Category: Covid-19 Vaccine

COVID-19 vaccine trials are well under way, but Bill Gates is not optimistic that phase III of these trials, which measures the efficacy and safety of a vaccine in a wide group of users, will be successful before the end of the year.

Gates spoke about the work toward a COVID-19 vaccine and how the coronavirus pandemic will continue to shape our future in a TED2020 live conversation with Chris Anderson on Monday. When asked about where we are in the quest for a vaccine, Gates mentioned three companies thatif they workare on track to have vaccines the earliest: Moderna, Johnson & Johnson, and AstraZeneca.

Those three will be gated by the safety and efficacy trial, he says. That is, well be able to manufacture thosealthough not as much as we wantbefore the end of the year. Whether the phase III will succeed, and whether it will be complete before the end of the year, I wouldnt be that optimistic about.

This echoes what leaders in the health tech industry think, according to a recent 300-person survey. Even though at least 90 vaccine candidates for COVID-19 are in development, seven of which had advanced to phase I trials by April, only 31% of the experts surveyed thought a vaccine would be broadly available by 2021.

Chinese officials did just approve a COVID-19 vaccine for use in its military, but the Chinese government is skipping phase III trials for this vaccine. Studies so far have shown this vaccine is safe and has some efficacy, according to Reuters, but phase III trials are a more robust consideration of a vaccines effects.

How helpful a vaccine is to curbing this pandemic still depends, ultimately, on how many people get the vaccine. Gates says that like mask wearing, vaccines have a huge community benefit. Getting a vaccine and wearing a mask are important to protect your community from the novel coronavirus, not only yourself.

In the U.S., mask wearing has become a point of political contention rather than something unilaterally adopted by the public as part of a collective effort to curb the viruss spread. Some have held onto the fact that the World Health Organization (WHO) initially did not advise people to wear masks. When asked if that was a terrible mistake the organization made, Gates replied, Yes.

The fact that the medical mask was a different supply chain than the normal mask, the fact that you could scale up the normal mask so well, the fact that it would stop that presymptomatic and never-symptomatic transmission, he says. Its a mistake, but its not a conspiracy. Its something that we now know more. And even now, our error bars on the benefit of masks are higher than wed like to admit, but its a significant benefit.

Looking forward to fall, Gates does not expect the COVID-19 pandemic to wane in the U.S., especially without widespread mask wearing, vaccines, or other drugs or innovative tools. While there is good progress on such tools, he says, theres nothing that would fundamentally alter the fact that this fall in the United States could be quite bad, and thats worse than I would have expected a month ago.

The degree to which shelter-in-place behavior has lapsed, the amount of people not wearing masks, and the presence of COVID-19 in cities it had not been in previously pose a challenge for the upcoming months.

Theres no case where we get much below the current death rate, which is about 500 deaths a day, but theres a significant risk we go back up to the even 2,000 a day that we had before because we dont have the distancing, the behavior change to the degree that we had in April and May, he says. We know this virus is somewhat seasonal, so that the force of infectionthrough temperature, humidity, more time indoorswill be worse as we get into the fall.

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Bill Gates says he's 'not optimistic' COVID-19 vaccines will successfully complete trials before end of the year - Fast Company

Dr. Scott Gottlieb offered hope over the weekend for those worried over the coronavirus pandemic and the need for a vaccine.

Gottlieb said the U.S. and the world will likely see a successful vaccine in early 2021. Thats almost more than six months away.

In the meantime, Gottlieb said there are two things that can help stop the spread right now. One of those is a mask. Wearing a mask can help protect you and others from spreading the coronavirus pandemic.

But Gottlieb said theres hope for something coming in the fall that could help Americans.

2020 will be a hard year but then well more fully vanquish COVID with our technology. It will recede into a more manageable threat. Preserving things most central to our lives requires all of us to work together to reduce risks every day. Collectively we can stop these epidemics

A vaccine is probably an early 2021 event based on publicly available data. But dont lose sight of therapeutic antibodies. They should be available this fall and could be produced at scale by the end of the year. Theres a lot of technology in development in addition to vaccines.

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Coronavirus: When will there be a COVID-19 vaccine? Therapeutic might come first - Deseret News

DURHAM, N.C. -- Speculation that a vaccine for COVID-19 might be widely available by the end of this year is overly optimistic, three Duke experts said Wednesday.

While there may be substantial scientific progress by the end of 2020, there will still be significant manufacturing hurdles to clear before a vaccine is available to most people, the experts said during a briefing for media.

Below are excerpts from the briefing:

David Ridley, health economist

Dr. Fauci is quite optimistic. I think optimism is good. I think optimism has a really important role. We need people within these companies being optimistic. If everyone sits back and talks gloom and doom nothings ever going to get done. So I respect that optimism.

But will you and I get vaccinated this year? No way. Its possible a vaccine will be approved this year. But not at scale. We wont have a lot of doses of this.

We might have some people vaccinated this year. But the average person wont be vaccinated this year.

Thomas Denny, chief operating officer, Duke Human Vaccine Institute

If youre going into a tough game, you need a coach thats getting the team revved up. We may have some good science by the end of the year and think we have some leading candidates. But manufacturing them to have it all administered, thats a tall order to be ready by the beginning of 2021.

Ooi Eng Eong, deputy director, Emerging Infectious Diseases Programme, Duke-NUS Medical School in Singapore

Once we get to the efficacy phase and ask the question of whether this vaccine will work to prevent infection, that depends on how common the infection is at that time. If the situation still goes on as it is, we shouldnt have any problem testing efficacy."

But if for whatever reason the prevalence of the disease goes down, it will take us a much longer time to assess efficacy.

Were not going to get rid of the coronavirus in a hurry. Its going to stay with us. Even if we can vaccinate people, protect them from infection the question is how long will immunity last?

If we think about using vaccines in stages, potentially we could get one, possibly at the soonest to me, about this time next year. Anything sooner than that is extremely optimistic. Others have said we could get it by the end of this year. Im an optimistic person, but Im not that optimistic.

David Ridley

Were preparing to manufacture at scale. Fortunately, some of these vaccine makers are already manufacturing now. Sanofi said theyre going to be able to make 100 million doses this year and a billion doses next year. Thats really unprecedented. Usually youd wait to see if your vaccine is having some success. If you think theres a 1-in-8 chance that youre going to get on the market, and youre already spending tens of millions, hundreds of millions of dollars, thats kind of crazy. But thats the crazy world we live in and I salute them for it.

Usually it takes years to manufacture. You want to be sure you got a good vaccine before you begin making it at scale. Typically this is going to take four or five years. Maybe now we can do it in one or two years. Part of this is going to depend on the appetite of these manufacturers to start building something now that they probably will never use.

My guess is this will take longer than people will assume because there will be a little bit of foot-dragging. If you drag your feet a little bit longer and make sure its a good vaccine, that its going to work before you make the huge investments in manufacturing, you can save a lot of money.

Thomas Denny

The duration of immunity post-vaccination is a major scientific issue were trying to understand. Were also trying to understand right now whats the duration of immunity after natural infection. That will help us probably understand how well or how well not vaccines will work for us.

One of the approaches were taking at the vaccine institute, were also exploring the potential development of a pan-coronavirus vaccine.

If we can develop a vaccine that would cover protection to all types of coronaviruses that may be a threat to us we think that would be a big benefit. Thats a longer-term goal for ours. Its 18 months to two years out. I dont think there are many playing in that space currently. Most are looking at the short-term COVID-19 pathogen and trying to get a rapid vaccine developed for that one.

Ridley

Its very common for the second product, a later product to be better than the first. Lipitor was fifth to market for cholesterol drugs and was arguably better than the previous four.

Its reasonable to expect that later entrants will be better. Assuming the virus is still with us and still a threat, Id expect other companies to continue product development.

Ooi Eng Eong

Obviously theres pressure. Theres pressure from the demand from the public for a solution so they can go back to some level of normality in their lives. Theres pressure from colleagues in the hospitals saying we need to deal with this.

Theres also competition from other groups working on vaccines. I think competition is good. It forces us to think harder to come up with better, more innovative ways of doing things. There is pressure but I think at some level of pressure is good to really push the boundaries.

Ridley

We need a lot of materials in this process. Some are very simple. Gowns and masks are pretty simple things. Swabs for diagnostics are pretty simple things. Rubber stoppers, medical glass sound pretty simple. But we really have a high standard for those because anytime we have something coming into contact with the vaccine thats going to go straight into your blood stream, we have a really high standard for sterility.

Sterile water always seems to be in shortage. Water should be easy to make. But it has to be sterile because its going straight into the bloodstream. We cant underestimate the importance of all these products along the line.

We might be a little concerned about hoarding. Theres cost to scaling up PPE. Theres cost to scaling up medical glass and rubber stoppers. Someone might hoard those. One of the vaccine manufacturers, one of the hospitals might try to grab those materials. Theres all sorts of parts in this process and if one of them breaks down, it slows the process of getting the vaccine to people."

Ridley

None of the major vaccine manufacturers will charge ridiculous prices. Theyre in this game to try to do good, to try to impress their employees, to try to impress their shareholders. Theyre not going to do that by charging ridiculous prices.

Ooi Eng Eong

Were testing (our vaccine) as a preventative vaccine. But is an intriguing possibility. Our fight against the virus relies on the body to recognize first of all its infected with the virus. It triggers a series of processes. So it is entirely possibly theoretically that because were using an RNA vaccine, the vaccine will trigger the processes that will allow the (body) to fight an RNA pathogen.

Weve only had this virus for seven months now. Theres a lot we dont know about this virus.

Think about it like a thief breaking into your house. If this person is very skilled at overcoming your alarm, they will be able to break into your house. If you have another system that can activate the alarm while the break-in is in process, you would actually trap the thief. So it is something that is possible.

Denny

Those with underlying medical conditions, and first-line responders. Hospital workers, theyre the highest priority. If we cant keep those folks going, were in trouble.

Faculty participants

Thomas N. DennyThomas Dennyis chief operating officer of the Duke Human Vaccine Institute, a professor of medicine and an affiliate member of the Duke Global Health Institute. His administrative oversight includes a research portfolio of more than $400 million. Denny has served on numerous committees for the NIH over the last two decades.thomas.denny@duke.edu

Ooi Eng EongOoi Eng Eongis a professor of medicine and deputy director of the Emerging Infectious Diseases Programme at Duke-NUS Medical School in Singapore. He also co-directs the Viral Research and Experimental Medicine Centre at the SingHealth Duke-NUS Academic Medical Centre (ViREMiCS), which studies therapies and vaccines against viral infections.engeong.ooi@duke-nus.edu.sg

David RidleyDavid Ridleyis a professor of the practice at Dukes Fuqua School of Business, where he is faculty director of the Health Sector Management program.He was lead author of the paper proposing a review program to encourage development of drugs for neglected diseases that became U.S. law in 2007.david.ridley@duke.edu

---Duke experts on a variety of other topics related the coronavirus pandemic can be found here.

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COVID-19 Vaccine in 2020 Highly Unlikely, Experts Caution - Duke Today

It's a simple way to take a look at when a panel of experts predict the U.S. will see a widespread vaccine.

Author: kare11.com

Published: 6:45 PM CDT June 30, 2020

Updated: 6:43 PM CDT June 30, 2020

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USA Today explores when a COVID-19 vaccine might be ready - KARE11.com

The final roadblock to distributing a coronavirus vaccine will be ensuring that enough people actually take it, Bill Gates said in a recent interview with CNN. The billionaire philanthropist and cofounder of Microsoft has contributed millions toward coronavirus research.

"You'll have a choice of whether you take the vaccine or not," Gates said to CNN's Anderson Cooper and Dr. Sanjay Gupta in a Coronavirus Town Hall. "So there's that final hurdle."

Three-quarters of Americans said they would take a coronavirus vaccine if they were assured it was safe, according to a Reuters/Ipsos poll published in May. About 40% of American adults surveyed said they would take if after it was approved by the Food and Drug Administration, while 38% said they would take it after extensive peer-reviewed clinical trials. Thirty-eight percent of respondents also said they would wait until much of the public had taken the vaccine before taking it themselves.

More than 28,000 people have also joined an organization called 1Day Sooner, which runs human challenge trials to help test vaccines and treatments for COVID-19, according to The Washington Post.

There are more than 140 vaccine projects in development, according to The World Health Organization. Although research is moving quickly, there are still many challenges around gathering data to show that a vaccine would work and ramping up the necessary production, as Business Insider's Andrew Dunn has reported.

The US Department of Health and Human Services is aiming to deliver 300 million doses of a coronavirus vaccine by January 2021 as part of its broader strategy around the development and distribution of COVID-19 vaccines and treatments.

The urgency of the coronavirus pandemic, which has killed 489,922 people around the globe and infected 9.6 million according to Johns Hopkins University, means it could be challenging for scientists to spend a lot of time trialing vaccines with various age ranges and populations.

"It's understandable that because of the urgency of this, the amount of time that you'll be out looking at it is just going to be less," Gates said when asked about the issue of vaccine hesitancy. "And so even for scientists really understanding, 'Ok, were the trial populations accounting for all of these different groups? How low does the age range go? . . . How do you feel about pregnant women in it, what about the elderly? It's a challenge to get that safety database to build up the confidence."

Gates and his wife Melinda have contributed $250 million toward developing treatments, testing, and vaccines for COVID-19 through the Bill & Melinda Gates Foundation. The funds will also contribute toward coronavirus relief efforts in low and middle-income countries.

Overall, Gates believes that "a lot of people" will be willing to take the vaccine and herd immunity could be achieved if between 70% and 80% of people do so.

"It really could then exponentially drop the numbers," Gates said. "But we need that for the entire world if we're going to go back and have people taking vacations, international students, international sports events. So it'll take a while until we get this thing finished off on a global basis."

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Bill Gates on COVID-19 vaccine: Getting people to take it may be hard - Business Insider - Business Insider

June 30, 2020 | :

by B. Denise Hawkins

Meharry Medical College has joined the COVID-19 Vaccine Trials Network and will be enrolling community members in studies of a handful of vaccine candidates, announced the Nashville, Tennessee-based historically Black institution on Tuesday.

I am excited given the importance of minority communities taking part in COVID-19 vaccine trials, said Meharrys president and CEO Dr. James E. K. Hildreth, referring to the disproportionate number of African Americans hit by the virus.

The vaccine trials will be conducted as a part of Operation Warp Speed, a public-private partnership the White House formed to fast track the development, testing and manufacturing of a vaccine to prevent the disease caused by the novel coronavirus and therapeutic drugs to treat those infected with COVID-19.

White House officials told the media on Tuesday that the COVID-19 vaccine, once available, will be distributed according to priorities, with the most vulnerable people ahead in line.

Globally, more than 100 coronavirus vaccinesare being studied, but fewer than a dozen are being tested on humans. Operation Warp Speed has narrowed its current list down to seven vaccine candidates, National Public Radio reported on June 12. South Africa, which has the highest number of cases of coronavirus in Africa, began vaccine testing in the country last week. In the U.S., the federal governments goal is to have a COVID-19 vaccine ready by January 2021.

Dr. James E. K. Hildreth

Since the pandemic, Hildreth, a renowned infectious disease expert, has expressed skepticism that a vaccine can safely be developed and approved in a year, which is considered an extremely short window by most in the scientific community. Then he is reminded that the need for a drug to halt the spread of the highly infectious novel coronavirus that causes COVID-19 is unprecedented and urgent, especially for people of color.

As of Tuesday, COVID-19 has claimed more than 126,000 lives in the U.S., according to Johns Hopkins Universitys coronavirus tracker. The latest data reveals a continued uneven toll among people of color, especially among African Americans. While overall mortality rates from COVID-19 are climbing for all racial and ethnic groups in the country, an APM Research Lab study called Color by Coronavirus found that African Americans continue to experience the highest overall mortality rates and the most widespread occurrence of disproportionate deaths.

Hildreth, who pushed hard to deliver mobile testing to Black communities in Nashville, Tennessee, opened a center on the Meharry campus in early April. Hes now pushing to ensure that those most impacted by this coronavirus have access to COVID-19 vaccines and clinical trials.

Thats what we want and need to happen, said Dr. Namandj Bumpus, a professor and chair of the Department of Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine.

African Americans are consistently underrepresented in clinical trials for diseases ranging from diabetes to heart disease to HIV, despite being disproportionately affected by many of them. Among people of color, only about 10% enroll in clinical trials. In her award-winning research, Bumpus studies genetic differences in how people metabolize leading HIV drugs, providing evidence that responses are different in African Americans who are disproportionately infected by the disease.

Clinical trials, said Bumpus, are the only way that researchers will know if a new COVID-19 vaccine will be effective in African Americans who have been hard-hit by the disease.

Having Meharry in the forefront on recruitment in the Black community is a really positive move, Bumpus said about Mondays announcement that the college has joined the COVID-19 Vaccine Trials Network. Black representation among researchers and those administering the tests, she added, also goes a long way to build trust in Black communities and increase participation.

In fact, in May, Hildreth told a virtual convening of the House Ways and Means Committee that Black medical colleges like Meharry are best prepared to tackle the disproportionate impact of the COVID-19 pandemic on African Americans.

Meharry and Meharrians are trusted in the communities we serve, which have a history of abuse at the hands of Americas medical establishment. We understand the subtle, yet critical cultural differences that have long been overlooked by mainstream providers, creating deep fear and distrust. We can deploy quickly, we know where to go, and we will be welcomed,

But Meharry is one institution. All those conducting COVID-19 vaccine trials around the country must be intentional about enrolling African Americans and other people of color, said Johns Hopkins Bumpus.

My hope is that Meharrys efforts will keep this need top of mind for people.

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Historically Black Meharry Medical College Joins the COVID-19... - Diverse: Issues in Higher Education

It's not an understatement to say that the entire nation's hopes are focused on what's happening in a Maryland laboratory step one in manufacturing a potential coronavirus vaccine.

Sean Kirk, executive vice president of Emergent BioSolutions, explained to correspondent Martha Teichner how a bioreactor is used to create the ingredients needed in the development and testing of a vaccine for clinical trials already underway in Australia. "This is where it begins, to produce the hundreds of millions of doses," he said.

Emergent BioSolutions is gearing up now, preparing 4,000-liter tanks, to have hundreds of millions of doses ready to go if and when any of its clients Novavax, Johnson & Johnson, Vaxart and AstraZenica make it to the finish line in the race to a vaccine.

Teichner asked, "What happens to all those vaccines that you're ramping up to have ready on Day One after approval, if it doesn't come?"

"Yeah, the federal government's made it clear that they're willing to invest a substantial amount of money," Kirk replied.

That's $628 million just to Emergent to manufacture them all anyway, before approval, whether they succeed or fail. "If they're deemed to be ultimately unusable, then it's quite possible that they could be discarded," Kirk said.

President Donald Trump announced Operation Warp Speed on May 15. "Its objective is to finish developing, and then to manufacture and distribute, a proven coronavirus vaccine as fast as possible," he said. "Again, we'd love to see if we could do it prior to the end of the year."

To try and meet that target, the federal government has already pumped more than $2 billion into what it's betting are the likeliest to win FDA approval fastest, out of more than 120 in development. Drug industry heavyweights are behind some of the frontrunners: Pfizer, Johnson & Johnson, Merck, AstraZenica. Not-so-well-known, the biotech firm Moderna touted promising early results for its vaccine, which uses an unconventional new approach to creating immunity.

"We are desperate for a vaccine," said Dr. Paul Offit, a member of the National Institutes of Health panel overseeing the accelerated development of a COVID vaccine. "As a consequence, we're looking for any sort of news that could be good. But I think what we should exercise here is humility."

Dr. Offit fears what he calls "an October surprise," and co-authored an op-ed in The New York Times: "Could Trump turn a vaccine into a campaign stunt?"

"I do worry that as we move to September and October and then Election Day, that there will be pressure to get a vaccine out there even if it hasn't been tested in the way it needs to be tested, which is a big phase 3 trial," he said.

What that means is giving a vaccine to at least 20,000 people, with another 10,000 getting a placebo, and then waiting ... to see who gets a disease and who doesn't.

Typically, those trials last years, not months. It took Offit more than a quarter of a century to get his own vaccine licensed for rotavirus, which killed half a million infants and young children each year around the world more than the total death toll from coronavirus.

Teichner said, "People are frantic. They're almost panicky about living in a world until there is a vaccine. How do you manage the public pressure to hurry up and get to the finish line?"

"Hopefully, there will be an understanding that in order for us to prove that a vaccine is safe and effective, that it needs to go through this process," Dr. Offit said. "I harken back to the polio days. We waited, despite the fact that every year in this country as many as 30,000 children would get polio and be permanently paralyzed or end up in iron lungs, and 1,500 died. And if you think that the terror of that was any different than the terror of this, you're wrong. So, we could even wait then, and we can wait now."

Abie Rohrig thinks he, and other people of his generation, can help speed up the process. "By my doing this, there is a very real, very immediate chance that a vaccine could be developed earlier," he said. "Lives'll be saved."

Teichner asked, "Even if the cost is getting very, very ill, or even dying?"

"Yes. That cost is real."

Rohrig is 20, a college student, and a member of 1 Day Sooner, an organization calling for controversial human challenge trials, in which healthy, young volunteers ages 18-25 would test vaccines by being exposed to the virus deliberately, no waiting. So far, more than 25,000 people worldwide say they'd do it.

Rohrig said, "I have some history taking on this sort of calculated medical risk, because I donated my kidney last summer. And so, I see this as a very similar situation. I am very willing to take this risk onto myself, because I know that COVID-19 is devastating the world. This is, I think, my generation's World War II, basically."

But with COVID, there are ethical and safety issues. According to Dr. Nadine Rouphael, an associate professor of medicine at Emory University, "We have multiple instances for many diseases, such as influenza, dengue, cholera, malaria, typhoid, where it has been shown that those human challenges actually were able to better understand the infection, but also test therapeutics and vaccines."

Dr. Rouphael has worked on four human challenge trials, which start out with deciding which strain of a virus to use and how big a dose to give.

She noted, "For coronavirus human challenge, we don't have a strain; we don't have a dose. We also don't have a good drug against COVID."

Teichner asked, "Ordinarily, do diseases or viruses that have human challenge trials, do they have rescue drugs?"

"Typically they do," she said. And with no rescue therapy for coronavirus, the risk is intensified. It would take 3-6 months, she said, just to set up human challenge trials. But she's in favor of moving forward.

Teichner asked, "Is it brave, or is it crazy?"

"If it's done the right way, it's really a service to society," Dr. Rouphael replied.

"So, you're leaning toward brave?"

"I guess so."

For COVID vaccines, human challenge trials are still only in the discussion phase, while several of the frontrunners are expected to begin phase 3 trials next month.

At a House Energy & Commerce Committee hearing this past week about the administration's response to the pandemic, Dr. Anthony Fauci said, "I still think there is a reasonably good chance that by the very beginning fo 2021, that if we're gonna have a vaccine, that we will have it by then."

For all Dr. Fauci's optimism, will that first vaccine allow us to take off our masks and feel safe? Will it keep us from getting COVID-19, or just from getting really sick, or dying?

"We have to make sure that people know that it's likely going to protect against moderate-to-severe disease, but maybe not mild disease associated with re-exposure," Dr. Offit said. "So, I think we need to manage expectations."

He predicts the first across the finish line may not be the ultimate winner: "You don't want it to be necessarily the first vaccine. You want it to be the best vaccine," he said.

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Story produced by Mark Hudspeth. Editor: Ed Givnish.

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The race to find a COVID-19 vaccine - CBS News

The excitement and enthusiasm for a COVID-19 vaccine by the end of 2020 is both palpable and understandable. We all hope for a rapid end to the pandemic and an effective vaccine would be a surefire solution. But there are risks that come with a fast-tracked vaccine delivered end of this year, not the least of which are the risks related to the safety of the vaccine itself.

Telescoping testing timelines and approvals may expose all of us to unnecessary dangers related to the vaccine. While preclinical trials to evaluate the potential safety and efficacy of vaccine candidates are likely to include tens of thousands of patients, it is still unclear whether that number will be large enough and a trial will last long enough to evaluate safety for a drug that would be administered to so many. The US alone plans to vaccinate hundreds of millions of people with the first successful candidate.One serious adverse event per thousand of a vaccine given to 100 million people means harm to 100,000 otherwise healthy people.

Aside from questions of safety that attend any vaccine, there are good reasons to be especially cautious for COVID-19. Some vaccines worsen the consequences of infection rather than protect, a phenomenon called antibody-dependent enhancement (ADE). ADE has been observed in previous attempts to develop coronavirus vaccines. To add to the concern, antibodies typical of ADE are present in the blood of some COVID-19 patients. Such concerns are real. As recently as 2016, Dengavxia, intended to protect children from the dengue virus, increased hospitalizations for children who received the vaccine.

Questions also arise around the efficacy of a potential vaccine. The little we know of the current generation of COVID-19 vaccines raises serious questions regarding their ability to protect people from infection. We know all the candidates tested to date in non-human primates failed to protect any of the monkeys from infection of the nasal passages, the primary route of human infection. Failure to protect entirely from infection fits with all we know about attempts to protect monkeys from two other deadly coronaviruses, those that cause SARS and MERS.

On a brighter note, at least some of the candidate vaccines did raise significant immune responses. How that translates to protection of humans is uncertain though as monkeys do not become noticeably ill or exhibit many of the life-threatening consequences of COVID-19, even when exposed to high doses of the virus via the nose, lung, and rectum simultaneously. As many of the most serious COVID symptoms do not appear until late in the disease course, sometimes four to five weeks following exposure, there is a possibility that we will not have sufficient time to judge efficacy of a new vaccine, even by the lower standard of symptom amelioration.

An effective COVID-19 vaccine also faces several hurdles beyond our control. The older we get the poorer our ability to respond to vaccines. Resistance to vaccination begins early at age 30 and becomes progressively more profound with time. That is especially troubling as those over 60 are the population most at risk. Vaccination of the elderly may sometimes succeed by administering repeated doses and by increasing the potency of the vaccine with powerful adjuvants. But these adjuvants can be especially risky for the very old.

It seems a folly then to rush our way towards a vaccine in 2020 if it is likely to have only limited benefit to the population most in need and may put otherwise healthy people at risk. The risk goes far beyond the dangers a COVID vaccine alone may hold. Public support for vaccines in general is already an issue. Trust in other lifesaving vaccines will be eroded even further if a COVID vaccine goes wrong and many more peoplechildren especiallywill be at risk if vaccination rates fall.

Yes, we are all increasingly longing for an end to the outbreak. But a safe vaccine, effective for all those at risk, is worth the wait, especially when we have other solutions in hand. We already know from the experience of countries in Asia that the epidemic can be stopped in its tracks with basic public health measures: widespread testing, contact tracing, and mandatory controlled quarantinenot necessarily in a dismal public health facility as many imagine, but in our own homes with virtual supervision or in a hotel environment. These efforts alone could bring new infections down to almost zero within just weeks.

In addition, I believe it will be possible before the end of this year to protect those most at risk from exposure with combinations of monoclonal antibodies or with truly effective antiviral drugs. These drugs could treat those who were ill and prevent further infection. In addition to pursuing a vaccine within a realistic timeframe, we should also be throwing our weight behind these other types of medical solutions which have historically been much quicker to bring to market safely.

There is no doubt we need an urgent end to the pandemic. Economies around the world are crashing. Governments are piling up trillions of dollars in debt. And, in the US alone, tens of millions are without work or income. But there are still costs that are too great, even when compared to such numbers. When we have solutions to the pandemic in hand we cannot risk the potential lives lost of rushing a COVID vaccine to market. We must hold dear the central dictum of the medical community, first, do no harm. Trust that given the time science will deliver a medical solution in the form of a vaccine or a chemoprophylactic drug treatment, and in the meantime let us immediately implement the public health strategies that we know will work today to drive new infections down to nothing.

Read more about the coronavirus outbreak from Scientific American here. And read coverage from our international network of magazines here.

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The Risks of Rushing a COVID-19 Vaccine - Scientific American

Who would be the first to get a COVID-19 vaccine?

Probably people in the country where the first effective vaccine is developed.

About a dozen different vaccines are in various stages of testing worldwide, including in Britain, China and the U.S. This week, Dr. Anthony Fauci, the top U.S. infectious disease expert, said he is cautiously optimistic there will be a COVID-19 vaccine by the end of the year or early 2021.

Several wealthy countries have already ordered millions of doses of those experimental vaccines.

Britain and the U.S., for example, have invested in a vaccine candidate being developed by Oxford University and produced by AstraZeneca. If it works, U.K. politicians have said Britons will be vaccinated with it. The U.S. expects to start stockpiling it this fall and also has invested in other vaccine candidates.

Groups including the vaccine alliance GAVI are also working to buy doses for poor countries, and AstraZeneca has agreed to license its vaccine to Indias Serum Institute for the production of 1 billion doses. The World Health Organization is drafting guidelines for the ethical distribution of COVID-19 vaccines.

How vaccines are distributed within a country will vary. Last week, U.S. officials said they were developing a tiered system for that. The system would likely prioritize groups at greatest risk of severe complications from COVID-19 and key workers.

___

The AP is answering your questions about the coronavirus in this series. Submit them at: FactCheck@AP.org.

Read previous Viral Questions:

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Who would be the first to get a COVID-19 vaccine? - Seattle Times

Thailand Says Its on Track for Covid-19 Vaccine Human Trials  Bloomberg

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Thailand Says Its on Track for Covid-19 Vaccine Human Trials - Bloomberg