Category: Covid-19 Vaccine

Duration: 02:06 1 day ago

Five weeks ago, Neal Browning became a human guinea pig. He volunteered to be the second ever patient to be injected with an experimental vaccine for COVID-19. Inside Editions Jim Moret caught up with Browning to see how hes feeling after he received his second vaccination, one month after the first. The Seattle area engineer reports that hes feeling totally normal, but he wont know if the experiment is a success until next year.

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Meet the second patient trying an experimental COVID-19 vaccine - msnNOW

Bill Gates visited The Late Show With Stephen Colbert Thursday night to discuss a possible timeline for a COVID-19 vaccine.

Colbert starts off the interview by asking a question thats on all of our minds: How long will we have to live the way we are now?

Ever the pragmatist, Gates offered up a measured response: There are two ways out, one is if we get miracle therapeutics that are greater than 95% cure rate. We cant count on that. The other is a vaccine thats highly effective that we get out to the world population. Some of these vaccines well understand by this summer, well see because theyre going into humans now well see if they get this strong antibody response. And then we have to do broad safety testing and get the manufacturing going. So even a year from now, even if everything went perfectly we could start the manufacturing.

He allows that if its harder to land on an effective vaccine, the timeline could stretch to two years, but offers up a ray of hope: Every day when I see the engagement of the vaccine groups, I actually think, Wow, we can surprise people on the upside here. I have been saying 18 months, but some of these vaccines are ahead of that schedule.

The Bill & Melinda Gates Foundations Therapeutics Accelerator program has been working hard on finding a vaccine for COVID-19, with musicians like Madonna donating $1 million to research efforts. Gates told Colbert that his foundation is currently at work on 7 vaccines and that, overall, more than 100 vaccines are being tested. Theres almost too many in a way, he said.

In a 2015 TED Talk, Gates practically predicted the COVID-19 outbreak. Earlier this month, he stopped by The Daily Show to reflect on his Nostradamus moment: One thing I feel good about is this is such a big change to the world that this time it wont be like Ebola, which was just there in West Africa or Central Africa, he said. This time, the tens of billions [of dollars] to have the diagnostics standing by, the manufacturing standing by, this time we will get ready for the next epidemic.

Colbert asked Gates to take a look into the future once more, and Gates rather bleak message sent the host into a fit of nervous laughter: I didnt want to be right, he said of his TED Talk. Then launched into a description of a possible bioterrorist attack.

The good news Im not trying to depress you is most of the work were going to do to be ready for pandemic two I call this pandemic one most of the work well do to be ready for that are also the things we need to do to minimize the threat of bioterrorism, he added, leaving the interview on a high(?) note.

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Bill Gates Maps a Road to a COVID-19 Vaccine on The Late Show - Rolling Stone

The outbreak of coronavirus disease 2019 (COVID-19) has brought with it fear and uncertainty. Many parents are asking about when there will be a COVID-19 vaccine and what to do about routine childhood vaccinations during the pandemic. We're here to provide answers to your most common questions.

As of now [23 April], there are no specific vaccines or treatments for COVID-19. Scientists around the world are working hard to develop a vaccine against the disease. In fact, many different vaccines are being developed simultaneously, with two of them at the front of the process. Innovative approaches to vaccine development are being used, based partially in what was learn from the responses to Ebola and SARS. If successful, this will be fastest vaccine development and validation process in history.

Researchers are also looking for drugs to slow down how the virus spreads in the body and reduce the serious breathing problems it can cause in ill patients. But even with the fastest methods, the use of drugs in humans for a new disease needs to be tested to ensure safety and efficacy.

>>See how to wash your hands and cleaning tips to protect against COVID-19.

While COVID-19 is disrupting our daily lives, the short answer is yes, do try to get your child vaccinated where services are available. It is important that children and babies keep their vaccinations up to date because they protect them from serious diseases. It means that when your children can return to interacting with other children, theyll have protection from some other diseases too.

If you are unsure of whether or not your immunization service is still running as usual, please check with your health care provider. Because the COVID-19 situation is changing every day, you might find your health care providers will be adjusting their way of providing care as things change. If you cannot get to a clinic when your childs next vaccinations are due, make a note somewhere to try again as soon as the services resume.

This outbreak reminds us of how valuable vaccines are. It shows us that when there is a vaccine available for a disease, we should keep our children and ourselves up to date with that vaccination. Without the protection of vaccines, diseases can spread quickly and with terrible consequences. For example, measles and other diseases remain a constant risk. We are so fortunate to have the protection of vaccines against these diseases.

Vaccines help train our immune system to fight infections by introducing an inactivated form of a germ (bacteria or virus) into the body. Since it is inactivated, it cannot make us sick. However, it triggers our bodys immune system to produce defences called antibodies. Then, if you ever catch the germ, your bodys immune system will already know how to fight it.

>>Watch our mini parenting masterclass on getting your babys first vaccines.

Contact your health care provider, consult your local and national health authority websites and follow guidance provided by WHO and UNICEF.

Some of theprecautions you and your family can take to help avoid infection include:

In addition to all of the advice already given to parents about hand washing, physical distancing and maintaining hygiene practices, they should take extra care to protect infants from infection. Breastfeed your baby if possible. There is currently no proven research that breastmilk can transmit the virus, but you should take the usual hygiene and respiratory protection (while breastfeeding as well as at other times) to avoid respiratory transmission. Use antibacterial wipes if available to wipe down countertops and diaper-changing surfaces once a day.

Try to ensure young children have the same caregivers to reduce the number of people they come into contact with. Those caregivers should be encouraged to wash their hands regularly, avoid sharing things that go in mouths such as cups and stay away if they feel at all sick.

If your child has a sore throat, a cough or a fever, call your doctor or health service for advice before bringing them in. They may have a special arrangement at the clinic to minimise spread of infection to others.If your child has more serious symptoms, like shortness of breath or seems unusually sick, call the emergency number or take them to the nearest emergency department.

Most children with COVID-19 have mild symptoms or may have no symptoms at all. But its important to protect the elderly and others more vulnerable to serious infections. So keep your child at home if you think they have been exposed to COVID-19 or have it, but make sure to call their doctor or a health worker for advice.

As with other respiratory infections like the flu, seek care early if you or your child are having symptoms. Try to avoid going to public places (like a workplace, schools, or public transport), and dont be in contact with the elderly or immunocompromised family members. If you live with an elderly person as well, it is recommended to separate the generations in the household.

You dont need to have your child tested if he or she is healthy and not showing any symptoms (such as fever, cough or difficulty breathing). Do also make sure to take all key steps to protect your family against COVID-19.

>>Learn more about immunization

>>World Immunization Week

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Vaccinations and COVID-19: What parents need to know - UNICEF

SALT LAKE CITY Scientists around the world are working on a vaccine to fight COVID-19, hoping to get us out of this pandemic.

Doctors believe it will save lives. But when its finally created, will you take the vaccine?

There is a growing concern that not enough people will get the shot. To give you a little context, the Department of Health and Human Services reports less than 45% of adults get the recommended flu vaccine each year. That number would need to be much higher to stop the worldwide pandemic.

Since the beginning of this pandemic, it has been a numbers game: The number infected, the number of deaths, the number hospitalized, the number of masks, the numbers on Wall Street and the number of lost jobs.

And how about the number of months waiting for a COVID-19 vaccine, potentially protecting millions around the world.

Yeah, thats the loaded million-dollar question, said Dr. Todd Vento, a physician with Intermountain Healthcare specializing in infectious diseases.

Similar comments from Dr. Andrew Pavia, chief of pediatrics and also an infectious diseases specialist with University of Utah Health.

The best minds in the world in science are working on it, he said.

It can take more than a decade to develop a vaccine. Even fast-tracked, it could be 12-to-18 months before we see a working vaccine for the novel coronavirus.

Two doctors. Both specializing in infectious diseases.

Both made it clear, this future vaccine will not save lives people taking the vaccine will.

Thats why we have children receive so many vaccines from the time theyre born, even into teenage years, Vento said. Because they work.

Our only acceptable tool in the long run is to develop effective vaccines, Pavia added.

The World Health Organization backs up those statements, testifying vaccines have been one of the biggest success stories of modern medicine. The WHO estimates at least 10 million deaths were prevented between 2010 and 2015, because of vaccinations around the world.

Pavia said the novel coronavirus is no different. Vaccination is key.

Theres a real danger that anti-vaxxers pose by creating a false narrative of danger around vaccine, he said.

A vaccine for it? No. No, I wouldnt, said Kristen Chevrier. I would not use a coronavirus vaccine.

Chevrier is co-founder of a group based out of Utah County called Your Health Freedom, and if you label her an anti-vaxxer, she said theres a misconception.

Most people who are anti-vaxxers are ex-vaxxers, she said. When you call someone an anti-vaxxer, you have no idea what their history is.

Chevrier said the reason her group was created is to educate people in making informed health decisions. Some of those informed health decisions focus on vaccines.

There has never been a safe or effective vaccine for a coronavirus, she said. The last one they tried didnt work out very well.

Chevrier was referring to the outbreaks of SARS and MERS. In both cases, the research on vaccines ended after the epidemics fizzled out.

And shes not wrong. Research showed animal trials for a SARS vaccine were plagued by a phenomenon known as vaccine-induced enhancement.

Simply put, the mice showed even worse symptoms after being injected.

Chevrier feared fast-tracking a new vaccine could be unsafe, and she certainly doesnt believe people should be pressured into getting the shot.

We feel like everybody deserves to make that choice because you will live with the consequences, Chevrier said. Nobody else is going to live with the consequences.

Most in the medical field will say that statement is simply not true.

Decades of scientific studies and research have proven and continue to prove, vaccinations protect the vaccinated and unvaccinated alike.

Its called herd immunity.

When most of the population is immune to an infectious disease, it provides indirect protection to those who are not immune to the disease.

The decision to not to get vaccinated for highly communicable disease affects not only the person making the choice but others around them, said Pavia. As a community, we depend on a high level of vaccine coverage to protect everyone. There are people who cannot get a vaccine or do not respond, and when there are a large number of unvaccinated people in the community, an infectious disease can spread and impact them.

Pavia said we see this every time theres a measles outbreak. Those who bear the worst impact are infants and people with cancer.

In order to wipe out COVID-19 in the United States, he said 80% of the population needs immunity.

Pavia believed the safest way to get there with the least number of casualties is vaccination.

You have to also admit that a very safe vaccine will still have very rare side effects that we have to be honest about and admit, said Pavia. But with all vaccines, the question is whats worse? A disease that kills one out of a hundred people, or a side effect that happens in one out of 10 million? The answer is pretty obvious.

Lets talk for a minute about herd immunity, said Scott Bradley. Herd immunity is a naturally occurring event.

Bradley represents the group Defending Utah.

Their website defines them as an organization working to expose those conspiring to take away your freedom and educate citizens on the principles of liberty.

Bradley believes herd immunity should not be forced through vaccinations. He said the world can achieve that goal naturally, letting the at-risk population self-quarantine if they so choose and letting the immune systems of the healthy protect the rest.

Herd immunity with this virus and everything else that comes along will happen naturally through just the events we bump into every day of our lives, he said.

God gave us an immune system, said Bradley. It needs practice and it does what it does best when its out and about existing in the mortal world weve been given.

Bradleys opinion is one medical experts believe would overwhelm hospitals.

An opinion history shows would claim an unnecessary number of lives and an opinion the families of nearly 175,000 now dead from COVID-19 may disagree with.

The more we have people unwilling to trust vaccines, unwilling to get them, the longer it will take to really control the disease, said Pavia.

And as the number of cases, hospitalizations and deaths continue to rise, the race for a vaccine moves forward.

When will it safely be completed?

Well, thats the big question.

But maybe the bigger question, is how many people will get vaccinated? An Emerson College Poll conducted last month shows a majority of Americans (66%) said that if there was a vaccine for coronavirus, they would take it. Another 11% said they would refrain from taking a vaccine, while 23% were still unsure.

In my opinion, it would not make sense to not use it, Vento said.

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KSL Investigates: Will the hope of a COVID-19 vaccine be derailed by mistrust? - KSL.com

Americans have been tolddaily that researchers are urgently working on COVID-19 vaccines, and that one might be available in 12 to 18 months. That timeline hasmade its way to high levels of government and throughnational mediacoverage.

Butone influentialbiopharmaanalyst doesn't buy itand he has plenty of reasons why.

In a 25-page note titled Sober Up! 25 Reasons Not to Count on COVID Vaccine for Herd Immunity in 1-2years, SVB Leerinkanalyst GeoffreyPorgessays itll takeseveralyearsnot monthsto developa safe and effectivevaccine and administer it to enough people for widespread protection.

We view the current expectations for a vaccine in this timeframe as the equivalent of standing 24 feet (the usual distance is 8 feet) from a dartboard, with one dart in hand, and counting on a bullseye from one throw, the analyst wrote. It is theoretically possible, but highly unlikely, that such expectations are correct.

RELATED:It could take 5 years for 2 leading COVID-19 vaccines to debut, AI analysis finds

As the title of his note suggests, Porges doesnt have one or two concerns about the 12-to 18-month vaccine development timeline. Hislist of worries spans more than two dozen about the target itselfanovel coronavirus thats highly communicableplus concerns aboutunleashing a vaccine with limited testing.

Just consider the history of vaccines, Porges and his team point out. For more than 10 key vaccines now widely used, the time betweenpathogen discovery to vaccine approvalranged from10 years to more than 100 years. Many pivotal trialsfor recently approved shots have takenmore than 3.5 years alone, he wrote.

Add on the time it would take to manufacture and deploya quickly developed shot to the masses, and the hoped-for herd immunity looks even farther away.

Even witha highly accelerated timeline" that includes demonstratingsafety and efficacy in humans and then designing, developing and implementinga mass immunization program,getting to a herd immunity of 70% to 80%would take until2023 or 2024, Porges figures.

That's still an optimistic view, Porges wrote. Itwould require robust first pass immunization results, lenient regulation, rapid development of manufacturing and highly cooperative behavior by the American people (or coercive behavior by government) during the immunization phase.Each one of those requirements couldbring its own challenges.

The analyst isnt alonein believingcurrently discussedtimelines are optimistic. A recent AI analysisof the two most advanced programs in the U.S.Moderna andInovio, which recently entered human testingfound it couldtake 5 years to complete development for full approval. That might well change, the firm noted, for a variety of reasons; for instance, if the companies are able to hit their ambitious goals for launching later-stage trials.

RELATED:Look for novel coronavirus treatments first, experts say, and vaccines are further off than you think

One difference this time, as Clarivate noted?Industry and others are coming together in an unprecedented fashionto advancedrugs and vaccines against the novel coronavirus. Johnson & Johnson, Sanofi, GlaxoSmithKline, Pfizer and many others are all working on programs, with more than 70 programs underway worldwide.

Meanwhile, Bill Gates has saidhis foundation iswilling to lose billions of dollars funding factories for sevenpromising vaccineseven ahead of the programs demonstrating efficacy. Only oneor twowill succeed, but Gates said the early investment in factories would advance manufacturing and distribution timelinesa worthwhile ventureto get vaccines to people faster.

More here:

A bull's-eye from 24 feet? COVID-19 vaccine timelines are overly hopeful, analyst says - FiercePharma

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

Extraordinary cooperation and accommodations are needed in the race to build a COVID-19 vaccine from scratch while chasing a pandemic, said members of industry and government who convened for an update on the vaccine clinical trial process.

The message came from representatives from the Food and Drug Administration, a think tank, and the nonprofit sector who provided some insight into the vaccine development process for COVID-19 at a press briefing hosted by the Commonwealth Fund.

Even in the best of times, vaccine development is not simple, said Litjen (L.J.) Tan, PhD, chief strategy officer for the Immunization Action Coalition. Ordinarily, the process can take from 10 to 20 years and cost well over a billion dollars. Many vaccines wind up being abandoned before phase 3 development just because the cost is prohibitive, he said.

Vaccines undergo extensive ongoing postmarketing surveillance even after approval, licensing, and distribution, noted Dr. Tan, adding that the development of a safe, effective vaccine is a "very complicated, significant process."

In these extraordinary times, many adjustments to the usual trial trajectory are needed, agreed all participants. To speed the process, the traditional vaccine trajectory is being accelerated and compressed; changes may include simultaneous rather than sequential clinical trials that are run in parallel. These trials may be optimized for multiple target populations at the same time, and run in different countries, explained Dr. Tan.

"We are likely going to use something called adaptive trial designs" in which results are gathered during the trial and used to modify the trial according to prespecified rules, he said. "These trials shift to accommodate data as it comes up."

Regulatory agencies are actively engaging in the process much earlier than usual, with input including how to incentivize scaling up production of vaccines and ensuring that vaccines will be fairly and equitably distributed across the globe, he added.

Esther Krofah is the executive director of FasterCures, a center within the nonprofit Milken Institute. Currently 86 different active COVID-19 vaccine projects are underway, she said, with 6 currently in clinical trials and about two dozen more expected to enter the clinical trial phase by the summer of 2020.

Many of these projects will involve a smaller biotech company or an academic research group with deep knowledge of a particular immune strategy partnering with a large pharmaceutical company that has economic capacity and global resources and reach, said Ms. Krofah.

From a policy perspective, she said, it's important for the FDA to have surge capacity with "enough arms, legs, and staff to actively provide input into clinical design and protocols of studies." The goal is to be able to review data in real-time and provide rapid feedback as studies are occurring so adaptive clinical trial design can be implemented.

As COVID-19 vaccine trials are rolled out, necessary compromises may include incorporation of real world evidence in later clinical trial stages. "There is a way to do randomized trials in the real world in situations that come up like this," said Peter Marks, MD, the FDA's director of the Center for Biologics Evaluation and Research. Long-term data about vaccine efficacy may be accrued over time, once a vaccine is being administered beyond the clinical trial stage, to see if efficacy wanes over time.

However, he said, "a lot will depend on where the vaccine is and what we encounter with whether there's circulating virus or not" in terms of clinical trial design, including whether surrogate efficacy markers such as antibody production would be used.

Unvaccinated members of a population may be used as controls against a vaccinated group during an active outbreak, he said, a break from traditional trial design. "It's not perfect. I'll acknowledge right away there are certain people at the [National Institutes of Health] that would like to tell me that's a horrible idea, but I think we are going to entertain and discuss all potential designs" for COVID-19 vaccine trials, he said. "We can't out-of-hand dismiss any design here, whether real world based or evidence based."

"This may be a little unusual hearing this from the FDA," he said, "but this is possibly one of the most important things we are going to have to do in the next few years." He added, "It's unfortunately not unlikely that we will see a second wave, or maybe even a third wave, if we don't get it right."

He pointed out that there was no candidate vaccine in the pipeline when the pandemic blossomed and began its race around the globe. Current coronavirus candidates aren't useful against COVID-19. "We know that there might be some complexities in development" related to the contributions of immune enhancement to the pathogenicity of the SARS-CoV-2 virus, he said.

The agency is currently working closely with sponsors of various candidate vaccines to take a hard look at preclinical data and trial design.

"Low efficacy could distract from capacity for more robust candidates to come forward," he said. "We'd like to encourage people to have the absolute best vaccines We hope to be able to facilitate rapid development of these," he said.

Moving forward, a whole-government approach is necessary for development and delivery of the best vaccine. Ms. Krofah elaborated that the FDA and the Centers for Medicare & Medicaid will need to collaborate closely as studies evolve. In particular, CMS needs to be ready with reimbursement codes, recognizing that both public and private payers will likely be providing reimbursement for COVID-19 vaccinations.

"When these vaccines get approved, we are going to have to decide who is going to pay for them," said Dr. Tan, who previously served as the director of medicine and public health at the American Medical Association. He noted that CPT coding comes through the AMA.

Dr. Marks stressed that ultimately, although treatments or prophylactic regimes against COVID-19 may be developed, "a vaccine is the most efficient way to protect large numbers of people." Though there's going to have to be a balancing act so speed doesn't come at the expense of vaccine safety and efficacy. "We are very much hoping that we can find vaccines that have relatively high levels of efficacy," he said, adding a hopeful point: "Right now there have not been mutations that have occurred ... that would alter vaccine development programs in terms of the targets they're going after."

Dr. Marks offered a wildly optimistic and then a more realistic judgment as to when a successful vaccine might emerge from the development, trial, and approval process. After acknowledging that the FDA might consider an Emergency Use Authorization (EUA) if coronavirus activity is high when a candidate vaccine emerges, he said that "if everything goes perfectly," an EUA for a vaccine might be issued within 9-12 months.

"The most likely timeline and this is total speculation is that it could be 12-18 months," he said.

Ms. Krofah concurred, adding, "We're seeing the big companies put a big bet on that timeline as well." She cited Johnson & Johnson, which has committed to a $1 billion COVID-19 vaccine development program by the end of 2021.

Finally, when a vaccine does become available, who is first in line to receive it? Ms. Krofah said that it will be important for the public to know that there will be a tiering scheme for vaccine administration in the early days. Healthcare workers, emergency responders, and the particularly vulnerable may be among the first to receive protection, she said.

Kari Oakes can be reached at koakes@mdedge.com. This article first appeared on MDedge.com.

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COVID-19 Vaccine Race a Balance of Safety and Speed - Medscape

When any new and dangerous infectious disease comes on the scene, theres an immediate and concerted push to develop a vaccine. For COVID-19, federal health officials have said we will have a vaccine in 12-18months.

Just last week, director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci told CBS, there have been no glitches in the process and that its possible to shave a couple months offthat.

But this timeline is optimistic perhaps exceedingly so. The reasons have to do with the complexities of vaccine testing, development andproduction.

Here are the basics about where we are, how its done and where weregoing.

The human body is actually really good at fighting off infection and diseases. You can thank your immune system for not letting you die of the common cold. But some germs are so virulent that your bodys immune system cant react in time to prevent serious damage. For some people, COVID-19 falls into thiscategory.

Vaccines work by tricking your immune system into thinking your body is being attacked by a bacteria, virus or another invading germ. Your immune system mobilizes and, in the process, learns how to fight off the germ. Your immune system can retain that skill for months, years, or if youre lucky, alifetime.

The key is to give your body a version of the germ that will not actually make you sick. Creating those versions is the crux of vaccinedevelopment.

There are many different kinds of vaccines each characterized by how researchers use or alter the original bacteria or virus to keep it from making you sick. Someexamples:

Attenuated vaccines (for measles, smallpox, chickenpox): To make these, scientists weaken the original germ often so it cant continue to reproduce in your body. These vaccines can generate a lifetime of immunity but cant be used for people whose immune system is alreadyweakened.

Inactivated vaccines (for polio, hepatitis A, flu): These vaccines are created by killing the original germ. Because the germs are dead, these vaccines are very safe, but your body also doesnt attack them as vigorously as something thats alive. This is why booster shots are oftenneeded.

Toxoid vaccines (for tetanus, diphtheria): Some germs dont harm your body directly, but instead produce a toxin that causes you to get sick. To make toxoid vaccines, scientists target and weaken that toxin so your body can learn to fight itoff.

Subunit vaccines (for HPV, whooping cough, shingles, hepatitis B): This is a broad category of vaccines where researchers use only a small segment of the germ as a vaccine. One technique is removing just the skin of a germ, and then attaching it to the body of another germ so your body thinks its attacking the realthing.

These methods take a long time to develop, in part because scientists have to grow and manipulate living viruses and bacteria and make sure they are safe and effective before proceeding to clinicaltrials.

In the United States, vaccines are extensively tested before being widely released. And usually, its a process that takes severalyears.

When you make a great vaccine, it should work as good as or better than the natural infection itself (at creating immunity), said OHSU professor Mark Slifka. It should be safe very, very safe - giving high rates of protection. And then give you long term immunity - hopefully even lifelong immunity if yourelucky.

Testing starts in the development phase with animal testing. Scientists use animals at the beginning to get a sense of whether their vaccine will trigger a response from the immunesystem.

Once researchers have a vaccine that shows promise, they enter humantesting:

Phase 1: The vaccine is administered to up to 100 volunteers. Scientists and regulators are focused on safety at this stage, looking for side effects and trying to determine what size of the dose issafe.

Phase 2: The vaccine is administered to hundreds of volunteers. Here researchers are still looking at safety, but are now focusing on how the immune system is responding to the vaccine. The question here: Is itworking?

Phase 3: The vaccine is administered to an even larger group of volunteers, perhaps thousands of people. These trials compare the immunity of people given the vaccine and those who are not. Scientists are also determining the most common sideeffects.

The Centers for Disease Control and Prevention says vaccines are only licensed if they are safe and effective and the benefits outweigh therisk.

This depends on several factors economics, the urgency of the need for a vaccine, and how common the disease is, to name afew.

Our goal is to develop vaccines that can protect at least 90% (of people vaccinated) - that would be a gold standard. But we dont always achieve that gold standard, Slifkasaid.

He said we have reached that goal with vaccines for measles, mumps, rubella and hepatitis A and B. But the flu vaccine is a different story. A good year is 50% perfection, and Slifka says its often muchlower.

But because its so common when you talk about 100,000 people being infected with something, if you could have 30% protection, well only 70,000 people would be infected. But look, you saved 30,000 from that disease, hesaid.

Another measure of effectiveness for vaccines is how long they provide immunity. Some last a lifetime, but many require boosterdoses.

When youre in the middle of a pandemic, you are happy to settle for six months of protection, said Dr. Kathleen Neuzil, director of the Center for Vaccine Development and Global Health at the University ofMaryland.

She says she would be thrilled with a COVID-19 vaccine that is 50%effective.

Look at the situation in New York or Louisiana or Seattle. If they could have half the number of cases, half the number of people coming to the hospital, half the number of health care workers who are sick, that would make a tremendous impact, shesaid.

There are dozens of COVID-19 vaccines in process worldwide, and theyre using a wide variety of techniques trying to find something that will work. This includes a new class of vaccines that utilize the genetic code of the harmful germ instead of the germitself.

The vaccine that is furthest along in the regulatory process is from U.S.-based biotechnology company Moderna. Its currently in Phase 1 human testing at Kaiser Permanente Washington Health Research Institute inSeattle.

The new vaccine type is called a messenger RNA-based vaccine (mRNA). To produce this vaccine, scientists dont need the virus, only the genetic code. They identify a key piece of genetic information a recipe for how to make a particular protein contained in the germ. Then they make copies of the recipe in the lab. When injected, those copies get absorbed into your cells, tricking them into following that genetic recipe. Your cells start producing that virus protein, which your immune system targets as a foreign invader and learns to fight. Essentially your cells are harnessed to produce their ownvaccine.

The Moderna vaccine is furthest along in testing, in part, because the development stage for mRNA can be much quicker than other kinds of vaccines that rely on using live germs. It was also helped by the fact that China sequenced the genome for coronavirus very early on in the pandemic and shared that information with researchers around theworld.

The less encouraging news is that because the technology is so new, no mRNA vaccine has ever been licensed by the Food and DrugAdministration.

Variety is important because history shows us that the success rate for vaccine development islow.

Its certainly somewhere less than 5 or 10%, Neuzil said. You cant count on a single vaccine. We want a lot of shots on goal right now, hoping that well score with at leastone.

These are extraordinary times, with an extraordinary level of effort going towards finding avaccine.

Were thinking about having a vaccine that is licensable in about 18 months. Thats a really tremendous feat. Its achievable and I think that its reasonable, said Dr. Wilbur Chen of the University of Maryland School of Medicine.

KerinSharma/OPB

But for that to happen, everything has to go to near perfection in the testingphase.

It can cost between $1 and $2 billion to produce a vaccine. And for all the vaccines that we currently have licensed, they take between eight and 16 years before they can make it to the market. So what were trying to do here is speed that up to light-year speed compared to how vaccines are typically produced, said OHSUsSlifka.

Once a vaccine is approved by federal regulators, then that opens up a new slate of challenges. Manufacturing and distribution are high on thelist.

Vaccine production facilities would have to be built or converted from existing facilities and extensively quality-tested by regulators. These facilities can run in the hundreds of millions of dollars and can take years tobuild.

Governments are stepping up to help facilitate this. For example, the U.S. government recently gave vaccine developer Moderna a $483 million grant to offset testing and help scale up the companys production of the mRNA vaccine currently in early humantesting.

By investing now in our manufacturing process scale-up to enable large scale production for pandemic response, we believe that we would be able to supply millions of doses per month in 2020 and with further investments, tens of millions per month in 2021, if the vaccine candidate is successful in the clinic, said Stphane Bancel, Modernas Chief Executive Officer, in astatement.

But even this would not meet the countrys demand to say nothing of the global demand for a COVID-19 vaccine. And this will introduce questions about who getsaccess.

Health care workers are often mentioned as getting first priority to vaccines. But beyond that, officials will have to figure out how to rationthem.

Do you vaccinate the vulnerable? Do you vaccinate the young people who might be spreading it to the vulnerable? So lots of questions come up with that. Slifkasaid.

I mean, it would be a great problem tohave.

Read the original here:

FAQ: Finding A Vaccine To Beat COVID-19 - OPB News

If you are young and healthy, would you volunteer to be infected with COVID-19 to help quickly develop a vaccine? With the pandemic sweeping the globe, its a reasonable question to be asking.

A group of 35 lawmakers, led by Reps. Bill Foster, D-Ill., and Donna Shalala, D-Fla., are urging the Food and Drug Administration to take more risks including infecting humans to shrink the time it takes to develop and approve a vaccine.

We are trying to give the FDA political cover to be somewhat more aggressive on the rapid rollout of vaccines than they would under normal circumstances, Foster told the Chicago Sun-Times on Tuesday.

The typical approval time for vaccines of normal diseases is 18 months to several years. Foster told me testing a COVID-19 vaccine using infected humans could cut that time to two or three months.

Foster, a physicist, and Shalala, who served as Health and Human Services Secretary under former President Bill Clinton, laid out the case for rethinking the risk/benefit ratio involved in COVID-19 human drug testing in a letter to HHS Secretary Alex Azar and FDA Commissioner Stephen Hahn.

They want the FDA to embrace expedited procedures for testing, approval and use of COVID-19 vaccines.

The pandemic, Foster and Shalala said in their letter, means a reevaluation of the essential tradeoff of having new drugs quickly even if the effectiveness and side effects are not fully known at the time of deployment.

In normal times, infecting human subjects to develop a drug is controversial, and while it has been done, it is rare. The Foster/Shalala letter is intended to let the FDA know that Congress or at least 35 House members will have their back.

The 35 included two Republicans and a total of five Illinois Democrats: Foster, Sean Casten, Danny Davis, Bobby Rush and Jesus Chuy Garcia.

We write to assure you that Congress understands that a more risk-tolerant development process is likely appropriate in the case of a COVID-19 vaccine, the letter said.

They suggest running two vaccine trials in parallel: One, the time consuming traditional way, not involving infecting anyone while at the same time deliberately infecting volunteers. Some infected volunteers would receive a vaccine; others a placebos.

We urge you to consider these and other options, provided they proceed with the principle of informed consent of truly voluntary subjects and backed by the best available science.

Any volunteer would head into a test knowing there is no widely accepted cure for COVID-19. There is no zero risk path here, Foster told me. Still, Anytime any new drug is approved theres a risk.

The discussion of infecting humans is done in the context that COVID-19 is a fire burning through the developed world right now and very soon the developing world, Foster said. ...So the benefits of getting a vaccine approve early is enormous.

An article in the April 3 edition of Science considered the ethics of using human volunteers to speed a vaccine.

Seema Shah, a bioethicist at Northwestern University, noted her misgivings in the article and said they could be addressed if the volunteers were people already trained to take on these risks, like health care workers.

She added, If were going to say were making an exception to the standard way we do things, then we really have to get that right.

Foster, from Naperville, who represents the 11th Congressional District, said young and healthy volunteers would be recruited because they would have a low probability of dying in a controlled testing situation. Also, You can get the right racial mixture so you can actually resolve some of these issues, why is it African-Americans are dying at a much higher rate.

The volunteers would have state of the art medical care if they got sick.

Said Foster, Its very much like the military, asking for volunteers for a very dangerous mission. The COVID-19 vaccine volunteers will be heroes to humanity and they will be responsible for saving thousands and maybe millions of lives.

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Would you volunteer to be infected with COVID-19 to develop a vaccine? - Chicago Sun-Times

Humanity will have to live with the threat of coronavirus for the foreseeable future and adapt accordingly because there is no guarantee that a vaccine can be successfully developed, one of the worlds leading experts on the disease has warned.

The stark message was delivered by David Nabarro, professor of global health at Imperial College, London, and an envoy for the World Health Organisation on Covid-19, as the number of UK hospital deaths from the virus passed 15,000.

A further 888 people were reported on Saturday to have lost their lives a figure described by communities secretary Robert Jenrick as extremely sobering while the total number who have been infected increased by 5,525 to 114,217.

The latest figures, which do not include deaths in care homes and in the community, put further pressure on the government amid continuing anger among NHS workers and unions over the lack personal protective equipment (PPE) for hospital and care home staff on the front line.

In late March the governments health advisers said that if UK deaths from Coronavirus could be kept below 20,000 by the end of the pandemic, it would be a good result for country. But with an estimated 6,000 people having already died in care homes from Covid-19 a figure not included in Saturdays official tally the 20,000 figure is likely already to have been exceeded.

In an interview with The Observer Nabarro said the public should not assume that a vaccine would definitely be developed soon and would have to adapt to the ongoing threat.

You dont necessarily develop a vaccine that is safe and effective against every virus. Some viruses are very, very difficult when it comes to vaccine development - so for the foreseeable future, we are going to have to find ways to go about our lives with this virus as a constant threat.

That means isolating those who show signs of the disease and also their contacts. Older people will have to be protected. In addition hospital capacity for dealing with cases will have to be ensured. That is going to be the new normal for us all.

The comments came as the former UK health secretary Jeremy Hunt said the only way forward was for nations to support a new global health system that would mean far more international cooperation between governments on health issues. It would also require richer nations doing more to support the health systems of the worlds poorest countries.

I think global health security is going to be on that small but critical list of topics like climate change that we can only solve in partnership with other countries, Hunt told The Observer.

In a clear criticism of US President Donald Trump who announced last week he was putting on hold funding to the World Health Organisation (WHO) Hunt added: Surely the lesson of coronavirus is cure not killIt certainly does not mean cutting their funding (to the WHO).

One of the big lessons from this will be that when it comes to health systems across the world, we are only as strong as the weakest link in the chain.

Although China has rightly been criticised for covering up the virus in the early stages the situation would have been whole lot worse if this had started in Africa. International cooperation and supporting health care systems of the poorest countries has to be a top priority in terms of the lessons we need to learn.

Nabarros message is the second grim warning to come from senior ranks of the WHO in the last three days. On Friday, Maria Van Kerkhove, head of WHOs emerging diseases and zoonosis unit, warned that there was no evidence that antibody tests now being developed would show if a person has immunity or is no longer at risk of becoming reinfected by the Covid-19 virus.

On Saturday it emerged that doctors and nurses treating Covid-19 face shortages of protective full-length gowns for weeks to come, as anger mounts over failures to stockpile them. Gowns were not included in a stockpile list prepared for a potential flu pandemic.

After The Guardian revealed new guidance from Public Health England which instructs healthcare workers to re-use disposable equipment, the GMB, which represents NHS and ambulance staff, said support was draining away from Health Secretary, Matt Hancock.

Saffron Cordery, deputy chief executive of NHS Providers which represents many trusts, told the Observer: We are in a situation where we think this [issue] will last a couple of weeks, which probably does just take us to May. There is a shortage of gowns which is affecting some trusts, but not all. Some have none, and are using the alternatives.

The government will attempt to gain control of the mounting PPE concerns by appointing Paul Deighton, chief executive of the London Olympics organising committee, to lead efforts to produce equipment in Britain.

Ministers also announced another 1.6bn cash injection to local councils as they attempt to stem a spiralling crisis in social care that is pushing some care providers into the red. Some have been paying inflated prices for commercial protective equipment.

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Dont bet on vaccine to protect us from Covid-19, says world health expert - The Guardian

Could antibodies found in the blood of llamas, the doe-eyed South American pack animal, hold a key to developing a vaccine for COVID-19? A team of researchers from Belgium believes so.

Researchers from the Vlaams Institute for Biotechnology in Ghent have found antibodies in llama blood which they think could help to neutralize the novel coronavirus that causes COVID-19, the pandemic that has swept across the globe. A new report on Brinkwire shows that the antibodies found in llama blood have been effective against MERS and SARS, which are close relatives of the virus that causes COVID-19. The team of scientists stumbled upon this discovery of the llama antibodies while previously researching HIV.

According to the report, the antibodies found in the blood of llamas are smaller than human antibodies. This, according to Brinkwire, raises the possibility of using the animal-based antibodies in nanotechnology as part of a delivery of antiviral activity into humans.

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Looking at llama antibodies is nothing new in the world of scientific research. Two years ago, a team from the Scripps Institute in Southern California used llama antibodies in their research on developing a universal flu vaccine. That team discovered that llama antibodies are effective enough to work on a wide number of flu viruses.

The Vlaams Institute for Biotechnology said the information gleaned from their research warrants additional investigation. There was no information provided as to whether or not the institute intended to fast-track the study into the clinic as the world waits for a vaccine for COVID-19.

Multiple life sciences companies and organizations have aimed their research programs at developing a vaccine candidate for the disease. Still, most data suggest a vaccine wont be available for use until the end of 2020 or the early months of 2021 at best.

There are currently more than 70 vaccine candidates being assessed for COVID-19. Only a handful of the candidates have moved into human trials, with CanSinos Adenovirus Type 5 Vector, Ad5-nCoV, being the farthest along in Phase II studies. Ad5-nCoV is a genetic engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express SARS-CoV-2 spike protein. Best estimates suggest that a vaccine will take up to 18 months to develop and launch, which puts earliest availability in early to mid-2021.

The llama isnt the only animal researchers are focused on in the hunt for a vaccine candidate. According to the Brinkwire report, scientists are also focused on ferrets and hamsters to help solve the need for antibodies and vaccines.

In South Korea, researchers are looking at ferrets as animal models for testing potential COVID-19 drugs in humans. The researchers found that the disease behaves similarly in ferrets as it does in humans. According to the study published in the journal Cell Host & Microbe, ferrets were good candidates for the research due to the fact that the anatomic proportions of the ferrets upper and lower respiratory tracts, the density of submucosal glands in the bronchial wall and the number of generations of terminal bronchioles reproduce the condition in the human respiratory tract. Because of this, the researchers said ferrets represent an infection and transmission animal model of COVID-19 that may facilitate development of SARS-CoV-2 therapeutics and vaccines. Additionally, the researchers were able to observe the spread of COVID-19 between ferrets in the same cage, as well as to adjacent cages. It reinforced the assumption of aerosol transmission of the disease over short distances.

In Hong Kong, researchers had similar success with Syrian hamsters. According to a report in Science, the research showed that hamsters displayed similar effects of the disease. The findings closely resemble the manifestations of upper and lower respiratory tract infection in humans, the researchers said. The study was published in the journalClinical Infectious Diseases.

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Could Llamas Hold the Key to a COVID-19 Vaccine? - BioSpace