TheWest Virginia Department of Health and Human Resources (DHHR) reports as of 10:00 a.m., on July 18,2020, there have been 225,385 total confirmatory laboratory results receivedfor COVID-19, with 4,894 total cases and 100 deaths.
In alignment with updated definitions fromthe Centers for Disease Control and Prevention, the dashboard includes probablecases which are individuals that have symptoms and either serologic (antibody)or epidemiologic (e.g., a link to a confirmed case) evidence of disease, but noconfirmatory test.
CASESPER COUNTY (Case confirmed by lab test/Probable case):Barbour (25/0), Berkeley (545/19), Boone(57/0), Braxton (7/0), Brooke (37/1), Cabell (226/7), Calhoun (4/0), Clay(15/0), Fayette (101/0), Gilmer (13/0), Grant (21/1), Greenbrier (76/0),Hampshire (46/0), Hancock (51/3), Hardy (48/1), Harrison (135/1), Jackson(149/0), Jefferson (263/5), Kanawha (486/12), Lewis (24/1), Lincoln (20/0),Logan (43/0), Marion (130/3), Marshall (80/1), Mason (27/0), McDowell (12/0),Mercer (68/0), Mineral (70/2), Mingo (49/2), Monongalia (686/15), Monroe(14/1), Morgan (20/1), Nicholas (19/1), Ohio (173/0), Pendleton (19/1), Pleasants(4/1), Pocahontas (37/1), Preston (89/25), Putnam (105/1), Raleigh (92/3),Randolph (196/2), Ritchie (3/0), Roane (12/0), Summers (2/0), Taylor (28/1),Tucker (7/0), Tyler (10/0), Upshur (31/2), Wayne (145/2), Webster (2/0), Wetzel(40/0), Wirt (6/0), Wood (193/10), Wyoming (7/0).
As case surveillance continues at thelocal health department level, it may reveal that those tested in a certaincounty may not be a resident of that county, or even the state as an individualin question may have crossed the state border to be tested.
Pleasenote that delays may be experienced with the reporting of information from thelocal health department to DHHR.
Please visit thedashboard at www.coronavirus.wv.gov for more detailed information.
More than 70,000 cases and over 2,000 deaths were reported among this population as of 6 July, according to the UN agency.
There have been at least six cases among the Nahua people, who live in the Peruvian Amazon, latest information has revealed.
WHO chief Tedros Adhanom Ghebreyesus explained that because indigenous people are among the worlds poorest and most vulnerable groups, they are especially at risk of contracting the disease.
Like other vulnerable groups, indigenous peoples face many challenges. This includes a lack of political representation, economic marginalization and lack of access to health, education and social services, he said, speaking from Geneva during the regular crisis update.
Indigenous peoples often have a high burden of poverty, unemployment, malnutrition and both communicable and non-communicable diseases, making them more vulnerable to COVID-19 and its severe outcomes.
WHOs Regional Office for the Americas recently published recommendations for preventing and responding to COVID-19 among indigenous peoples.
The agency also is working with the Coordinator of Indigenous Organizations of the Amazon River Basin, to step up the fight against the disease.
WHO also used the briefing to underline the importance of contact tracing to suppress COVID-19 transmission among indigenous communities and the population at large.
The process is essential as more countries begin to re-open after lifting lockdown measures.
One of the lessons from the recent Ebola outbreak in the eastern Democratic Republic of the Congo, which was declared over the last month, is that contact tracing can be done even in the most difficult circumstances, with security problems, Tedros told journalists.
Dr Ibrahima Soc Fall, WHO Assistant Director-General for Emergency Response, said contact tracing helps break further transmission of COVID-19, thus reducing its caseload and impact.
What we need to understand is that contact tracing is not an isolated practice. It is part of the best practices for epidemiology, he said, speaking in French.
WHO has welcomed promising news about a potential vaccine against COVID-19, as research into treatments in multiple countries, continues.
An experimental vaccine developed by Oxford University and the pharmaceutical company AstraZeneca, appears safe and triggers an immune response, according to a study published in the medical journal The Lancet.
It is good news, said Dr. Michael Ryan, Executive Director of WHOs Health Emergencies Programme, though he cautioned that the data is very new.
Dr. Ryan said the vaccine was given to 1,000 healthy adults aged 18 to 55 years. None appeared to suffer any serious adverse effects, other than chills, muscle aches and headaches, which were expected.
But again, there is a long way to go, he said. These are phase one studies. We now need to move into large-scale, real-world trials, but it is good to see more data and more products moving into this very important phase of vaccine discovery.
Dr. Ryan reported that 23 COVID-19 candidate vaccines are currently in clinical development.
Facebook has removed one of the largest anti-mask groups on its platform for violating its policies against spreading misinformation about COVID-19.
The About section of the public group Unmasking America! which had more than 9,600 members described it as here to spread the TRUTH about masks! It made several claims which have been widely debunked about masks obstructing oxygen flow and having a negative psychological impact. It is a psychological anchor for suppression, enslavement and cognitive obedience. When you wear a mask you are complicit in declaring all humans as dangerous, infectious and threats, the post stated.
It is one of dozens of such groups easily found in a search for unmasking on Facebook. Some of the groups are private, meaning a group admin has to approve new members before they can join. But the theme is the same: the groups oppose the public health intervention championed by medical experts. The US Centers for Disease Control and Prevention recommends people wear masks in all public areas, which should limit the spread of the virus. These Facebook groups are for people who dont want to wear masks, and there are a lot of them.
Facebooks action came after an inquiry about the group from The Verge. We have clear policies against promoting harmful misinformation about COVID 19 and have removed this group while we review the others, Facebook spokesperson Dami Oyefeso said in an email.
According to Facebooks rules, if a group shares false news repeatedly, the platform will show the groups content lower in users News Feeds and stop suggesting people join the group to reduce its growth.
The Unmasking America group page included posts of photos from members wearing masks emblazoned with the Make America Great Again slogan or other references to President Trump, usually as a way of protesting mask requirements. Other posts described experiences dealing with stores that require masks, and many posters asked how to claim an exemption from mask rules.
An image of a Face Mask Exempt Card issued by the Freedom to Breathe Agency was linked to prominently; one poster advised others to print it, laminate it and use it. The number is legit. No such government agency exists and law enforcement officials have warned that such cards which use a version of the justice departments eagle logo do not carry the force of law, The New York Times reported.
Among the private groups are the Million Unmasked March group, which has more than 7,800 members. Parents are powerful! We are a group of moms, dads, grandparents, uncles, aunts, teachers, friends, nurses and anyone who is concerned with our children wearing masks to school in fall, the groups about section reads. We believe that our children wearing masks to school is physically and psychologically damaging. Join us in saying NO MORE MASKS! And the Unmasking Fear group, which has about 400 members, is promoting an August 1st event rallying against mandatory masks.
Medical experts, however, say there are very few medical reasons to preclude most people from wearing cloth face coverings when they go out in public. About two dozen states now have some kind of public mask requirement in place. Even President Trump, who has been largely resistant to wearing a mask in public, tweeted Monday that it was patriotic to wear a face mask when you cant socially distance.
Facebook has taken several steps to attempt to stem the flood of coronavirus misinformation on its platforms, with mixed results. A scathing report in April from human rights group Avaaz found 100 pieces of misinformation regarding the virus on Facebook were shared more than 1.7 million times and viewed about 117 million times. Facebook announced April 16th that it was adding a warning label when a person liked, commented, or reacted to a post with fake coronavirus information. Also in April, the company said it was removing pseudoscience from the list of categories advertisers could use to target potential customers to prevent potential abuse in ads.
In May, the company released a report describing its use of artificial intelligence along with human fact-checkers and moderators to enforce its community standards. According to the report, in April, Facebook put warning labels on 50 million pieces of content related to COVID-19, and since March 1st, has removed more than 2.5 million pieces of content related to mask sales, hand sanitizers, and COVID-19 test kits.
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
Top vaccine makers predict a vaccine or vaccines may be available as early as the beginning of 2021and at least twopledged doses will be free or low-cost for all Americans.
Speaking before a House subcommittee Tuesday, executives from AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer said their goal is to have effective vaccines available as soon as possible while following all safety and regulatory guidelines.
None of the pharmaceutical executives would commit to having a vaccine ready for the general public before early 2021, despite repeated questioning by House members.
The United States has so far invested nearly $2.3 billion in the effort to find a vaccine to stop SARS-CoV-2, the virus that causes COVID-19, which has killed morethan 140,000 Americans.
Safety emerged as a key concern among lawmakers, with several pressing executives on whether the unprecedented speed of vaccine development or potentially laxgovernment regulations would put the public at risk. All the panelists said safety would not be compromised.
The Food and Drug Administration released extensive guidance covering what would be necessary for a vaccine to be approved on June 30. One of the requirements was that any vaccine be at least 50% effective at preventing COVID-19 infections.
None of AstraZenecas interactions with regulators have indicated there has been any lowering standards, said Executive Vice President MenelasPangalos.
Dr. Julie Gerberding, executive vice president and chief patient officer for Merck, said the company wasrelieved the FDA insisted on applying the same safety restrictions it applies to all vaccines.
Dr. Macaya Douoguih head of clinical development and medical affairs for Johnson and Johnson,offered hypothetically that ifthe FDA guidance were to be changed to require only 10% effectiveness, Johnson & Johnsonwould not release its vaccine.
We would not feel comfortable bringing forth a product that was not efficacious according to our protocol, she said.
Pricing was another questionraised by several House members.
AstraZeneca'sPangalos said the company would be selling to the government at cost, as didJohnson & Johnson'sDouoguih.
The other three companies said they would not.
"We will not sell it at cost, no ma'am," saidModernapresident Dr. Stephen Hoge.
Merck'sGerberding said:"No, we will not be selling vaccine at cost."
Pfizer's chief business officer John Young would not commit to providing vaccine at cost, but said,"We recognize that these are extraordinary times and our pricing will reflect that during the pandemic."
Company leaders also provided updates on their ongoing vaccine efforts:
AstraZeneca will make two billion doses of its vaccine on a non-profit basis, Pangalos told lawmakers.The company, which is creating a vaccine in conjunction with the United Kingdom'sUniversity of Oxford, said Monday it hopes to have a vaccine available by early next year.
The company'svaccine candidate is now in Phase 2clinical trials based on data from pre-clinical studies and being tested onover 1,000 volunteers.
"We are rapidly progressing these clinical programs with the hope that results from our late-stage trials, which are currently planned to involve close to 50,000 volunteers collectively, will be available this fall,"Pangalos said.
The British-Swedish company has entered into agreements with the U.S. and several other countries and organizations to supply vaccine.
The United Statespaid $1.2 billion for access to 300 million doses of the candidate vaccine through Operation Warp Speed, a White House task force focused on bringing therapies and vaccines for coronavirus to market as soon as safely possible.
A paper published Monday gavehope to the overall success of possible vaccines. The results showed theOxford candidate vaccine, AZD-1222, led to strong immune responses for nearly two months in a trial that continues to track more than 1,000 healthy adults.
Pangalos saidhis company plans to supplyapproximately two billion doses globally to provide "broad and equitable access." The company is building parallel supply chains around the world to produce those doses, he said.
More: UKs Oxford University coronavirus vaccine candidate is safe and effective with few side effects, early trial results show
More: A COVID-19 vaccine at what price? Should all Americans be able to get a shot for free?
Johnson & Johnson will charge one price globally for its vaccine, regardless of country or income tier, saidDouoguih.
It plans to manufacture at least 400,000 doses of its candidate vaccine in the United States, she said.
The company is committed to making an affordable COVID-19 vaccine available on a "not-for-profit basis for emergency pandemic use," she said. It will pursue external validation for calculating the price point and will make an external audit or certification available.
The company has received approximately $500million from Operation Warp Speed for its work.
Johnson & Johnson plans to being testing its vaccine candidate in humans late this month in the United States and Belgium. If preliminary results are positive, it will launcha global Phase 3 clinical trial in September.
Phase 3 trials are the final and largest testing stage for vaccinesonce they have become established, don'tcause immediate adverse effects and provoke an immune response. COVID-19 Phase 3 trials will involve 30,000 patients for each vaccine candidate and take many months.
U.S. pharmaceutical company Merck is pursuing two possible vaccine candidates. It is focused on its long track record developing vaccines and the need for safety, and wasopen-minded about the possibility that a breakthrough is not a given.
"If approaches developed by others ultimately are proven superior to those being pursued by Merck, we will work to support those efforts for the benefit of global health during the pandemic," saidGerberding.
Merck holds the record for creating the fastest vaccine ever brought to market, a mumps vaccine in 1967 that took four years from start to finish. But the company has repeatedly emphasized safety over speed in its COVID-19 work.
Speed is important, but we will not compromise scientific efficacy, quality, and above all, safety, despite the sense of urgency we all feel, said Gerberding intestimony provided to the committee.
The company'sCEO, Kenneth Fraizer, said on June 30a vaccine can't be rushed and rigorous science is necessary.
"When people tell the public that there's going to be a vaccine by the end of 2020, for example, I think they do a grave disservice to the public," he said during an interview with the Harvard Business School.
Merck has received $38 million for vaccine research from the U.S. Biomedical Advanced Research and Development Authority, BARDA.
Moderna has made agreements with a Swiss-based vaccine manufacturer with sites in the United States and around the world, which will allow it to reach an annual manufacturing capacity of more than 500 million doses, said company president Dr. Stephen Hoge.
Its candidate vaccine research has been partially facilitated by $536 million from Operation Warp Speed.
Moderna, headquartered in Massachusetts, hopes to beginPhase 3 clinical trials of its vaccine candidate this month,Hogesaid.
Phase 1 resultswere presented last week. The vaccineappears to be safe and to trigger an immune response. Whether the immune response is enough to protect someone from thecoronavirusthat causes COVID-19 remains unclear, according to several experts who reviewed the results.
The company has already enrolled 600 volunteers in its Phase 2 studies, Hoge said.
Alone among the five companies testifingTuesday, Pfizer has not taken any money from the U.S. government as it works on four different vaccine candidates for COVID-19.
"We are uniquely positioned with the scientific expertise and experience, manufacturing scale and financial resources to have the potential to deliver a potential vaccine without funding from the federal government," John Young, Pfizer's chief business officer, said in a prepared statement.
He anticipated the company will invest about $1 billion in its vaccine development efforts during 2020.
Pfizer is partnering with a German biotech companyBioNTech to work on a COVID-19 vaccine. It is currently running early state clinical trials in the U.S. and the European Union.
Last week it announced two of its four vaccine candidates had received fast-track designation from the FDA. It hopes to begin Phase 2 testing later this month.
The company believes it could be submitting an application in to the FDA as early as October, Young said.
If theclinical trials progress well, the companyhopes to manufacture up to 100 million doses by the end of 2020, and potentially more than 1.3 billion doses in 2021 globally, Youngsaid.
"I have great confidence that our industry can prevail in the ultimate outcome of our battle against COVID-19 and that science will win," he said.
Contributing: Karen Weintraub
(Photo: Getty Images)
Read or Share this story: https://www.usatoday.com/story/news/health/2020/07/21/top-covid-vaccine-makers-safe-cheap-doses-may-ready-early-2021/5478232002/
A safe and effective vaccine could end the coronavirus pandemic, but for it to succeed, enough people will have to get inoculated.
Recent polls suggest that the U.S. is far from ready. Most surveys have found that only about two-thirds of adults say they would get the vaccine. While that might protect most people who get vaccinated, it may be insufficient to reach herd immunity and stop the viruss spread.
As a law professor who has written about the legal questions around vaccination laws, employment discrimination and religious exemptions, I see four possible approaches that governments and employers can take to ensure enough Americans are immunized against COVID-19.
Which ones are legal might surprise you.
The most intrusive policy would involve government mandating vaccination for all Americans, with the exception of those with a medical exemption.
People are often surprised to learn that states would likely have the legal right to enforce such a rule.
In the 1905 landmark case Jacobson v. Massachusetts, the United States Supreme Court upheld the constitutionality of a state criminal law that required all adult inhabitants of Cambridge to get a smallpox vaccine or be fined. The Supreme Court explained that an individuals liberty rights under the U.S. Constitution are not absolute and the mandatory vaccination law was necessary to promote public health and safety.
While Jacobson v. Massachusetts is over 100 years old, courts continue to rely on the reasoning of the case. State governments still occasionally enact broad compulsory vaccination policies. In 2019, in the midst of a measles outbreak, New York City mandated that anyone over six months of age who lived, went to school or worked in several ZIP codes within the city had to be vaccinated against measles or be subject to a fine.
[Expertise in your inbox. Sign up for The Conversations newsletter and get expert takes on todays news, every day.]
Requiring people to be vaccinated against the SARS-CoV-2 coronavirus could similarly be justified by governments need to promote public health and safety. In late May, the New York State Bar Associations Health Law Section even recommended mandatory COVID-19 vaccination for all Americans.
Yet in the United States today, where even mask mandates are controversial, it is unlikely that many states will enact a compulsory vaccination policy for everyone. Additionally, there is a risk that heavy-handed public health tactics can backfire and escalate tensions, increase mistrust of government and unintentionally increase the influence of the anti-vaccination movement.
A less intrusive tactic would be for state governments to require COVID-19 vaccinations for only certain segments of the population.
All 50 states currently have some type of compulsory vaccination laws covering K-12 schoolchildren, and many states have compulsory vaccination laws covering college students. These laws typically allow for some type of medical exemption. States may also have mandatory vaccination laws covering employees in nursing homes and health care facilities.
If states required this type of targeted mandatory COVID-19 vaccination, they could cover those most at risk and those most likely to be in contact with others in ways that could stem the viruss spread.
Another approach would be legislation that requires proof of vaccination to obtain a passport, use public transportation or go to a gym.
One of the most controversial issues surrounding compulsory vaccination laws is the religious or philosophical exemption, which some states have eliminated in recent years. In the aftermath of the recent measles outbreaks, both New York and California eliminated these exemptions from vaccination laws covering schoolchildren. Courts have explained that while compulsory vaccination laws may burden religious practices, religious exemptions are not constitutionally required under the First Amendments free exercise clause since mandatory vaccination does not single out religion and is not motivated by a desire to interfere with religion.
Private employers have significant flexibility for requiring vaccination. Yet few businesses outside of health care facilities have done so, partly out of fear that employees would consider these policies to be unacceptable invasions of their personal lives.
There is a risk in a unionized workplace that a mandatory vaccination policy could be struck down if it violates a collective bargaining agreement. However, unlike government-mandated policies, these would not be subject to constitutional restrictions.
Employers may also be concerned that if policies do not include significant religious exemptions, workers could sue, claiming religious discrimination. However, it is unlikely that federal law would require employers to accommodate employees requesting a religious exemption to a COVID-19 vaccine. Under Title VII of the 1964 Civil Rights Act, the federal law prohibiting religious discrimination in the workplace, employers are not required to accommodate religious employees if doing so involves more than a de minimis, or minimal cost.
Certainly, in the midst of one of the worst public health and financial crises in recent history, there is a significant cost to having an unimmunized workforce.
Beyond mandates and laws, employers, politicians and government agencies have other ways to encourage people to get vaccinated. In particular, the messages they send matter. That was evident in the public controversy over mask-wearing after President Donald Trump and other prominent Republicans ridiculed the precaution.
In New York, Gov. Andrew Cuomo mandated wearing face masks in public, but he also successfully convinced New Yorkers to wear them by emphasizing that doing so showed respect for others, particularly essential workers, health care providers and high-risk individuals.
Government can similarly encourage Americans to get vaccinated through education campaigns led by trusted community members, such as religious leaders or celebrities. During the New York measles outbreak, the Orthodox Jewish Nurses Association was at the forefront of educating the Orthodox Jewish community on the safety and efficacy of vaccination.
Government and employers also could make vaccines free and available at convenient locations.
As the U.S. government fast-tracks the development of potential vaccines, its important to remember that a COVID-19 vaccine will stop the virus only if enough people get vaccinated. Now is the time for governments and employers to develop policies to ensure it succeeds.
A "New York Times:articlehighlights that 22 states are experiencing rapid increases in COVID-19 cases while reopening their economies. Although Texas, Florida, and Arizona have beenparticularly affected, the Center for Infectious Disease Research and Policy at the University of Minnesota finds most of the country is in asimilar situation.
Escalating new cases have prompted many to prepare for future outbreaks. Restaurants across Phoenix, Ariz., arereclosingto prevent COVID-19 exposure. The Arizona Department of Health Services recently directed hospitalsto activate emergency plans, expandinghospital-bedcapacity for COVID-19 patients.
Others believe more drastic actions are required. Columbia University virologist Dr. Angela Rasmussenrecentlysaidthat "at least 4 states are going to need to reinstitute stay-home orders this weeklike NOWto stop upward case trajectories."
New York may soon become one of those states. New York Gov. Andrew CuomoAndrew CuomoVisitors from 31 states now required to quarantine when visiting New York, New Jersey, Connecticut Watch live: NY Gov. Andrew Cuomo holds press briefing Ice cream store manager in NY says he was fired for not serving customer coughing without mask MORE recently threatened to reinstate a lockdown for Manhattan and the Hamptons if citizens continued to (allegedly)violatesocial-distancing rules. In his ownwords, "Im not going to allow situations to existthat we know have a high likelihood of causing an increase in the virus.
Unfortunately, the only ways to end the pandemic are herd immunity, prolonged lockdowns, or the development of avaccine. Each option comes with its own downsides.
Herd immunity would likely require70 to 90 percentof the population to contract COVID-19,endangeringthe lives ofmillions withpreexisting conditions. Reinstituting widespread lockdowns would likely extenddepression-likeeconomic hardship and themental tollof prolonged isolation.
Developing avaccine, although much less invasive than the other options, will requirepioneering medical breakthroughs at record speed.
Hoping to beat the odds, President TrumpDonald John TrumpMore than a dozen people wounded in shooting near Chicago funeral home Cleveland Indians players meet with team leadership to discuss potential name change Pelosi calls coronavirus the 'Trump virus' MORE launchedOperation Warp Speedlast May. The operation creates apartnershipbetween private drug developers and several federal agencies to develop and distribute avaccineby January.
Having considered14 different drugdevelopers, Operation Warp Speed recentlyselected five finalistsfor its partnership. Sparing no expense, it has distributed over$2 billionin R&D funds to these producers.
But why only five?
Even the most promising potentialvaccinesarejust beginningthe large-sample human-testingvaccineapproval process, the most time-consuming and difficult component. With over100vaccinesunder development, there are a variety of options to diversify the risk for finalists that do not receive approval.
Evidence indicates that including more drug developers would provide us with the highest chance to get avaccine. A model created byAccelerated Health Technologiespredicts that a candidate pool of15-20vaccineswould have an 80-to-90 percent chance for one to succeed.
Perhaps more important, providing a few producers with extensive financial support is no substitute for the collaboration among a diverse set of researchers that is often required to make a medicinal breakthrough. In his book "TheOrganization of Inquiry,"economist Gordon Tullock stressed that the scientific field closely resembles thedivision of labor, where a large network of scientists collaborates directly or indirectly by working on narrow aspects of a larger puzzle.
Similar collaboration has brought us pathbreakingvaccinedevelopment before.
From 2014 to 2016 the Ebola virus rapidly spread through western Africa, where it caused over11,000 deaths. Similar to COVID-19, Ebola was difficult to contain and exceptionallydifficultto develop avaccinefor.
Despite the odds, scientists, public-health experts, and drug producers indirectly collaborated across the globe to create a "miracle"vaccinewithin a year. As one "STAT"articlenotes:
While thevaccinehas come to be known as Mercks Ebolavaccine, in reality, scores of researchers and Ebola outbreak response workers in Canada, the U.S., Europe, and Africa played a role in paving Ervebos path to licensure, whether that was in designing it, conducting pivotal pre-clinical studies in animals, or the clinical trials Merck used to support its application.
Our best hope to develop a COVID-19vaccinequickly is to allow drug developers to employ a diverse set of approaches and let the scientific method dictate solutions. Unfortunately, I fear Operation Warp Speed undermines this approach with government-selected winners and losers, which decreases the chances of success. Heres hoping Im wrong.
Raymond J.Marchis a research fellow and director of FDAReview.org at theIndependent Instituteand an assistant professor of agribusiness and applied economics and faculty fellow in the Center for the Study of Public Choice and Private Enterprise at North Dakota State University.
The race to develop an effective COVID-19 vaccine is speeding ahead as new, promising data comes from human trials.But when a vaccine is finally given the green light, how will it work and how long will it last?WLWT talked with a local infectious diseases doctor about what he foresees.University of Cincinnati Health is set to take part in a third-phase Moderna vaccine trial soon.Doctors predict there will be a need for several vaccines to be produced globally."I think that will be very hard for one vaccine company to cover the entire world," Dr. Carl Fichtenbaum said.Fichtenbaum is leading studies at UC Health to fight COVID-19, including the upcoming Moderna vaccine trial.Participants will get two injections of the vaccine or a placebo, officials said."We won't know how long the vaccine is effective, so we'll have to figure out whether or not people need boosters, does it need to be annual or not," Fichtenbaum said.The spotlight is now on new data showing candidate vaccines from BioNTech SE and Pfizer, and Astra-Zeneca appearing to be safe, having minor to moderate side effects and stimulating t-cell and antibody responses.Scientists said the Astra-Zeneca, Oxford University candidate produced a response lasting at least two months.Moderna reported promising early results last week.Fichtenbaum believes several vaccines by different companies will be needed around the world to make them widely available."In doctor's offices, pharmacies, hospitals and, you know, there might even be school campaigns," Fichtenbaum said.He said it's not clear if multiple doses will be required or if vaccines will need to be retooled yearly like the flu vaccine, but he hopes people will follow science and get a shot when the time comes."As a society, we have to take that on because if too few of us do it, there will continue to be outbreaks," Fichtenbaum said.He said the 500-patient Moderna vaccine trial at UC Health is not open yet, but start-up calls are underway and the first national sites for the study are set to open later this month.Doctors said there are more than two-dozen vaccines being developed across the country.If you're interested in the Phase 3 clinical trial at UC Health, there are qualifications to be eligible.Officials said those eligible include adults 18 years or older with no known history of COVID-19, but are at risk of being infected.Read more from UC Health about the eligibiltiy requirements and the study here.For more information, call 513-245-3417 or email UCCovidResearch@UCHealth.com.
The race to develop an effective COVID-19 vaccine is speeding ahead as new, promising data comes from human trials.
But when a vaccine is finally given the green light, how will it work and how long will it last?
WLWT talked with a local infectious diseases doctor about what he foresees.
University of Cincinnati Health is set to take part in a third-phase Moderna vaccine trial soon.
Doctors predict there will be a need for several vaccines to be produced globally.
"I think that will be very hard for one vaccine company to cover the entire world," Dr. Carl Fichtenbaum said.
Fichtenbaum is leading studies at UC Health to fight COVID-19, including the upcoming Moderna vaccine trial.
Participants will get two injections of the vaccine or a placebo, officials said.
"We won't know how long the vaccine is effective, so we'll have to figure out whether or not people need boosters, does it need to be annual or not," Fichtenbaum said.
The spotlight is now on new data showing candidate vaccines from BioNTech SE and Pfizer, and Astra-Zeneca appearing to be safe, having minor to moderate side effects and stimulating t-cell and antibody responses.
Scientists said the Astra-Zeneca, Oxford University candidate produced a response lasting at least two months.
Moderna reported promising early results last week.
Fichtenbaum believes several vaccines by different companies will be needed around the world to make them widely available.
"In doctor's offices, pharmacies, hospitals and, you know, there might even be school campaigns," Fichtenbaum said.
He said it's not clear if multiple doses will be required or if vaccines will need to be retooled yearly like the flu vaccine, but he hopes people will follow science and get a shot when the time comes.
"As a society, we have to take that on because if too few of us do it, there will continue to be outbreaks," Fichtenbaum said.
He said the 500-patient Moderna vaccine trial at UC Health is not open yet, but start-up calls are underway and the first national sites for the study are set to open later this month.
Doctors said there are more than two-dozen vaccines being developed across the country.
If you're interested in the Phase 3 clinical trial at UC Health, there are qualifications to be eligible.
Officials said those eligible include adults 18 years or older with no known history of COVID-19, but are at risk of being infected.
Read more from UC Health about the eligibiltiy requirements and the study here.
For more information, call 513-245-3417 or email UCCovidResearch@UCHealth.com.
Russia could be only a few weeks away from starting mass production of a vaccine for Covid-19, but the unorthodox approach adopted to speed up the process is likely to reduce the chances of the Russian vaccine gaining worldwide adoption.
The first domestic vaccine against the novel coronavirus infection is ready, stated Russian Deputy Minister of Defense Ruslan Tsalikov in an interview with Russian newspaper Argumenty i Fakty on Tuesday.
The statement came one day after a last group of volunteers was discharged from hospitals showing positive results in Phase I trials of the vaccine. All of them, according to Russian authorities, had developed immunity to Covid-19.
Russias research into the vaccine has been led by the state-run Gamaleya National Research Centre for Epidemiology and Microbiology and the Main Military Clinical Burdenko Hospital, Tsalikov said.
The research was supported by the Ministry of Defense, which has significant experience with vaccine development, having previously made major contributions to an ebola vaccine, Tsalikov said.
The research was funded by Russias sovereign wealth fund, the Russian Direct Investment Fund.Fund head Kirill Dmitriev told the media on July 16 that the vaccine would be ready to enter mass production by the end of August.
According to Dmitriev, Russia could produce 30 million doses for domestic usage in 2020 and 170 million for abroad, with several countries already expressing interest in producing it.
The Russian Health Ministry, however, has been more cautious in assessing the progress, pointing out that the vaccine needed to complete two more trial phases.
An intense international race is underway to find a vaccine for the novel coronavirus, which so far has killed more than 600,000 people around the world. More than 150 vaccines are now being developed, with Chinas Sinopharm and the UKs Oxford University and AstroZeneca among the leaders in the research.
With Russia having 782,040 Covid-19 cases and 12,561 deaths, Moscow has now emerged as a front runner as it charges through clinical trials.
The phase one tests which involved military personnel were completed last week and included tests of both powder and liquid vaccines. The second phase trials are due to be completed within the next two weeks.
The last phase of the trials, due to start on August 3, will be conducted on thousands of people in not only Russia, but also in Saudi Arabia and the United Arab Emirates.
But according to Anton Gopka, head at the health-care investment firm ATEM Capital, such speedy advancement in vaccine development has only been possible by sacrificing the quality of the testing.
There wont be enough data to prove that the vaccine is completely safe. Normally you need over a year to guarantee that level of safety, he told Asia Times.
Separately, senior South Korean officials told reporters last week, citing safety concerns, that they do not anticipate the rollout of a vaccine to be feasible this year.
Another question hanging over the Russian effort is why the country took unorthodox steps in testing. Not only has it used military personnel instead of regular volunteers, scientists have also been self-testing.
As revealed by Alexander Gintsburg, the head of the Gamaleya Institute, in an interview on state channel Rossiya 1, scientists have been testing the experimental vaccine on themselves since May, before any authorization was given by the Ministry of Health. Gintsburg admitted publicly that he tested the vaccine on himself and his family.
Scientists self-testing triggered widespread condemnation, even from the domestic clinical research association, which defined it as a crude violation of the foundations of clinical research conduct, Russian legislation and international norms.
Even more criticism arose after anonymous sources cited by Bloomberg in an investigative report claimed that members of the Russian elite have been getting shots of the experimental vaccine since April.
Among those who took the vaccine were government officials and top managers at aluminum giant United Co Rusal.
The Bloomberg story raised many questions within Russia.
Asked whether President Vladimir Putin had been among those who took the vaccine, his spokesperson Dmitry Peskov replied that it probably wouldnt be a good idea to use an uncertified vaccine on the head of state.
Commenting on the Bloomberg allegations, Gintsburg said he was not aware that members of the elite had access to the vaccine. Meanwhile, the Ministry of Health denied that the vaccine was tested on anyone apart from volunteers officially enlisted for trials.
And Moscows efforts to win the upper hand in the race for the vaccine may have gone even further than Gintsburgs statements and the Bloomberg story suggest.
According to American, British and Canadian authorities, the Kremlin has been deploying hackers to steal information on vaccines from Western research centers.
Western cybersecurity agencies claim the Russian hacker group known as Cozy Bears was behind the attack. The group, which is considered to have ties to Russian secret services, was involved in hacking the Democratic Partys database during the 2016 US Elections.
The allegations, made at the highest levels, have generated a major diplomatic row. It is completely unacceptable that the Russian Intelligence Services are targeting those working to combat the coronavirus pandemic, said UK Foreign Secretary Dominic Raab.
Russian officials denied any involvement in the hacks.
Meanwhile, some observers are considering the rationale behind Moscows headlong rush in vaccine development.
As pointed out by Gopka, even if Russia is the first to release its vaccine, that would not necessarily bring many benefits to the country if its research protocols are suspect.
At the end of the day, the winner of the race will be the vaccine which will be accepted worldwide, said Gopka.
According to the venture capitalist, given the highly unorthodox methodologies adopted for testing, it is highly unlikely the Russian vaccine will be sold worldwide. These methods cast a shadow on the overall process and on the quality of the research, Gopka said.
Still, at a time when Russia is facing Western economic sanctions and suspicions on multiple fronts, Moscow may not simply want the kudos of winning the vaccine race.
A further motive could be that the Kremlin does not want to end upbeing dependent on an upcoming Western vaccine hence the urgent need for a Plan B.
Russia needs a domestic vaccine as a way to negotiate prices down, suggested Gopka. If the prices of a Western-developed vaccine are too high, they will use a domestic one.
Asia Times Financialis now live. Linking accurate news, insightful analysis and local knowledge with the ATF China Bond 50 Index, the world'sfirst benchmark cross sector Chinese Bond Indices.Read ATFnow.
Another COVID-19 vaccine candidate recently entered the races. The difference this one is a live attenuated (weakened) virus expressing the coronaviruss signature spike protein on its surface. And its delivered nasally, not a shot.
COVID-19 vaccine development will be more of a marathon than a sprint, Martin Moore, Ph.D., co-founder and CEO of Meissa Vaccines, told BioSpace. A live attenuated vaccine may not be first-in-class, but their historically high efficacy could make it the best-in-class.
ad
Moore spoke with BioSpace about live attenuated vaccines, interim data from their RSV vaccine candidate, and how they are building on their RSV vaccine platform to create a COVID-19 vaccine.
Live attenuated vaccines (LAVs)
Think about it what is the best way to generate an effective vaccine against a virus? Mimic natural infection as close as possible by giving someone a form of the virus that cant make them sick.
This is just what live attenuated vaccines (LAVs) do. LAVs contain a weakened form of a virus that is given to someone the same way that natural infection occurs, such as via a nasal spray (intranasally) for the flu LAV. This provokes all aspects of the immune system: innate local (mucosal), cell-based, and systemic antibody (humoral) responses.
Once inside the body, the weakened virus can replicate at a low level for a few days, but it is easily cleared by the immune system. After just one or two doses, the weakened virus produces strong, long-lasting immune responses that are almost as good as the full-strength virus that causes sickness.
By mimicking infection, LAVs generally provide more robust immune responses compared to injected non-living vaccines that typically only induce the antibody-based immune response. Thats why you usually have to get booster shots of injected vaccines.
This concept is hardly new. In fact, LAVs are already available against multiple viruses, including measles, mumps, rubella (as the combined MMR vaccine); rotavirus; and chickenpox.
The oral polio vaccine is a great example of a live attenuated vaccine, Moore said. Its low cost, able to be given widespread, and easy to administer with no needles or adjuvants needed. From a manufacturing standpoint, its also inexpensive and pretty easy to produce.
Advantages and limitations of live attenuated vaccines (LAVs)
Advantages
Limitations
1-2 doses
Cant be given to immunocompromised people
Lower cost
Need to be refrigerated
Administered through the same route as natural infection (intranasal, oral, etc.)
Genetic stability of virus is important for safety
No needles or adjuvants needed
Strict safety levels to adhere to during development
Induces both cellular and humoral (antibody) immune responses
Need to balance attenuation with potency/immunogenicity
As you can imagine, there is an inherent risk in using the actual (albeit weakened) virus for a vaccine. Viruses constantly mutate, so the weakened virus used in the vaccine has a chance of regaining its ability to be infectious and cause disease.
Creating a LAV is a balancing act the virus must be weakened enough to significantly reduce the risk of it mutating to become infectious, but still close enough to the full-strength virus to create a similar immune response.
The trick is balancing attenuation with immunogenicity, Moore commented.
Moore explained that if a virus is attenuated based on one or two gene mutations, the virus could revert to being infectious in the vaccine recipient and they can shed live virus, spreading it to others. This is the worst-case scenario and why there are such strict safety standards for vaccines, especially LAVs.
Safety is critical, there are no cutting corners with safety, explained Moore. Coronaviruses, in particular, are prone to genetic recombination, so using a live attenuated coronavirus in a vaccine would run the risk of becoming infectious again. Weve mitigated this risk by using RSV, which is more genetically stable, as a backbone.
Building from the foundation of another respiratory vaccine
The backbone of Meissas COVID-19 vaccine comes from another vaccine in their pipeline their respiratory syncytial virus (RSV) vaccine candidate. RSV, a common respiratory virus, usually causes mild cold symptoms; however, infants and the elderly may be hit particularly hard. RSV is infamous for being the culprit behind serious illness and pneumonia in infants less than 1 year old.
To create their intranasal RSV vaccine candidate (called MV-012-968), Meissa genetically engineered RSV to be weakened and safe, yet still potent, by using codon deoptimization.
Codon deopti-what?
Quick genetics review: a codon is a group of three bases in DNA or RNA that encodes a certain amino acid (the building block of proteins). Codons are the genetic code that translates genes into proteins. (Think of bases as the letters of the alphabet, codons as the words, and each gene as a sentence.) There are 64 different codons, but only 20 amino acids that they code for. Almost all amino acids are encoded by multiple codons; some codons for a particular amino acid are used more commonly than the others.
Codon deoptimization is changing the more common codons into the less common codons for the same amino acid throughout a gene. This introduces many silent mutations, changes in the genetic code that do not alter the resulting proteins being made.
This approach to viral genes has been called death by thousands of cuts, Moore explained. By using rare codons, codon deoptimization can change the expression efficiency of proteins.
The rare codons do not have as many amino acid transporters, called transfer RNA (tRNA), so they can slow down the translation process of turning genes into proteins. The slower the gene is translated, the fewer corresponding proteins is made (the lower the protein expression).
Using codon deoptimization, weve downregulated three RSV genes involved in the viruss ability to inhibit the human immune response to create our attenuated RSV, said Moore. This gives us optimized manufacturability, attenuation, and immunogenicity.
By taking away the viruss ability to inhibit immune pathways, Meissa is engineering attenuated vaccine strains that produce a solid immune response. This is key for viruses that dont provide strong immunity to begin with, like RSV or coronavirus.
Their RSV vaccine candidate, which received Fast Track Designation from the FDA in January, is currently in Phase I trials in healthy adults and young children. Previously, it was shown to produce a robust immune response in rats despite being highly weakened. The company recently provided an interim update announcing that initial clinical data showed the vaccine generate an immune response in healthy adults.
There are three main takeaways from the clinical data: the RSV in the vaccine was heavily weakened (as indicated by the lack of viral shedding from the nose); the vaccine prompted an RSV-specific immune reaction in the nose; and the vaccine was reported to be safe and well-tolerated up to 56 days.
All adults in this study have pre-existing titers of serum neutralizing antibodies systemically, Moore explained. All adults have already been infected with RSV previously. Ideally, we want to give our RSV vaccine to RSV seronegative babies so it will produce nasal and humoral immune responses.
Creating the COVID-19 vaccine candidate
Based off the interim RSV vaccine data, researchers at Meissa thought Could we modify our weakened RSV to create a COVID-19 vaccine?
COVID-19 patients dont seem to have a robust neutralizing antibody response, with lower titers that decrease rapidly over short periods of time, said Moore. This is bad news for developing a live attenuated coronavirus-based vaccine if you weaken the coronavirus further, how are you going to get the immunogenicity needed for a robust immune response?
You would overcome that issue by deeply understanding the biology of the coronavirus, Moore continued. Unfortunately, coronaviruses are some of the largest RNA viruses on the planet (genetically speaking), making them extraordinarily complex. Fortunately, RSV is not nearly as complex (about half of the size of coronaviruses, genetically), making it much easier to work with.
Using an RSV backbone for the COVID-19 vaccine also makes a lot of sense given the similarities between the two viruses: they are both respiratory viruses and inhibit the innate immune response during infection.
To create their COVID-19 vaccine, Meissa removed the surface proteins of their weakened RSV and replaced them with the coronavirus spike protein. The RSV-coronavirus hybrid virus was optimized to express the spike protein. This chimeric virus has the best of both worlds the established, weakened RSV construct and high expression of the coronavirus spike protein. Because this vaccine is RSV-based, they completely avoided the slippery genetic slope of using a weakened coronavirus.
Meissa plans to submit an IND later this year and anticipates a Phase I trial of their COVID-19 LAV to begin at the end of 2020. Moore said that the company is working on scaling up manufacturing now so that the COVID-19 vaccine could be in a large pivotal study in 2021.
Other COVID-19 vaccines in development
We all know that the COVID-19 vaccine development pipeline is becoming quite the rapid race. As of July 8, 2020, there were 165 vaccines in development, according to Bio. You can follow development of the most famous vaccine candidates using the New York Times Coronavirus Vaccine Tracker tool, which is periodically updated with new information.
Out of all the other COVID-19 vaccines being developed, only a few use live attenuated viruses. There arent enough LAV candidates in the broader pipeline, which is dominated by nonreplicating vaccines, commented Moore.
In late January, Yuen Kwok-Yung, Chair of Infectious Diseases at the University of Hong Kong, said his lab modified an intranasal flu vaccine they had previously developed so that the influenza virus also expressed coronavirus surface antigens. (There hasnt seemed to be any updates about that vaccines progress.)
Another company, Codagenix, Inc., is using codon deoptimization (like Meissa) to create vaccines against respiratory diseases like RSV and influenza. Theyve also jumped into the COVID-19 vaccine race with their candidate, called CDX-CoV. They successfully created the vaccine in mid-June and it is still in preclinical studies.
Only 5-7 percent of Americans have been infected and natural immunity doesnt seem to be that robust, so we could be in for quite a slog, Moore concluded.
