Category: Covid-19 Vaccine

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LONDON Hopes are rising that a Covid-19 vaccine could be approved by the end of the year, with drugmakers and research centers scrambling to help bring an end to the pandemic.

Dozens of candidate vaccines are in clinical evaluation, according to the World Health Organization, with some already conducting late-stage tests before seeking formal approval.

The outcome of the trials is being closely monitored around the world.

The U.S.'s leading expert on infectious disease believes it will only be a matter of weeks before the findings of a potential vaccine will be known.

"We will know whether a vaccine is safe and effective by the end of November, the beginning of December," White House coronavirus advisor Dr. Anthony Fauci said in a BBC interview on Sunday.

"The question is: Once you have a safe and effective vaccine, or more than one, how can you get it to the people who need it as quickly as possible?"

Fauci said a vaccine deemed safe and effective would be rolled out according to a set prioritization, with individuals such as health care workers and those in a higher risk category likely to receive the first doses. He said it would be "several months into 2021" before a vaccine becomes more widely available.

The development of a vaccine, Fauci warned, would not replace the need for public health measures to help protect people from the disease for some time.

To date, more than 43 million people have contracted the coronavirus worldwide, with 1.15 million related deaths, according to data compiled by Johns Hopkins University.

The race for a Covid vaccine has seen governments step in to try to help the process along by providing funds to allow companies to scale up manufacturing even before drugs have been approved.

Leo Varadkar, Ireland's deputy prime minister, has said he is hopeful an inoculation against the coronavirus could be approved before the end of the year.

"I'm increasingly optimistic, as is government, that we will see a vaccine approved in the next couple of months and that in the first half or first quarter of next year it'll be possible to start vaccinating those most at risk," Varadkar, who is a qualified doctor, told RTE radio on Sunday.

A Rehab Support worker checks on patient notes as the first patients are admitted to the NHS Seacole Centre at Headley Court, Surrey, a disused military hospital, which has been converted during the coronavirus pandemic.

Victoria Jones | PA Images via Getty Images

Not all public health experts share the same level of optimism about the development of a Covid vaccine before year-end, however.

The Mail on Sunday reported plans had been drawn up for frontline National Health Service staff to receive a coronavirus vaccine within weeks, citing an email sent by an NHS Trust chief to his staff.

In response to the report, U.K. Health Minister Matt Hancock said on Monday that it was not the government's expectation for NHS staff to receive access to a potential vaccine this year.

He did rule out the possibility of a Covid vaccine being delivered to hospital staff in 2020 but said the bulk of the rollout would likely take place in the first half of next year.

The U.K.'s chief scientific advisor, Patrick Vallance, has said he doesn't believe a Covid vaccine will be available for widespread use in the community until at least the spring.

He also told the National Security Strategy Committee in London last week that the coronavirus was likely to become as endemic as the annual flu.

This means the infection rate of the coronavirus, like other coronaviruses, will eventually stabilize at a constant level so that the virus becomes present in communities at all times.

Vallance said creating a vaccine from scratch took approximately 10 years on average. The fastest vaccine ever developed was for mumps, and it took more than four years.

Small bottles labeled with a "Vaccine COVID-19" sticker and a medical syringe are seen in this illustration taken taken April 10, 2020.

Dado Ruvic | Reuters

Separately, Dr. David Heymann, who led the WHO's infectious disease unit during the SARS epidemic in 2002-2003, believes some governments may be over-reliant on the development of a vaccine at a time when effective communication, diagnostic testing and outbreak containment activities are all critically important tools.

"The difficulty right now is that in many countries, they are looking forward to a vaccine which may or may not come, which may or may not be effective in the short or long term, and they are looking at possible therapeutic (options) which could solve many of the problems," Heymann said during a webinar for think tank Chatham House last week.

"But, that's not a good way to proceed at present. We have to learn to live with the pandemic."

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Hopes are rising for a potential Covid vaccine and Fauci says findings will be known by early December - CNBC

As optimistic voices say that there may be an approved COVID-vaccine before the end of the year, the race is on to ensure its safe and efficient transportation. Finnair, the first carrier in the world to receive IATAs pharmaceutical air cargo certification, is preparing to provide a reliable supply chain.

While the world is still waiting for a functioning COVID-19 vaccine to arrive, airlines and airports are busy making preparations so that they can transport and store it safely when it does. Several companies have now declared that their vaccines have entered the final stage of development.

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Air cargo will most likely be one of the main forms of transportation for the vaccine. However, one does not simply load vaccines into the cargo hold and store it along with other products. All pharmaceutical transports are sensitive, but vaccines particularly so. In order to ensure their viability and efficiency, the so-called cold chain must remain unbroken.

Those responsible for logistics and storage must make sure they have contingency plans in place in case of a power short-cut. Finnairs cargo branch is busy doing just that.

It is a known fact that there is always a risk when transporting temperature-sensitive items, thats why our job is to make sure we protect the product integrity in all possible ways, Tommie Voss, Head of Operations at Finnair Cargo, said in a statement seen by Simple Flying.

We have a dedicated pharma area to manage the arrival and build-up of temperature-controlled cargo. And our aircraft can be parked right outside the terminal, which makes the process fast; temperature-sensitive items can be loaded in the plane in under 30 minutes, Voss continued.

Finnair was the first airline in the world to receive IATAs CEIV Pharma certificate in 2015. CEIV stands for the Center of Excellence for Independent Validators in Pharmaceutical Logistics. The certification binds airlines to standards for transporting and storing medicines. Originally conceived to help increase air cargos market share of the global pharma logistics industry, its role has now taken on different proportions entirely.

CEIV Pharma defines consistent and recognized standards for transporting the vaccine, or vaccines, ensuring international reliability. While much of the global economy may remain stagnant until a vaccine is widely available, the ability to trust in its efficiency post-transportation will also be of utmost importance.

Since 2018, Finnair already boasts a state-of-the-art cargo terminal at Helsinki Airport. Its COOL Nordic Cargo Hub is generally considered one of the most advanced in Europe. Its solar-paneled roof generally covers fresh seafood, flying the short route to Asia from Norway to Japan.

However, medicines are stored in an area of the terminal dedicated to pharmaceutical goods. There, sensors record and control the temperature, and an alarm goes off if the readings are even a little bit of track.

We have a history of excellence in pharma logistics, and with our new terminal, we have lifted all the monitoring and control to 100% in our premises, Fredrik Wildtgrube, Head of Global Sales at Finnair Cargo, said Monday.

Do you think we will see a vaccine approved and available before the end of the year? Let us know your thoughts in the comments.

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How Finnair Is Preparing To Transport The COVID-19 Vaccine - Simple Flying

Posted: Oct 26, 2020 / 04:34 AM EDT / Updated: Oct 26, 2020 / 06:17 AM EDT

AUGUSTA, Ga. (WJBF) A local home healthcare company is part of the research to help find COVID-19 treatment and potentially a vaccine. Theyre called Interim Healthcare of Augusta.

Interim Healthcare Company is going to trial participants homes and gathering data for 3 different clinical trials. They work with Regeneron.

Thats the pharmaceutical company that made the antibody cocktails President Donald Trump received.

Interim Healthcare works with Augusta University. They found it could lessen symptoms and reduce viral loads, which reduces medical visits.

Director of Business Development at Interim Healthcare of Augusta, Cutter Mitchell, says, look, I think any time you can be a part of history I think thats pretty neat, and I think if you can do it while positively impacting your community and the people around you like I said, we take care of these clients day in and day out.

Trial participants are low to medium risk patients and those who have come out of the hospital and are recovering at home.

You know, were there with the immunocompromised kids. Were there with the 70 year-old man who, you know, his kids live in a different state, and he needs some help, and we care about what happens to them, says Mitchell.

They check on these patients and make sure they dont see negative effects. The spokesperson says so far they have not. If you tested with AU and are positive and would like to participate, it is advised to call AU and ask.

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Local home healthcare company joins the research for a COVID-19 vaccine - WJBF-TV

The worlds most promising coronavirus vaccine candidates need to be kept in cold storage to be safe and effective.

Health officials have noted progress in equipping developing countries with the machinery needed to keep the vaccine cold. Yet nearly 3 billion people live in places where temperature-controlled storage is lacking for a vaccination campaign to bring the virus under control.

The result: Poor people who were among the hardest hit by COVID-19 are also likely to be the last to recover from it.

Maintaining the cold chain for coronavirus vaccines will not be easy even in the richest countries. To stay effective, some vaccines must be kept in temperatures of around minus 70 degrees Celsius. Investment in cooling technology is lower this year because of the COVID-19 health crisis. So is spending for transportation and other infrastructure.

Experts warn that large parts of the world lack the refrigeration equipment necessary to administer an effective vaccination program. This includes most of Central Asia, much of India and Southeast Asia, parts of Latin America, and all but a very small part of Africa.

Broken cold chain

The cold chain breaks down at Gampela, a small medical center in the West African nation of Burkina Faso. The center serves a population of 11,000. And it has gone nearly a year without a working refrigerator.

After its refrigerator broke last year, the center could no longer keep vaccines against diseases such as tetanus, yellow fever, and tuberculosis. Nurse Julienne Zoungrana said workers used motorbikes to get vaccines from a hospital in the capital, Ouagadougou. They made the 40-minute round-trip on a narrow road.

Adama Tapsoba is a mother of two small children. She often walks four hours under the hot sun to get vaccinations for her baby and waits hours more to see a doctor. Recently, her 5-month-old son had missed a scheduled vaccine shot because Tapsobas daughter was sick and she could only bring one child on foot.

It will be hard to get a (COVID-19) vaccine, Tapsoba said, People will have to wait at the hospital, and they might leave without getting it.

To maintain the cold chain in developing nations, international organizations have added tens of thousands of solar-powered vaccine refrigerators. From the time vaccines are made until they are given to patients, the cold chain also requires mobile refrigeration, dependable electricity, good roads and careful planning.

For poor countries like Burkina Faso, the best chance of receiving a coronavirus vaccine is through the Covax initiative. It is a project of the World Health Organization (WHO) and the Gavi vaccine alliance.

The goal of Covax is to place orders for several promising vaccine candidates and to provide the safest, most successful ones to all nations.

The United Nations childrens agency (UNICEF) began preparing for the distribution of COVID-19 vaccines months ago in Copenhagen. There UNICEF crews are busy at work in the worlds largest supply center for humanitarian aid. They are trying to predict shortages by learning from the past, like when protective equipment disappeared from airports or was stolen.

The WHO says 42 coronavirus vaccine candidates are currently being tested in human volunteers. The vaccines most likely to be offered by the Covax initiative must be stored at 2 to 8 degrees Celsius.

The American drug company Pfizer is testing one of the most promising vaccine candidates. It requires storage at temperatures of minus 70 degrees Celsius. The company has designed a special carrying case for its vaccine. Pfizer has signed deals to supply the vaccine to the United States, Europe and Japan. It has also expressed an interest in Covax.

Medical freezers that go down to minus 70 degrees Celsius are rare even in U.S. and European hospitals. Many experts believe some West African countries may be best positioned. Those areas suffered through the Ebola health crisis from 2014 to 2016. Like the coronavirus vaccine, the Ebola vaccine requires very cold storage.

Since 2017, Gavi and UNICEF have worked to supply much of Africa and Asia with freezers for storing vaccines. UNICEF is now offering governments a list of what they will need to maintain a vaccine supply chain and they are asking them to develop a plan.

The governments are in charge of what needs to happen in the end, said Benjamin Schreiber, who is among the directors of the UN agencys vaccination program.

Transporting vaccines

Vaccines do not last long. Container ships are not equipped to refrigerate drugs for long periods. Shipping vaccines by air costs a lot more.

The WHO estimates that as much as half of vaccines are lost internationally because of waste, theft or heat during shipping.

The German shipping company DHL estimated that 15,000 flights would be needed to send COVID-19 vaccines around the world. That would stretch the availability of aircraft and supplies of cooling materials such as dry ice to protect the vaccines.

We need to find a bridge for every gap in the cold chain, Katja Busch of DHL said. Were talking about investments ... as a society, this is something we have to do.

Gavi and UNICEF have experimented with sending vaccines by drone aircraft. Indian officials have also suggested the idea of setting aside part of the countrys large food storage system for coronavirus vaccines.

In countries such as India and Burkina Faso, a lack of public transportation presents another barrier to protecting citizens before vaccines go bad. When parts of Venezuela lost power for a week last year, the largest childrens hospital in the country had to throw away thousands of shots of vaccines for diseases like diphtheria.

Back in Burkina Faso, a solar-powered freezer finally arrived days after reporters from The Associated Press visited the health center near the capital. Health workers are waiting to be sure the freezer works before storing it with vaccines.

Nationwide, Burkina Faso needs another 1,000 medical freezers. Health officials said less than 40 percent of the health centers that provide vaccines have working freezers.

If Burkina Faso were given 1 million shots of coronavirus vaccine today, the country would not be able to administer the vaccine program.

Jean-Claude Mubalama is UNICEFs head of health and nutrition for the African nation. He said, If we had to vaccinate against the coronavirus now, at this moment, it would be impossible.

I'm Dorothy Gundy.

And I'm Jonathan Evans.

The Associated Press reported this story. Hai Do adapted the story for Learning English. George Grow was the editor.

________________________________________________________________

maintain - v. to provide support, to keep something in good condition

chain - n. a series of things that are connected to each other

nurse - n. a person who is trained to care for sick or injured people

scheduled - adj. planned at a certain time

solar - adj. of or relating to the sun

distribution - n. the act of delivering something

gap - n. space where something is missing

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Storage Issues Could Leave 3 Billion without COVID-19 Vaccine - VOA Learning English

A COVID-19 vaccine once seemed a distant dream. Now, its a matter of when, not if, one is available.

For Charlotte Thomas, thats welcome news.

Each time the critical care nurse practitioner enters a COVID-19 patients room at Scripps Mercy Hospital Chula Vista, she dons a black helmet with a broad, clear face shield. She calls it her Star-Lord mask, because it resembles the high-tech mask worn by the Guardians of the Galaxy superhero.

Weve all been really looking forward to the day where we can come to the hospital with that extra suit of armor and feel really confident that we are going to be able to care for these patients and not get sick and not take it home, Thomas said.

Nurse Practitioner Charlotte Thomas gets her supplies ready to stabilize a patient who was just intubated inside a negative pressure isolation room at the ICU at Scripps Mercy Hospital in Chula Vista, Calif., on April 23, 2020.

(Marcus Yam / Los Angeles Times)

That urgent desire for a sense of safety and a return to normalcy has fueled an unprecedented search for a vaccine against the worst pandemic humanity has faced in a century.

CEOs of Pfizer and Moderna, two of the vaccine developers furthest along in that search, have said they could request emergency-use authorization for their COVID-19 vaccines by late November and December, respectively, depending on results from trials that have enrolled tens of thousands of volunteers (including San Diegans).

On Wednesday, Health and Human Services secretary Alex Azar said there could be enough doses of a COVID-19 vaccine for those most vulnerable to the disease by the end of 2020, with enough vaccine for all Americans by early April.

Many experts say that is overly optimistic. But regardless of the exact timeline, public officials are already planning how to distribute the first doses of a vaccine and assure the public that it has been thoroughly vetted.

Its unclear how effectively and quickly a vaccine would quell a pandemic that has killed more than 223,000 Americans. Some vaccines have totally or nearly eradicated diseases think smallpox and polio. But dont expect a COVID-19 vaccine to be a panacea, says Dr. Davey Smith, UC San Diegos director of infectious diseases and global public health.

If you have a vaccine, thats just another tool in your toolbox, Smith said.

That toolbox includes strategies public health officials have stressed throughout the pandemic. Testing. Contact tracing. Social distancing. And wearing a mask, which researchers estimate could save nearly 130,000 lives by the end of February.

When combined with these measures, a vaccine could substantially slow the spread of COVID-19, reducing your chances of getting infected or developing serious illness.

Thats the approach Vista educator Rick Worthington plans to take. Hes a wellness teacher at Vista High School, which reopened this past week, and says he would take the vaccine if its available.

I would still take precautions. I would still wear a mask. I would err on the side of caution, Worthington said.

Rick Worthington, who teaches wellness at Vista High School, says he would take a COVID-19 vaccine but would continue wearing a mask and washing his hands.

(Jarrod Valliere / The San Diego Union-Tribune)

Whats unclear is how many people will do the same.

Expect people to react to the prospect of a COVID-19 vaccine in radically different ways, says On Amir, a researcher at UCSDs Rady School of Management who studies how we make decisions and weigh risks.

We have to acknowledge that there are different groups of people out there, both with respect to adherence and with respect to vaccination, Amir said.

He thinks peoples behavior will likely fall into a few categories. In one, those tired of following public health precautions might trust that a vaccine will be the ultimate fix and throw caution to the wind.

That may already be happening, as the number of community outbreaks in San Diego County has trended upward, and the countys latest COVID-19 case rate nearly pushed it into the states most-restrictive reopening tier. Infectious disease experts like Davey Smith worry about these developments, as driving up transmission of the virus could cancel out a vaccines protective effects.

But the sense that a vaccine is on the horizon could also have the opposite effect, Amir says, citing what researchers call the goal gradient effect. The idea: The closer you are (or think you are) to completing a task, the more motivated you are to stick it through for the reward. In this case, that reward would be some semblance of a return to normalcy.

How people react, he says, will depend on whether public officials frame the rollout of a vaccine as an instant triumph or a series of steps.

For instance, making clear a vaccine would be rolled out in phases.

In early October, the National Academies of Sciences, Engineering and Medicine released a four-phase guideline for distributing the first doses of a COVID-19 vaccine when one becomes available.

At the front of the line would be front-line health care workers, first responders and those who provide cleaning and transportation services for health care facilities about 5 percent of the population.

Without these people, the health care system breaks down. And routinely working in high-risk settings has taken its toll. One study found that front-line health care workers in the U.S. and U.K. had about 12 times the risk of getting COVID-19 as the general population.

That would place Mark Selapack, a paramedic with American Medical Response in San Diego, among the first to get a vaccine. In February, Selapack became one of the first health care providers in the region to handle COVID-19 cases among evacuees quarantined at Marine Corps Air Station Miramar. Since then, hes handled coronavirus surges at skilled nursing facilities and stabilized and transported countless patients.

As a front-line worker, I feel obligated to get the vaccine because we are helping some of the most vulnerable people, Selapack. If I can do my part, I will get the vaccine.

Mark Selapack, a paramedic with American Medical Response San Diego, stands by an ambulance on Oct. 22, 2020. Selapack would be among the first to receive a COVID-19 vaccine.

(Jarrod Valliere / The San Diego Union-Tribune)

The next-highest priority group, about 10 percent of the public, includes those with multiple medical conditions strongly associated with severe disease, such as cancer or serious heart conditions. About 90 percent of COVID-19 patients who end up in the hospital have at least one underlying condition.

Also in this group are adults 65 and older living in nursing homes, homeless shelters and other group living settings. Thats because about 80 percent of COVID-19 deaths have been among people 65 and up, and close quarters make it hard to follow social-distancing guidelines.

From there, vaccine access would gradually broaden to all older adults, teachers, other essential workers and, eventually, the entire population.

Thats the idea, anyway.

The National Academies report, totaling more than 200 pages, wont matter if no one is willing to take a vaccine.

A recent poll by STAT and The Harris Poll found that 58 percent of Americans said they would get a vaccine once it was available, down from 69 percent in August, in part due to a sense that the push for a vaccine has become polluted by politics.

There are efforts underway to allay those fears. On Monday, California Gov. Gavin Newsom announced a scientific panel that would independently review any authorized vaccine. That panel includes Dr. Rodney Hood, president and founder of the Multicultural Health Foundation, a consortium of health providers serving San Diego Countys most diverse neighborhoods.

Its unclear if these efforts will boost the percentage of people willing to get a vaccine. That percentage matters, as it will determine whether we reach what epidemiologists call herd immunity the point where a disease outbreak slows because enough people in a community are protected, leaving the virus with nowhere to go.

The Centers for Disease Control and Prevention estimates between 55 percent and 82 percent of the public would need to be protected against the virus, either by getting a vaccine or recovering from the disease, to reach herd immunity.

That percentage range is so broad because it depends on two unknown factors: How well the vaccine works (and for how long), and how widely the coronavirus is spreading at the time vaccination begins.

We cant control the first factor, but we can control the second, says UCSD psychologist and mindfulness expert Karen Dobkins. And thats one key thing to keep in mind during these uncertain times.

I dont have control over when the vaccines going be ready, I just dont. I do have control about whether I want to put a mask on or not, Dobkins said. If people could get a little better at discriminating between those areas of risk where they do and dont have control, thered be less anxiety.

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Were getting closer to having a COVID-19 vaccine. Hold onto that mask, though - The San Diego Union-Tribune

There was plenty to mull over after Thursdays US Food and Drug Administration (FDA) meeting on the

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Second wave of COVID-19 vaccines unlikely to be required to improve on protection data of frontrunners, says GlobalData - The Pharma Letter

This COVID-19 vaccine trial in Florida and others could be disrupted if the Food and Drug Administration authorizes one vaccine before others.

By Jon CohenOct. 23, 2020 , 3:45 PM

Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

Concerns raised yesterday by an advisory group to the U.S. Food and Drug Administration (FDA) may once again tap the brakes on Operation Warp Speed, the U.S. governments $10.8 billion push to rapidly move candidate COVID-19 vaccines from concept to communities.

As new U.S. cases of the pandemic coronavirus set a daily high of more than 75,000, FDAs Vaccines and Related Biological Products Advisory Committee (VRBPAC) held a 9-hour virtual meeting to discuss a regulatory pathway that could permit the widescale use of a COVID-19 vaccine that has only minimal evidence of safety and efficacy. A so-called emergency use authorization (EUA) could use preliminary data from vaccine efficacy trials now underway to shave many months off the standard approval process, and FDA wanted VRBPAC to weigh in about the wisdom of taking this shortcut. The hearing, live-streamed on YouTube, drew intense interest, and some of the committee membersa mix of academics, consumer representatives, and government scientistshad an unsettling but clear message to FDA: Hold your horses.

Several VRBPAC members worried an EUA could contribute to the publics growing hesitancy toward COVID-19 vaccines by fueling the perception that FDA was compromising its famously high standards. Sheldon Toubman, an attorney on the committee who represents consumers, flat out urged FDA not to issue an EUA for a COVID-19 vaccine, arguing that the agency should stick to the traditional approval process. Theres only one chance to do this right, Toubman said. And if we do it wrong, then were done for, itll be years. Because theres already a serious problem with a lack of trust, and the [lack of] trust will become so severe at that point, we wont be able to dig out of it.

The committee also discussed the possibility that an early authorization of a vaccine could disrupt many of the COVID-19 vaccine efficacy trials now underway, derailing attempts to obtain the most robustand convincingsafety and efficacy data. And several members worried FDAs most recent guidance for vaccine companies that might seek an EUA still does not have stringent enough safety criteria.

Four candidate vaccines selected by Operation Warp Speed now are in efficacy trials, which are comparing the incidence of COVID-19 disease in at least 30,000 participants who blindly receive either a vaccine or a placebo. They are designed to end when they have about 150 cases of symptomatic disease, but independent monitoring boards will tell investigators whether a vaccine looks like its working at 50 cases and again at 100 cases. FDA guidance issued in June says the agency will consider issuing an EUA for a vaccine if it shows at least 50% efficacy at any of these analyses.

FDA has committed to seeking VRBPACs feedback if a COVID-19 vaccine company does request an EUA. Doran Fink, deputy director of FDAs vaccine division, cautioned the committee that permitting the use of a weakly effective COVID-19 vaccine could do more harm than goodand not only because of its impact on trials of other candidates. It could do so by providing a false sense of security that interferes with measures to reduce [COVID-19] transmission, Fink cautioned, citing effective nonmedical interventions such as wearing masks and social distancing.

Researchers from the Reagan-Udall Foundation, a nonprofit set up by Congress to advance the mission of the FDA, told the committee about sobering findings from its COVID-19 Vaccine Confidence Project, which underscored misgivings held by people in underrepresented communities and frontline workers in service, retail, and health care settings. Some people interviewed would want to wait months, or even years, before choosing to receive a vaccine because of widespread distrust of government and the health care system itself, the foundation researchers noted. The countrys racial and ethnic disparities also played a role, especially given the infamous Tuskegee experiment in which Black men were denied syphilis treatment so researchers could better understand the disease. The more they study me, the more they know how to get rid of me, one interviewee told the researchers.

President Donald Trump repeatedly pushed for a COVID-19 vaccine EUA before the 3 November elections, but FDA effectively removed that possibility earlier this month when it issued a second guidance that added a safety stipulation: Two months must have passed after at least half the people in the trial have received all doses of the vaccine, in order to see whether side effects emerge over time. Several committee members and public commenters contended that 2 months was not long enough, however, and urged FDA to extend this to at least 6 months.

Committee member Paul Offit, a vaccine researcher at the Childrens Hospital of Philadelphia, noted that EUAs already issued for COVID-19 treatments have created confusion about how early approval might be granted to a vaccine. Under pressure from the Trump administration, FDA issued EUAs for hydroxychloroquine and convalescent plasma based on the standard that they may be effectivea very low bar that did not require convincing efficacy data from a randomized, controlled trial. Neither treatment actually works, Offit asserted, adding that those EUAs tainted the validity of the process. I think we have a language problem, said Offit, who argued for renaming the process. A vaccine EUA, in contrast, requires evidence of efficacy and at least some safety assurances, which is much closer to the full approval process.

FDA explicitly asked the committee for guidance on what the meetings chair, epidemiologist Arnold Monto of the University of Michigan School of Public Health, referred to as a very thorny issue: whether an EUA for a COVID-19 vaccine could undermine efforts to assess the safety and efficacy of that product and other candidates as well. Before the meeting, Pfizer, which has one of the candidates furthest along in efficacy trials, put the dilemma in sharp focus in a letter it submitted to FDA.

If FDA granted the company an EUA, a senior vice president for the company wrote, Pfizer would want FDAs approval to give those in the placebo arm its vaccinea step that would then compromise the ability of the 2-year study to continue to gather comparative safety and efficacy data of the vaccine and the placebo. A representative from Moderna, which also has a candidate thats far along in efficacy trials, told the committee that participants are beginning to ask when they will know if they receive study vaccine or placebo.

Once a decision is made to unblind an ongoing placebo-controlled trial, that decision cannot be walked back, Fink noted, stressing that future data from the control arm is lost forever.

The FDA representatives suggested a way out of the dilemma: Instead of receiving an EUA, a vaccine could be approved for expanded access, which would limit its use to select populations at high risk of COVID-19. This pathway typically is reserved to allow the use of experimental treatments in patients who have life-threatening conditions, but it has been used before for vaccines, such as one for meningitis B in college students. Because access to the vaccine would be limited, the approach has the advantage of allowing efficacy trials to continue.

Offit suggested after the meeting that to keep collecting vital vaccine efficacy data from trials, FDA may well need to use a mechanism like expanded accessor create a new onethats somewhere in between an EUA and full approval. They just dont have a lot of leeway right now, Offit said.

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'There's only one chance to do this right'FDA panel wrestles with COVID-19 vaccine issues - Science Magazine

SALT LAKE CITY On Wednesday, Dr. Anthony Fauci, the director of the U.S. National Institute of Allergy and Infectious Disease, said he is "cautiously optimistic that we will, in fact, have a safe and effective vaccine (for COVID-19) by the end of the year, which we can begin to distribute as we go into 2021."

Good news, right? Except trust in the vaccine is hard to come by, according to a recent study.

A Qualtrics study released this week showed that 40% of respondents were either unsure or not planning on getting the vaccine once it becomes available. Of that group, 91% said they didn't think it would be safe enough and 90% said they would have concerns about side effects. So where is the distrust coming from?

In early September, Lt. Gov. Spencer Cox tweeted a plea into the universe: "Let's pray we never have another global pandemic ... but if we do, let's pray it's not during an election year."

The vaccine, like so many other things, has turned into a political argument. That was seen Thursday when President Donald Trump and former Vice President Joe Biden squabbled over the vaccine timeline in the final presidential debate.

The president said: "It's going to be announced within weeks. And it's going to be delivered." Biden responded by going through a list of the times the president's virus timelines were inaccurate. Biden said he would "make sure it's totally transparent," and "have the scientists of the world see it, know it, and go through all the processes."

The vaccine is something that each side is using to try and win points in an election year, so it's no surprise that public trust in a potential vaccine is lacking. With companies and scientists attempting to get a vaccine to market in record time years faster than the average pace for development it only adds to the uncertainty.

COVID-19 cases have skyrocketed in Utah Thursday and Friday were back-to-back record-shattering days and in the country, which means a lack of confidence in a vaccine could be especially troubling.

"Not only are people apprehensive about it but not in our lifetime, maybe in the world, have we had to embark on a worldwide vaccination project. So this is on an entirely new scale for history," Chelsie Bright, the global industry leader of the public sector at Qualtrics, said.

Qualtrics has designed a vaccine management program to help governments deliver the COVID-19 vaccine efficiently to their communities. The program is an automated workflow the company claims will help prioritize which at-risk residents should receive the vaccine first, schedule appointments and follow-ups, and provide a record of vaccination after it has been administered. The hope is it will also allow governments to monitor the capability, impact and reach of the vaccine.

People are going to have to have confidence. And the only way to do that is, first of all, understand what concerns people have, and then be responsive to that feedback.Chelsie Bright, global industry leader of the public sector at Qualtrics

The Provo-based company is currently in talks with state governments for the service. Qualtrics has a current contract with the state of Utah to provide "management software as a service for the state of Utah," but KSL.com has been told that the vaccine management program would not fall under that contract.

"We have just signed up a couple, but we haven't made the announcements," Bright said. "We are in conversations with over a dozen other states right now. It's the really early stages, for most states, right now as they are figuring it out."

Distributing the vaccine will be a big undertaking, but the most important step right now may be gaining trust. Even if a vaccine is ready, what good will it be if no one is willing to take it?

"People are going to have to have confidence," Bright said. "And the only way to do that is, first of all, understand what concerns people have, and then be responsive to that feedback."

The Qualtrics survey found that 81% of responders were more likely to get the vaccine if a doctor recommended it.

That makes the message pretty clear: keep the politics out of it.

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There is distrust in a potential COVID-19 vaccine Qualtrics is trying to solve that - KSL.com

(CNN) When Anny Ku heard that there were coronavirus vaccines on offer in Yiwu, a city in Chinas eastern Zhejiang province, she traveled more than 600 miles (965 kilometers) for a chance to get the shot.

Ku worked in Chile for more than 20 years as an importer and exporter, but she returned to her home in southern China earlier this year after thecoronavirus pandemicworsened and a large number of cases appeared in South America.

There had been no official announcement that a vaccine was available in Yiwu just a series of articles in local media but Ku believed she needed the shot in order to leave China and get back to her job overseas. If one has (the vaccine), its much safer to leave the country, she said.

Yiwu is one of a small number of cities which in recent weeks have begun reportedly offering an experimental coronavirus vaccine to select members of the public, despite the drug still undergoing clinical trials. Jiaxing, another city in Zhejiang province, announced on October 15 it would sell vaccines to citizens with an urgent need.

Citizens with urgent vaccination needs can go to the community clinic for consultation with the premise of voluntary and informed consent, the Jiaxing Center for Disease Control posted to its official WeChat account on October 15. In Jiaxing the vaccine will cost about $60 for the required two doses once it is distributed, according to the statement.

Globally, there is currently no coronavirus vaccine which has been successfully tested and proven safe to use. As of October, four COVID-19 vaccine candidates designed by Chinese companies were in Phase 3 clinical trials, the final and most important step before regulatory approval can be sought for a drug.

When CNN visited the hospital in Yiwu where Ku had gone on October 19, staff confirmed that in the past week they had been giving experimental coronavirus vaccinations to citizens who had an urgent need to travel overseas. No one who CNN spoke to had received the vaccine, however.

The Yiwu government has yet to make a public statement on the release of the experimental vaccines. CNN has contacted them for comment.

Authorities in Jiaxing and Yiwu have not explicitly outlined what constitutes an urgent need for the experimental vaccine, what proof is required to show you need a shot, or why these cities in Zhejiang were allowed to give out emergency doses rather than larger metropolises such as Beijing or Shanghai.

An article in the state-run tabloid Global Times on Tuesday denied that the COVID-19 vaccines were publicly available at all.

However, that hasnt stopped some regular citizens arriving in Yiwu and Jiaxing by train or plane in the hope of getting their hands on the experimental vaccine.

Other cities in Zhejiang are still announcing a rollout of vaccinations using the experimental drugs. On Tuesday, the city of Shaoxing said that emergency vaccinations would be given out in the autumn and winter, with the time and date yet to be announced.

Since the initial outbreak in December 2019, China has slowly brought its local coronavirus epidemic under control, through a combination of citywide lockdowns, mass testing and sophisticated track and trace tools.

Now Beijing is at the forefront of a global effort to finda coronavirus vaccine, with Chinese President Xi Jinping repeatedlyurging the countrys scientiststo accelerate their work. On October 20, Tian Baoguo, an official from the Ministry of Science and Technology said that 60,000 people had been injected as part of the drug trials and no serious adverse reactions had been recorded.

At present, Chinas vaccine research and development work is generally in a leading position, he said.

But ahead of any vaccines approval, the Chinese government has been moving forward with a series of vaccinations for people they consider at risk or in high-profile positions.

The apparent push to make the vaccine publicly available contrasts with other countries, including the United States, where drug makers and regulators have so far exercised caution.

In June, Beijing approved the use of the experimental vaccine byCanSino Biologicsin the countrys military.

Three months later, the Chinese government approved the emergency use of the vaccine by the Chinese National Pharmaceutical Group, also known as Sinopharm, for medical professionals, diplomats in high-risk countries and state-owned company employees working overseas.

A large number of people have already been vaccinated. As of early October, Yang Xiaoming, the chairman of China National Biotec Group, which has two vaccines currently in Phase 3 trials, said their drug had been given to about 350,000 people so far in emergency doses authorized by the Chinese government. These vaccinations are not part of the ongoing drug trials.

Dr. Jin Dong-yan, a virologist at Hong Kong University, told CNN that it was risky to push forward with immunizations before the drug had been fully tested and cleared.

In the history of vaccine development there are many examples that even if the vaccine has passed the phase 3 trials still there might be problems, Jin said. None of the experimental vaccines have passed phase 3 yet.

The Yiwu and Jiaxing vaccine programs are not the first time an unapproved coronavirus vaccine has been offered to select members of the public in China.In early October, an offer was distributed online apparently by Sinopharm for a free vaccine for Chinese students heading overseas to study.

After being advertized for a few days however, the offers were pulled and its not clear whether or not any vaccines were actually provided.

Mino Guo was one of the students who registered for the vaccine while living in her hometown of Guangdong, in the countrys south, because she was keen to return to her studies in the United States in November.

The US situation is a little bit serious. Im not very worried it, but my family and my friends around me worry about my life there. So thats why I think it is necessary to get a vaccine, to make my family feel safe, she said.

Guo said she had been a bit concerned about what effect the vaccine might have on her, but in the end she never received it.

So far, no special treatment is being given in China to people who have received the experimental coronavirus vaccine, such as being allowed to travel without a mask.

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People traveling across China in hopes of getting experimental COVID-19 vaccine shot - WSVN 7News | Miami News, Weather, Sports | Fort Lauderdale

In the final debate of the US presidential election on Thursday (Oct. 22), president Donald Trump said that two companies are within weeks of having a Covid-19 vaccine ready for the public. Trump also said that he would be putting a military logistics leader in charge distributing hundreds of thousands of doses to the American people as soon as possible.

Earlier in the day, the US Food and Drug Administrations advisory committee held a meeting on Covid-19 vaccines and sought once again to reassure the American people that any approved vaccine would be safe and effective. But no matter how safe the vaccine or sophisticated its rollout, people will still need to choose to take it. A survey from the Harris Poll and STAT News found that as of this month, 59% of people in the US would opt to get a Covid-19 vaccine.

Given that a vaccine is going to be one of the catalysts in ending the pandemic, could the president mandate that people take it? In a word, no. The US president has never been able to impose a federal mandate of vaccines across the country, and that wont change anytime soon.

It goes back to the fact that the federal government is one of limited power, says Dorit Reiss, a professor specializing in healthcare law at the University of California Hastings College of the Law.

First, presidents dont create laws; Congress does. The president signs bills into law (or vetoes them) after the House of Representatives and Senate go through a lengthy back and forth. The president could issue an executive order that covers people who work for or with government agencies, but Congress would still be able to write up another bill to supersede it. Of course, the president could also veto that billbut the whole scenario is highly unlikely.

Largely, matters of public health fall onto states shoulders. The tenth amendment of the constitution says that any law the constitution doesnt cover goes to the statesand the constitution doesnt mention the words public health, Reiss says.

What it does mention are things like collecting taxes, declaring war, and regulating interstate business. If the federal government really wanted to find a way to enforce vaccines, it could look for a way to do so by exercising one of those powers. Congress could pass laws to limit disease spread across state borders, like requiring that all Amtrak passengers be vaccinated, says Reiss. But the US Supreme Court might not let such a law stand, if the justices determined that Congress was overreaching.

States, on the other hand, can mandate vaccines. In the 1905 case Jacobson vs. Massachusetts, the Supreme Court ruled that states have the power to enforce vaccinations when theyre necessary for the public health or the public safety. Back then, the country was worried about smallpox; today, the precedent could let state governors mandate a Covid-19 vaccine.

Not that theyll use that power, necessarily. For one thing, states can only mandate vaccines that have been recommended by the Advisory Committee on Immunization Practices (ACIP), part of the US Centers for Disease Control and Prevention. ACIP would have to recommend the vaccine for all adults and children based on ample evidence that it is safe and effective, beyond the FDAs approval or emergency authorization of a Covid-19 vaccine.

And even with ACIPs blessing, theres still a lot of debate about whats necessary for public health, per the language in the Jacobson ruling. For example, even though Gretchen Whitmer, the current governor of Michigan, mandated masks and limited gatherings in executive orders as the state saw spikes in Covid-19 cases, the states supreme court overthrew that order. Currently, the Michigan Department of Health is trying to uphold these mandates instead.

This is likely why states dont mandate vaccines across the board; instead they require that certain populations get them. Childhood vaccines, for example, are required to attend school (they do allow various exceptions, however, depending on the state). Parents who dont want to vaccinate their children often have to homeschool them instead.

Its not clear whether states would deploy the same strategy for Covid-19 vaccine requirements. Theres just not enough history to go on. Weve never had a universal adult mandate in the US, says Reiss, even at the state level.

So how might the federal government legally get states to require the Covid-19 vaccine? Two words: ample incentives.

I think that the path of least resistance would be for the federal government to establish guidelines for the states, says Margaret Riley, a professor of law at the University of Virginia. Although the federal government wouldnt force states to enforce vaccination, it could dangle a nice carrot, like it did in 1984 by holding federal highway funding over states heads if they didnt raise the drinking age to 21. (It still took four years for every state to get around to it.)

Once a Covid-19 vaccine becomes widely available, however, the commander in chief will probably have to consider all the options on the table to increase confidence in vaccine adherence. When asked on Thursday what he would do to encourage vaccines, former vice president Joe Biden said hed ensure that all the data behind the approved vaccines would be completely transparent to help people make their decisions.

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Will the Covid-19 vaccine be mandatory? - Quartz