Category: Covid-19 Vaccine

It wont be enough to find a vaccine that works against COVID-19. Scientists will then need to quickly make enough vaccine for hundreds of millions perhaps billions of people.

One San Diego biotechs solution to this manufacturing challenge? A vaccine that makes more of itself.

TriLink Biotechnologies is working with researchers at Imperial College London to test such a vaccine in a trial slated to begin in mid-June. If successful, the approach could help get a COVID-19 vaccine to a wide swath of the population quickly, says Anton McCaffrey, TriLinks director of emerging science and innovation.

Right now, everybody wants to go at warp speed, McCaffrey said. You need to know that you can make (a vaccine) at the scale thats required to vaccinate a substantial part of the population.TriLinks vaccine uses genes that viruses normally rely on to copy their genetic material. Only this time, those genes help copy a vaccine that focuses the immune systems attention on the surface of the novel coronavirus. After copying itself over the course of a couple weeks, the vaccine would eventually be cleared from a persons system, according to McCaffrey.

The viral genes that allow the vaccine to copy itself also make it larger and trickier to produce, but scientists wouldnt need to make as much. The company estimates that the approach reduces the amount of vaccine each person would need by 25- to 50-fold.

Because a self-replicating vaccine copies itself in the same way that a virus does, it would set off the same alarm bells triggered by infection. That could be a good thing, McCaffrey says, as an antiviral response would lead to a stronger immune counterattack.

That will need to be shown by clinical trials. Imperial College researchers will begin a Phase 1 clinical trial to test the vaccines safety in mid-June. If that goes well, UK scientists will run a larger trial testing whether the vaccine protects against COVID-19.

TriLink can make enough vaccine for the clinical trials. But McCaffrey says that it would need to build new facilities or license out its technology to make enough vaccine for global use.

TriLink Biotechnologies employs about 200 people and was founded in San Diego in 1996.

San Diego biotech Arcturus Therapeutics is exploring a similar COVID-19 vaccine strategy in partnership with Singapores national health authority.

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San Diego biotech to help with trial of COVID-19 vaccine that makes more of itself - The San Diego Union-Tribune

DUBLIN--(BUSINESS WIRE)--The "COVID-19 Vaccine Development News - Bundle" newsletter has been added to ResearchAndMarkets.com's offering.

The COVID-19 Vaccine Development News Bundle includes the following:

1. Daily Report: COVID-19 Vaccine Development News

Offers five multiple time-zones updates, daily, for 20+ global news each related to COVID-19 Vaccine Development, comprehensively compiled and curated from global as well as regional and local news media.

Key features:

2. COVID-19 Vaccine Development News: Weekly Summary

50+ news summaries of the week relevant to COVID-19 vaccine development for global companies, research institutes, academia, hospitals/healthcare systems and organizations rounded up and summarized succinctly to present a complete overview of the current happenings worldwide here.

Key features:

3. COVID-19 Monthly Synthesis: Vaccine Development

Every month, progress related to COVID-19 vaccine development news from all over the world is monitored and synthesized to reflect the prevailing trends and directions in vaccine development.

Key features:

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COVID-19 Vaccine Development News: Daily, Weekly and Monthly Round-up for Global News on Progress on Vaccines Development for COVID-19 -...

Manoj Joshi

Distinguished fellow, Observer Research Foundation, New Delhi

EVEN as the US is tightening the screws on China on account of 5G technology, another, perhaps more consequential, front may be opening up in its new Cold War with China. According to a report, Beijing may deploy a coronavirus vaccine as early as September, even if the clinical trials are not finished. This is being justified as an effort to protect at risk groups like medical personnel, but it is also about who comes first in the race for an effective vaccine.

While a gold standard vaccine will take time, thecontest is as much about prestige as about saving millions of lives and earning billions of dollars.

This contest is as much about prestige, as about saving millions of lives and earning billions of dollars. For China, it is also about redemption, given its inexplicable delay in informing the world about the outbreak.

We can only hope that following the unseemly conduct of countries in restricting the export of medicines and medical equipment at the outbreak of Covid-19, we will not see vaccine nationalism when their efforts bear fruit.

The Chinese see themselves against a US effort triggered by President Trumps call, in mid-May, for developing a vaccine at warp speed. To meet the target of a vaccine by October in part motivated by the US elections in November the USs Biomedical Advanced Research & Development Authority (BARDA) said they would provide $1.2 billion support to Oxford University-AstraZeneca to deliver 300 doses of their potential vaccine by the end of September.

As of now, there are 224 candidate vaccines in development globally, according to the data collected by the Coalition for Epidemic Preparedness Innovations (CEPI). While North America has the largest number of projects 49 per cent China is the furthest along the track with five vaccines in phase II human trials, more than any other country.

Of the 10 vaccines that are at the stage of human trials, six are Chinese, and it is the only country with a vaccine which has advanced to phase II. This is the Can Sino Biologics-Beijing Institute of Biotechnology product using the non-replicating viral vector design, similar to the Oxford University one, and whose phase I trial was reported on May 22 by Lancet.

Other leading candidates are being developed by Pfizer and BioNTech of Germany, Moderna and Inovio of the US, and a clutch of Chinese institutions like Sinovac Biotech, the Wuhan Institute of Biological Products and the Shenzhen Geno-Immune Medical Institute. Most of them are completing their phase I trial.

Both the US and Chinese militaries are active in the vaccine development front. The Beijing Institute of Biotechnology, which is working with Can Sino, is part of the Academy of Military Medical Sciences, whose star is a top virologist, Major General Chen Wei. In the US, the Army Medical Research Institute and the Walter Reed Institute of Research are also working to develop a vaccine.

The effort is seeing innovative approaches and new kinds of partnerships to ensure that, when certified, the vaccine will be available at the fastest speed and most widely distributed. Besides AstraZeneca, BARDA has also agreed to give $483 million to Moderna and $500 million to Johnson & Johnson for their efforts. But, BARDAs 300 million doses are obviously aimed to cover all US citizens. The real battle is to ensure that it reaches the globes billions.

For this reason, Oxford University has a prior agreement with AstraZeneca to distribute the potential vaccine at no profit for the duration of the epidemic. Another British effort through the Imperial Colleges laboratory would bypass the drug industry entirely. According to the New York Times, the vaccine, using specifically engineered genetic materialRNAis cheaper and easier to make than Modernas, which uses a similar technique, and so would be ideal for global use.

A major player in these efforts is CEPI, launched in Norway in 2017 to finance new vaccines. It has among its sponsors, the Norwegian and Indian governments, the Bill and Melinda Gates Foundation and the Wellcome Trust. CEPI has provided initial support and funding to Curevac, Inovio, Moderna, Novavax, University of Queensland, University of Hong Kong and Oxford University and a consortium led by Institut Pasteur and Clover Biopharmaceuticals.

AstraZeneca has arrived at a $750 million agreement with CEPI and GAVI to provide 300 million doses of their vaccine for the poorer countries by the end of the year. A major share of this effort will be achieved through the partnership with the Serum Institute of India, the worlds biggest vaccine maker based in Pune, to make a billion doses of their vaccine eventually.

Vaccines against viruses are notoriously difficult to develop. There is none, despite huge expenditure and effort, against HIV as yet. They can take a great deal of time, but the coronavirus pandemic is pushing its own envelope. A gold standard vaccinegiving protection of six months, at least 50 per cent effective and able to prevent the transmission of the viruswill take time. The early vaccines may provide limited protection for frontline workers and medical personnel.

Technology has always been a major element in global power equations. Some of it has been good, and some bad. In some cases like nuclear power, it has both facets. But now, for the first time, we may be seeing biotechnology emerge as a factor as well.

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The race for Covid-19 vaccine - The Tribune India

Sen. Rick Scott (R-Fla.) accused China of trying to sabotage the development of a coronavirus vaccine on Sunday withoutproviding details to back up his claims.

"We have got to get this vaccine done. Unfortunately we have evidence that communist China is trying to sabotage us or slow it down," Scott said on the BBC's "Andrew Marr Show."

Scott said China "wont cheer" if the U.S. or England is the first country to develop a COVID-19 vaccine.

US-China #Covid_19 row: "We have got to get this vaccine done. Unfortunately we have evidence that communist China is trying to sabotage us or slow it down," says Republican Senator Rick Scott#Marr https://t.co/8fIAQff8oG pic.twitter.com/BrSKiFHPmU

Marr pressed Scott on his comments, asking him what evidence he was referencing.

"China can't stop us developing a vaccine, can it?" Marr asked.

"It came to our intelligence community. ... Im on Armed Services, so clearly there's things I can't discuss. ... I get provided information. But there's evidence that they've been trying to either sabotage or slow it down," Scott responded.

When asked for additional comment from The Hill, a spokesperson for Scott pointed to a bill the senatorand other GOPcolleagues introduced last month that aims to prevent China from stealing or sabotaging American COVID-19 vaccine research.

Scotts commentscame as China released a report defending its response to the virus. The report says China provided information in a timely and transparent manner, The Associated Press reportedSunday.

--This report was updated on June 8 at 12:07 p.m.

Continued here:

Scott: China trying to sabotage, slow COVID-19 vaccine development | TheHill - The Hill

Children in the Philippines will not attend school until a vaccine to protect against Covid-19 becomes available, officials confirmed, prompting fears millions of students could be left without access to education.

Scientists around the world are racing to develop a vaccine for Covid-19, but most experts caution that it will take at least a year or two for one to become available.

On Monday, Philippines education secretary Leonor Briones said online or TV classes would resume at the end of August, but there were concerns that children from the poorest or most remote communities, who do not have internet access, will miss out.

The country recently eased a strictly enforced quarantine that had been in place for more than two months, despite hundreds of new cases continuing to emerge daily. The lockdown has succeeded in slowing transmission, but it has also devastated the economy, and left millions of people work and in need of urgent social assistance.

Restrictions on movement remain in place, including for children, whoare generally not allowed outside their homes unless they are going out to get essentials or going to work.

On Monday, 579 new infections were announced in the Philippines, bringing total cases to 22,474 cases. So far, 1,011 fatalities have been recorded.

The total number of known global cases of coronavirus was 7,119,454, with 406,540 deaths worldwide, according to Johns Hopkins University. The World Health Organisation (WHO) warned on Monday that the pandemic was worsening.

Governments have pledged billions of dollars to fund research into Covid-19, with teams across the world focused on developing vaccines and therapies. One of the contenders is the British-Swedish pharmaceutical company AstraZeneca, which said last week that it is on track to begin rolling out a vaccine in September if ongoing trials prove successful.

Most scientists have predicted that a vaccine is likely to take longer,but there is hope that antiviral therapiescould emerge more quickly. In the UK, five new drugs are being trialled in 30 hospitals in an effort to find a treatment.

On Sunday, it was reported that AstraZenecamay be close to a breakthroughon an antibody treatment that could save the lives of people in the early stages of infection.

Across the world, governments are grappling with how to reopen schools without causing a surge in transmission. Children can be infected with the virus, according to the WHO, though there are relatively few cases of Covid-19 reported among children.

A number of countries have resumed face-to-face classes, including France, Vietnam, Australia and New Zealand. South Korea, however, was forced to delay the reopening of schools late last month following a surge in case.

In Indonesias capital Jakarta, officials allowed businesses to reopen this week, but schools will remain closed for the next month.

Offices, restaurants and grocery stores reopened with a reduced number of employees and customers present, as the country seeks to reopen its economy. On Friday, mosques and all other places of worship were also allowed to reopen at half capacity and with social-distancing requirements in place.

Public transportation also resumed with limits on passenger numbers on Monday, causing long queues at train stations.

The reopening of the capital comes just days after Indonesia reported a recorded daily spike of 993 cases, and amid concerns the virus is continuing to spread across the country.

Indonesia has recorded 31,186 infections, mostly in Jakarta and East Java, though on Monday officials in Bali reported an increase in local transmissions on the island.

Bali governor, I Wayan Koster, reported 25 news cases on Sunday, including one imported case, and raised alarms over a lack of awareness among residents. The governments official tally suggested 12 new cases were confirmed in Bali on Monday, the Jakarta Post reported, bringing the total number of infections to 594. Inconsistencies in data, and delays in testing, have proved a challenge in monitoring the outbreak.

Across Indonesia, there have been 31,186 confirmed infections and 1,851 fatalities.

In other coronavirus developments:

New Zealand awoke to the lifting of all restrictions except border controls on Tuesday.

Australia recorded no locally transmitted cases of Covid-19 on Tuesday.

Brazil now has reported 707,412 cases and deaths have risen to 37,134. It marks a continuing steep rise.

Mexico reported 2,999 new cases on Monday and 354 deaths.

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Global report: Philippines says schools won't reopen until there is a Covid-19 vaccine - The Guardian

CAMBRIDGE, Massachusetts I was recently stunned to learn of the serious consideration being given to deliberately infecting human volunteers with the SARS-CoV-2 virus in order to assess the effectiveness of potential COVID-19 vaccines.

My first reaction was that the advocates of such human challenge studies had gone so mad with panic that they had forgotten the history and horrors of medical experimentation on humans. But on closer inspection, I saw that they included some of the worlds most respected vaccine researchers and medical ethicists, and even the World Health Organization.

As far as I can tell, their principal argument is that waiting for an answer from naturally occurring infections will take too long. The new coronavirus has already infected 6.5 million people worldwide and killed more than 386,000, including 107,000 in the United States alone. And in the absence of safe, effective vaccines and treatments, measures aimed at controlling the viruss spread are ruining economies around the world. The WHOs recent white paper on the use of human subjects for vaccine research makes it clear that such trials are a desperate last resort.

Vaccines are indeed the most effective medications we have. Some have conferred long-term immunity against great scourges such as smallpox, polio, typhoid, diphtheria, typhus and tetanus. But there are just as many diseases for which no truly effective vaccine exists, including HIV/AIDS, malaria and tuberculosis. And some vaccines can do more harm than good, as attempts to develop a dengue vaccine have demonstrated.

Caveats notwithstanding, the rush to develop a COVID-19 vaccine that will definitively end the loss of life and stop the economic devastation has already produced more than 100 candidates, all in very early stages of development. With so many pharmaceutical companies and governments scrambling to get some skin in the game, each day seems to bring announcements of new programs, most of them unaccompanied by supporting data.

But deliberately infecting volunteers with SARS-CoV-2 to test the efficacy of vaccine candidates is unnecessary, uninformative and unethical.

Why unnecessary?

Most vaccines are developed in the context of active epidemics. But one prominent British researcher recently opined that there is only a 50 percent chance that enough people in the United Kingdom will be infected with the virus for the University of Oxford vaccine field trial (as currently designed) to yield a statistically significant result. What a curious statement. Does it mean that the trial is too small, or too short, or that the Oxford team expects their vaccine to be only partly effective or all three?

After all, there is no shortage of new infections. On an average day, close to 100,000 newly confirmed cases are reported worldwide, and I cannot recall another disease for which such a number was insufficient for a field trial of a drug or vaccine. Surely, with more time and patience, a real test is possible.

Moreover, the major departure from the norm entailed by human challenge studies presupposes a lack of alternative means to control the pandemic. But many East Asian countries, as well as some Nordic states, New Zealand and Australia, have so far successfully controlled the virus in the absence of highly effective drugs or vaccines. And Wuhan, the Chinese city where it originated, is now essentially free of COVID-19, save for minor, containable flare-ups.

In each case, the relevant authorities have executed well-known, proven public health measures: clear messaging, strong stay-at-home orders, vigorous disease detection, contact tracing and mandatory supervised controlled isolation for all those exposed to the virus.

Although not every country is capable of implementing what works, all should try their best to control the pandemic through proven methods, rather than pinning their hopes on a vaccine that either will be slow in coming or may not work at all. In addition, medical ethicists should consider governments moral obligations to protect citizens through proper use of public health measures, rather than by opening a Pandoras box of unnecessary human experimentation.

Challenge studies are also uninformative. To the best of my knowledge, all current protocols for vaccine trials envisage enrolling only young, healthy adults. This is understandable from a recruitment perspective, but COVID-19 morbidity and mortality are highest among the elderly, who have a plethora of underlying chronic diseases.

Numerous studies have shown that vaccines that are effective among the young can fail in older populations sometimes completely. Our bodies ability to respond to most, if not all, vaccines declines precipitously with age. Are todays COVID-19 vaccine developers seriously entertaining the idea of trials that use a live virus in this vulnerable population?

Furthermore, preliminary studies using non-human primates have already shown that potential vaccines may not provide complete protection; when confronted with the virus, the vaccinated animals were spared serious infection of the lungs, but not of the nasal passages. The same was true of the wide variety of vaccine candidates previously developed for severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), also coronaviruses. And the implications of partial protection for both community spread and human disease are not well understood.

Finally, human challenge trials are unethical. SARS-CoV-2 causes multi-system disease in about 20 percent of those infected, and the incidence may be even higher in challenge studies, given the large virus doses likely to be used. Infection may permanently damage the heart, lungs, brain and kidneys, in the young as well as the old. Moreover, once someone is infected, there is no known drug that completely cures or even ameliorates COVID-19, much less reverses serious damage. And because it is extremely unlikely that all vaccine candidates will work in all trials, a number of volunteers will be permanently harmed.

If such trials are unnecessary, uninformative and dangerous, then they are by definition unethical. I fear that in the rush to find a medical miracle to end the pandemics toll in human lives and livelihoods, we will jeopardize the centuries-old moral imperative to do no harm, possibly destroying trust in the integrity of science and medicine for generations to come. In that case, the losses we will face will be far greater.

William A. Haseltine, a scientist, biotech entrepreneur and infectious disease expert, is chair and president of the global health think tank ACCESS Health International. Project Syndicate, 2020. http://www.project-syndicate.org

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COVID-19 vaccine trials are unnecessary, uninformative and unethical - The Japan Times

Since 1984, hes been at the table and helping lead the fight to keep Americans healthy and virus-free.

Now in the era of the COVID-19 pandemic, Dr. Anthony Fauci has become the voice and symbol of both promise and resolve in the battle against the new coronavirus.

Dr. Fauci sat down with Healthline for an exclusive interview on Fridayto talk about the COVID-19 pandemic, working with six presidential administrations, and what he does to deal with pandemic stress.

Here are some excerpts from our conversation with the director of the National Institute of Allergy and Infectious Diseases (NIAID), who served as a member of President Trumps task force on COVID-19.

Dr. Anthony Fauci:Its interesting we are speaking today. On June 4, 1981, the first report of the Centers for Disease Control and Prevention morbidity and mortality weekly report showed that five gay men, all from Los Angeles, had presented with a strange new syndrome.

In 1984, when I became director of [the NIAID], it was the very beginning of an outbreak that we didnt fully understand the full implications of. We thought incorrectly that it was restricted to the gay community and to injecting drug users.

We didnt realize that throughout the world and in Africa it was bubbling up as a mostly heterosexual disease, which right now, today, fast-forward, more than 80 million people have been infected, more than 37 million people have died, and there are 37 million people living with HIV. That was my first interaction with the presidency, with the administration of Ronald Reagan.

So it wasnt the explosive, immediate nature of COVID-19, which essentially impacts, directly or indirectly, everybody in the world because everyone feels they are at risk. Thats different than with HIV, when it was clear it was defined by a risk behavior and not something that was completely out of your control, like respiratory illness.

And then we had the anthrax attacks and the pandemic flu, and we had Ebola and Zika, so for better or worse Ive had the opportunity to be involved in six different administrations through outbreaks, some of which were much more severe than others; some of which were threatening, but they didnt really impact us like Ebola. You know, there were headlines, but there was never really any risk in the United States that there would be an outbreak.

But to answer your question: This, that we are living through now, is truly unprecedented.

People have asked me this because of the length of time Ive been doing this, that throughout all the years, whats your worst nightmare?

And I always say my worst nightmare and I said this years ago, not just recently to coincide with COVID Ive been saying for decades that my worst nightmare is the evolution of a new infection that jumps species easily from an animal model to a human thats a respiratory virus, because those are the ones that can spread easily, and that it is highly efficient in its ability to spread from person to person, and that it has a high degree of morbidity and mortality. Thats what I was always saying would be my worst nightmare.

Fauci:Here we are, folks. My worst nightmare. To put it bluntly, Ive been doing this for 36 years, and this is the most unprecedented, disturbing situation weve had because of the potential of being what it is and not just potential. Its a global pandemic.

Fauci:I think its the capability of our scientific community to come up with solutions. I mean, we are well into the development of a vaccine, which is the fastest that weve ever gone from the recognition of a new pathogen, in this case a virus. And starting off on vaccine development with multiple candidates [being tested] in humans already.

Hopefully by the end of this year we will develop a vaccine we can deploy. We can never guarantee that. You can never, ever guarantee the success of a vaccine. We just have good experience to know that we are aspirationally, cautiously optimistic that we will have one by the end of the year.

If we do that, that will overwhelmingly be the fastest weve ever gotten a vaccine. That gives me hope. The fact that we are working hard on developing different therapies so that as we get into the fall and winter season we hopefully will have a couple of therapies that have shown to be effective.

Weve already proven in one randomized control trial with remdesivir that it has a statistically significant but modest effect on decreasing the time it takes to recover in hospitalized patients with lung disease.

The other thing is that we know that when we do physical separation, we can actually blunt the effect of the spread of the virus. The only difficulty with that, as you well know, is that when you shut down society to prevent physical closeness and interaction, it has unintended consequences on the economy, on employment, even on the health of individuals who need medical care for other things besides coronavirus. So, its a complicated situation.

Fauci:Im worried on two sides of the coin. Well, I mean, Im not worried, I dont worry about things.I try to do things about it. Im attentive to and concerned about making sure we indeed get good control of this outbreak.

Weve seen it going in the right direction over the last couple of weeks with a major decrease in the number of deaths in this country, and certainly a decrease in hospitalizations. We have a less dramatic but nonetheless real gradual decline in the number of new cases, so were going in the right direction.

But I want to make sure we stay in the right direction, and that as we begin to reopen, we dont have a surge of cases.

I also am, as someone who realizes that we need to have society function, that weve got to try to get back to normal in a safe and prudent way because, if not, the unintended consequences of shutting down can be really serious.

Fauci:You want to make sure that, in your desire to get back to normal, that we dont leapfrog over some of the benchmarks we need to reach in order to get to the next stage.

Weve put out a series of guidelines that are very well delineated. We do need to be patient and careful, but we need to proceed both to try and suppress the virus and to get back to normality.

Fauci:Its a combination. We are producing vaccine at risk, which means we are producing it even though we dont know yet if the vaccine works, which means if we are lucky and it does work, we will have saved several months and made it available as soon as the winter.

If we are wrong and it doesnt work, then we will have essentially wasted a few hundred million dollars. We feel it is worth the risk because the consequences of not having a vaccine ready by the winter for those who need it.

Fauci:My wife Christine is always the go to person when I have to talk through a particularly difficult issue, or when I need an outside trusted judgment on a particularly thorny problem.She is an amazing, levelheaded, analytical person with a heavy dose of common sense.

Also, running has been my major stress reducers for decades.The combination of those two is critical in getting me through highly stressful times.

Fauci:The things weve discussed, the therapies and vaccines: We should all be hopeful about those. I think they need to be heads-up and cautious that this is not over yet.

We are still in the middle of an outbreak, and weve got to all pull together as a community, as a nation, and as a global population. Because were all in the same boat here. This is threatening to all of us, and we cannot forget that. Weve got to continue to work hard to get control of it.

Fauci:You know, there are a lot of similarities and differences. It isnt as if this is different thanallthe others. Each is different. Reagan was different than Clinton, and Clinton was different than Bush. Bush was different from Obama, and this is different than Obama.

I dont think you can pull this [administration] out and say this is unique. You know, we have a big government, and it generally works very well.

Fauci:How will it end? We will have control over it. Unfortunately, we will have suffered a terrible burden, but it will end, and we will get back to normal, hopefully sooner rather than later.

I think as a word of hope, people should realize: Dont despair. This will end, and we will get control over it.

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Dr. Anthony Fauci: COVID-19 Will End and We Will Get Control Over It - Healthline

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U.S. Reps. Annie Kuster (D-NH) and Hakeem Jeffries (D-NY) introduced legislation to ensure that the United States can mass produce and administer a COVID-19 vaccine as soon as it is available.

The Coronavirus Vaccine Development Act requires the Biomedical Advanced Research and Development Authority (BARDA) to expand the nations manufacturing capacity for COVID-19 vaccines as well as the products necessary to administer the vaccines.

In order to fully reopen our economy, put the COVID-19 pandemic behind us, and move onto our new normal, the majority of Americans will need to be vaccinated for this virus, Kuster said. Our nations top doctors and vaccine experts tell us that we are still a ways away from identifying and approving a vaccine for this virus, but we must begin working now to ensure that we are prepared to administer vaccines once one is available. This legislation will help to ensure that Americans especially communities that have been disproportionately affected by the novel coronavirus will not face unnecessary delays or obstacles to getting vaccinated.

The bill also requires the administration to provide a report assessing the vaccine supply chain and manufacturing capacity. In addition, the administration must provide an update on efforts to prepare to vaccinate Americans once a vaccine is identified and approved.

While we havent gotten to the end of the COVID-19 pandemic, we must start preparing to reopen America in a way that protects our public health, Jeffries said. A vaccine will be crucial to that effort, and our nation will need a plan to get one to the American people swiftly. I am proud to join Rep. Annie Kuster in introducing legislation to help create a comprehensive plan to mass-produce and administer a COVID-19 vaccine quickly and efficiently.

Originally posted here:

Reps. Kuster, Jeffries introduce bill to ensure mass production of COVID-19 vaccine - Homeland Preparedness News

Emergency coronavirus vaccine could be ready within months  South China Morning Post

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Emergency coronavirus vaccine could be ready within months - South China Morning Post

New York The way the COVID-19 crisis ends is with vaccines not a vaccine. More than one horse can win this race. Some of us might end up getting a shot of a more traditional vaccine, which uses parts of an inactivated virus to stimulate immunity. Others might get vaccines based on emerging technologies that use synthetic versions of the viruss genetic code.

One such novel candidate, based on RNA the single-stranded cousin of DNA and made by Moderna, showed promising results in early human trials, though critics warned the evidence is preliminary. Meanwhile, a different prototype based on DNA made headlines for an experiment that showed it worked in monkeys.

In the end, some vaccines might be extremely effective but harder to scale; others the opposite. Even a less-effective vaccine might work well enough to provide herd immunity in a wider population. Other vaccines might be more appropriate for health care workers, who have to risk exposure on the job, and need protection as soon as possible.

Scientists have created more than 70 vaccine candidates so far. If we end up with two, three, or four vaccines, thats good, since we have seven billion people, says Harvard vaccine researcher Dan Barouch, who led the development of one of the vaccines featured in recent news. His group began working on a vaccine in January, after the virus started spreading in China.

There are good reasons for him and other scientists to be optimistic.

For COVID-19, its clear most humans who get infected recover that alone shows the human immune system can eliminate the virus, he says. That makes it a much easier target than HIV, which he calls unprecedented in the history of vaccinology for its ability to evade the immune system. And the SARS-Cov2 virus doesnt have the fast mutation rate that makes flu viruses a moving target.

Art Krieg, a physician and founder of Checkmate Pharmaceuticals, says hes very optimistic that because the human immune system can successfully battle the virus, so will one or more of the many experimental vaccines.

All vaccines have to provide a danger signal to prime the immune system into acting against an invader. In 1995, Krieg reported the discovery one of these danger signals called CpG DNA which has been used in several vaccines, including one for hepatitis B, and is in some of the experimental candidates fighting against the virus that causes COVID-19.

Next, the vaccine has to mimic the invader in order to get the immune system to create specific antibodies that target the intended enemy. Vaccine designers using genetic material (DNA or RNA) have to stimulate the immune system enough to generate those antibodies, but not so much that the immune system destroys the vaccine before it can complete its mission.

The biggest driver of recent headlines (and stock market drama) was a vaccine produced by the Massachusetts-based company Moderna, which is based on synthetic genetic material identical to parts of the code carried by the coronavirus. The genetic material is RNA. (Other RNA vaccines are being studied by BionTech, Translate Bio, and Curevac.) The RNA tricks human cells into making proteins identical to the spike proteins the virus uses to penetrate human cells. And that, in turn, stimulates the immune system to make antibodies that will be ready to block that protein if the real coronavirus invades.

The excitement about Modernas vaccine followed the release of data from a trial that involved 45 volunteers, though the company only described results for eight of them. Of the eight, all produced antibodies with the desired neutralizing property needed to attack the virus in the future. What happened to the other 37 people? Since this vaccine requires two doses, they probably just didnt have that data yet, says Krieg.

A similar concept is behind DNA vaccines. The one developed by Harvards Barouch made the news for a successful experiment in monkeys. Other DNA vaccines are already in early human trials, including candidates developed by Oxford University, Johnson & Johnson and the Chinese company CanSino Biologics.

These DNA vaccines use synthetic strings of code for making the spike protein carried by the virus. In some of these, the synthetic DNA is injected alone, while in others, it rides into human cells inside a deactivated cold virus (called an adenovirus). The human cells transcribe the DNA to RNA, and then into the decoy spike protein used to create immunity to the real thing. While the prototype developed by Barouchs group at Harvard can be given in two shots, the Oxford DNA vaccine and several others that use cold viruses confer immunity with just one shot, says Krieg.

DNA and RNA arent our only options. Yet another vaccine concept, made by Dynavax, uses the spike protein itself and stimulates the immune system using a synthetic DNA danger signal the CpG DNA. These protein-based vaccines would have to be produced in bulk in fermentation vats, which Krieg says is something the biotech industry is equipped to do.

Krieg says all the novel vaccines work through the same well-established scientific principles, and are very likely to be safe. Still, he says, its well known that vaccines dont work as well in the elderly and immunocompromised. Imperfect vaccines could still eradicate the virus through herd immunity but only if the bulk of the population gets vaccinated. Once the technical hurdles are overcome, there will be social hurdles already, there are movements among anti-vaxxers to resist but its not too soon to plan to surmount them.

Barouch says the ordinarily competitive nature of science has changed, as everyone understands how much is at stake in terms of lives and economic damage. In retrospect, critics might be able to criticize approaches that didnt work, but right now, we need all the ideas we can get.

Science writer Faye Flam is a Bloomberg Opinion columnist.

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The more COVID-19 vaccines, the merrier - The Japan Times