, Pfizer is also conducting clinical trials in the US and Europe for its BNT162 vaccine against SARS-CoV-2 virus with with German mRNA company BioNTech.

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COVID-19 mRNA vaccine: Will it save the world? Here's what you need to know - Gulf News

The world waits with bated breath for a COVID-19 vaccine, which could effectively end the pandemic once its widely available. Until then, more people will die from the disease, and economies will struggle to fully recover.

With such intense pressureto get a vaccine quickly, many experts are contemplating a controversial shortcutto the usual vaccine testing protocol: human challenge trials.

Instead of vaccinatinghundreds to thousands of people and waiting to see if they naturally catch thevirus, scientists would purposely infect a smaller number of vaccinated volunteerswith COVID-19 in a controlled setting to see if a vaccine offered protection.If successful, such studies could fast-track vaccine evaluation, as well as ourunderstanding of COVID-19 immunity.

However, doctors andresearchers dont all agree on whether its ethical to infect people with adisease that remains poorly understood, and for which there is currently noreliable treatment. That leaves it to those bioethicists, researchers andregulators to weigh the pros and cons.

If scientists stick to theusual playbook, a licensed vaccine is at least 12 to 18 months away, expertssay. Thats not because it takes long to develop possible vaccines dozens are already in the testing stage (SN: 5/20/20) but because of the time that ittakes to be sure a vaccine is safe and actually works.

The final and most involvedstage of this process, Phase III clinical trials, requires thousands of volunteersto get the vaccine or a placebo. Then, scientists track them over months to seewhether vaccinated people are less likely to get sick compared withunvaccinated people.

And it could take longer nowthat lockdowns and social distancing have flattened the curve of new cases.You can only test vaccine efficacy if incidence [of the disease] is highenough, says Helen McShane, a vaccine biologist at the University of Oxford.The less the disease is spreading, the longer traditional Phase III trials willtake.

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Challenge trials might shavemonths off the process. Human challenge trials have been done for hundreds ofyears, says Seema Shah, a bioethicist at Northwestern University MedicalSchool in Chicago. They come with a lot of promise, but also with seriousethical concerns.

For example, in 1796, Englishphysician Edward Jenner, an earlier popularizer of vaccination, demonstratedthat inoculation with cowpox worked as a vaccine against smallpox by injectinghis gardeners 8-year-old son with cowpox and then exposing him to the disease.Clearly, thats problematic, Shah says.

Nowadays, challenge trialsare typically done on diseases about which scientists know a lot, and for whichthere are numerous treatment options, such as influenza or malaria. But therescurrently no established drug safety net for COVID-19, though some drugs show promise (SN: 4/29/20).And much still remains unknown about the virus, including all the risk factors for severe disease (SN: 4/22/20).Consequently, most advocates are calling for such trials to be done only onyoung and healthy volunteers, who seem least at risk for serious illness.

Still, researchers,clinicians, bioethicists and policymakers are debating the ultimate utility ofhuman challenge trials for COVID-19. The ethical calculus could change as welearn more about the virus and continue developing treatments, but some expertsare already putting out rough plans for how to minimize risk to participants.

Here are two perspectives onthe issue, from scientists weighing both the risks and potential benefits.

We face a worldwideepidemic with a high mortality, and the only thing likely to stop it is vaccination,says Stanley Plotkin, a vaccine developer at the University of Pennsylvania.Human challenge trials have the potential to get us an effective vaccine soonerand thus save lives, Plotkin says, and we should start planning how to do themethically now.

I would, of course, notwant to subject anyone to harm, but the fact is that harm is accumulating allover now, and if we can reduce the total amount of harm, I think its worthdoing, Plotkin says. Extraordinary circumstances require extraordinary solutions.

Human challenge trials couldhelp scientists answer important unknowns about the virus more quickly thananimal studies can, Plotkin says. A human challenge trial could tell uswhether prior infection is protective or not, as well as what sort of immuneresponses are protective, Plotkin says. Both of those have very largeimplications in terms of whether people with prior infection could take care ofthe sick, as well as our ability to evaluate the efficacy of vaccine candidatesoutside of challenge trials.

Plotkin acknowledges thepotential risks to participants. Giving someone an infection can cause seriousharm, he says, but the usual way of doing things also means that many peoplewill become ill and possibly die. To minimize risk, Plotkin says such trialsshould only be carried out on young, healthy people who understand the risksand give their full consent. There are thousands of people willing to bevolunteers for such studies on moral grounds, with knowledge of the risks.

A vaccine shown to work in achallenge trial on young people may not work in older people, or may be lesseffective, Plotkin says. But a challenge trial could allow us to more easilydetermine whether the immune responses we see in younger people are also seenin older people, who get the experimental vaccine but arent subjected to achallenge virus. Even if the vaccine only worked in younger folks, that couldstill protect older people simply because they wouldnt be getting infected byyounger [vaccinated] people, he says.

While some have argued that challenge trials could replace Phase IIIclinical trials, Plotkin doesnt seehuman challenge trials as a full substitute for normal safety trials. He also doesntexpect them to result in regulators licensing a vaccine for widespread use.But it could allow for emergency use among high-risk people or health careworkers, he says. It could also help us determine which vaccine candidatesshow signs of working, which could allow manufacturers to get a potentiallylifesaving head start on mass production.

This is not an exclusivepathway, he says, its a supplementary pathway to try to speed things up. Ifnormal vaccine trials revealed a candidate, or we learn more about the risks tovolunteers, Plotkin says challenge trials should be stopped. But if we dontstart planning human challenges now, they wont be available if we decidemonths from now that it wouldve been a good idea.

I still havent beenpersuaded that a human challenge trial would be informative enough to make afinal decision about which vaccine is the right vaccine to roll out at scale,says Angela Rasmussen, a virologist at Columbia University.

The hallmark of any humanchallenge trial is fully informed consent from participants. But Rasmussenquestions whether thats possible at this stage. I dont know that we canactually inform them of all the risks because theres still so much thats justunknown about this virus, she says.

Evidence suggests thatyoung, healthy people are least likely to suffer severely from COVID-19infection, but were still learning about different types of disease that itmay cause, Rasmussen says. Reports of young people suffering strokes, andtaking damage to the kidneys, heart and other organs have emerged in recentmonths, making it difficult to quantify the actual risks. I just dont see howa subject could provide their fully informed consent.

Accepting those risks may resultin more harm than good, Rasmussen says. By design, any COVID-19 challenge trialwould be done on a small, homogenous group. That could limit its broaderapplicability, she says, and could miss issues with the vaccine that can onlybe caught in a larger, more diverse study population.

She points to previousexamples, like the mid-2000s HIV vaccine candidate that actually increased risk of HIV infection in those who got the vaccine, or a SARS classicstudy in which older vaccinated mice experiencedmore severe disease after beinginfected.

My concern is that youcould have a major safety issue like that if you are doing only human challengetrials in young, healthy volunteers, Rasmussen says. A robust response inyoung people could mask harmful effects that emerge in older people or adifferent population, she says.

While a challenge trialcould identify promising vaccine candidates more quickly, it might also prop upthe wrong one based on limited results. If serious issues come up for otherpopulations, the consequences could be dire, Rasmussen says. And wed have wastedresources that could have been devoted to standard Phase II and III trials.

Other unknowns limit achallenge trials potential utility, too, Rasmussen says. We dont know theinfectious dose for COVID-19, she says, meaning the amount of virus that someonemust get to kick-start an infection. If a challenge trial got the dose or routeof infection wrong, it might not be comparable to pathogenic SARS-CoV-2, thevirus that causes COVID-19. A vaccine would appear to work under thoseconditions, but it might not be applicable to how people actually need to beprotected in the real world.

Rasmussen doesnt rule outthat challenge trials could be helpful. Its important to keep an open mindabout anything that can speed our way to a vaccine, but we need to be cautiousand be humble, Rasmussen says. Theres a lot more we dont know about thisvirus than what we do know. If a human challenge trial goes wrong, it could gocatastrophically wrong, which could ultimately be harmful for all vaccinedevelopment efforts.

Exactly who gives the green light for a COVID-19challenge trial remains unclear. Normally the decision to proceed with such a triallies with the funder of the research (the U.S. National Institutes of Health,for example) and ethics boards at the research institutions or regions wherethe study will be done.

But given the extraordinary nature of the currentsituation, the World Health Organization, as well as leaders of the NIH, have called for an additional layer of review for anyCOVID-19 challenge trials, which could include an independent panel ofethicists, clinical trial researchers and vaccine development experts.

In the United States, the Food and DrugAdministration would license a vaccine for widespread use, and they would haveto decide whether results of a human challenge study would weigh on theirultimate decision. Its not a given that the agency would take those resultsinto consideration.

Meanwhile, people are already volunteering to take part in COVID-19 human challenge trials, were they to happen. Already, over 20,000 people around the world have expressed interest in participating in COVID-19 challenge trials through 1 Day Sooner, a campaign to collect volunteers.

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Infecting people with COVID-19 could speed vaccine trials. Is it worth it? - Science News

Beginning to end, vaccine development usually takes 10 to 15 years. There are various ways to shorten the time table. Phase three will go quicker, for example, if you vaccinate a lot of people. Thats why AstraZeneca plans to enroll about 30,000 U.S. volunteers in its phase three trials of AZD1222 starting this summer. Even in the best-case scenario, however, it will take several months for researchers to get the most preliminary sense of whether the vaccine is working or not.

Typically, you wait at least two weeks or a month later to characterize the immune response, says Mark Feinberg, president and CEO of Iavi, a nonprofit research organization developing its own vaccine. It just inherently takes time for the immune system to mount to maximal immune response, and then you have to follow those people with time to make sure that the immune response is maintained. Its not going to help anybody if you have a vaccine that might protect you for a month or two and then protection wanes.

Come October, AstraZeneca will likely have started supplying the United States with hundreds of millions of doses of a vaccine for which it will have only the most preliminary phase three data. If its efficacy is still unclear, but no evidence has emerged that it is immediately harmful, will the Trump administration greenlight its use?

In the past the answer would almost certainly have been no. The FDA always focus their decision on robust scientific evidence, says Bottazzi, who believes that the earliest robust data can be available is the end of 2021.

This administration is different. President Trump has consistently ignored scientific advice about the coronavirus, undermined his advisers health-policy recommendations, and urged the use of untested medications. After a Google Doc touting chloroquine went viral on the internet, Trump deemed it a potential miracle cure. His administration sidelined critics while spending tens of millions of dollars to buy and study the drug. Last week The Lancet published a study that found it provided no therapeutic benefits and increased the risk of death. That same week Trump declared, Im taking it, hydroxychloroquine. Right now, yeah. Couple of weeks ago, I started taking it. Cause I think its good, Ive heard a lot of good stories.

Just as the FAA has been criticized for being too lax in overseeing Boeings manufacturing of the 737 Max, the FDA has taken fire for loosening the reins on drug development. Janet Woodcock, the head of the agencys drug-approval department, has led efforts to make it more friendly to industry, and drew fire for pushing the agency to approve a $300,000-per-year treatment for muscular dystrophy that lacked any proven medical benefit. Last week she temporarily left her role to be part of Warp Speeds vaccine-development efforts.

With the coronavirus pandemic raging, the FDA is easing the rules further still. According to Soriot, AstraZeneca has worked with the agency to rewrite its vaccine-approval playbook. We are actually trailblazing here because we are not following the standard process, he told CNN. We are working hand in hand with the FDA. We are sharing data on a day-to-day basis, on a real-life basis, and basically they have committed themselves to help look at our data as they come, so that by the time we finish with our phase three program in August, they can rapidly approve the vaccine for emergency use.

On Wednesday, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN that he was optimistic about the administrations timeline. I still think that we have a good chance, if all the things fall in the right place, that we might have a vaccine that would be deployable by the end of the year, by December, November, he said.

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Why Trumps Warp Speed Race for a COVID-19 Vaccine Is Dangerous and Likely to Fail - Vanity Fair

Chinese Covid-19 Vaccine Expected to Begin Mass Output This Year  Bloomberg

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Chinese Covid-19 Vaccine Expected to Begin Mass Output This Year - Bloomberg

Several more drug manufacturers have joined the global effort to develop a coronavirus vaccine.

The announcements, from Merck and Novartis, follow earlier initiatives by pharmaceutical companies Moderna and Inovio, as well as from the United Kingdom's Oxford University.

However, experts remain unconvinced a vaccine proven to be safe and effective will be available this calendar year.

"I think we'll have to have one more cycle of this virus in the fall, heading into the winter, before we get to a vaccine," Dr. Scott Gottlieb, former head of the Food and Drug Administration, told CNBC this week.

"I really think a vaccine is probably a 2021 event, in terms of having wide availability of a vaccine for the general population."

Here is a roundup of the most notable vaccine news of the week.

Drug giant Merck announced this week that it's investigating two potential COVID-19 vaccines.

The first is from Themis, a Vienna-based company that Merck has acquired. The Themis candidate is based on a previously developed vaccine that contains a weakened version of the measles virus. Scientists are adding bits of the coronavirus to the vaccine in an effort to teach the body's immune system to recognize the virus.

"We are eager to combine our strengths both to develop an effective COVID-19 vaccine in the near term and to build a pandemic preparedness capability directed toward emerging agents that pose a future epidemic threat," Dr. Roger Perlmutter, president of Merck Research Laboratories, said in a statement.

Studies for safety and efficacy in humans could begin in the next month or so.

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Merck is also partnering with the nonprofit scientific research organization IAVI to re-engineer an existing vaccine for Ebola. Clinical trials are expected to begin this year.

Also this week, Novartis announced it plans to make a gene-based coronavirus vaccine, which is in development at the Massachusetts Eye and Ear hospital, the Massachusetts General Hospital and the University of Pennsylvania.

A subsidiary of Novartis called AveXis would manufacture the vaccine.

"The COVID-19 pandemic is the most urgent public health crisis of our time and we recognize the significance of evaluating the potential role of a gene-based vaccine," AveXis President Dave Lennon said in a statement.

The approach uses an inactive form of the coronavirus to deliver the virus's DNA into the body, teaching it to make proteins found on the surface of coronavirus particles. Those proteins are the spikes seen on microscopic images of the virus. (The coronavirus gets its name from the crown-like spikes on its surface. "Corona" is Latin for "crown.")

Manufacturing is expected to begin this month, and clinical trials could start later this year.

The Maryland-based biotechnology company Novavax said it's launched preliminary clinical trials of its coronavirus vaccine candidate. The first results, on whether the drug is safe and effective, could be released as soon as July.

The company aims to provide vaccines for those on the front lines of the COVID-19 pandemic: health care workers.

"If our phase two data support the safety and immunogenicity that we hope it will and we're able to see a signal for efficacy, it's possible that that first line would be vaccinated sometime in the fourth quarter of this year," Stanley Erck, CEO of Novavax told CNBC.

As scientists worldwide scramble to develop a vaccine for the virus that's killed more than 350,000 people globally in just five months, a poll from the Associated Press-NORC Center for Public Affairs Research finds many Americans would refuse the shot.

About half of the more than 1,000 people surveyed in the U.S. said they would get a vaccine for the coronavirus.

Nearly a third were unsure whether they'd get it. Another 1 in 5 said they would refuse such a shot.

Older adults, who tend to be most vulnerable to COVID-19, were more likely than younger adults to say they'd get the vaccine. Sixty-seven percent of those over age 60, compared to 40 percent of younger people, confirmed they would be willing to be vaccinated.

Many are counting on the vaccine to get back to normal life. About 7 in 10 of those surveyed who said they would get the vaccine said it was necessary before lifting all restrictions.

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Erika Edwards is a health and medical news writer and reporter for NBC News and "TODAY."

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Coronavirus vaccine: Merck and Novartis join the hunt for a COVID-19 vaccine - NBC News

Testing is one piece of reopening society, but experts are still relying on the help of a COVID-19 vaccine to keep the public safe. Researchers are increasingly optimistic that scientists are getting closer to developing a vaccine, even though were barely months into identifying and learning about the novel coronavirus that causes COVID-19. Human and clinical trials are well underway, but just when they will be ready for manufacture and distribution is another story.

What is a realistic timeline and does one exist? Briana Vannozzi of NJTV News asked Dr. Vincent Silenzio, an expert in urban and global public health at Rutgers University.

This post appeared first on NJTV News.

See the original post here:

How Long Will a COVID-19 Vaccine Really Take? - NJ Spotlight

Segment 1, beginning at 4:29: Coronavirus outbreaks in places meant to offer long-term care has changed perceptions about their safety.

The coronavirus pandemic has introduced unprecedented challenges for nursing homes and the nursing home industry. Those involved say they are facing some of the same problems as hospitals, and that, until a vaccine is found, the future will mean a different operating model.

Segment 2, beginning at 33:26: How vaccine trials in Kansas City, Missouri, are progressing

The Center for Pharmaceutical Research is one of two clinics selected to conduct trials on vaccines being developed for COVID-19. The center's founder explained how the vaccines are meant to work, how quickly the work is progressing and the methodology for testing.

Segment 3, beginning at 41:01: The streaming films and series to take your mind off pandemic life.

With theaters still shuttered, everyone has recommendations for what to stream instead. From films sourced through Kansas City's art houses to tours of area museums, there's enough to entertain even the most seasoned viewer.

Read the rest here:

How Nursing Homes Recover | COVID-19 Vaccine Trials | What To Stream - KCUR