Category: Covid-19 Vaccine

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Jones sponsors bill for insurance plans to cover COVID-19 vaccines when they’re available – alreporter.com

March 18, 2020

On Sunday night, her sons fever spiked, and in the morning he woke with body aches, a sore throat and a bad headache.

The mother, a nurse practitioner in the Birmingham area, told APR on Tuesday that shed spent the morning trying unsuccessfully to get her 10-year-old tested for COVID-19.

She wasnt able to, in part because drive-thru testing at the Church of Highlands Grandview campus closed after hundreds of cars clogged U.S. 280, cutting off access to and from a nearby hospital.

But there are also concerns over a lack of tests and testing supplies in Alabama and across the country, and public health officials cautioned that those without symptoms dont need to be tested, which could overwhelm a system already under strain.

She first called a pediatrician and was told the office couldnt help her.

Theyre seeing patients with fever via telehealth, they will not stop for strep or flu, she said.

She was told to call Urgent Care for Children, which is operating drive-thru COVID-19 testing for people up to 20-years-old, but her son wasnt experiencing a cough at the time, so she was turned down for a test.

She said we have a limited number of tests, which is completely understandable, she said.

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Her son has since developed a cough, so she tried to get him tested at the Church of the Highlands Grandview campus only to find herself stuck in traffic next to others on U.S. 280, who seemed to also be trying to get to the church.

I saw people enjoying conversation and laughing, and I saw a lot of people smoking cigarettes out of their car windows, she said. Theres no way that all these people meet criteria for testing and Ive got a sick kid in my backseat.

By the time she got up to the intersection, police officers were telling drivers that the testing site was closed.

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They didnt say why at the time, but it was very clear to me, looking at Grandview hospital, that this was really compromising access to the hospital, she said.

Attempts Tuesday to reach the church were unsuccessful, but Al.com reports that the church will move the testing to the churchs Grants Mill Road campus and reopen for testing on Wednesday.

She said theyve left a message with Urgent Care for Children and will try there again on Wednesday since hes developed a cough.

So Im hopeful, but if that doesnt pan out, I have no idea, she said.

As a health care provider herself, the nurse said shed like to see more communication to the public about who needs to be tested and who doesnt.

Try to keep people from panicking, but we need more tests, and we need more testing capacity, she said. Its not just the test, its the people who are going to process those tests.

Thats a concern expressed by Dr. Jeanne Marrazzo, head of infectious diseases at the University of Alabama at Birmingham, who told reporters Monday that the state simply doesnt have the staffing and resources to test as quickly and as widely as is needed.

Marrazzo urged the public to seek a test only if they have symptoms, which are fever, shortness of breath and a cough.

Its a message echoed by other state health officials in recent days who have pleaded for the public to first call the states COVID-19 hotline at 1-888-264-2256 before driving to a testing location.

Sen. Doug Jones, D-Alabama, on Tuesday told reporters that were seeing long lines in the drive-thru test center yet people are still having trouble getting a test.

Ive got a friend who sent me a text just a moment ago, whos been trying to get a test for five days. Now shes got symptoms, shes got a fever, shes got respiratory issues, but she cant get a test, Jones said. And that is in part because so many people are willing to get tests that dont really have any symptoms and arent really sick. Im not criticizing. What Im asking people to do is to hold back if you dont have a fever and respiratory issues.

The nurse said she also worries that if theres a panic, asymptomatic people could flood emergency rooms and primary care offices, which would cut off access to care for people like her son, whose fever had come down some Tuesday afternoon.

Hes probably improving, and I hope that will continue, but again, I dont know. I cant be certain of what it is without testing, she said.

After 3 hours on hold with Urgent Care for Children, the nurse said she was able to get her son an appointment to be tested later on Tuesday.

That took far too much effort for someone who even knows how to navigate the healthcare system. I cant imagine what its like for those uninsured, she said.

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Jones sponsors bill for insurance plans to cover COVID-19 vaccines when they're available - alreporter.com

The U.S. Should Make COVID-19 Testing, Prevention And Care Free To All – WBUR

March 18, 2020

The first COVID-19 case in the United States was discovered in January. Since then approximately,12,000 tests have been conducted by U.S. public health laboratories. South Korea also announced their first case in January, and theyve conducted nearly250,000 teststo date.

A shortage of testing kits in the U.S. has been well documented, and will eventually be resolved. But patient costs will continue to be front and center. We must prevent high costs from decreasing the availability of testing and treatment. The U.S. Department of Health and Human Services must cover vaccination (once a vaccine is developed and approved), diagnostic testing and treatment without any cost-sharing (i.e. co-payments, co-insurance or deductibles).

As the pandemic explodes across the country, we know that costs are weighing heavily on the minds of many Americans andlegislators.

Americas Health Insurance Plans (AHIP), the chief lobbying organization for private insurers, recently announced that it will work to ensure out-of-pocket costs are not a barrier to people seeking testing for, and treatment of, COVID-19. But this is not enough.

Insurance is complicated and hard to navigate. With complex networks and bills that frequently perplex beneficiaries, many rightlyquestion AHIPs transparency. Meanwhile, President Trump hasnot been clear or accurate: after announcing that insurance companies would waive all co-pays for testing and treatment, the insurance industry pushed back, saying it had not agreed to include treatment.

The recently passed U.S.House bill would make COVID-19 diagnostic testing free for everyone, but it remains to be what will happen with the legislation in the U.S. Senate. A uniform requirement from the federal government is needed to clarify what services are covered, and how expensive they are.

As healthcare providers, we are disheartened that we cannot tell our patients who are literally and figuratively worried sick how much the COVID-19 care they need and deserve will cost.

In the early stages of a local outbreak,Massachusetts-- along with several other states, includingWashingtonandNew York-- issued a bolddirectivefor free diagnostic testing and in some cases treatment. The U.S. government should follow the lead of these states.

A uniform requirement from the federal government is needed to clarify what services are covered, and how expensive they are.

There is precedence for requiring private insurers to cover preventive care (vaccines and screening tests) without cost-sharing. Under the Affordable Care Act (ACA), private insurersmust covervaccines approved by the Centers for Disease Control and Prevention (CDC) without cost-sharing.Diagnostic testing, while not strictly a preventive service, should also fall under the purview of the ACA mandate. Vaccination coverage clearly falls under the current requirement by the ACA. For example, influenza vaccination is covered under this directive.

The eventual COVID-19 vaccine should be treated similarly, and must be added to the CDCs list of covered vaccinations to make this possible.

Vaccinations require herd immunity, a concept in immunology that dictates a critical mass of the society needs to have immunity to prevent community spread of an infectious disease. If the immunization is free at the point of care, Americans willmore readily obtain it.

In the case of a pandemic disease such as COVID-19, diagnosis is preventative care because it encourages better compliance with isolation measures intended to avoid disease spread. Testing could also streamline quarantine and isolation measures if cases are detected earlier.

A federal directive requiring free access to diagnostic tests, treatment and the eventual vaccine will reduce the spread of the virus within communities.

One of the most progressive measures the U.S. government could take, would be waiving all cost-sharing related to COVID-19 care. In the past few years, there has been an increase in high deductible health plans. Many underinsured individuals will facecost-sharing exceeding a thousand dollarsto receive inpatient care.

While no precedent that we are aware of exists, covering all treatment related cost-sharing is morally and financially responsible. Decreasing barriers to care will likely help control community spread and thereby reduce U.S. health system costs overall. Worst-case estimates implyover 20 million Americans could be hospitalized. Unsurprisingly, insurers oppose removing cost-sharing related to COVID-19 treatment. However, it is possible for a compromise to be reached that would waive most elements of cost-sharing such as deductibles for related treatment.

A federal directive requiring free access to diagnostic tests, treatment and the eventual vaccine will reduce the spread of the virus within communities. Federal intervention also provides a regulatory framework to enact faster responses to future public health crises.

Coronavirus is a threat. To thoroughly contain it, we must thoroughly screen for it. And to thoroughly screen for and prevent it, the U.S. government must make allCOVID-19 care free for patients.

Nicole Bustosis a rising fourth-year graduate student at Massachusetts Institute of Technology. Her research examines transmission of respiratory infectious diseases.

Alex Pomerantzis a rising fourth-year medical student at Harvard. He has conducted health care delivery and public health research that has been published locally and nationally.

Aakash Shah M.D. M.B.A. M.Sc.is a practicing emergency room doctor and public health expert who was involved in the care of the first confirmed cases of COVID-19 in New Jersey.

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The U.S. Should Make COVID-19 Testing, Prevention And Care Free To All - WBUR

The FDA Regulatory Landscape for Covid-19 Treatments and Vaccines – JD Supra

March 18, 2020

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The FDA Regulatory Landscape for Covid-19 Treatments and Vaccines - JD Supra

Montgomery Co. life science companies work together on COVID-19 vaccine – WDVM 25

March 18, 2020

GAITHERSBURG, Md. (WDVM) A global life sciences company headquartered in Montgomery County is making headway when it comes to manufacturing products to stop the spread of the coronavirus.

With local facilities in Gaithersburg, D.C., and Baltimore, Emergent BioSolutions has started the development of products to prevent and treat coronavirus.

We are actively funding the advancement of two different technologies, said Sean Kirk, Executive Vice President of Manufacturing and Technical Operations at Emergent.

In a remote briefing with 6th District Congressman David Trone on Tuesday morning, executives from Emergent broke down the biology behind manufacturing therapeutic medications.

Well begin collecting plasma from citizens who have navigated their way through the infection, so they have antibodies in their blood. We can purify those antibodies to create a treatment for folks who are actively sick, Kirk explained.

Theyre also planning to collect and purify antibodies from horses to create a potential treatment.

Developing these products takes time, and theyre partnering with Maryland-based vaccine developer Novavax to bring a COVID-19 vaccine to market.

The team is in active execution of that project, they have a target of June for their clinical trial, said Senior Vice President and head of Contract Development and Manufacturing Organization Syed T. Husain.

Congressman Trone says he hopes to help the companies through the process as much as he can.

Weve got to get all hands on deck, were all part of one team and thats the American peoples health, he said.

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Montgomery Co. life science companies work together on COVID-19 vaccine - WDVM 25

Meet the volunteers testing the new experimental COVID-19 vaccine – CTV News

March 18, 2020

SEATTLE -- The first people to roll up their sleeves to receive an experimental vaccine for the coronavirus say they were inspired to help because they wanted to do more to fight the disease than wash their hands and work from home.

Three of the study participants spoke to The Associated Press on Monday following the trial's first injections in Seattle. They said the shots were no more painful than an ordinary season flu vaccine.

Some will get higher dosages than others to test how strong the dose should be. They will be checked for side effects and have their blood tested to determine whether the vaccine is revving up their immune systems.

The volunteers said they weren't acting in hopes of protecting themselves. They understand their role is a small part of what could be an 18-month hunt for a successful shot that could be distributed widely.

They work in the tech industry and in health research. Two have children, and all three are working from home to slow the spread of COVID-19.

They are a 43-year-old operations manager at a small tech company, a 46-year-old network engineer at Microsoft and a 25-year-old editorial co-ordinator at an independent global health research centre at the University of Washington.

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Jennifer Haller, 43, still cuts up apples for her 16-year-old son and 13-year-old daughter each morning, even though the teenagers now make their own lunches. She leaves for work before they head to school on a normal day.

On Friday, however, the governor ordered the closure of all Washington state schools that were still open. Her company wants everyone to work from home.

Her husband, a software tester, was laid off last week, a move unrelated to the pandemic. The family's income was cut in half. The job market looks grim.

"I figure we probably need to prepare for him to be off work for six months," she said.

Haller works as an operations manager at a small tech company that normally runs out of a shared working space in Seattle. She learned of the vaccine study through Facebook on March 3, the day Kaiser Permanente Washington Research Institute started recruiting. She submitted her application immediately.

Two days later, she was dining at a Mexican restaurant when she answered a phone call from an unknown number. It was a member of the research team asking if she wanted to participate and if she had 15 minutes to answer some questions. She interrupted her dinner and agreed.

"We all feel so helpless. This is an amazing opportunity for me to do something," she said Monday.

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Neal Browning, 46, lives in Bothell, Washington, north of Seattle, with his fiancee and their daughters. He works as a network engineer at Microsoft, one of the first companies to require its employees to work remotely.

At a neighbourhood gathering Sunday, Browning watched his daughters and other children improvise a game of tag without touching each other. They'd been told about social distancing, a way to fight the virus by staying away from others.

"Kids are fairly adaptable," Browning said. "If you give them a set of rules, they like to follow them if at all possible."

Browning and his fiancee have three daughters between them, ages 8, 9 and 11. The girls are proud of him for testing the first vaccine for the new virus, he said.

"Every parent wants their children to look up to them," Browning said Monday after his shot. But he's told the girls not to brag to their friends too much. "It's other people too. It's not just Dad out there."

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Rebecca Sirull, 25, barely stopped working to get her shot Monday, participating in a conference call for work while sitting in the research institute's clinic.

She moved to Seattle from the Boston area in December to work as editorial co-ordinator for the Institute for Health Metrics and Evaluation.

She lives in an apartment with roommates, and her social life took a hit with the coronavirus restrictions. The ultimate frisbee team she joined for the spring season is no longer playing: "Our very first game was cancelled," she said.

"The dating scene is kind of on hold for the moment," Sirull added. "You know, people talk about finding their quarantine buddy, but I'm happy to kind of wait another couple months. You know, it's not that pressing an issue right now for me."

She's heard friends make dark jokes about parallels between the coronavirus pandemic and the start of every zombie apocalypse movie ever made. "I say, `No, guys, it doesn't have to go that way!"'

She joined the vaccine study as "a way to contribute to the situation in a positive way, considering, you know, the main guidelines that we all have right now are to stay home and do nothing, which is sort of a hard message to hear when you want to help out."

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.

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Meet the volunteers testing the new experimental COVID-19 vaccine - CTV News

Regeneron aims to have coronavirus antibody treatment ready for human testing by early summer – CNBC

March 17, 2020

Biotech giant Regeneron said it aims to have doses of a potential drug for COVID-19 ready to start human clinical trials by early summer.

The approach involves creating antibodies to the virus that could be used to treat the disease and to prevent it, Regeneron said in a statement Tuesday.

The company had previously said it aimed to have hundreds of thousands of doses ready for human testing in late summer, so the new goal is a significant acceleration. Regeneron said it plans to start large-scale manufacturing by the middle of next month and still plans to ramp up to hundreds of thousands of preventive doses a month by the end of summer.

"There are always so many moving parts, but we're hitting our best numbers, our best timelines, and things are going really well," Dr. George Yancopoulos, Regeneron's co-founder, president and chief scientific officer, said in a telephone interviewMonday night.

Regeneron is developing the therapy the same way it created a drug for Ebola, which is now under review by the FDA, and four other drugs already on the market: It uses mice genetically engineered to have human-like immune systems. The mice are exposed to a target protein and generate human antibodies in response.

Those antibodies are now used in medicines approved to treat such maladies as asthma, high cholesterol, rheumatoid arthritis and cancer.

The approach has been heralded by health experts including former Food and Drug Administration Commissioner Dr. Scott Gottlieb as among the most promising for new tools to apply against the novel coronavirus potentially in the fall, when infections could resurge even if they tamp down during the summer.

For COVID-19, the mice were exposed to part of the SARS-CoV-2 virus. Regeneron said its scientists have now isolated hundreds of antibodies that neutralize the virus, and they're sorting through them as well as antibodies isolated from people who have recovered from COVID-19 to find the best two with which to create a cocktail treatment.

Yancopoulos said Regeneron plans to combine two antibodies because "you want to ensure if, God forbid, there's a mutation or variation in the virus, you don't lose [efficacy] due to that one antibody."

For Ebola, Regeneron used the same approach to create a three-antibody cocktail, which proved life-saving in a clinical trial in the Democratic Republic of Congo in 2018.

The approach to provide treatment and protection in one potential medicine for COVID-19 puts Regeneron somewhere in between the vaccine projects underway at Moderna, Johnson & Johnson, Sanofi, and others, and the hunt for medicines across the industry, including at Gilead Sciences. Yancopoulos said the duration of protection that Regeneron's antibodies could provide is unknown before human studies are run, but extrapolating from earlier experience, they "expect one dose to last at least a month."

The dose needed for protection is a lot less than for treatment after someone is infected, he said, which is why Regeneron's goal of hundreds of thousands of doses by late summer applies to preventive use.

"For every hundred people you 'prophylax,' you can probably treat like five or 10 people," Yancopoulos said.

He noted the first people likely to receive the prophylactic treatment would be health-care workers and others at high risk for the disease. They would likely need a dose once a month until a vaccine conferring longer-term immunity becomes available. (National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci, who is leading the nation's COVID-19 vaccine development, has said a vaccine won't be available for a year to 18 months.)

And though Regeneron is meeting its own most optimistic timelines for the project, Yancopoulos said, "it still depends on a lot of things going right. This is biology, not coding or writing an app. There are a lot of things that can still go wrong."

The company also said Monday it is starting clinical trials of its rheumatoid arthritis drug, Kevzara, to treat the severe immune response that can occur in the lungs of patients with COVID-19. Since that drug is already on the market, it could provide an immediate option for the most critical patients, if it's successful.

"We really do feel," Yancopoulos said, "like we've been preparing for years for this opportunity to make a difference."

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Regeneron aims to have coronavirus antibody treatment ready for human testing by early summer - CNBC

Covid-19 outbreak: the key to quicker vaccine development – Pharmaceutical Technology

March 17, 2020

]]> According to NIAID directer Dr Anthony Fauci, it will take a year for a Covid-19 vaccine to be available globally. Credit: Shutterstock.

Covid-19 has now been declared to be a pandemic by the World Health Organisation. Since the very beginning of the outbreak early in 2020, the pharma industry and the medical community have been focusing their efforts on investigating drugs that can be repurposed to treat the symptoms, as well as developing new vaccines to tackle the viruss spread.

To date, the Chinese authorities have approved an anti-viral against Covid-19 called fapilavir. This drug, which is manufacture red by Zhejiang Hisun Pharmaceutical, and was developed to treat influenza. Other antiviral drugs being studied for repurposing are Gileads Ebola drug remdesivir, Roches rheumatoid arthritis treatment Actemra and AbbVies HIV drugs Kaletra and Aluvia.

Visit our Covid-19 microsite for the latest coronavirus news, analysis and updates.

Although there has been success in repurposing, development of novel treatments takes much longer. Vaccines are crucial to viral pandemic management because they can confer immunity among the general population, meaning this virus will be more easily contained in the future.

There has been some debate about precisely how long this will take, primarily because Israeli researchers from the state-funded Migal Galilee Research Institute announced they might have a vaccine for the virus in eight to ten weeks. This is because they have been working on a vaccine for Infectious Bronchitis Virus, which has been found to be genetically similar to Covid-19.

Readers of Pharmaceutical Technology have been voting on how long they think it will take for a vaccine to be available to patients. With over 164,000 votes cast, the results show than almost 33% of readers believe it will take over a year, while slightly more 28% are optimistic there could be a vaccine available within three months.

Experts are clear that it will take at least a year for a vaccine to be developed against Covid-19; this situation is not helped by the likelihood that the virus has already mutated into two strains.

US National Institute of Allergy and Infectious Diseases (NIAID) director Dr Anthony Fauci told the US House of Representatives Oversight and Reform Committee on 11 March: With regard to vaccines, we were able to go very quickly from understanding the virus and its genetic sequence to actually develop a vaccine. However, in the next four weeks or so, we will go into Phase I trials getting it into Phase I in a month is the quickest that anyone has ever done in the history of vaccinology.

So we go into Phase I, it will take around three months to determine if it is safe, then you go intoPhase II to determine if it works. Since this is vaccine, you dont want to give it to normal healthy people with the possibility that it will hurt them or that it will not work. So [this] phase is critical [and] will take another eight months or so.

So when youve heard me say that we would not have a vaccine that will be ready to start to deploy for a year to a year and half; that is the time frame. Anyone who thinks they can move more quickly than that, I believe would be cutting corners that would be detrimental.

Although this 12 to 18-month timeline will be difficult to speed up significantly for this pandemic, the scale of the spread and panic Covid-19 has caused must open the pharma industrys eyes about how to ensure the world is better prepared for future outbreaks and pandemics. This is particularly important given that research shows deadly outbreaks are more likely as the climate crisis progresses.

In this context, Virtual Clinical, a clinical research organisation specialising in virtual trials, has called for speeding up the clinical development process through virtualising clinical trials.

We need to learn from the past, and look at how it took the US Food and Drug Administration more than five years to approve the Ebola vaccine after the start of the first human trials, Virtual Clinical CEO Mark Thomas said in a press release. Using virtual clinical trials, enrolment will be quicker, costs will be reduced, and symptom and safety reporting can be more accurate.

He explains that currently there are hybrid versions a noteworthy example is Medidatas aspirin study in the US but there is a need to further virtualise. Every week is critical in a global emergency, he says. By changing the way we run clinical trials, we can provide more hope to get a vaccine [developed] earlier. This transformation of clinical trials will require regulators to accept these virtual initiatives as an equivalent to the existing approaches.

Another way to improve and speed up the clinical trial process is through better and connected data collection. To this end, Amsterdam-based data company Castor announced it would provide free access to its electronic data capture (EDC) system for all non-profit Covid-19 research projects.

Being able to standardise clinical data being accessed globally would help all researchers to understand the natural history of the disease, and describe clinical phenotypes and treatment interventions, CEO Derk Arts noted in a statement.

He adds: Epidemics and pandemics spread fast, they do not wait for clinical trials or academic journals to publish results.

With Covid-19, we have an opportunity to get it right and accelerate the discovery of cures through cooperation and collaboration. The best way to save lives is to share meaningful data in real-time. This new global health crisis caused by Covid-19 may spark systemic change a data revolution that could save thousands of lives.

Focusing on the vaccines specifically, one of the leaders in vaccine development for this current outbreak is the Norwegian Coalition for Epidemic Preparedness Innovations (CEPI).

Since the outbreak first started spreading globally in January, CEPI has funded multiple vaccine candidates from biotech firms, pharma companies and university labs; importantly, the innovations CEPI supports are those that not only intend to produce a vaccine against this novel virus, but involve pioneering technologies that can speed up the development of vaccines in future outbreaks.

The so-called platform technologies they support are those where the basic components of the vaccine can be used as a backbone and adapted for use against new, emerging pathogens simply by inserting their genetic sequence.

One example is CEPIs partnership with US-based Moderna; this company has already received support from NIAID. The biotech leverages mRNA technology and its Covid-19 vaccine is encoded for a pre-fusion stabilised form of the Spike S protein.

Moderna CEO Stphane Bancel said: We believe our mRNA vaccine technology offers potential advantages in the speed of development and production scalability, which positions Moderna to potentially develop a vaccine against coronavirus, 2019-nCoV, which is now known as Covid-19. At the end of February, Moderna announced it had shipped its novel vaccine against Covid-19 for Phase I testing.

Read more from the original source:

Covid-19 outbreak: the key to quicker vaccine development - Pharmaceutical Technology

COVID-19 Vaccine Test Begins With U.S. Volunteer | Time

March 17, 2020

(SEATTLE) U.S. researchers gave the first shot to the first person in a test of an experimental coronavirus vaccine Monday leading off a worldwide hunt for protection even as the pandemic surges.

With a careful jab in a healthy volunteers arm, scientists at the Kaiser Permanente Washington Research Institute in Seattle begin an anxiously awaited first-stage study of a potential COVID-19 vaccine developed in record time after the new virus exploded from China and fanned across the globe.

Read more: Want a Coronavirus Vaccine, Fast? Heres a Solution

Were team coronavirus now, Kaiser Permanente study leader Dr. Lisa Jackson said on the eve of the experiment. Everyone wants to do what they can in this emergency.

The Associated Press observed as the studys first participant, an operations manager at a small tech company, received the injection inside an exam room. Several others were next in line for a test that will ultimately give 45 volunteers two doses, a month apart.

We all feel so helpless. This is an amazing opportunity for me to do something, said Jennifer Haller, 43, of Seattle. Shes the mother of two teenagers and they think its cool that shes taking part in the study.

Mondays milestone marked just the beginning of a series of studies in people needed to prove whether the shots are safe and could work. Even if the research goes well, a vaccine wouldnt be available for widespread use for 12 to 18 months, said Dr. Anthony Fauci of the U.S. National Institutes of Health. Thats still important if the virus becomes a long-term threat.

This vaccine candidate, code-named mRNA-1273, was developed by the NIH and Massachusetts-based biotechnology company Moderna Inc. Theres no chance participants could get infected from the shots because they dont contain the coronavirus itself.

Its not the only potential vaccine in the pipeline. Dozens of research groups around the world are racing to create a vaccine against COVID-19. Another candidate, made by Inovio Pharmaceuticals, is expected to begin its own safety study in the U.S., China and South Korea next month.

The Seattle experiment got underway days after the World Health Organization declared the new virus outbreak a pandemic because of its rapid global spread, infecting more than 169,000 people and killing more than 6,500.

COVID-19 has upended the worlds social and economic fabric since China first identified the virus in January, with regions shuttering schools and businesses, restricting travel, canceling entertainment and sporting events, and encouraging people to stay away from each other.

Starting what scientists call a first-in-humans study is a momentous occasion for scientists, but Jackson described her teams mood as subdued. Theyve been working round-the-clock readying the research in a part of the U.S. struck early and hard by the virus.

Still, going from not even knowing that this virus was out there to have any vaccine in testing in about two months is unprecedented, Jackson told the AP.

Some of the studys carefully chosen healthy volunteers, ages 18 to 55, will get higher dosages than others to test how strong the inoculations should be. Scientists will check for any side effects and draw blood samples to test if the vaccine is revving up the immune system, looking for encouraging clues like the NIH earlier found in vaccinated mice.

We dont know whether this vaccine will induce an immune response, or whether it will be safe. Thats why were doing a trial, Jackson stressed. Its not at the stage where it would be possible or prudent to give it to the general population.

Most of the vaccine research under way globally targets a protein aptly named spike that studs the surface of the new coronavirus and lets it invade human cells. Block that protein and people wont get infected.

Researchers at the NIH copied the section of the virus genetic code that contains the instructions for cells to create the spike protein. Moderna encased that messenger RNA into a vaccine.

The idea: The body will become a mini-factory, producing some harmless spike protein. When the immune system spots the foreign protein, it will make antibodies to attack and be primed to react quickly if the person later encounters the real virus. Thats a much faster way of producing a vaccine than the traditional approach of growing virus in the lab and preparing shots from either killed or weakened versions of it.

But because vaccines are given to millions of healthy people, it takes time to test them in large enough numbers to spot an uncommon side effect, cautioned Dr. Nelson Michael of the Walter Reed Army Institute of Research, which is developing a different vaccine candidate.

The science can go very quickly but, first, do no harm, right? he told reporters last week.

The Seattle research institute is part of a government network of centers that test all kinds of vaccines, and was chosen for the coronavirus vaccine study before COVID-19 began spreading widely in Washington state.

Kaiser Permanente screened dozens of people, looking for those who have no chronic health problems and arent currently sick. Researchers arent checking whether would-be volunteers already had a mild case of COVID-19 before deciding if theyre eligible. If some did, scientists will be able to tell by the number of antibodies in their pre-vaccination blood test and account for that, Jackson said. Participants will be paid $100 for each clinic visit in the study.

___

Neergaard reported from Washington, D.C.

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COVID-19 Vaccine Test Begins With U.S. Volunteer | Time

Army command continues work on COVID-19 vaccine, treatment | Hospital near Fort Detrick to setup drive-through testing site – WUSA9.com

March 17, 2020

FREDERICK, Md. The Army Command working on a COVID-19 vaccine and treatment briefed the community Monday in a virtual town hall on Facebook. Officials from the U.S. Army Medical Research and Development Command, or USAMRDC, the Barquist Army Health Clinic on Fort Detrick, Frederick Health Hospital near the base and other groups answered questions and gave updates about concerns surrounding COVID-19.

Leaders of USAMRDC reported a task force with multiple laboratories within the command is meeting daily. They are looking at preventing, detecting and treating COVID-19.

According to USAMRDC, theyre doing everything ranging from validating testing kits, doing some early vaccine work and looking at therapeutics for COVID-19.

The work is done in partnership with other government agencies, as part of the larger response to COVID-19.

Frederick Health Hospital is looking to set up a drive-through testing site. They are hoping to have that running sometimes in by the middle or end of this week and plan to follow the Centers for Disease Control guidelines for who should be tested.

With allergy season approaching, we want to make sure you're aware of the differences in symptoms between them, Coronavirus and the Flu.

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On Fort Detrick, currently, there are no plans to start testing people at the visitors center. Right now, officials reported no confirmed cases of COVID-19 within the Fort Detrick community.

RELATED: 'We're getting very good at this' | Military researchers talk COVID-19 vaccine work at Pentagon

Leaders attempted a calming tone for this virtual town hall. They asked those listening to be patient, remind them things will change on a daily basis, so the advice is likely to change. They promised to update the community as this happens.

RELATED: VERIFY: No confirmed sources for viral coronavirus quarantine voicemail

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Army command continues work on COVID-19 vaccine, treatment | Hospital near Fort Detrick to setup drive-through testing site - WUSA9.com

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