Thailand to Begin Its Covid-19 Vaccine Human Trials in September Bloomberg
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Thailand to Begin Its Covid-19 Vaccine Human Trials in September - Bloomberg
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New Delhi: Microsoft founder Bill Gates said Saturday the Covid-19 medication and vaccines should go to the people who need it the most and not just to the highest bidder.
If we just let drugs and vaccines go to the highest bidder, instead of to the people and the places where they are most needed, well have a longer, more unjust deadlier pandemic, a CNBC report quoted Gates as saying at an online Covid-19 conference organised by the International AIDS Society.
We need leaders to make these hard decisions about distributing based on equity, not just on market-driven factors, he said.
With the coronavirus pandemic continuing to claim thousands of lives across the globe every day, medical researchers across the world are working on a war-footing to come up with a vaccine for the deadly virus as early as possible.
However, with countries across the world, especially Europe and the US, investing billions of dollars to develop Covid vaccines, concerns have also arisen that richer nations may scoop up potential Covid treatment, leaving developing countries empty-handed, a Reuters report noted Saturday.
The report said the European Commission and the World Health Organization have cautioned against unhealthy competition in the race to develop Covid medication and save as many lives and prevent as much economic loss as possible.
The US now has the worlds highest confirmed cases of Covid-19 totalling 3,355,646, followed by Brazil (1,840,812), India (850,827) and Russia (720,547).
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Also read: CanSino, Moderna, Novavax: A list of Covid vaccines under clinical trials across the world
Speaking at the online event, Gates recalled how countries united to battle HIV/AIDS and made medication available across the world, including in Africa, in the past. He said this should serve as a model method to also make Covid-19 treatment available across the world.
One of the best lessons in the fight against HIV/AIDS is the importance of building this large, fair global distribution system to get the drugs out to everyone, he said.
Calling for global cooperation, Gates said the world would see remarkable impact when it has nations, institutions and advocates working together on this collective response.
The World Health Organization has said 21 vaccine candidates under clinical trials are currently being tested on human volunteers. Three of these vaccines are in the third phase of the trials.
According to the CNBC report quoted above, the companies that have made the most progress in developing vaccines are US firm Moderna, UK firm AstraZeneca, and Chinese firm Sinovac Biotech.
There is only one Indian company in WHOs list of21 candidate vaccines currently in clinical evaluation ZyCov-D by Ahmedabad-based Cadila Healthcare Limited (Zydus Cadila).
The Indian Council of Medical Research (ICMR) has also fast-tracked clinical trials of an indigenous Covid-19 vaccine, which it is producing with the Bharat Biotech International Limited (BBIL).
Nine of the 21 vaccines have the involvement of a Chinese research institute or company, while five of the vaccines have the involvement of an American firm. Among others are those being developed by firms from South Korea, Japan, Australia, Germany, and Russia.
Also read: Why the fight over a coronavirus vaccine will be intense, irrational and even nasty
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Bill Gates warns of a deadlier pandemic if Covid vaccines go only to the highest bidder - ThePrint
Moderna Advances its Mid stage Covid 19 Trial
Moderna Inc (NASDAQ:MRNA) provided an update about its Phase II clinical trial of Covid 19 vaccine candidate. The company reported that it has completed the patient enrollment for both the cohort of the trial. Moderna has already completed the Phase III trial protocol based on the FDA feedback. For its randomized, placebo-controlled Phase III trial, the company will be recruiting nearly 30,000 patients across the US.
Earlier this month, Moderna had released early stage data for the vaccine candidate. The results demonstrated that mRNA-1273 produced protective antibodies in a small group of healthy volunteers. The company also announced that the vaccine candidate was found to be generally safe. It is looking to initiate late stage trials in July. Moderna has completed manufacturing vaccine doses required for the Phase III trial.
Moderna had completed the enrollment for the first cohort of the trial last month. The group consisted of healthy young adults between the age of 18 years and 55 years. The second cohort comprises older adults aged 55 years and above. The safety results from the older adults cohort were reviewed by the trials Data and Safety Monitoring Committee, which recommended the Phase II enrollment to be continued.
The Phase II trial aims to evaluate the safety, reactogenicity and immunogenicity of two mRNA-1273 vaccinations administered 28 days apart. Moderna chief medical officer Tal Zaks said: We are committed to helping address this ongoing public health emergency and continue to focus on our Phase III study, which remains on track to start in July, less than seven months from the sequencing of the virus. The Phase II trial is a dose-confirmation, placebo-controlled study.
In Phase II trial, the participants will be administered placebo, a 50g or a 100g dose at both vaccinations. The company also elaborated that it has completed enrollment, or the cohorts of older adults aged 56-70 and elderly adults aged 71 and above in the US National Institutes of Health -led Phase I trial. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has formed a clinical trials network for streamlining the process of enrolling participants for COVID 19 vaccine trials.
The Phase III trial will be a randomized, placebo-controlled study with around 30,000 patients enrolled in it. These participants will be given 100g dose level of the vaccine candidate. The company anticipated to deliver nearly 500 million doses annually at 100g level. This count may up to one billion doses annually starting next year.
Moderna also recently reported inking a new agreement with Laboratorios Farmacuticos Rovi SA. The agreement pertains to vial filling and packaging capacity for the companys potential COVID-19 vaccine for serving the markets outside of the Unites States. The Spain based company will start and new production line and equipment for compounding, filling, automatic visual inspection and labeling.
As per the data provided by the company, Phase II trial is likely to be completed in August, 2021 while the estimated primary completion date is expected to be March, 2021. The primary date is the date the last participant in the clinical study was analyzed or was provided an intervention for collecting final data for the primary outcome measure.
Palatin Technologies Inc. (PTN) announced reinitiating the enrollment of its Phase 2 study with PL9643 for the treatment of dry eye disease. The company had suspended the enrollment for the trial on account of pandemic breakout to ensure safety of the patients. Palatin expects the enrollment to be completed in next 30 to 45 days.
The Phase 2 study is a multi-center, randomized double-masked, placebo-controlled trial. It aims to evaluate the safety and efficacy of PL9643 ophthalmic solution in comparison to placebo for treating the signs and symptoms of dry eye disease. Carl Spana, Ph.D., President and CEO of Palatin said, We are very happy to resume patient recruitment in this Phase 2 study of PL9643 exploring treatment of both the signs of eye damage and the physical symptoms experienced by patients with dry eye disease. The company expects the data readout to be available in the fourth quarter of 2020.
The study aims to enroll up to 150 participants across three sites in the United States. These patients will be randomized in a 1:1 ratio into two arms, PL9643 or placebo. The participants will then have to go through 12-weeks of treatment. The company had initially started the enrolment in February this year.
The two primary endpoints for the trial are inferior corneal fluorescein staining and ocular discomfort. The trial also has several secondary and exploratory outcome measures as well. Palatin is a biopharmaceutical company focusing on developing treatments based on molecules that regulate the melanocortin and natriuretic peptide receptor systems. The company aims to develop targeted, receptor-specific drug candidates for treating diseases with substantial unmet medical need and commercial potential.
Viveve Medical (VIVE) announced that the FDA has given its go ahead to the companys PURSUIT trial for evaluating Cryogen-cooled Monopolar Radiofrequency treatment for managing stress urinary incontinence in women. The trial will enroll 240 participants across 25 sites across the United States and is expected to be launched next quarter.
PURSUIT is a randomized, double-blinded, sham-controlled 12-month trial. The participants will be randomized in a 2:1 ratio for active and sham treatments. The members in the active treatment arm will be administered the CMRF treatment of 90J/cm2 RF and cryogen-cooling. Control arm participants will be given a clinically inert sham treatment consisting of 1J/cm2 RF and <2 degrees tissue cooling cryogen.
The primary efficacy endpoint for the trial is the 1-hour Pad Weight Test at 12 months post-treatment. Scott Durbin, Viveve's chief executive officer. "As we proceed with plans to initiate the PURSUIT Trial, we are equally focused on progressing our short-term, three-arm, SUI feasibility study that is targeted for readout in late summer of this year. The company plans to keep up the momentum for developing its CMRF technology.
The secondary endpoints for the trial include evaluation through the 3-day bladder voiding diary and Quality of Life and SUI benefits. These endpoints will be measured using various tools such as Urogenital Distress Inventory-6, Incontinence Quality of Life, and International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form. The participants will be monitored throughout the study for subject safety.
Viveve Medical, Inc. is a medical technology company and it focuses on developing treatments for various womens intimate health issues. It mainly uses its internationally patented Viveve System incorporates CMRF technology for developing its therapies. The System has been approved by the FDA for use in general surgical procedures.
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Moderna's COVID-19 Vaccine And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha
Dr. Anthony Fauci, the nation's leading infectious disease expert, said Friday the development of a coronavirus vaccine must be for the benefit of all countries, calling it a "responsibility to the entire planet."
That responsibility is "not just to the individual country thats making the vaccine," he said during a virtual presentation at the COVID-19 Conference.
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Because of this, he continued, the companies that the U.S. government is working with are "already in discussion to start gearing up to make hundreds of millions of doses." Some companies are promising to have a billion doses of a vaccine within a year or so, he added.
There were likely to be several types of vaccines for the virus, which work in different ways.
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Fauci, the director of the National Institute of Allergy and Infectious Diseases, likened the development of these different vaccines to taking "multiple shots on goal" in hockey. There are "some that you could get off quickly and ramp up quickly, some that have more experience, and some that we know are tried and true."
An mRNA vaccine was one that researchers were able to get off the ground quickly, he said. Moderna, a Cambridge, Massachusetts-based company, started the first clinical trial in the United States with its mRNA-based vaccine in March. This type of vaccine uses genetic material to teach cells how to defend against the coronavirus.
Another type of vaccine, which uses the virus' protein to teach cells to fight it, took longer to develop but was not any less important, he said.
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The COVID-19 Conference brought together experts from around the world to discuss the latest science on the disease that's infected more than 12 million people globally and caused more than 550,000 deaths.
During the same session, Fauci pointed out the challenges of containing the spread of the virus from asymptomatic individuals.
"The situation that were facing in the U.S. is significant and serious in that we have community spread in areas where many of these individuals are without symptoms," he said. "That is complicating our task."
Dr. Deborah Birx, the White House Coronavirus Task Force coordinator, who also spoke at Friday's session, noted the importance of finding asymptomatic cases.
"This is something that has been done so extraordinarily well in HIV, where you have to find the asymptomatic individuals to stop community spread," she said. "Same principle in this respiratory disease."
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Sara G. Miller is the health editor for NBC News, Health & Medical Unit.
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Fauci on COVID-19 vaccine development: 'We have responsibility to the entire planet' - NBC News
In January, vaccine researchers lined up on the starting blocks, waiting to hear a pistol. That shot came on January 10, when scientists in China announced the complete genetic makeup of the novel coronavirus. With that information in hand, the headlong race toward a vaccine began.
As the virus, now known as SARS-CoV-2, began to spread like wildfire around the globe, researchers sprinted to catch up with treatments and vaccines. Now, six months later, there is still no cure and no preventative for the disease caused by the virus, COVID-19, though there are glimmers of hope. Studies show that two drugs can help treat the sick: The antiviral remdesivir shortens recovery times (SN: 4/29/20) and a steroid called dexamethasone reduces deaths among people hospitalized with COVID-19 who need help breathing (SN: 6/16/20).
But the finish line in this race remains a safe and effective vaccine. With nearly 180 vaccine candidates now being tested in lab dishes, animals and even already in humans, that end may be in sight. Some experts predict that a vaccine may be available for emergency use for the general public by the end of the year even before it receives expedited U.S. Food and Drug Administration approval.
Velocity might come at the expense of safety and efficacy, some experts worry. And that could stymie efforts to convince enough people to get the vaccine in order to build the herd immunity needed to end the pandemic.
Were calling for transparency of data, says Esther Krofah, executive director of FasterCures, a Washington, D.C.-based nonprofit. We want things to accelerate meaningfully in a way that does not compromise safety or the science, but we need to see the data, she says.
Traditionally, vaccines are made from weakened or killed viruses, or virus fragments. But producing large amounts of vaccine that way can take years, because such vaccines must be made in cells (SN: 7/7/20), which often arent easy to grow in large quantities.
Getting an early good look at the coronaviruss genetic makeup created a shortcut. It let scientists quickly harness the viruss genetic information to make copies of a crucial piece of SARS-CoV-2 that can be used as the basis for vaccines.
That piece is known as the spike protein. It studs the viruss surface, forming its halo and allowing the virus to latch onto and enter human cells. Because the spike protein is on the outside of the virus, its also an easy target for antibodies to recognize.
Researchers have copied the SARS-CoV-2 version of instructions for making the spike protein into RNA or DNA, or synthesized the protein itself, in order to create vaccines of various types (see sidebar). Once the vaccine is delivered into the body, the immune system makes antibodies that recognize the virus and block it from getting into cells, either preventing infection or helping people avoid serious illness.
Using this approach, drugmakers have set speed records in devising vaccines and beginning clinical trials. FasterCures, which is part of the Milken Institute think tank, is tracking 179 vaccine candidates, most of which are still being tested in lab dishes and animals. But nearly 20 have already begun testing in people.
Some front-runners have emerged, leading the pack in a neck-and-neck race. Some have been propelled by an effort by the U.S. federal government, called Operation Warp Speed, which has picked a handful of vaccine candidates to fast-track.
First out of the starting gate was one developed by Moderna, a Cambridge, Mass.based biotech company. It inoculated the first volunteer with its candidate vaccine on March 16, just 63 days after the viruss genetic makeup was revealed. The company has since reported preliminary safety data, and some evidence that its vaccine stimulates the immune system to produce antibodies against the coronavirus (SN: 5/18/20).
That company and several others now have vaccines entering Phase III clinical trials. Moderna and the National Institute of Allergy and Infectious Diseases, in Bethesda, Md., will begin inoculating 30,000 volunteers with either the vaccine or a placebo in July to test the vaccines efficacy in large numbers of people.
Modernas vaccine requires two doses; a prime and a boost. That means it will take 28 days to get any individual person vaccinated, NIAID director Anthony Fauci said June 26 during a Milken Institute webinar. It will take weeks and months to give the full set of shots to all those people. Then it will take time to determine whether more people in the placebo group get COVID-19 than those in the vaccine group a sign that the vaccine works. Those results could come in late fall or early winter.
NIAID launched a clinical trials network July 8 to recruit volunteers at sites across the United States for phase III testing of vaccines and antibodies to prevent COVID-19. Modernas vaccine will be the first in line for testing.
Some researchers propose accelerating clinical trials even further by trying controversial challenge trials, in which vaccinated volunteers are intentionally exposed to the coronavirus (SN: 5/27/20). None of those studies have gotten the green light yet.
Three other global drug and vaccine companies have announced plans to launch similarly sized trials this summer: Johnson & Johnson; AstraZeneca, working with the University of Oxford; and Pfizer Inc., which has teamed up with the German company BioNTech. Like Moderna, all are part of Operation Warp Speed, or will be joining it.
Usually, Phase III trials are about determining efficacy. But the rush to get through earlier stages designed to make sure a drug doesnt cause harm means that scientists also will be keeping a keen eye on safety, Fauci said. Researchers will be watching, in particular, for any suggestion that antibodies generated by the vaccine might enhance infection.
That can happen when antibodies stimulated by the vaccine dont fully neutralize the virus and can aid it getting into cells and replicating, or because the vaccine alters immune cell responses in unhelpful ways. Vaccines against MERS and SARS coronaviruses made infections with the real virus worse in some animal studies.
Such enhanced infections are a worry for any unproven vaccine candidate, but some experimental vaccines in the works may be more concerning than others, says Peter Pitts, president of the Center for Medicine in the Public Interest, a nonprofit research and education organization headquartered in New York City.
For instance, China-based CanSino Biologics Inc. has developed a hybrid virus vaccine: Its made by putting the coronavirus spike protein into a common cold virus called adenovirus 5. That virus can infect humans but has been altered so that it can no longer replicate.
In a small study, reported June 13 in the Lancet, CanSinos vaccine triggered antibody production against the spike protein. But many volunteers already had preexisting antibodies to the adenovirus, raising concerns that that could weaken their response to the vaccine. A weakened response might make an infection worse when people encounter the real coronavirus, Pitts says.
Thats of particular concern because CanSino said in a June 29 statement to the Hong Kong stock exchange that its vaccine was approved by the Chinese government for temporary use by the Chinese military. Thats essentially turning soldiers into guinea pigs, Pitts says.
The type of antibodies stimulated by the vaccine will be important in determining whether the vaccine protects against disease or makes things worse, Yale University immunologists Akiko Iwasaki and Yexin Yang, warned April 21 in Nature Reviews Immunology. Some types of antibodies have been associated with more severe COVID-19.
And it will be important to monitor the ratio of neutralizing antibodies and non-neutralizing antibodies, as well as activity of other immune cells triggered by the vaccines, an international working group of scientists recommended in a conference report in the June 26 Vaccine.
Public health officials will also be tracking side effects closely. As big as the vaccine trials may be, we cant be sure that there arent rare side effects, Anne Schuchat, principal deputy director of the Centers for Disease Control and Prevention, said June 29 during a question-and-answer session with the Journal of the American Medical Association. Thats why even when we get enough to vaccinate large numbers, were going to need to be following it.
In 1976 for instance, it turned out that Guillain-Barr syndrome, a rare neurological condition in which the immune system attacks parts of the nervous system, was a rare side effect of the swine flu influenza vaccine. That didnt become obvious until the vaccine had already been rolled out to 45 million people in the United States.
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Early on, it was unclear whether scientists could devise a vaccine against the coronavirus at all. Its now a question of when rather than if well have a vaccine.
But some researchers have expressed concern that rushing clinical trials might lead federal regulators to approve a vaccine based on its ability to trigger antibody production alone. Its still unclear how well antibodies protect against reinfection with the coronavirus and how long any such immunity may last (SN: 4/28/20). The measure of whether the vaccine works should be its ability to protect against illness, not antibody production, Fauci said.
I really want to make sure that we dont have a vaccine thats distributed among the American people unless we know its safe and we know it is effective, he said. Not that we think it might be effective, but that we know its effective.
So far though, companies are measuring success by the antibody. For instance, INOVIO, a biotechnology company based in Plymouth Meeting, Pa., announced June 30 that 94 percent of participants in a small safety trial made antibodies against the coronavirus. The data, delivered via news release like that from numerous other companies rushing to show progress, had not been peer-reviewed and other details about the companys DNA-based vaccine were sparse.
Despite still having much to prove, companies are gearing up manufacturing without knowing if their product will ever reach the market. By the end of the year, companies promise they can have hundreds of millions of doses. We keep saying, Are you sure? And they keep saying yes, Fauci said. Thats pretty impressive if they can do it.
For instance, if everything goes right, a vaccine in testing now from Pfizer might be available as soon as October, Pfizer chairman and chief executive Albert Bourla said during the Milken Institute session. If we are lucky, and the product works and we do not have significant bumps on our way to manufacturing, he said, the company expects to be able to make 1 billion doses by early next year.
Pfizer released preliminary data on the safety of one of four vaccine candidates it is evaluating July 1 at medRxiv.org. In the small study of 45 people, no severe side effects were noted. Vaccination produced neutralizing antibodies at levels 1.8 to 2.8 times levels found in blood plasma from people who had recovered from COVID-19, researchers reported.
Novavax Inc., a Gaithersburg, Md.-based biotechnology company, announced July 7 that it was being award $1.6 billion from Operation Warp Speed to conduct phase III trials and to deliver 100 million doses of its vaccine as early as the end of the year.
If manufacturers can deliver a vaccine as promised, there could be another big hurdle: Theres no guarantee people will line up for shots. About a quarter of Americans said in recent polls that they would definitely or probably not get a coronavirus vaccine if one were available. Thats a pending public health crisis, Pitts says.
Krofah agrees. We need to think about the post-pandemic world in the midst of all of this, she says. We need to start building that public trust now. Tackling issues of vaccine hesitancy shouldnt be left until a vaccine is available, she says.
Whether with vaccines or treatments, we need to expedite, but not rush, Pitts says. Theres a perception that therapeutics or vaccines will be approved willy-nilly because of politics, and thats a dangerous misperception. The FDA laid out guidelines, including an accelerated approval process, on June 30 that should ensure any approved vaccines work, he says.
There is good news for those who are eagerly awaiting vaccines, Krofah and Pitts say: There wont be just one winner in the race. Instead, there may be multiple options to choose from. Thats not a luxury; it may be a necessity. Multiple vaccines may be needed to protect different segments of the population, Krofah says. For instance, elderly people may need a vaccine that prods the immune system harder to make antibodies, and children may need different vaccines than adults do.
Whats more, long-term investments in development will be needed so that vaccines can be altered if the virus mutates. We need to stay the front and not declare victory once a vaccine has been approved for emergency use, she says.
For now, vaccine makers are moving both as quickly and as carefully as possible, Bourla said. I am aware that right now that billions of people, millions of businesses, hundreds of governments are investing their hope for a solution in a handful of pharma companies.
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A COVID-19 vaccine may come soon. Will the blistering pace backfire? - Science News
Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time. USA TODAY
As researchers race to develop a potential vaccine to combat the new coronavirus, rapper Kanye Westmade false claims about vaccinations and expressed hesitancy in receiving one.
In an interview with Forbes, West referred to getting vaccinated as "the mark of the beast" and hinted at a debunked conspiracy theory that a potential COVID-19 vaccine would be part of a larger effort to "put chips inside of us."
The rapper's comments come as recent polling suggests that only half of Americans say they would get a COVID-19 vaccine if it were developed.
The fears occurwith the backdrop of anti-vaccination sentiments havingreached mainstream conversation in recent years despite the medical community consensus that vaccines are safe and effective in preventing disease.
Last January, the World Health Organization said"vaccine hesitancy," or "the reluctance or refusal to vaccinate despite the availability of vaccines" was among the organization's top global threats for the 2019.
How far are we from a COVID-19 vaccine?One-third of the way, experts say
The risk of autism is cited by a small yet increasingly vocal group of parents that opt not to vaccinate their children. The Centers for Disease Control and Prevention says there is nolink. West's claims also similarly lack evidence.
Kanye West sent out a tweet on Independence Day calling for a "unified vision" as he announced he's running for president in 2020. USA TODAY
In the Forbes interview published Wednesday, West, who says he is running for president this year,revealed he was sick with COVID-19 in February. The story includes a long quotation "on vaccines" from West, who said:
Its so many of our children that are being vaccinated and paralyzed So when they say the way were going to fix COVID is with a vaccine, Im extremely cautious. Thats the mark of the beast. They want to put chips inside of us, they want to do all kinds of things, to make it where we cant cross the gates of heaven. I'm sorry when I say they, the humans that have the Devil inside them. And the sad thing is that, the saddest thing is that we all wont make it to heaven, that therell be some of us that do not make it. Next question.
More from West's interview: Kanye says he no longer supports President Trump, details his own run for office
There is no evidence linking current vaccinations to paralysis in children, said Daniel Salmon, the director of theInstitute for Vaccine Safety atJohns Hopkins Bloomberg School of Public Health.
The oral polio vaccine, which is no longer used in the United States, did cause1 in 750,000 people receiving the first dose of the vaccine to contract polio, which could lead to paralysis,Salmon said.
The oral polio vaccine was extremely effective at preventing disease,Salmon said, but its use has since been phased out and replaced with the inactivatepoliovaccine, which cannot cause the disease.
Other vaccines still in use in the United States can cause some minor, adverse reactions, including a minor fever or a sore arm, which Salmon says indicate the body is responding to the vaccine and creating an immune response. Serious adverse reactions are extremely rare, he added.
"When you think about vaccines, it's like anything. It's risk vs. benefits. And the benefit really outweighs the risk," he said.
Facts alone don't sway anti-vaxxers: So what does?
Westsaying that people want to"put chips inside of us" also appears to reference a debunked conspiracy theory concerning Bill Gates, microchips and a global surveillance state, though West did not directly name Gates.
The Bill and Melinda Gates Foundation recently announced that it was committing $1.6 billion to work to deliver vaccines to the worlds poorest countries through the Vaccine Alliance.
Its possible the microchipping conspiracy theory may have had its roots in a small study funded by his foundation and published in December.
It involved technology developed at the Massachusetts Institute of Technology to include a tiny bit of dye with vaccines. The dye would be invisible to the naked eye but could be seen with a cellphone app that shines near-infrared light onto the skin.
A study explaining the technique was published in December in the journal Science Translational Medicine, but the technique was tested only in animals, never in children, and has never been put into use.
In a way, its so bizarre you almost want to see it as something humorous, but its really not a humorous thing, Gates said in a media call last month. Its almost hard to deny this stuff because its so stupid or strange that even to repeat it gives it credibility.
More on the Gates conspiracy theory: Bill Gates is not secretly plotting microchips in a coronavirus vaccine. Misinformation and conspiracy theories are dangerous for everyone.
As misinformation spreads around vaccines, surprisingly low numbers of Americans say they would get one for COVID-19 if developed.
AMay poll from The Associated Press-NORC Center for Public Affairs Research found just halfof Americans say they would get a vaccine. One in 5 Americans said they would not while roughly 1 in 3 weren't sure.
AWashington Post-ABC News poll in June found a more promising 7 in 10 Americans say they "definitely" or "probably"would get vaccinated.
Salmon said it's the group of people who are hesitant about, though are not necessarily outright against, receiving vaccines that he worries about, given that they make up a larger share of the population than staunch anti-vaccination advocates.
Two shots?A coronavirus vaccine may not be as simple as one jab and you're immune.
"It's a very difficult climate to introduce a vaccine,"Salmon said.
Like any vaccine development, there are potential risks with developing a vaccine for COVID-19.
Clinical trials may not detect some rare outcomes, a delayed onset of an adverse effect could occur after the trial ends and some populations may not be captured in the trial, Salmonsaid.
But the potential benefit of vaccination would outweigh those risks given the current safety protocols of vaccine trials in the United States,he added.
Some have expressed concern the Food and Drug Administration might face pressure from the White House to approve a COVID-19 vaccine as quickly as possible, under an Emergency Use Authorization rather than the agency's typical process.
FDA guidance issued last week indicates that at least the first vaccine to be approved must go through the full FDA licensure process, including Phase 3 clinical trials to show it protects people against disease or infection.
More on FDA guidance: A coronavirus vaccine would have to be at least 50% effective to be approved
Phase 3 trials would need to show people have developed protection against the virus, not just that their blood indicates they may be protected, several vaccine experts said.
"While the FDA is committed to expediting this work, we will not cut corners in our decisions and are making clear through this guidance what data should be submitted to meet our regulatory standards, FDA Commissioner Stephen Hahn said.
A clear concern in the FDA's guidance for the coronavirus vaccine is whether vaccine candidates might cause enhanced respiratory disease not only failing to decrease the severity of COVID-19 but causing it to get worse.
While rare, data from animal studies in some vaccine candidates for other coronaviruses, such as SARS-CoV and MERS-CoV, has raised concerns regarding COVID-19, the FDA said.
Coincidental events could also contribute to opposition or hesitation to vaccines, Salmon said. Any time someone gets sick or dies after receiving a vaccine, there's a risk people will perceive the vaccine as causing that illness. What's needed in these cases is thorough scientific research into whether the adverse outcome was causal or coincidental, Salmon said.
"The science needs to answer those questions, andscience takes time,"Salmon said.
Contributing:Elizabeth Weise and Brett Molina
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Anti-vaxxers, Kanye West denounce potential COVID-19 vaccine; here's the science - USA TODAY
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The pandemic has affected every aspect of the economy. If there is no vaccine in the foreseeable future, the overwhelming majority of the workforce will require more safety protections, job flexibility, and better health care.
Only 25% of U.S. workers are employed in industries where they can work from home, says Marissa Baker, assistant professor of occupational health sciences at the University of Washington. The other 75% of workersin industries such as retail, health care, and transportation, where working from home isnt an optionwill need added protections to stay safe.
At a minimum, they will need more personal protective equipment, and training on how to use it properly. People who interact with large numbers of people, such as bus drivers, may even need to wear N95 masks, which provide a greater level of protection than cloth or paper masks.
Another challenge will be ensuring that everyone who interacts with workers also wears a mask. Baker says employers may need to hire a person trained to deal with customer confrontations to stand at the door to enforce mask wearing.
Essential workers will also need paid time off if they get sick or need to take care of children or other family members. Ideally, says Baker, these workers need a way to work flexibly while still maintaining their job and benefits.
The 25% of the workforce who dont have to go to an office, store, factory, or other physical location could benefit from a new working-at-home economy, says Nicholas Bloom, professor of economics at Stanford Graduate School of Businessalthough some studies have shown that working from home is linked to a decrease in productivity and an increase in inequality. Educated, higher-paid employees who can afford to work from home will develop skills and advance their careers, but those who cant will be left behind, says Bloom.
Still, as the pandemic wears on, both the at-home workers and those making commutes will face a significant mental health crisis, Baker predicts. People who cant work from home but who arent doing essential work will face job displacement and job insecurity, which Baker says is linked to depression.
Even those who can work through the pandemic are likely to face mental health stress from trying to balance their work and home life, especially parents if schools remain closed. Greater access to affordable health care, including mental health care, will be necessary for workers, says Baker.
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What Happens If There Isnt a Covid-19 Vaccine Soon? - Barron's
Despite the race to replenish the domestic needle and syringe supply, about 400 shipping containers of syringes have left the U.S. for countries including Germany, Colombia, Australia, Brazil and Italy this year, according to Panjiva Inc., a service that independently tracks global trade. Thats the same, on average, as syringe exports over the past five years.
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Maryland man treated with experimental COVID-19 vaccine
A Maryland man who was one of the first people to be vaccinated with an experimental COVID-19 vaccine through Pfizer/Biontech says the vaccine may be working.
COLLEGE PARK, Md. (FOX 5 DC) - A Maryland man who was one of the first people to be vaccinated with an experimental COVID-19 vaccine through Pfizer/Biontech says the vaccine may be working.
FOX 5first interviewed David Rach, a graduate immunology student, back in May.
A University of Maryland's School of Medicine spokesperson is now telling FOX 5that Phase 1 and 2 early results from the first roughly 40 individuals in this multi-site study show some signs of promise and some signs of an immune response. This means that the patients have generated antibodies that stop the virus from being able to affect cells.
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"Going into the trial, I wasn't certain the vaccine would be effective at producing an immune response, because we were the first people being tested with the vaccine... At the same time, just because I have antibodies doesn't mean you are protected against the virus, So i'm monitoring my symptoms every day," said Rach.
It's also important to remember that this was a randomized blind trial meaning that some participants received a placebo saline solution and some actually got the vaccine. The participants don't know which one they received, but based on his blood tests, his symptoms and the fact that he's a scientist in training, Rach says he's confident he got the vaccine.
Researchers are also comparing the immune response of those vaccinated with patients who have recovered from covid in the hospitals... and are seeing some promising results there as well.
As for safety, Rach says the research shows some fever in participants with the low dose of the vaccine, but no serious symptoms.
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Another important factor with a trial, is that the participant is surrounded by the virus. Rach says he's trying to get out more.
"I'm starting to move around, going to and from work... I still do my own grocery runs- and I'm still social distancing so I can do my own part," said Rach.
This is one of many vaccine trials underway. In July, the University of Maryland School of Medicine is expected to take part in a phase 3 trial for another covid 19 vaccine developed by Moderna. The focus will be to target the most vulnerable communities impacted by coronavirus-- the Latino and African American communities and older adults with underlying health issues.
For the first few months researchers will follow Rach closely and check in on him every 6, 12 months to see how long the antibodies last.
If the trial proves to be successful, Pfizer promises to produce 100 million doses before the end of 2020 and more than a billion doses next year
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Maryland man treated with experimental COVID-19 vaccine says it may be working - FOX 5 DC
