Category: Corona Virus Vaccine

Dr. Sonia Macieiewski (R) and Dr. Nita Patel, Director of Antibody discovery and Vaccine development, look at a sample of a respiratory virus at Novavax labs in Rockville, Maryland. Photo: Andrew Caballero-Reynolds/AFP via Getty Images

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The world is watching the medical science community closer than ever, looking for every morsel of hope as researchers race to develop a treatment for COVID-19. Just this week, the CEO of Moderna, a biotech company with a vaccine that began human trials last month, said that her company could begin distributing its vaccine to health-care workers as soon as this fall. On Thursday, Stat News reported that an antiviral medicine developed by Gilead Sciences is getting positive results in clinical trials on severe coronavirus patients. On Friday, French drugmaker Sanofi said that it could produce 600 million doses of its vaccine next year, if it clears its clinical trials. To sort through all of the news, Intelligencer spoke to Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of Texas Childrens Hospital Center for Vaccine Development, where he is developing a coronavirus vaccine.

What do you make of the news that patients in a remdesivir trial are making rapid recoveries?

Remdesivir is an interesting drug because it actually works by inhibiting an enzyme that the virus needs to replicate, so it makes sense that this could have some antiviral activity. This is opposed to things like chloroquine or ivermectin some of the other things youve been hearing about where there would be no specific reason why they would work for COVID-19. Remdesivir is actually designed as an antiviral drug, so the fact that you are seeing some clinical-therapeutic effect is a good sign.

This was a study of about 125 patients with COVID-19. Of those, 113 had severe disease and they were treated with daily infusions of remdesivir. The point is, most of those patients have been discharged and only two of the patients died. Thats a fairly low mortality rate for 113 patients. The problem is, this is not a published study. We dont have a lot of information about what actually happened from these results. Theres some initial promise but, again, were going to need a lot more information before we can say anything definite.

We talk a lot about the timeline of vaccines, what about treatments like remdesivir what kind of role will they play in reducing the death toll of a second wave?

Something like remdesivir, right now, as its currently being looked at, is a treatment for ill patients its not really being used as a preventive. Thats not to say it couldnt one day be advanced as a preventive. What do I mean by preventive? We have, for instance, for HIV/AIDS, things like PrEP. Were not there yet, but there is evidence that this is showing some benefit. Well have to see.

What kind of timeline are we looking at for a treatment like that? Can we look for something in the fall?

Potentially. It all depends on how quickly we can accumulate the data. Right now, the attack rate is pretty high so were going to get a lot more information over the next few weeks. Remember, this may be our one window when well be able to get that information. If everybody practices social distancing, and transmission goes down, it will be more difficult to enroll lots of patients after June.

What do you think of chloroquine as a treatment?

Its not a matter of what I think. I havent seen any large, well-controlled studies that point to its effectiveness. Theres been a couple of small studies with a hint of effectiveness, which have been shown to exhibit replication in the laboratory. But its fairly toxic at high doses and theres no particular reason why the drug would work, other than the fact that it has shown some effects of inhibiting the replication of the virus in the test tube. But it did that for influenza as well and it never really panned out. Given that history, and the fact that weve only really had a few small studies and its fairly toxic at high doses, and theres no particular reason why it should work against the virus, I would put chloroquine at a much lower likelihood.

Are there any other promising treatments in trials right now?

Im a vaccine person, not a small molecule drug person, but there are other antiviral drugs being looked at right now. In fact, theres something that the WHO has called the solidarity study. This is a solidarity clinical trial for treatments. There are 90 countries that are participating and theyre looking at remdesivir, chloroquine, and a combination of antiviral drugs called lopinavir and ritonavir, and then theyre looking at it with an interferon beta.

Earlier this week, Dr. Fauci said that its possible a vaccine could be available sooner than the 12-to-18-month window he and many others have talked about. What do you think accounts for that possibility?

Were making a vaccine and were working late into the night and up early in the morning trying to move this vaccine into clinical trials, trying to meet Dr. Faucis aspirational goal. Were going to do our best but it really depends on how things progress in terms of evidence of safety and also efficacy.

The CEO of Moderna reportedly told Goldman Sachs that the companys vaccine could be available for emergency use on health-care workers as early as this fall. How would a limited roll-out like that work?

I dont know. As it is, 12 to 18 months would be a record. It is possible, after a year or 18 months, to get an efficacy signal that a vaccine shows some effect to prevent the infection? The key is going to be showing that its safe. To show all of those things in a year to 18 months would be unprecedented. I dont know what kind of data hes looking at in particular.

Our vaccine could be ready by the fall as well. Well have up to 200,000 doses. But unless youve shown that it actually works and unless youve shown that its safe, youre not going to do that. Without having the efficacy and safety data, I think you have to be really careful about bold statements like that. As I often like to say, these nucleic acid vaccines have been around for 30 years and they offer great promise, they work in laboratory animals, but, historically, they have not worked well in people. Maybe now theres been modifications to improve that. Lets wait and see.

Should we be concerned that this expediency factor, loosening regulations or foregoing animals trials, might impact public safety?

The biotechs are being very aggressive in their press statements. What theyre doing is talking to their investors. I think you have to filter that away from what the FDA is thinking. A wishlist from the CEO of a biotech or a pharma company means nothing to me. Its what the clinical trialists are finding in collaboration with the FDA that matters.

So theres nothing that the FDA has done to the process that significantly changes the safety standards of these trials.

I dont know. I dont have access to that information. But the branch of the FDA called the Center for Biologics Evaluation and Research has been around for a while and has some of the smartest vaccine scientists that Ive ever worked with. Im fairly confident they would not do anything that would jeopardize the health and safety of Americans. I tend not to pay attention to the statements from the CEOs of biotech and pharma companies. Theyre talking to their shareholders.

Once a vaccine is available, how will it be administered in the United States?

Ultimately, there will be more than one vaccine. There could be several vaccines that have different uses. Some vaccines might be used for older Americans at risk of disease or those with underlying comorbid conditions like diabetes or obesity. There might be some use for younger adults. Maybe some for health-care workers. Same with the other technologies that were talking about, like remdesivir, there may be a prophylactic use for it as well. All of this is being accelerated through a lot of studies in parallel and well have to see how the target product profiles will look.

Is everyone going to go to Walgreens at once? Or will it be gradually expanded by targeting vulnerable populations?

I dont think those kinds of decisions have been made yet. Right now, theres a focus on trying to shape the target product profile on the populations that have to be prioritized. You also have to worry about the fact that COVID-19 is a global health problem. Some of these vaccines are very high tech and may not be available for people in the poorest countries places like India, Bangladesh, and Ecuador. Thats one of the things were trying to do, develop the first global health vaccine

Whats the biggest challenge to doing that?

Let me give you the flip side of that. Our vaccine uses the same technology as the recombinant protein hepatitis B vaccine thats made all over the world. Its made in Brazil, its made in India. We did that deliberately so we could have a global health vaccine that could be made locally. Right now, Im not aware of any capability of that capacity for some of the vaccines now being ruled out. Its not so much that its hard to make a piece of DNA or RNA, its the kind of unique packaging that theyre doing to make it work in people. In the past, RNA and DNA vaccines have worked well in mice, but not well in people. They say they have evidence through the different kinds of the constructs they have in the packaging that it can improve efficacy. How easy it is to scale that up for low and middle income countries, for me, is a total unknown.

Will we experience anything that resembles everyday life before a vaccine is distributed?

I think so. I think what were going to see is, as transmission goes down because of the social distancing and the economy opens up, youll see parts of American life restored to some level of normalcy. It will be different in the sense that well probably have to figure out a way to do testing on a regular basis and then have individuals responsible for tracing down contacts, and the contacts of the contacts of infected individuals. There will need to be some adjustment. And the virus could come back next year or the year after that. Theres some models coming out of Harvard to suggest thats a high probability. Things wont be the same for a couple of years. Its not clear that this virus will be around forever and well have a whole array of new technologies to apply to it.

The one piece that were focusing on that youre not hearing anything about is the fact that were all focused on what to do for the United States. I understand that emphasis, but Im very worried when I hear stories of bodies piling up in Guayaquil, Ecuador. Or how are you going to implement social distancing in the crowded urban areas of Mumbai, Dhaka, or Lagos. Thats where were coming in. Were using our expertise in developing low-cost global health vaccines to see how we can also take on that component of the pandemic. The frustration that we have is that even now were still struggling to raise money to do our clinical trials. Thats unfortunate, even at this stage.

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What to Expect From the Race to Develop Coronavirus Vaccines - New York Magazine

Dr. Rhonda Flores looks at protein samples at Novavax labs in Rockville, Maryland, one of the labs developing a vaccine for the coronavirus, COVID-19. ANDREW CABALLERO-REYNOLDS/AFP via Getty Images hide caption

Dr. Rhonda Flores looks at protein samples at Novavax labs in Rockville, Maryland, one of the labs developing a vaccine for the coronavirus, COVID-19.

According to new White House guidelines, a state, city, or county has to show a decreasing rate of confirmed coronavirus cases for 14 days before reopening their economy.

A year may seem like a long time to develop a vaccine for the coronavirus, but vaccine development typically takes longer. NPR's Joe Palca explains why it's so hard and what researchers are doing to speed things up.

Food banks around the country have been stretched, including one in San Antonio. Last week it served 10,000 families, many of whom are dealing with joblessness and food insecurity caused by the pandemic.

Plus, the man who developed the N95 mask filter technology comes out of retirement.

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This episode was produced by Anne Li, Gabriela Saldivia, and Brent Baughman, and edited by Beth Donovan.

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Coronavirus Vaccine Timeline; What It Takes To Reopen The Economy - NPR

The government has announced a new vaccines taskforce to help the development of a vaccine for Covid-19 and ensure its rapid production and rollout if one arrives.

The business secretary, Alok Sharma, also gave details of cash grants for work into both vaccines and potential treatments. Among the projects receiving cash is one led by Public Health England (PHE), which hopes to develop an antibody drug, something that has the potential to work as both a prophylactic and a treatment for those infected.

A potential antibody drug could be given as a regular infusion to healthcare workers and other high-risk groups, and would provide protection perhaps over a few weeks or months. It could also be used as a treatment to help people fight off the virus when infected.

Sharmas announcement, at the daily Downing Street press briefing, focused mainly on the idea of the vaccines taskforce, combining government and industry, which would both coordinate research efforts to develop a vaccine and then seek to ensure it could be provided to people as soon as possible.

Led by Sir Patrick Vallance, the governments chief scientific adviser, and Jonathan Van-Tam, the deputy chief medical officer for England, the taskforce will also include representatives from the drugs firm AstraZeneca and the Wellcome Trust medical foundation.

UK scientists are working as fast as they can to find a vaccine that fights coronavirus, saving and protecting peoples lives. We stand firmly behind them in their efforts, Sharma said.

The vaccine taskforce is key to coordinating efforts to rapidly accelerate the development and manufacture of a potential new vaccine, so we can make sure it is widely available to patients as soon as possible.

The taskforce will have the brief of first helping provide research groups and industry with support and resources to help develop a vaccine, and then when one arises, to boost manufacturing, if needed reviewing regulations to ensure it can be provided widely and at speed.

The consensus among pandemic experts is that the mass use of a reliable vaccine against coronavirus is likely to be the only way governments around the world can fully ease distancing measures.

Work is taking place in numerous countries, with some human trials already starting. Vallance has maintained that a year to 18 months is a reasonable timeframe for a vaccine to be widely available.

Some teams are aiming to move faster than this. Prof Adrian Hill, director of the University of Oxfords Jenner Institute, whose vaccine candidate is expected to enter human trials this month, said the team hoped to be able to confirm efficacy by September and is already scaling up manufacturing. The aim is to have at least a million doses [available] by around about September and move even faster from there, he said.

The government has already announced 250m in funding towards worldwide efforts to develop a vaccine, with 10.5m allocated to six projects in March. On Friday, another 14m was allocated to 21 new projects, based on both vaccines and treatments.

Among these is funding for the possible new antibody drug, being developed by PHE, billed as intended to offer protection against infection and disease progression of coronavirus.

A 3.2m grant will go to a study called Virus Watch, conducted by University College London, that will test 10,000 participants every time they report any symptoms that could be linked to Covid-19 and trace participants movements using mobile apps. Other research funded will look at the impact of Covid-19 on pregnancy outcomes and track the rates of infection, through antibody tests, in children and teenagers, who have made up only a tiny fraction of confirmed cases.

There has been considerable focus on drugs usually used to treat malaria as a possible way to alleviate coronavirus symptoms. Some of the grant money will go to a clinical trial led by Oxford University in which more than 3,000 patients over the age of 65 presenting at GP surgeries will be given the anti-malarial drug hydroxychloroquine to see whether it reduces the need for them to go to hospital or speeds up recovery.

Hydroxychloroquine, also known by its brand name, Plaquenil, is a drug used to treat malaria. It is a less toxic version of chloroquine, another malaria drug, which itself is related to quinine, an ingredient in tonic water.

A widely publicized study in France where 40 coronavirus patients were given hydroxychloroquine, with more than half experiencing the clearing of their airways within three to six days has led to it being touted in some quarters as a potential cure for Covid-19. This apparent improvement is important as it would curtail the timeframe in which infected people could spread Covid-19 to others.

However, experts have warned that the study is small and lacks sufficient rigour to be classed as evidence of a potential treatment. The French study followed work by Chinese researchers which suggested that hydroxychloroquine can slow infections by blocking the virus behind Covid-19 from entering cells in the body. But more recent, albeit small-scale, research from China has shown that patients who were treated with the drugs fought off coronavirus no more quickly than those who didnt get it. Indeed, one patient given hydroxychloroquine severely worsened in condition while four patients on the medicine developed signs of liver damage and experienced diarrhoea.

Regardless of these findings, any drug being used for a certain purpose before full clinical trials are completed is, by definition, untested and unproven. Its too early to say if hydroxychloroquine can have a major benefit or not. The European Medicines Agency, an agency of the EU, has said hydroxychloroquine should not be taken by coronavirus patients except for clinical trials or emergency use programs.

Oliver Milman

Vallance said the taskforce would ensure that any potential coronavirus vaccine, when available, can be produced quickly and at scale so it can be made available to the public as quickly as possible.

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New UK taskforce to help develop and roll out coronavirus vaccine - The Guardian

Here's what we know about where possible coronavirus treatments, vaccines and antibody tests stand.

Antibody tests are often cited as key to returning to normal, and they would verify whether a patient had already been infected with the coronavirus and developed antibodies to it. That could mean the patient is immune or protected from being re-infected by the coronavirus, but it's unclear how certain that is.

There are currently four antibody tests approved by the US Food and Drug Administration, meaning the agency has reviewed data showing those tests work. The FDA approved one of these tests Thursday and two of them Wednesday.

In a controversial move, the FDA is allowing other companies to sell their tests without supply data that show they work.

After receiving complaints, the National Cancer Institute, a part of the National Institute of Health, is working to validate some antibody tests in hopes of getting better quality tests on the market.

Possible treatments

Right now there is no specific treatment for Covid-19. And while doctors are trying out various drugs and procedures, it's still not known if they'll work.

You've likely heard about hydroxychloroquine, a drug that's already approved and used to treat malaria, lupus and rheumatoid arthritis.

President Donald Trump has often touted hydroxychloroquine as a possible treatment, calling it a "game changer."

Results from most clinical trials are not expected until June or July.

Scientists are also looking at remdesivir, an experimental drug designed to treat Ebola. Several trials are underway in the US and worldwide.

Another possible treatment is convalescent plasma, which involves injecting blood products that contain antibodies from recovered Covid-19 patients into people who are still infected.

The hope is that the antibodies from the patients who've successfully recovered from Covid-19 will help the patients who are currently fighting off the disease.

It's an old concept, and it hasn't always been successful -- it was tried with Ebola patients, but it didn't work -- but several trials are underway in New York and Orange County, California.

Vaccines

Vaccines are seen as the holy grail. If the US population can be successfully vaccinated for the coronavirus, that would make it easier for the country to reopen.

Kizzmekia Corbett, NIH's lead scientist for coronavirus vaccine research, told CNN that a vaccine could be ready in the fall for "emergency use."

"That would be for healthcare workers and people who might be in constant contact and risk of being exposed over and over," she said. "And then for the general population our target goal is for next spring," she added, assuming all goes well.

Other researchers are skeptical, saying the type of vaccine she's referring to has not been successful in humans.

Several companies are testing vaccines, but it will take months -- or more likely at least a year -- to complete those trials.

The US biotech firm Moderna has begun enrolling patients with Kaiser Permanente and Emory University.

Johnson & Johnson, which plans to start human testing by September with the Biomedical Advanced Research and Development Authority.

Inovio Pharmaceuticals is testing its first human subjects this week, while Novovax plans to start human testing in mid-May.

Pfizer is also working on a vaccine with BioNTech.

CanSino Biological Inc. and the Beijing Institute of Biotechnology have a vaccine in clinical evaluation.

But again, researchers are skeptical, saying there are likely other reasons for reports of low coronavirus rates in those countries.

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What we know about the state of coronavirus treatments, vaccines and antibody tests - CNN

Some supporters of President Donald Trump have latched onto a new villain to attack during the COVID-19 pandemic: Microsoft co-founder Bill Gates.

AsThe Daily Beast'sWill Sommer reports, Trump-loving social media personalities Diamond & Silk this week uncorked a bizarre conspiratorial rant about Gates working to develop a vaccine for the coronavirus to use unsuspecting Americans as "guinea pigs" in a plan to "rule the world with vaccines."

And Diamond & Silk are far from their alone in their suspicions about Gates Newsmax White House correspondent Emerald Robinson said he believes that Gates is going to use the vaccine to "track" people, while Trump ally and convicted felon Roger Stone has flat-out said that Gates will use the vaccine to "microchip" people.

Brooke Binkowski, the managing editor of fact-checking site Truth or Fiction, tells Sommer that Bill Gates is rapidly becoming the right's biggest bogeyman after financier George Soros.

"These are all just recirculated, warmed-over storiesthey're just switching the names around," she said. "George Soros was the bogeyman, now it's Bill Gates."

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Binkowski also fears that these conspiracy theories will make millions of Americans reluctant to take a COVID-19 vaccine when one is eventually developed, which will further put people's lives in danger.

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Diamond & Silk claim Bill Gates work on coronavirus vaccine is part of plot to rule the world" - Salon

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As soon as it became clear how quickly coronavirus was spreading across the world, and how deadly it was, the race for the vaccine was on. As of now, there are as many as 115 vaccine programs in the works, reports the journal Science Translational Medicine. One of the first in the world to be tested on humans was created by Moderna, Inc, a biotech company in Massachusetts. One month ago, that vaccine was given to the first set of human subjects as part of a safety trial.

The first person to receive the Moderna coronavirus vaccine was Jennifer Haller of Seattle; she spoke to Refinery29 the day after getting the shot. Around a month later, on April 14, she received the second and final dose. We took the opportunity to check in with her. She answered our questions about what symptoms she experienced as a result of the vaccine, and how shes handling all the attention she received after news of her participation in the Moderna trial went public.

This interview has been condensed for clarity and length.

Refinery29: What has the last month been like?

Jennifer Haller: As far as side effects from the vaccine, Ive had basically, zero. My arm was sore the day after the first shot, and my arm is sore again today after getting the second shot. But Ive experienced no other side effects, which has been great. Ive just been living my life as normal as possible, since Im under the same restrictions as everybody else no special restrictions from participating in the trial.

Did you have to go in for any blood tests or anything in the interim between these two vaccines?

Yes. After the first one, I went back one week later for a blood draw. That one was to just check my overall health and make sure that I was doing well. Two weeks after the first vaccination, I went in for another blood draw. That one was to check my overall health as well, but also to check for any antibodies that may have been produced. [Antibodies would indicate an immune response to the vaccine, which would be a positive sign.]

As of now, even the study doctors dont know what the results of the antibody production was, so neither do I. My understanding is similar, that this first phase is just to determine safety. And in the second phases theyll focus more on efficacy. I dont believe I will know any results until they are published publicly.

I got the second dose of the vaccine yesterday, and Ill go through a repeat of four weeks ago: I keep a log for the next eight days of my temperature and any symptoms. There will be a phone call today and tomorrow to just do a check in, get some vitals from me over the phone. In a week, Ill go back for a blood draw, and in two weeks, Ill go back for a second blood draw.

Then from there, over the next 12 months Ill have three more visits for blood draws.

But Im done there are no more doses of the vaccine.

Has being part of the trial affected your day-to-day at all? Does it feel different knowing that youve taken part in this trial or not really?

No, I dont presume any kind of inoculation or anything from the trial. Im conducting myself the same as if I wasnt in the trial, just taking the same precautions as everyone else.

Im based in New York City, where the vibe is still pretty anxious. What is it like in your area, in Seattle? Are you still pretty locked down?

Yes. In the last week or so, weve seen that our state has generally done a good job on the stay-at-home mandate. We leveled off on new cases. We dismantled our field hospital last week, and sent it back to the federal government for them to redeploy and returned a bunch of ventilators.

So, our state is feeling cautiously optimistic about the success of the stay-at-home order. But were certainly not out of the woods. I dont think were near lifting the stay-at-home order. Were feeling pretty lucky, especially seeing whats happening in areas of our country that didnt take it as serious.

After the first time we spoke, I noticed people reacted almost with a sense of relief to be hearing something positive. And not just that they were testing a vaccine, but that you and the other participants in the trial had volunteered and were taking this step to help the greater community. What was it like to be faced with that kind of overwhelmingly positive reaction when the news of you being part of the vaccine trial began getting around?

Yeah, I think a big piece of me wanting to do this is because I have a lot of privilege: I have a secure job, friends and family nearby, plenty in savings. Being part of a trial like this is something that a lot of people cant do because theyre under so many more stressors, and have so many more immediate concerns. So it was important to me to find something to do that others necessarily couldnt. By that I mean to use my privilege to do something a little more risky than what others could do.

And all the praise was difficult at first I did receive a ton of love and thanks and prayers from thousands of people on Facebook, Instagram, LinkedIn, and all of that. It was very overwhelming and I didnt know what to do with that. It didnt feel right to me to have all this praise because Im just one of many that are participating in a vaccine trial. Im just one small piece of this effort.

So I didnt know what to do with all that. And I talked to a trusted advisor, a spiritual leader, that Ive turned to in the past. She said, If somebody criticizes you or is mean to you, its because theyre projecting or they have something else going on in their life. So you dont take that personally. And she helped me understand that this is just the flip side of that. That praise is also not to be taken personally, and its not about me. Its about people looking for hope and some kind of positive future. And so that really helped me release and pass on the positive messages I was receiving.

And I wanted to pass it on to those who were actually putting their lives on the line here. The ones who are working to feed their family and keep their housing.People that are working minimum wage jobs, working on the farms or driving trucks or cleaning hospitals all those who are now termed essential workers. Those are the real people that are making sacrifices and going through some scary times.

Have there been any stories or news youve heard thats touched you in the same way that people were being touched by your story? Has there been anything youve heard that youve just been like, Wow, I cant believe someones doing that or people are doing that?

I dont have specific stories, but I am thinking a lot about undocumented workers right now. My birthday was just last week and for the past couple of years Ive done a fundraiser on Facebook. This year I picked a non-profit to support undocumented workers. Thats a group that has completely fallen through the cracks and received zero help from the federal government, certainly.

They have the hardest jobs in our country, I believe, and critical jobs. And so that was something that was important to me to support and to recognize.

I dont know how to say it, but I know my family and my neighbors are going to look back on this time and be like, Wow, wasnt that magical? We got to slow down. We got to spend some quality time with our family. We got to connect. And Im really kind of embarrassed by that, because half of our country, even prior to this crisis, was living paycheck to paycheck.

So I hope, when Im doing interviews, when people are hearing my story, what I really hope is that it inspires them to think beyond themselves. Its natural, when were in crisis, to go inward to protect ourselves and to protect our family. But I really hope that this can inspire people to step outside of that and to think bigger. And I hope, certainly more broadly, that this is a wake-up call for our country to recognize the inequality that has always been there and to take some important steps to meet everybodys basic human needs: universal healthcare, paid sick time, a livable minimum wage, I could go on

COVID-19 has been declared a global pandemic. Go to the CDC website for the latest information on symptoms, prevention, and other resources.

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She tested a coronavirus vaccine a month ago. Here's what the last 4 weeks have been like. - msnNOW

"So I hope, when I'm doing interviews, when people are hearing my story, what I really hope is that it inspires them to think beyond themselves. Its natural, when we're in crisis, to go inward to protect ourselves and to protect our family. But I really hope that this can inspire people to step outside of that and to think bigger. And I hope, certainly more broadly, that this is a wake-up call for our country to recognize the inequality that has always been there and to take some important steps to meet everybody's basic human needs: universal healthcare, paid sick time, a livable minimum wage, I could go on"

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I Tested The Coronavirus Vaccine A Month Ago. Heres What The Last Four Weeks Have Been Like - Refinery29

Vaccine with incomplete immunity could offer faster solution to pandemic  Better Life

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Vaccine with incomplete immunity could offer faster solution to pandemic - Better Life

When will we have a Covid-19 vaccine? Public-facing scientists such as the UKs chief scientific adviser, Sir Patrick Vallance, and his US counterpart, Anthony Fauci, keep repeating that it wont be before 12 to 18 months. But other voices including some of those in the race to create a vaccine themselves have suggested that it could be as early as June. Who is right?

The former, probably, but its complicated because this pandemic is forcing change at almost every step in the process by which a new vaccine arrives at a needle near us.

It really depends on what you mean by having a vaccine, says Marian Wentworth, president and CEO of Management Sciences for Health, a Massachusetts-based global not-for-profit organisation that seeks to build resilient health systems, and a long-time observer of vaccine development. If you mean one that can be used in a mass vaccination campaign, allowing us all to get on with our lives, then 12 to 18 months is probably right.

But in terms of an experimental vaccine that is deemed safe and effective enough to be rolled out in a more limited way to high-risk groups such as health workers, say that could be ready within weeks or months, under emergency rules developed by drug regulatory agencies and the World Health Organization in the context of the recent Ebola epidemics in Africa.

When the University of Oxfords Adrian Hill told the Guardian that his groups Covid-19 vaccine candidate could be ready by the summer, it was this kind of readiness to which he was probably referring. The group, led by Sarah Gilbert, has since stated that a vaccine shown to be effective in phase-3 clinical trials that could be manufactured in large quantities wont be ready before the autumn even in a best-case scenario. And that scenario is highly ambitious and subject to change.

Normally, a vaccine is developed in the lab before being tested on animals. If it proves safe and generates a promising immune response in this pre-clinical phase, it enters human or clinical trials. These are divided into three phases, each of which takes longer and involves more people than the previous one. Phase 1 establishes the vaccines safety in a small group of healthy individuals, with the goal of ruling out debilitating side effects. Phases 2 and 3 test efficacy, and in an outbreak like the present one they are conducted in places where the disease is prevalent. In parallel with these later phases, production capacity for the candidate vaccine is gradually built up, so that factories are capable of producing it on a large scale if and when regulatory agencies judge that it should be licensed.

In an article published in The New England Journal of Medicine on 30 March, representatives of the Oslo-based not-for-profit Coalition for Epidemic Preparedness Innovations (Cepi), which is helping to finance and coordinate Covid-19 vaccine development, laid out an accelerated version of this process that they believe is more suited to a pandemic. This pandemic paradigm implements certain steps in parallel, such as animal and phase-1 clinical testing. It also involves scaling up production capacity before sufficient safety and efficacy data are available a financially risky step, given that that may never materialise, and one that requires governments and not-for-profit organisations such as Cepi to share that extra financial risk with pharmaceutical companies if they want them to engage. Mass production is critical in a pandemic, when hundreds of millions if not billions of doses are needed and many countries are now scrambling to build new vaccine production facilities.

People now appreciate that the lengthy process of conventional licensing of vaccines is not going to be helpful in the context of an epidemic, says Beate Kampmann, who heads the vaccine centre at the London School of Hygiene and Tropical Medicine.

Bringing a new vaccine to the clinic has taken 10 to 20 years in the past

Prudently, Cepi did not attach a timeline to its accelerated paradigm, but the 12- to 18-month estimate already takes it into account. Bringing a new vaccine to the clinic has taken 10 to 20 years in the past. Nevertheless, the accelerated paradigm is being implemented now. A Boston-based biotech firm, Moderna, saw its experimental Covid-19 vaccine enter human trials on 16 March, just 10 weeks after the first genetic sequences of Sars-CoV-2 the virus that causes the disease were released. Others will follow soon.

Were getting to candidates much more quickly, says Kampmann, who puts this progress down to advances made in the fight against Ebola. The step-up in technology that we have seen in the last five years has really made a difference.

There are many hurdles ahead, though. Most of the 70-odd Covid-19 vaccine candidates being developed and tested will not make it to the licensing stage, and those that have been fastest out of the blocks may still encounter problems later on. Modernas innovative technology allowed it to generate a candidate quickly, but no vaccine using this platform has been licensed to date.

At the Pasteur Institute in Paris, on the other hand, a Covid-19 vaccine candidate is still in pre-clinical development, but because it piggybacks on established technology a licensed measles vaccine the testing and licensing processes will go faster. And this kind of vaccine can already be produced in large quantities.

While there can be no shortcuts to establishing safety and efficacy, proposals have been put forward for how these experimental vaccines might be tested more rapidly without sacrificing scientific rigour. In February, for example, the WHO published a draft protocol for phase 2 and 3 trials that would test a number of candidates simultaneously, in multi-country trials according to standardised criteria.

Another proposal is to conduct controlled human challenge trials, in which healthy volunteers are given a candidate vaccine and then infected with Sars-CoV-2. These are ethically questionable, especially before scientists understand why young and otherwise healthy people are ending up on ventilators. A similar approach, being implemented by the London-based clinical research group Hvivo, invites volunteers to be infected with a milder coronavirus but how applicable its findings will be to Sars-CoV-2 is not clear.

If our own body cant prevent us from getting it again, that would be one pretty damning signal

There are still many unknowns with respect to Covid-19, including for how long any vaccine will provide protection. A strong indication of this will be whether people who have recovered from the disease can catch it again. There have been anecdotal reports of re-infection, but the phenomenon is not well understood. If our own body cant prevent us from getting it again, that would be one pretty damning signal, says Wentworth.

Once a vaccine is licensed, there will still be political obstacles to getting it to where its needed, because each country or public health jurisdiction has to make its own decision to roll it out. There will also be issues of prioritisation who should get it first, if supplies are limited which authorities are discussing now.

A vaccine that is approved a year from now may arrive after the end of the current pandemic, but if so it wont be wasted first because Covid-19 may recur seasonally, and second because the vaccine could itself be repurposed in the event of an outbreak of a different coronavirus. That will be no consolation to victims of this pandemic, or their relatives, but it does mean that humanity will be better protected in future. As Wentworth says: That learning, we wont unlearn.

Due to the unprecedented and ongoing nature of the coronavirus outbreak, this article is being regularly updated to ensure that it reflects the current situation as best as possible. Any significant corrections made to this or previous versions of the article will continue to be footnoted in line with Guardian editorial policy.

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Coronavirus vaccine: when will we have one? - The Guardian

Three potential coronavirus vaccines are making fast progress in early-stage testing in volunteers in China and the U.S., but its still a long road to prove if theyll really work against COVID-19.

CanSino Biologics of China has begun the second phase of testing its vaccine candidate, the Chinese Ministry of Science and Technology said Tuesday.

In the U.S., a shot made by the National Institutes of Health and Moderna Inc. isnt far behind. The first person to receive that experimental vaccine last month returned to a Seattle clinic Tuesday for a second dose.

NIH infectious disease chief Dr. Anthony Fauci said there are no red flags so far and he hoped the next, larger phase of testing could begin around June.

A third candidate, from Inovio Pharmaceuticals, began giving experimental shots for first-step safety testing last week in the U.S. and hopes to expand its studies to China.

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Initial tests in a clinical trial focus on safety, and researchers in both countries are trying out different doses of different types of shots.

But moving into the second phase is a critical step that allows vaccines to be tested in many more people to look for signs that they protect against infection.

Last week, CanSino filed a report showing it aimed to enroll 500 people in its phase 2 study, comparing two doses of the vaccine to placebo shots. As of Monday, 273 of the volunteers had been injected, state media said.

Looking ahead, Fauci said if the new coronavirus continues to circulate widely enough over the summer and fall, it might be possible to finish larger studies slightly sooner than the 12 to 18 months hed originally predicted maybe toward mid to late winter of next season.

Please let me say this caveat: That is assuming that its effective. See, thats the big if, Fauci stressed. Its got to be effective and its got to be safe.

During a news conference in China, authorities also cautioned that the studies must be done properly.

Although we are in an emergency, we cannot lower the standards of safety and effectiveness in the reviews of vaccines, said Wang Junzhi, a Chinese biopharmaceutical expert. The public is paying huge attention.

The World Health Organization this week counted more than five dozen other vaccine candidates in earlier stages of development being pursued around the world. Many research groups are teaming up to speed the work. On Tuesday, vaccine giants Sanofi and GSK announced that they had became the latest to partner on a candidate.

The WHOs list includes a wide variety of ways to make vaccines, so if one approach doesnt pan out, perhaps another one will.

CanSinos vaccine is based on a genetically engineered shot it created to guard against Ebola. The leading U.S. candidates use a different approach, made from copies of a piece of the coronavirus genetic code.

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Three potential coronavirus vaccines moving ahead - Los Angeles Times