News Release
Monday, August 31, 2020
A multi-site, Phase 3 clinical trial evaluating an investigational COVID-19 vaccine known as AZD1222 has begun. The trial will enroll approximately 30,000 adult volunteers at 80 sites in the United States to evaluate if the candidate vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19). The United Kingdom-based global biopharmaceutical company AstraZeneca is leading the trial as regulatory sponsor. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, are providing funding support for the trial.
Safe and effective vaccines will be essential to meet the global need for widespread protection against COVID-19, said NIAID Director Anthony S. Fauci, M.D. Positive results from preclinical research led by NIH scientists supported the rapid development of this vaccine candidate, which has also showed promise in early-stage clinical trials.
The Phase 3 trial is being implemented as part of Operation Warp Speed, a multi-agency collaboration led by HHS that aims to accelerate the development, manufacturing and distribution of medical countermeasures for COVID-19. The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership also guided the development of the trial protocol to ensure a coordinated approach across multiple vaccine efficacy trials. NIH experts have emphasized the importance of a harmonized process to generate data for multiple investigational vaccines in parallel to assess the relative effectiveness of each.
NIH is committed to supporting several Phase 3 vaccine trials to increase the odds that one or more will be effective in preventing COVID-19 and put us on the road to recovery from this devastating pandemic, said NIH Director Francis S. Collins, M.D., Ph.D. We also know that preventing this disease could require multiple vaccines and were investing in those that we believe have the greatest potential for success.
Oxford Universitys Jenner Institute and Oxford Vaccine Group developed AZD1222. The candidate vaccine was licensed to AstraZeneca for further development. The vaccine uses a non-replicating chimpanzee adenovirus to deliver a SARS-CoV-2 spike protein to induce an immune response. SARS-CoV-2 is the virus that causes COVID-19.
Scientists at NIAIDs Rocky Mountain Laboratories (RML), based in Hamilton, Montana, conducted a preclinical study of AZD1222. Their findings recently published in Nature indicate the candidate vaccine rapidly induced immune responses against SARS-CoV-2 in mice and rhesus macaques. A single dose of the vaccine protected six rhesus macaques from pneumonia caused by the virus. Based on the RML data, a Phase 1 trial of the candidate vaccine began on April 23 in healthy volunteers in the U.K. Investigators recently reported promising results in The Lancet. Currently, the vaccine candidate is being evaluated in Phase 2/3 trials in the U.K. and Brazil and in a Phase 1/2 trial in South Africa.
The NIAID COVID-19 Prevention Network (CoVPN) will participate in the Phase 3 clinical trial of AZD1222 in the U.S.The CoVPN is composed of existing NIAID-supported clinical research networks with infectious disease expertise and is designed for efficient and thorough evaluation of vaccine candidates and monoclonal antibodies for the prevention of COVID-19.
Ann R. Falsey, M.D., professor of medicine, University of Rochester School of Medicine in New York, and Magdalena E. Sobieszczyk, M.D., associate professor of medicine at Columbia University Medical Center in New York, will serve as coordinating investigators for the trial.
Volunteers 18 years and older are eligible and must provide informed consent to participate in the trial. Participants will be randomly assigned to the investigational vaccine group or the placebo group, and neither the investigators nor the participants will know who is assigned to which group. After an initial screening, participants will receive two injections of either the investigational vaccine or a saline placebo approximately four weeks apart. One person will receive a placebo injection for every two people who receive AZD1222, which will result in approximately 20,000 people receiving the investigational vaccine and 10,000 people receiving a placebo.
The trial primarily is designed to determine if AZD1222 can prevent symptomatic COVID-19 after two doses. The trial also will evaluate if the vaccine candidate can prevent SARS-CoV-2 infection regardless of symptoms and if it can prevent severe COVID-19. It also will assess if the experimental vaccine can reduce the incidence of emergency department visits due to COVID-19.
Participants will be closely monitored, particularly after injections, for safety and reactogenicity, which refers to symptoms usually mild and self-limiting that can occur after vaccination. Investigators will evaluate participants after each vaccination and will ask participants to record any symptoms after returning home as well. An independent Data and Safety Monitoring Board (DSMB) will provide oversight to ensure the safe and ethical conduct of the study.
Participants will be followed for two years after their second vaccination. They will be asked to provide blood and nasopharyngeal samples at their initial visit and will be asked to provide blood samples periodically for the duration of the trial. Scientists will examine the blood samples in the laboratory to measure and characterize immune responses. The severity of the disease observed will be measured and used to assess the activity of the investigational vaccine.
Participants suspected to have COVID-19 will be asked to undergo a nasal and nasopharyngeal swab for testing. Participants who test positive for SARS-CoV-2 infection will be followed closely and referred for medical care if symptoms worsen.
Adults who are interested in joining this study can visit Coronaviruspreventionnetwork.org or ClinicalTrials.gov and search identifier NCT04516746.
NIAID conducts and supports research at NIH, throughout the United States, and worldwide to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the COVID-19 Prevention Network: The COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health to respond to the global pandemic. Through the CoVPN, NIAID is leveraging the infectious disease expertise of its existing research networks and global partners to address the pressing need for vaccines and antibodies against SARS-CoV-2. CoVPN will work to develop and conduct studies to ensure rapid and thorough evaluation of vaccines and antibodies for the prevention of COVID-19. The CoVPN is headquartered at the Fred Hutchinson Cancer Research Center. For more information about the CoVPN, visit: coronaviruspreventionnetwork.org.
About HHS, ASPR, and BARDA: HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, BARDA-supported products have achieved 55 FDA approvals, licensures or clearances. To learn more about federal support for the nationwide COVID-19 response, visit www.coronavirus.gov.
About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIHTurning Discovery Into Health
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Confirmed cases of COVID-19 have now reached more than 25.4 million globally, according to the Johns Hopkins Coronavirus Resource Center. The number of confirmed coronavirus deaths now stands at more than 850,000.
India has reported 69,921 new coronavirus cases, taking its overall total to nearly 3.7 million. It represents the lowest daily jump in six days.
New Jersey and California, USA, are to allow limited indoor dining again. New Jersey will lift restrictions from Friday, while the easing in California will only take effect in 19 counties where transmission rates are lower.
Spain has registered more than 23,000 new COVID-19 cases since Friday, the country's health emergency chief told a press conference yesterday.
The European Commission has said it will contribute to a World Health Organization (WHO) vaccine initiative. The Commission will provide 400 million euros (US$479.5 million) in guarantees to COVAX.
Victoria, Australia has reported its lowest rise in virus-related deaths in two weeks. Positive tests were at a seven-week low. The state was the epicentre for an outbreak of cases in the country.
The first global pandemic in more than 100 years, COVID-19 has spread throughout the world at an unprecedented speed. At the time of writing, 4.5 million cases have been confirmed and more than 300,000 people have died due to the virus.
As countries seek to recover, some of the more long-term economic, business, environmental, societal and technological challenges and opportunities are just beginning to become visible.
To help all stakeholders communities, governments, businesses and individuals understand the emerging risks and follow-on effects generated by the impact of the coronavirus pandemic, the World Economic Forum, in collaboration with Marsh and McLennan and Zurich Insurance Group, has launched its COVID-19 Risks Outlook: A Preliminary Mapping and its Implications - a companion for decision-makers, building on the Forums annual Global Risks Report.
The report reveals that the economic impact of COVID-19 is dominating companies risks perceptions.
Companies are invited to join the Forums work to help manage the identified emerging risks of COVID-19 across industries to shape a better future. Read the full COVID-19 Risks Outlook: A Preliminary Mapping and its Implications report here, and our impact story with further information.
2. Disruption to health systems
The survey covered 105 countries from March to June 2020, and found that low- and middle-income countries faced the greatest difficulties.
Most countries reported that elective and routine services were suspended. But, critical care, such as cancer screening or HIV therapy, has also seen interruptions in low-income countries.
Disruption has been highest in low-income countries.
Image: WHO
"The survey shines a light on the cracks in our health systems, but it also serves to inform new strategies to improve healthcare provision during the pandemic and beyond, said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. "COVID-19 should be a lesson to all countries that health is not an either-or equation. We must better prepare for emergencies but also keep investing in health systems that fully respond to peoples needs throughout the life course."
3. Can't 'pretend the pandemic is over': WHO
"If countries are serious about opening up, they must be serious about suppressing transmission and saving lives," he said. Opening up without control over the virus is a 'recipe for disaster', he added.
And, while the WHO supports efforts to re-open economies and societies, he stressed the need to do this safely.
"No country can just pretend the pandemic is over."
He outlined the four essential things that everyone can do to 'take control' of the virus.
1. Prevent amplifying events, where clusters of people gather.
2. Reduce deaths by protecting vulnerable groups, such as the elderly and essential workers.
3. Individuals should protect themselves and others by avoiding the 'three Cs' - closed spaces, crowded places and close-contact settings.
4. Governments must take action to find, isolate, test and care for cases, and trace and quarantine contacts.
Since the COVID-19 pandemic first surfaced in the United States, the number of cases and deaths in long-term care (LTC) facilities has been rising. As of August 20, 2020, over 70,000 COVID-19 related resident and staff deaths have been reported in nursing homes and other long-term care facilities, which is a conservative estimate because not all states publish these data. The increase in deaths among long-term care facility residents and staff has become an urgent concern for federal and state policymakers, the long-term care industry, family members of residents, residents themselves, and the general public.
While COVID-19 outbreaks and deaths in nursing homes have received a fair amount of attention, assisted living facilities (ALFs), which are home to over 800,000 mostly frail, elderly residents, have been largely overlooked. Unlike nursing homes, assisted living facilities are not federally regulated, leaving states to decide whether or not to publicly report data or to impose restrictions to protect residents. This analysis examines the impact of COVID-19 on assisted living facilities as well as changes over time, using state-level data on COVID-19 cases and deaths reported in early June 2020, and again in early August. These counts are a subset of the state-level COVID-19 cases and deaths in all long-term care facilities, including nursing homes, as reported in other KFF analyses. (See Methods for details).
As of August 2020, 19 states identify COVID-19 cases or deaths specific to assisted living facilities, an increase of four states since June 2020. Of these 19 states, 13 [CO, CT, FL, KY, MA, NV, ND, OH, PA, RI, TN, TX, UT] report COVID-19 data for assisted living facilities in its own, distinct category, and 6 [CA, GA, LA, NC, NY, SC] report COVID-19 data for assisted living facilities along with congregate settings other than nursing homes (Tables 1 and 2). This leaves 31 states and DC that do not identify COVID-19 cases and deaths occurring in assisted living facilities specifically, as of August 2020.
CASES: As of early August 2020, a total of 22,080 COVID-19 cases have been reported among residents and staff in assisted living facilities, based on the 18 states reporting COVID-19 cases data. This total reflects both the number of cases among 14 states that were reporting this information in June and the addition of 4 states that started reporting since then. Among the 14 states that reported COVID-19 cases in both June and August, the number of cases among residents and staff has increased by 66% and the number of cases among residents only has increased by 63%. This is an undercount because it is based on data reported by a minority of states.
As of early August 2020, a total of 7,626 cases were reported among assisted living staff in the 14 states reporting staff cases, including 6 states that started reporting since June. Among the 8 states that reported in both June and August, the number of staff cases has increased by 156% from 2,085 to 5,333 cases in early August.
DEATHS: As of early August 2020, a total of 2,651 deaths among residents and staff have been reported in the 14 states that identify COVID-19 deaths specific to assisted living facilities, including the 10 states that reported deaths in both June and August, and 4 states that started reporting since June. Among the 10 states that reported deaths in both June and August, the total number of deaths increased by 59% from 1,483 to 2,356 deaths in early August. The majority of reported COVID-19 deaths are among assisted living facility residents (2,257); a relatively small number represent deaths among staff (99).
As of early August 2020, a total of 99 deaths were reported among assisted living staff in the 7 states reporting staff deaths, including 2 states that started reporting since June. Among the 5 states that reported in both June and August, the number of deaths has increased by 219% from 31 to 99 deaths in early August.
In the 10 states reporting cumulative COVID-19 CASE numbers for assisted living facilities in both June and August, the percentage increase in the aggregate number of COVID-19 cases in the population overall was significantly greater than the percentage increase in aggregate resident and staff cases in ALFs (223% versus 61%). But the opposite is true in the states reporting cumulative deaths in assisted living facilities. In the nine states reporting cumulative DEATH data for assisted living facilities separately from nursing homes, the aggregate percentage increase in COVID-19 deaths occurring in the overall population in these states was roughly half of the increase in resident and staff deaths occurring in ALFs between June and August (36% vs. 60%).
Despite intense scrutiny of the number of COVID-19 cases and deaths in nursing facility settings, less than half of all states are reporting data for COVID-19 in assisted living facilities specifically. As a result, it is difficult to know the extent to which residents and staff in assisted living facilities have been affected by COVID-19 or the extent to which interventions are urgently needed. Our analysis finds a significant increase in COVID-19 cases and deaths among residents and staff in assisted living facilities in the two-month period between June and August. The rise in cases among staff is especially noteworthy. Notably, four out of five states [CA, FL, NV, SC] with the largest increase in cases among staff are also considered hotspot states with widespread community transmission. The rise in COVID-19 cases among staff is most likely to disproportionately affect female, Black, and low-wage workers, based on a recent analysis.
Since COVID-19 data for assisted living facilities are reported separately from nursing facilities by a minority of states, the counts of cases and deaths presented in this analysis are undoubtedly conservative. Compounding this data limitation, states that do report for assisted living facilities separately from nursing homes vary significantly in what they report: some states report cases, but not deaths, and some do not report cases or deaths among staff. In fact, only seven states separately report deaths among staff working in assisted living facilities. Additionally, while some states (e.g., NY, LA) have been reporting cumulative case and death data dating back to early March, others do not specify the start date of their retrospective data reporting, leading to potential undercounts of cases and deaths that have occurred since the beginning of the pandemic. The reporting of active cases only by some states (such as Florida) is likely to result in an undercount of the true magnitude of cases and deaths since the numbers do not take into account cases and deaths that may have occurred but are no longer active.
Overall, the incomplete system of state-level reporting of COVID-19 data in assisted living facilities results in an incomplete picture of disease incidence and mortality among staff and residents in these facilities. Based on data from the states that do report, outbreaks in assisted living facilities, and protections for residents and staff, warrant more careful attention.
No one is immune to the effects of coronavirus disease 2019 (COVID-19). Although the United States has >4 million confirmed cases and >144000 deaths at the time of this writing,1 COVID-19s effects on individuals and communities extend far beyond hospitalizations and mortality. Pandemics disturb individual and community well-being through direct effects of the illness and through emotional isolation, economic loss, work and school closure, and inadequate distribution of needed resources, among others.2 Previous research highlights consequences of pandemic mitigation efforts (such as quarantine) on stress, depression, fear, anger, boredom, stigma, and other negative states.3 Adults already report worse psychological well-being now as compared to before COVID-19.4 Because data suggest that children might less frequently transmit5 or become severely ill from the virus,6,7 the unique consequences that COVID-19 exerts on children risk being overlooked. Data on child and family well-being during COVID-19 are sparse, yet recent reports of increased family violence are ominous.8 Given the body of knowledge of the damaging effects of toxic stress and adverse childhood experiences on
Address correspondence to Ryan J. Coller, MD, MPH, Department of Pediatrics, School of Medicine and Public Health, University of WisconsinMadison, 600 Highland Ave, Madison, WI 53792. E-mail: rcoller{at}pediatrics.wisc.edu
TheWest Virginia Department of Health and Human Resources (DHHR) reportsas of 10:00 a.m., on August 29, 2020, there have been 426,074 total confirmatory laboratory results receivedfor COVID-19, with 9,967 total cases and 212 deaths.
DHHRhas confirmed the deaths of a 40-year old male fromKanawha County, a 70-year old female from Taylor County, an 86-year old malefrom Logan County, a 52-year old male from Wayne County, a 73-year old malefrom Cabell County, a 77-year old female from Grant County, a 42-year oldfemale from Kanawha County, a 71-year old male from Monroe County, a 77-yearold male from Monroe County, and an 88-year old female from Nicholas County. Eachdeath reported is a heartbreaking reminder of the seriousness of this disease,said Bill J. Crouch, DHHR Cabinet Secretary. We extend our sympathies as wemourn this loss to both the families and our state.
CASESPER COUNTY: Barbour (33), Berkeley (794), Boone(139), Braxton (9), Brooke (88), Cabell (524), Calhoun (9), Clay (20),Doddridge (6), Fayette (247), Gilmer (18), Grant (139), Greenbrier (106),Hampshire (91), Hancock (121), Hardy (72), Harrison (263), Jackson (200),Jefferson (352), Kanawha (1,363), Lewis (32), Lincoln (113), Logan (476),Marion (216), Marshall (133), Mason (101), McDowell (70), Mercer (290), Mineral(144), Mingo (232), Monongalia (1,093), Monroe (114), Morgan (37), Nicholas(50), Ohio (290), Pendleton (44), Pleasants (15), Pocahontas (42), Preston(139), Putnam (274), Raleigh (346), Randolph (222), Ritchie (5), Roane (26),Summers (19), Taylor (105), Tucker (11), Tyler (15), Upshur (43), Wayne (246),Webster (7), Wetzel (45), Wirt (7), Wood (305), Wyoming (66).
Pleasenote that delays may be experienced with the reporting of information from thelocal health department to DHHR. As case surveillance continues at the localhealth department level, it may reveal that those tested in a certain countymay not be a resident of that county, or even the state as an individual inquestion may have crossed the state border to be tested.Such is the case of Grant,Mason, and McDowell counties in this report.
Pleasevisit the dashboard located at www.coronavirus.wv.gov for more information.
Governor Tom Wolf signed a second renewal of his 90-day disaster declaration for the COVID-19 pandemic yesterday. He originally signed it March 6 following the announcement of the first two presumptive positive cases of the virus in the commonwealth.
As we approach the six-month mark of this crisis, I continue to be amazed at the resiliency and strength shown by Pennsylvanians during this pandemic, Gov. Wolf said. We are going to continue to combat the health and economic effects of COVID-19, and the renewal of my disaster declaration will provide us with resources and support needed for this effort.
The emergency disaster declaration provides for increased support to state agencies involved in the continued response to the virus and recovery for the state during reopening. This includes expediting supply procurement and lifting certain regulations to allow for efficient and effective mitigation.
The disaster declaration has allowed for waivers and extensions to continue to provide for Pennsylvanians and businesses under the unprecedented circumstances of the pandemic, including the ability to waive the one-week waiting period to receive unemployment compensation, work search requirements, and the registration with PA CareerLink for applicants, and to provide relief from charges for employers; and allowing the commonwealth to suspend numerous training requirements and certification and licensure renewals for health care professionals, child care workers, direct care workers, direct support professionals, among other professional groups who provide life-sustaining services to our children, seniors, and vulnerable residents.
Through the disaster declaration, PEMA has been able to mission assign the National Guard to provide various types of support for long term care facilities, including providing direct patient care support, ancillary support, and testing, and at community-based testing sites. It also provides PEMA with the ability to leverage continued federal support such as non-congregate sheltering.
The renewed disaster declaration will continue to support all of these efforts, as well as allow PEMA to rapidly scale response efforts and employ new intervention tactics, such as the administration of a vaccine.
The Department of Healths Department Operations Center at PEMA continues to be active, as is the CRCC there.
Read the amendment to the emergency disaster declaration here.
The COVID-19 pandemic has impacted the U.S population and the hardest hit have been traditionally minoritized and marginalized peoplein particular Black, Brown and Indigenous communitieswhere health inequities were already present.
Cities, states and various organizations are responding to health and racial equity in the COVID-19 response by putting in place projects and initiatives that center equity while assisting health care, public health, neighborhood and community stakeholders, and residential communities.
We partnered with these organizations to collect their insights to help us better understand the history of the project or initiatives, the overall goals of the project/initiative, the expected results and early wins, as well as the key partners involved in the effort. They also gave recommendations and advice to consider when engaging in similar efforts.
See how health care, governmental and community organizations across the country are working to provide resources to minoritized and marginalized populations, dismantling racist systems and improving patient trust in the health care system.
Workers watch the crowd below outside Jordan-Hare Stadium in Auburn, Ala., on Saturday, Sept. 21, 2018. (Photo: Jake Crandall)
AUBURN More than 500 Auburn University students tested positive for COVID-19 between Aug. 22-28. That's more than double the previous week's total of 202.
Four hundred and ninety on-campus students tested positive, as did 18 fromthe Auburn University Regional Airport and one from the E.W. Shell Fisheries Center.
Eight employees (faculty and staff) also tested positive.
Auburn did not share how many tests were conducted last week, so it's not clear what the positivity rate is.
UPDATE:A university spokesman told theAdvertiserthat the number cannot be accurately tracked those 490 positives include both tests conducted by the Auburn University Medical Clinic and self-reported positives from other testing sites, and the AUMC tests more than just students.
"You can't take that positive number and use it in a denominator or numerator situation with the other number," the spokesman said, "because they don't match."
Asince-deleted postbyAUMC to itsFacebook page Tuesday morning said that 567 of 1,416 total samples (40%) came back positive, but that information has not been corroborated.
AUMC director Dr. Fred Kam said Auburn University has seen no hospitalizations as a result of COVID-19.
"Not unexpected," Kam said of the more than 500 positive tests. "In fact, my expectation was going to be over 700.
"When you put together as many people as we have, students coming back together, the expectation is that there will be, again, a spike;an ongoing increase in numbers. That's to be expected, not unexpected. These are relatively young, healthy people who are going to socialize. They've done that. We've gone through two or three weeks of them interactingwith each other and not taking all the preventative measures, something that we keep pushing and educating about. But it is a challenge."
Auburn has now discovered 1,043 student cases on campus since March 16. Seven hundred and thirty-three of those have come over the past three weeks, and that does not include any students might have gone somewhere other than AUMC to get tested and did not self-report results. Only 859 tested positive prior to returning to campus as part of the state-wide GuideSafe re-entry program.
Lee County reported a single-day record 109 confirmed new cases on Friday and has seen its seven-day average increase from 11.3 on Aug. 17 (the first day of classes) to 64.1, according to Bama Tracker.
"We expect to see multiple spikes, as least three to four, between now and Nov. 24," Kam said, referencing the final day of the fall semester (finals will be conducted remotely in December.
This story will be updated if more information becomes available.
Josh Vitale is the Auburn beat writer for the Montgomery Advertiser. You can follow him on Twitter at @JoshVitale. To reach him by email,click here. If you enjoy Josh's coverage, consider a digital subscription that will give you access to all of it.
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In April, more than three months before any coronavirus vaccine would enter large clinical trials, the mayor of a picturesque island town in the Pacific Northwest invited a microbiologist friend to vaccinate him.
The exchange occurred on the mayors Facebook page, to the horror of several Friday Harbor residents following it.
Should I pop up and get your vaccine started?????, wrote Johnny Stine, who runs North Coast Biologics, a Seattle biotech company with a focus on antibodies. Dont worry Im immune I have boosted myself five times with my vaccine.
Sounds good, Farhad Ghatan, the mayor, wrote after a few follow-up questions.
Several residents interjected skepticism in the exchange. They were swatted down by the mayor, who defended his friend of 25 years as a pharmaceutical scientist on the forefront. When residents raised additional concerns about Mr. Stines credentials and the unfairness of encouraging him to visit San Juan Island despite travel restrictions Mr. Stine lobbed back vulgar insults. (The geekiest and least R-rated: I hope your lung epithelial cells over express ACE2 so you die more expeditiously from nCoV19.)
Several residents reported all of this to a variety of law enforcement and regulatory agencies. In June, the Washington attorney general filed a lawsuit against Mr. Stine not only for pitching the mayor with unsupported claims, but also for administering his unproven vaccine to about 30 people, charging each $400. In May, the Food and Drug Administration sent a letter warning Mr. Stine to stop misleadingly representing his product.
Although his promotional tactics were unusual, Mr. Stine was far from the only scientist creating experimental coronavirus vaccines for themselves, family, friends and other interested parties. Dozens of scientists around the world have done it, with wildly varying methods, affiliations and claims.
The most impressively credentialed effort is the Rapid Deployment Vaccine Collaborative, or RaDVaC, which boasts the famous Harvard geneticist George Church among its 23 listed collaborators. (The research, however, is not happening on Harvards campus: While professor Churchs lab works on a number of Covid-19 research projects, he has assured Harvard Medical School that work related to the RaDVaC vaccine is not being done in his lab, a spokeswoman for Harvard Medical School said.)
Among the most tight-lipped projects is CoroNope, which refuses to name anyone involved because, according to the person responding to messages sent to the groups anonymous email account, the less than half a dozen biologists dont want to risk getting in trouble with the F.D.A. or with their employers.
Each D.I.Y. effort is motivated, at least in part, by the same idea: Exceptional times demand exceptional actions. If scientists have the skills and gumption to assemble a vaccine on their own, the logic goes, they should do it. Defenders say that as long as they are measured about their claims and transparent about their process, we could all benefit from what they learn.
But critics say that no matter how well-intentioned, these scientists arent likely to learn anything useful because their vaccines are not being put to the true test of randomized and placebo-controlled studies. Whats more, taking these vaccines could cause harm whether from serious immune reactions and other side effects, or offering a false sense of protection.
Take it yourself and there is not much anyone can or should do, said Jeffrey Kahn, the director of the Johns Hopkins Berman Institute of Bioethics. But once a person starts encouraging other people to try an unproven vaccine, youre headed right back to the days of patent medicine and quackery, he said, referring to a time when remedies were widely sold with colorful but misleading promises.
The RaDVac vaccine effort, first reported on by MIT Technology Review, is different from Mr. Stines project in two important ways. No one involved plans to charge for the vaccine. And unlike Mr. Stines expletive-laden Facebook rants, RaDVaC has a 59-page scientific document to explain how it works and to guide others who might want to mix up the vaccine formulation on their own.
The white paper is quite impressive, said Avery August, an immunologist at Cornell University in Ithaca, N.Y., who is not involved with RaDVaC.
But the impetus of both projects is similar. In March, as Preston Estep, a genome scientist who lives in the Boston area, was reading about people dying amid the pandemic, he vowed not to sit complacently on the sidelines. He emailed some chemists, biologists, professors and doctors he knew to see whether any were interested in creating their own vaccine. Soon they had devised a formula for a peptide vaccine that could be administered through a spritz in the nose.
Its very simple, Dr. Estep said. It consists of five ingredients you could mix together in a physicians office.
The key ingredient: tiny bits of viral proteins, or peptides, which the scientists ordered online. If all went well, the peptides would train the immune system to defend against the coronavirus, even with no actual virus present.
In late April, Dr. Estep joined several collaborators in a lab as they stirred the concoction and sprayed it in their nostrils. Dr. Church, a longtime mentor to Dr. Estep, said he took it alone in his bathroom to maintain social-distancing precautions.
Dr. Estep soon gave the vaccine to his 23-year-old son, and other collaborators also shared it with their family members. So far, no one has reported anything worse than a stuffy nose and a mild headache, Dr. Estep said. He has also refined the recipe, removing and adding peptides as new coronavirus research has emerged. So far, he has sprayed eight versions into his nose.
A traditional drug development workflow begins with mouse or other animal studies. For RaDVaC, Dr. Estep said, we are the animals.
But without rigorous clinical trials, Dr. August said, theres no reliable way to know if it is safe or effective. He said he feared that the scientists prestigious credentials might imply otherwise.
Dr. Church said that he respected the traditional evaluation process but that there should also be room for pre-research, and that most of what he had been involved with throughout his career including editing genes in human cells was considered fringe at first.
As of last week, Dr. Estep said, about 30 people in the United States, Sweden, Germany, China and Britain had taken the vaccine. He said a university professor in Brazil had told him he was considering making it in his lab and distributing it for free.
There is a long history of scientists openly testing vaccines on themselves and their children, but in recent decades it has become less common, according to Susan E. Lederer, a medical historian at the University of Wisconsin-Madison. Whats ethically and legally acceptable for testing and distributing your own medical product varies by institution and by country.
Updated September 1, 2020
In August, the Scientific Research Institute for Biological Safety Problems, a government institution in Kazakhstan, announced that seven employees had become the first people to try the Covid-19 vaccine they were developing. Russian and Chinese scientists affiliated with government and academic institutions have made similar pronouncements amid the pandemic.
The problem with Mr. Stines product, according to Attorney General Bob Ferguson of Washington, is not that he took it. Its that he sold this so-called vaccine to people in Washington who are frightened and more apt to look for a miracle cure in the midst of a worldwide pandemic, Mr. Ferguson said in a statement. The lawsuit also cites Mr. Stines unsupported safety and effectiveness claims.
In March, a few months after he said he vaccinated himself and his two teenage sons, he posted an ad on the Facebook page for North Coast Biologics. After decades of working with antibodies, Mr. Stine said in an interview, he knew that making a vaccine should be pretty goddamn easy.
He described a job that sounded a bit like writing Hollywood screenplays that never become movies. He makes antibodies that could be used against various pathogens and sells them to companies that could use them to develop drugs, but they probably wont. According to the Washington attorney generals suit, Mr. Stines company was administratively dissolved in 2012.
To make his vaccine, he used a genetic sequence for the spike protein on the outside of the coronavirus to make a synthetic version. He put it in a saline solution, injected himself just under the surface of the skin of his upper arm and then took a so-called titer test to look for antibodies in his bloodstream. It took me 12 days from downloading the sequence to being titer positive, he said.
In his Facebook ad, he claimed that this left him immune to the virus and offered interested parties the opportunity to pay $400/person.
As part of an agreement that Mr. Stine eventually struck with prosecutors, he must refund all 30 people who had taken his vaccine.
Mr. Stine seemed amused by this, insisting that few people are likely to apply for a refund. His fee, he said, barely covered travel costs, and often he didnt charge.
A man in his 60s in Montana, who asked to remain anonymous for privacy concerns, said he flew Mr. Stine out to inoculate him and his family. Now, he said, they have been able to return to normal behavior, such as having lunch with friends whose jobs put them at high risk for exposure. The man even joined Mr. Stine to visit a police officer friend in Washington State who had been diagnosed with Covid-19 and was on deaths door. According to all three who were present, no one wore a mask. And Mr. Stine sat close to the sick officer in an enclosed space as he gave him a treatment.
Mr. Stine says his vaccine is similar to a recombinant vaccine being developed by the University of Pittsburgh in Pennsylvania. He also claims that a shot will not only protect people against the virus, but also treat those who have it. Dr. Louis Falo, a lead researcher on University of Pittsburghs effort, said he was skeptical that Mr. Stines vaccine could be safe or effective based on how it was assembled. Even if it was, he said, its unlikely it would help sick people.
In the 1990s, Mr. Stine worked for Patrick Gray, a molecular biologist who contributed to the discovery of a hepatitis B vaccine and is now the chief executive of a biotech company.
Dr. Gray said in an interview that the science Mr. Stine published at Icos, the biotech company where they worked together, was sound but that the young scientist had a penchant for making too much of too little. Johnny was in a hurry to publish his work and advance his career, he said. We often insisted on more confirmation and more controls.
Regarding his current scientific efforts, I dont believe Johnny is a scam artist, but he has ignored F.D.A. regulations necessary for drug development, he wrote in an email. Its just not possible for an individual like Johnny to create a viable vaccine.
The mayor of Friday Harbor said he regretted responding to Mr. Stines message on his Facebook wall, instead of privately. But he does not see why he should apologize for accepting his friends formulation for free. Id rather have the chance of having some protection than no protection at all and waiting and waiting, Mr. Ghatan said.
The controversy, however, has derailed their plans to meet, he said. But if another opportunity arises to get the jab, he said, I would.
TheWest Virginia Department of Health and Human Resources (DHHR) reportsas of 10:00 a.m., on September 1, 2020, there have been 438,255 total confirmatory laboratory results receivedfor COVID-19, with 10,507 total cases and 222 deaths.
DHHRhas confirmed the deaths of a 72-year old female fromMonroe County, a 65-year old female from Kanawha County, an 84-year old malefrom Kanawha County, a 65-year old female from Logan County, a 62-year oldfemale from Logan County, an 82-year old male from Logan County, a 41-year oldfemale from Mingo County, and a 91-year female from Kanawha County. Thisis another difficult day for West Virginia as the death toll continues to rise,said Bill J. Crouch, DHHR Cabinet Secretary. Our heart goes out to these WestVirginians and their families. Please continue taking every precaution we canto slow the spread of this disease.
CASESPER COUNTY: Barbour (33), Berkeley (804), Boone(143), Braxton (9), Brooke (94), Cabell (544), Calhoun (10), Clay (27),Doddridge (6), Fayette (360), Gilmer (19), Grant (141), Greenbrier (104),Hampshire (92), Hancock (121), Hardy (75), Harrison (269), Jackson (205),Jefferson (360), Kanawha (1,491), Lewis (32), Lincoln (119), Logan (493),Marion (219), Marshall (133), Mason (105), McDowell (70), Mercer (311), Mineral(147), Mingo (249), Monongalia (1,170), Monroe (124), Morgan (37), Nicholas(52), Ohio (291), Pendleton (45), Pleasants (15), Pocahontas (45), Preston(140), Putnam (286), Raleigh (366), Randolph (226), Ritchie (5), Roane (33),Summers (20), Taylor (106), Tucker (11), Tyler (15), Upshur (43), Wayne (253),Webster (7), Wetzel (46), Wirt (8), Wood (310), Wyoming (68).
Pleasenote that delays may be experienced with the reporting of information from thelocal health department to DHHR. As case surveillance continues at the localhealth department level, it may reveal that those tested in a certain countymay not be a resident of that county, or even the state as an individual inquestion may have crossed the state border to be tested.Such is the case of Greenbrier,Hancock, and Wirt counties in this report.
Pleasevisit the dashboard located at www.coronavirus.wv.gov for more information.
