Soon, the virus was storming the vast, gridded passages of the Central de Abasto, and Mr. Arriagas father fell ill, too. Dozens in the market died, perhaps hundreds. Not even the government knows for sure.
There is this moment when you start to see people dying, and the stress begins to destroy you, Arriaga, 30 said. It made me realize what a trapped animal feels like.
The market became the epicenter of the epicenter, the teeming heart of a neighborhood that has registered more Covid deaths than any other part of the capital, which is itself the center of the national crisis.
In Iztapalapa, it was clear from the start that the virus would strike hard. Of all the districts in the Mexican capital, it is the most densely populated, with some two million people packed into 45 square miles of heaving commerce and virtually uninterrupted construction.
Poverty circumscribes life, with chronic water shortages. Hundreds of thousands live, day by day, far more fearful of hunger than any virus.
Over the months, a deep-seated skepticism among people like Mr. Arriaga turned to shock, and eventually to resignation, as their neighbors, friends and loved ones died and their neighborhood became ground zero for the outbreak.
The virus left few lives untouched in Iztapalapa, if not by illness then by economic distress. Starvation haunted people who had never considered themselves poor, and rituals that had bound the community for generations were scrapped, including one of the biggest Christian celebrations in Latin America, which was canceled for the first time in more than 150 years.
Another 38 coronavirus cases have been reported in Maine, health officials said Wednesday.
Wednesdays report brings the total number of coronavirus cases in Maine to 5,171. Of those, 4,643 have been confirmed positive, while 528 were classified as probable cases, according to the Maine Center for Disease Control and Prevention.
The agency revised Tuesdays cumulative total to 5,133, down from 5,146, meaning there was an increase of 25 over the previous days report, state data show. As the Maine CDC continues to investigate previously reported cases, some are determined to have not been the coronavirus, or coronavirus cases not involving Mainers. Those are removed from the states cumulative total.
New cases were reported in Androscoggin (6), Aroostook (1), Cumberland (4), Oxford (6), Sagadahoc (1), Washington (1) and York (18) counties, state data show. Information about where another case was reported wasnt immediately available.
The seven-day average for new coronavirus cases has risen to 34.9, up from 28.1 a week ago and 23.1 a month ago.
Turner-area schools have become the latest to transition back to remote learning after four positive coronavirus cases within the MSAD 52 system. Superintendent Kimberly Brandt said in a Tuesday letter to parents that the cases arent considered part of an outbreak because they have occurred in three different schools. The Maine CDC defines an outbreak as three or more linked cases.
The schools Turner Primary School, Turner Elementary School, Tripp Middle School and Leavitt Area High School will hold classes remotely through the beginning of October, Brandt said. The schools will undergo a thorough cleaning during the closure.
That follows the first reported outbreak in a Maine school system. Sanford High School and Sanford Regional Technical Center have moved to remote learning after an outbreak that has infected at least 13 people. Other cases have been detected in school systems in Falmouth and Lewiston.
No new deaths were reported Wednesday, leaving the statewide death toll at 140. Nearly all deaths have been in Mainers over age 60.
So far, 441 Mainers have been hospitalized at some point with COVID-19, the illness caused by the coronavirus. Of those, 14 people are currently hospitalized, with two in critical care.
Meanwhile, 38 more people have recovered from the coronavirus, bringing total recoveries to 4,445. That means there are 586 active confirmed and probable cases in the state, which is down from 599 on Tuesday.
A majority of the cases 2,981 have been in Mainers under age 50, while more cases have been reported in women than men, according to the Maine CDC.
As of Monday, there have been 377,931 negative test results out of 385,064 overall. About 1.6 percent of all tests have come back positive, the most recently available Maine CDC data show.
The coronavirus has hit hardest in Cumberland County, where 2,290 cases have been reported and where the bulk of virus deaths 70 have been concentrated. It is one of four counties the others are Androscoggin, Penobscot and York, with 693, 252 and 1,115 cases, respectively where community transmission has been confirmed, according to the Maine CDC.
There are two criteria for establishing community transmission: at least 10 confirmed cases and that at least 25 percent of those are not connected to either known cases or travel. That second condition has not yet been satisfied in other counties.
Other cases have been reported in Aroostook (43), Franklin (60), Hancock (53), Kennebec (207), Knox (36), Lincoln (41), Oxford (132), Piscataquis (9), Sagadahoc (65), Somerset (85), Waldo (73) and Washington (16) counties.
As of Wednesday morning, the coronavirus had sickened 6,902,930 people in all 50 states, the District of Columbia, Puerto Rico, Guam, the Northern Mariana Islands and the U.S. Virgin Islands, as well as caused 201,120 deaths, according to Johns Hopkins University of Medicine.
1. How COVID-19 continues to affect the globe
There are now more than 31.6 million confirmed coronavirus cases worldwide, according to the Johns Hopkins University of Medicine. The number of confirmed deaths has risen to more than 970,000.
Canada is at a COVID-19 crossroads, health officials have warned and could see more than 1,000 new daily cases per day over the next two weeks. The countrys Public Health Agency said: Canada is at a crossroads and individual action to reduce contact rates will decide our path.
Canada: Standing at the coronavirus crossroads
Image: Our World in Data
Brazils ministry of health confirmed 33,536 new cases, as the countrys total COVID-19 count rose to 4,591,364. An additional 836 deaths brought the death toll up to 138,108, the second-highest globally.
Airlines in Europe are hoping a COVID-19 test that delivers a result in just 15 minutes will restore travellers confidence in flying. Lufthansa, Germanys national airline, has teamed up with the pharmaceutical company Roche on the tests. In Italy, Alitalia already offers flights between Milan and Rome for passengers who test negative.
Japan may begin relaxing its strict border controls next month. At the moment, even permanent residents cannot return from overseas without permission. Although the country is considering allowing some visitors to enter, there will still be restrictions in place for tourists.
The Australian state of Victoria may start relaxing more lockdown restrictions this week. The two-week average for new confirmed cases has dropped below 30 in the city of Melbourne. The countrys second-largest city has been under strict lockdown since 2 August.
A public health emergency has been declared in the US state of Wisconsin. Governor Tony Evers said: We are seeing an alarming increase in cases across our state, especially on campus. Wisconsinites will be required to wear face masks in public spaces, indoors and out, until at least November.
Fujifilm Toyama Chemical has said its antiviral drug, Avigan, has reduced recovery times for non-severe COVID-19 patients. A study involving 156 patients in Japan found those given the drug saw an improvement after 11.9 days. A control group, who received a placebo recorded recovery times of 14.7 days.
Responding to the COVID-19 pandemic requires global cooperation among governments, international organizations and the business community, which is at the centre of the World Economic Forums mission as the International Organization for Public-Private Cooperation.
Since its launch on 11 March, the Forums COVID Action Platform has brought together 1,667 stakeholders from 1,106 businesses and organizations to mitigate the risk and impact of the unprecedented global health emergency that is COVID-19.
The platform is created with the support of the World Health Organization and is open to all businesses and industry groups, as well as other stakeholders, aiming to integrate and inform joint action.
As an organization, the Forum has a track record of supporting efforts to contain epidemics. In 2017, at our Annual Meeting, the Coalition for Epidemic Preparedness Innovations (CEPI) was launched bringing together experts from government, business, health, academia and civil society to accelerate the development of vaccines. CEPI is currently supporting the race to develop a vaccine against this strand of the coronavirus.
2. Argentinas economy plunges record 19.1% in second quarter on pandemic impact
The pandemic has pushed Argentinas economy into a steep decline, contracting by a record 19.1% in the second quarter of the year. Although not as bad as some analysts had been expecting, it is worse than the countrys last major financial setback in 2002, when the economy shrank by 16.3%
According to Reuters, analysts had forecast an average contraction of 19.9% for the April-June period.
Argentina has been in recession since 2018 and in May of this year it defaulted on its sovereign debt, after missing a $500 million interest payment on approximately $65 billion of foreign debt.
The pandemic pushed Argentinas economy into a steep decline, contracting by a record 19.1%.
Image: REUTERS/Agustin Marcarian
South America's third-largest country by population has been in lockdown since mid-March and has recorded 652,174 confirmed cases and 13,952 deaths.
The strong isolation restrictions imposed from the second half of March and that lasted until August had a significant economic cost for the entire country, economist Natalia Motyl of consultancy Libertad y Progreso, told Reuters.
Lockdown has been relaxed but there are restrictions still in place which are expected to stay until 11 October.
3. PAHO: Pregnant women face greater COVID-19 risk and must receive vital support
The Pan American Health Organization (PAHO) is warning of the increased risk to pregnant women from COVID-19. It has recorded 60,458 confirmed cases of COVID-19 among pregnant women, including 458 deaths.
Mexico saw the highest number of deaths 140 from 5,574 cases in pregnant and postpartum women. Brazil, which has been particularly hard-hit, recorded 135 deaths in 2,256 women. The US had 44 deaths among 20,798 women.
The smallest number of deaths came from Panama eight deaths in 525 pregnant women, but that is the highest maternal mortality ratio PAHO found.
The agency has urged health services across the Americas to work harder at making sure pregnant women have access to vitally important prenatal care services. Recently published results and studies based on COVID-19 surveillance data have indicated an increased risk among pregnant women of presenting with severe forms of COVID-19 and, therefore, of being hospitalized and admitted to intensive care units, PAHO warned.
PAHO also found the number of cases among indigenous populations is increasing.
Of the 11 countries that reported data on their indigenous populations, there were 120,593 confirmed cases and 2,639 deaths. Colombia had the largest increase in cases and Ecuador had the largest increase in deaths in indigenous populations, relative to the general population of both countries, the agency said.
Here are five things you need to know about the coronavirus pandemic this Wednesday morning. We'll have another update for you at 18:00 BST.
Six months after lockdown was imposed, the country must "summon discipline, resolve and a spirit of togetherness" to get through a second battle against coronavirus. That was the message from Boris Johnson on Tuesday night. He said there had been "too many breaches" of the rules which were leading to a surge in infections, and therefore, new restrictions were needed - here they are in full. The PM warned he'd have to get "tougher" if they were ignored or not effective, but health correspondent Nick Triggle says that's being weighed against the recognition within government that the public is tiring of the fight.
Boris Johnson only decides the rules for England and he stopped short of joining Scotland and Northern Ireland in banning people visiting each other's homes. First Minister Nicola Sturgeon urged people in Scotland to comply from today, with enforcement being introduced on Friday. Exemptions are in place for certain groups of people. The feeling is it's almost inevitable that England will follow suit in the coming weeks.
Media playback is unsupported on your device
Emails sent by the government's most senior scientific and medical advisers, seen by the BBC, have revealed their alarm about claims at the start of the pandemic that they were pursuing a herd immunity strategy. That's the idea that if enough people are allowed to catch a disease and build up some immunity, ultimately it will no longer be able to spread. In one email from March, chief scientific adviser Sir Patrick Vallance asks for help to "calm down" academics who expressed anger at his repeated references to the concept and the delays in announcing a lockdown.
About 600 drink-only bars in Northern Ireland can welcome back customers today for the first time since March. Until now, pubs could only sell alcohol if they also served food or if customers were outside. Northern Ireland hasn't yet imposed earlier closing, but in England, Scotland and Wales kicking out time will soon be 22:00 BST. Industry representatives want to align with the Republic of Ireland, where it's 23:30. The BBC has spoken to landlords who say early closing could halve their takings.
Chris Gorman's drone photos have revealed extraordinary scenes during the UK lockdown. From panic-buying to empty shopping centres and theme parks, he says "every day provided a new and unique picture". Check out some of his images.
Get a longer coronavirus briefing from the BBC in your inbox, each weekday morning, by signing up here.
Find more information, advice and guides on our coronavirus page.
Plus, meet the pop star doctor who decided to scrub up and help out on the wards again after coronavirus put paid to her tour.
What questions do you have about coronavirus?
In some cases, your question will be published, displaying your name, age and location as you provide it, unless you state otherwise. Your contact details will never be published. Please ensure you have read our terms & conditions and privacy policy.
Use this form to ask your question:
If you are reading this page and can't see the form you will need to visit the mobile version of the BBC website to submit your question or send them via email to YourQuestions@bbc.co.uk. Please include your name, age and location with any question you send in.
What happens when a major city allows the coronavirus to rage unchecked?
If the Brazilian city of Manaus is any answer, it means about two-thirds of the population could get infected and one person in 500 could die before the epidemic winds down.
During May, as the virus spread rapidly in Manaus, the equatorial capital of the state of Amazonas, dire reports described overwhelmed hospitals and freshly dug graves. Demand for coffins ran at four to five times figures for the previous year. But since hitting a peak four months ago, new coronavirus cases and deaths in the city of 1.8 million have undergone a rapid and unexplained decline.
Now a group of researchers from Brazil and the United Kingdom say they know whyso many people got infected that the virus is running out of hosts.
In a report posted to the preprint server medRxiv, a group led by Ester Sabino, of the Institute of Tropical Medicine at the University of So Paulo, says it tested banked blood for antibodies to the virus and estimates that between 44 and 66% of the population of Manaus has been infected since the city detected its first case in March.
From what we learned this is probably the highest prevalence in the world, Sabino said in a phone interview. Deaths have dropped very rapidly, and what were saying is that its related.
In the US, President Donald Trump has attracted ridicule for saying the virus will go away on its own. His comments may be a reference to the fact that if enough people get vaccinated or infected by a virus and develop antibodies to fight it off, so-called herd immunity starts to build in the population: As more people gain immunity, it becomes harder for the virus to infect new people and continue its spread.
Thats exactly whats happening in Manaus, the authors believe. Although nonpharmaceutical interventions, plus a change in population behavior, may have helped to limit SARS-CoV-2 transmission in Manaus, the unusually high infection rate suggests that herd immunity played a significant role in determining the size of the epidemic, they wrote.
The Amazon region has seen the virus at its worst, with people dying at home and infections hitting indigenous groups. However, by mid-August, the Washington Post was documenting a sudden turnaround in Manaus. From a peak of 79 deaths on one day in May, the rate in the city is down to two or three a day in September, according to its health department.
It remains unclear why the virus spread so quickly in Manaus, where mobility data shows people did begin social distancing in March. Sabino and her colleagues think the outbreak may have been accelerated by dense housing, poor water supplies, and crowding on boats that serve as local transportation.
According to the authors, the infection fatality rate in Manaus was about 0.28%, or one death in every 350 people infected by the virus. Considering that not everyone has caught the virus in Manaus, the city-wide covid-19 death rate would be between one in 500 and one in 800 people overall.
Florian Krammer, an immunologist at Mt. Sinai Hospital in New York, says it was expected that some regions would reach levels of immunity high enough to interrupt local outbreaks, but that such events should be considered public health failures, not successes.
Community immunity via natural infection is not a strategy, its a sign that government failed to control an outbreak and is paying for that in lives lost, Krammer tweeted.
Other cities should be cautious about drawing conclusions from Manaus since, among other factors, it has a fairly young population. Just 6% of citizens there are over 60, according to Brazils Institute of Geography and Statistics. In New York City, that figure is around 16% and for the US overall, its 20%. Elderly people have a much, much higher risk of dying if they catch the virus than younger people.
The Brazilian figures do suggest just how many people in one place could get infected as the virus spreadsa concept known as the attack rate. Were two-thirds of the US population to be infected, the virus could easily claim more than 500,000 American lives, mostly among the elderly. Thats in line with early projections for worst-case scenarios and with recent events on the ground. The US today surpassed the grim record of more than 200,000 deaths attributed to the virus. Tens of thousands of people are still being infected daily.
In Brazil, Sabinos team was well placed to study the trajectory of the pandemic because the group was previously involved with checking blood donations for transmissible pathogens. Since Brazilian blood banks retain samples of donated blood, they were able to go back and look for coronavirus antibodies at several points in timea technique known as serial sampling.
Very few people have the capacity to do serial sampling, but in Brazil its mandatory to save samples, so we could, says Sabino. During the month of June, a high of 40% of new blood donors were positive for coronavirus antibodies, though the number has decreased since then as antibodies tend to wane over time.
Gabriela Gomes, a mathematical modeler at the University of Strathclyde, says the new report finds that twice as many people in Manaus had coronavirus antibodies as a previous study had suggested; there could be ongoing discussion among immunologists over which finding is more accurate. Sabino says her team used an improved antibody test developed by Abbott Laboratories for their analysis, which she says is more sensitive than the test used for the earlier study and misses fewer cases.
Going forward, the Amazonian capital could now help public health officials better understand how long immunity to covid-19 lasts and how often the virus reinfects people. The blood survey clearly showed that with time, peoples antibodies become harder to detect. That could mean individual immunity to the virus is not permanent. Manaus may act as a sentinel to determine the longevity of population immunity and frequency of reinfections, the authors wrote in their preprint.
Weekly update: Coronavirus activity high across the board in Northeast Wisconsin Fox11online.com
MIAMI I really did not want to have heart surgery. Who wants their chest sliced open and carved like a turkey in the middle of a pandemic hot zone? But thats what I did in August.
An unruptured aneurysm quietly bulged in my aorta, the main artery of the body. For more than a year, blood pressure pills had helped manage it.
In January, the coronavirus which was spreading in parts of Asia still seemed like a distant problem.
My cardiologist said it was time. On his advice, I sought a second opinion from Dr. Steve Xydas, chief of the Columbia University Division of Cardiac and Thoracic Surgery at Mount Sinai Medical Center in Miami Beach, who specializes in aortic aneurysms.
Surgery was necessary, Dr. Xydas agreed, because I had two uncles who died from aneurysms and mine had grown to five centimeters. Any bigger, and Id risk a rupture.
He urged me to have a valve sparing aortic root repair, a procedure that involved cutting out the aneurysm and implanting a soft cloth graft. Given my age (I was 46) and overall good health (Im a runner), I would be a good candidate.
He suggested late spring for the surgery. You know what happened next.
While I am from Miami, I was living in New York City, where coronavirus infections surged in March and April. Hospitals were overwhelmed with people seriously ill and dying from Covid-19, the disease caused by the virus. The anxiety and uncertainty led me to wait. The New York Times, where I am a reporter, shut down its newsroom and turned to remote work. I temporarily moved back to Florida.
I was not alone in wondering what to do about my surgery. Around the country, people like me with a heart issue or other health problems such as cancer were questioning whether to delay or cancel important or time-sensitive procedures that could save our lives. At the time, many hospitals had canceled elective surgeries as coronavirus cases spiked. But as virus safety measures took effect, elective surgeries eventually resumed.
I had always planned to have my procedure at Mount Sinai in South Florida, where I have my partner, family and friends. But the region was also becoming a coronavirus hot spot. In April, a 39-year-old sheriffs deputy became Floridas first law enforcement officer to die from the virus. Many tourists who had visited Miami Beach for a circuit party and for spring break returned home infected. By April 11, Florida had confirmed more than 17,500 coronavirus cases and nearly 400 deaths.
Covid-19 scared the hell out of me. But an inner voice nagged me to schedule surgery anyway. Every time I ran, I could not help but think of the aneurysm growing, waiting to burst.
Aortic aneurysms are most common in men over 60. Complications account for about 15,000 deaths each year, according to Columbia University Irving Medical Center in New York. Medicines for blood pressure or surgery are the main treatments for aneurysms. Covid-19 was new, and there was no cure.
I did not know which was worse, the silent grenade in my heart or the virus, but I wanted to take control of my situation.
In early July, I scheduled an appointment to plan the procedure. At the hospital entrance, a staff member took my temperature, asked why I was there and if I had any Covid-19 symptoms (I did not).
Dr. Xydas recommended having the repair sooner than later while it was a choice and not an emergency. He gently explained that Covid-19 patients were kept separately in an old section of the hospital. My surgery and recovery would be in a new surgical tower.
I felt reassured. It seemed like the hospital might be the safest place to be during the pandemic. A date was set Aug. 17.
The day before, a nurse tested me for the virus. Negative. The following morning, I had the procedure. Success. The aneurysm was removed. No leaks from the graft.
When I came to, I noticed other safety measures that added to my peace of mind. I had my own room in the intensive care unit. Employees donned masks, changed gloves and used hand sanitizer whenever they visited. Local newscasts kept me abreast of pandemic developments, and I felt thankful that I was in a safe environment.
Two days later, I was in another private room that was wiped down, often every day. I was isolated from other patients, except those I saw from a distance when I walked with therapists. Hallways were mostly empty.
Like so many hospitals nationwide, Mount Sinai had banned most visitors. My family and friends were not allowed to see me, but Kelly Clarkson and Phil McGraw kept me company with their TV chatter.
After five days, I was discharged. When an aide wheeled me out of the hospital, nurses and patients wished me well.
Despite the soreness beneath the five-inch scar on my chest, I knew I would be OK. So far, I am and grateful.
A health worker holds blood samples during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida, on Wednesday, Sept. 9, 2020.
Eva Marie Uzcategui | Bloomberg | Getty Images
London is set to host the first human coronavirus "challenge trials," where volunteers are deliberately exposed to Covid-19 in order to test whether vaccines work, according to a report in the Financial Times.
The government-funded trials are due to be announced next week, the report said which cited several anonymous sources involved in the project, and are expected to begin in January in a quarantine facility in east London.
Volunteers in the challenge trials would first be given the experimental vaccine and then receive a dose of the virus around a month later.
Around 2,000 people in the U.K. are said to have volunteered for the study so far through the organization 1Day Sooner, with 37,000 volunteers signed up globally. In July, the organization published an open letter addressed to Dr. Francis Collins, the head of the National Institutes of Health (NIH) in the U.S., which called for the trails and included signatories from 15 Nobel laureates.
The FT report said 1Day Sooner is launching a campaign this week to get public funding for a biocontainment facility for the studies, big enough to quarantine 100 to 200 volunteers.
Read the full article here.
Through his attorney, Tony Spell on Tuesday entered not guilty pleas to six misdemeanor charges of violating the governor's emergency order by holding large gatherings at his Life Tabernacle Church in Baton Rouge.
Spell was not allowed inside the 19th Judicial Circuit Court in Baton Rouge, because he would not wear a face covering -- which is required to enter the building.
His attorney, Jeff Wittenbrink, was not available to answer questions on Wednesday morning, but did confirm that Spell was not in court.
"We don't get our rights to worship freely from the government we get those from God," Spell said. "We'd rather obey God than man."
Louisiana has had 162,214 confirmed cases of Covid-19 and 5,388 deaths according to Johns Hopkins University Center for Systems Science and Engineering.
Spell's next hearing is scheduled for January 25, 2021.
News Release
Wednesday, September 23, 2020
Trial evaluating investigational Janssen COVID-19 vaccine.
A fourth Phase 3 clinical trial evaluating an investigational vaccine for coronavirus disease 2019 (COVID-19) has begun enrolling adult volunteers. The trial is designed to evaluate if the investigational Janssen COVID-19 vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a single dose regimen. Up to 60,000 volunteers will be enrolled in the trial at up to nearly 215 clinical research sites in the United States and internationally.
The Janssen Pharmaceutical Companies of Johnson & Johnsondeveloped the investigational vaccine (also known as Ad.26.COV2.S) and is leading the clinical trial as regulatory sponsor. Janssen, 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 funding the trial.
U.S. and international trial sites part of the NIAID-supported COVID-19 Prevention Network (CoVPN) will participate in the trial. The CoVPN is composed of existing NIAID-supported clinical research networks with infectious disease expertise and designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodiesfor the prevention of COVID-19.
Four COVID-19 vaccine candidates are in Phase 3 clinical testing in the United States just over eight months after SARS-CoV-2 was identified. This is an unprecedented feat for the scientific community made possible by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia, said NIAID Director Anthony S. Fauci, M.D. It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need. The Janssen candidate has showed promise in early-stage testing and may be especially useful in controlling the pandemic if shown to be protective after a single dose.
The Janssen vaccine candidate is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 spike protein in cells. Adenoviruses are a group of viruses that cause the common cold. However, the adenovirus vector used in the vaccine candidate has been modified so that it can no longer replicate in humans and cause disease. Janssen uses the same vector in the first dose of its prime-boost vaccine regimen against Ebola virus disease (Ad26.ZEBOV and MVA-BN-Filo) that was recently granted marketing authorization by the European Commission.
Preclinical findings published in Nature show that the investigational Janssen COVID-19 vaccine induced neutralizing antibody responses in rhesus macaques and provided complete or near-complete protection against virus infection in the lungs and nose following SARS-CoV-2 challenge. The safety, reactogenicity and immunogenicity of the investigational vaccine are being evaluated in a Phase 1/2a trial in the United States and Belgium enrolling adult volunteers. Positive interim results from the Phase 1/2a clinical study demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development.
Scientific partners from government, industry and academia are working hand-in-hand to develop safe, effective vaccines to put this pandemic in our rear-view mirror, said NIH Director Francis S. Collins, M.D., Ph.D. While administrative steps are being streamlined to speed the process, safety and effectiveness measures are just as rigorous than ever.
The Phase 3 trial is being conducted in collaboration with Operation Warp Speed (OWS), a multi-agency collaboration overseen by HHS and the Department of Defense that aims to accelerate the development, manufacturing and distribution of medical countermeasures for COVID-19. OWS and CoVPN also are assisting with additional COVID-19 preventive candidate vaccines, including mRNA-1273, an investigational vaccine co-developed by NIAID and the Cambridge, Massachusetts-based biotechnology company Moderna, Inc., and AZD1222, a vaccine candidate being developed by United Kingdom-based biopharmaceutical company AstraZeneca.
To have just one candidate vaccine in Phase 3 trials less than a year after a virus was first reported would be a remarkable accomplishment; to have four candidates at that stage is extraordinary, said HHS Secretary Alex Azar. By building a portfolio of candidate vaccines, Operation Warp Speed is maximizing the chances that we will have substantial supplies of a safe and effective vaccineand maybe multiple vaccine optionsby January 2021.
The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership helped to ensure the protocols of all NIH- and OWS-supported Phase 3 trials of investigational vaccines use the same assays and are designed to evaluate the same primary objective: whether the vaccine can prevent symptomatic COVID-19. This approach enables transparent evaluation of the relative performance of each vaccine approach across trials.
Paul A. Goepfert, M.D., director of the Alabama Vaccine Research Clinic at the University of Alabama in Birmingham; Beatriz Grinsztejn, M.D., Ph.D., director of the Laboratory of Clinical Research on HIV/AIDS at the Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation in Rio de Janeiro, Brazil; and Glenda E. Gray, M.B.B.Ch., president and chief executive officer of the South African Medical Research Council and co-principal investigator of the HIV Vaccine Trials Network (HVTN), will serve as principal investigators for the Phase 3 trial of the investigational Janssen COVID-19 vaccine.
Volunteers must provide informed consent to participate in the trial. After providing a baseline nasopharyngeal and blood sample, participants will be assigned at random to receive either a single dose of the investigational vaccine or a saline placebo. The trial is blinded, meaning neither investigators nor participants will know who is receiving the investigational vaccine. Participants will be followed closely for safety and will be asked to provide additional blood samples at specified time points after the injection and over two years. Scientists will analyze the blood samples to detect and quantify immune responses to COVID-19. Of note, specialized assays will be used that can distinguish between immunity as a result of natural infection and vaccine-induced immunity.
The trial is designed primarily to determine if the investigational vaccine can prevent moderate to severe COVID-19 after a single dose. It also aims to understand if the vaccine can prevent COVID-19 requiring medical intervention and if the vaccine can prevent milder cases of COVID-19 and asymptomatic SARS-CoV-2 infection.
An independent Data and Safety Monitoring Board (DSMB) will provide oversight to ensure the safe and ethical conduct of the study. All Phase 3 clinical trials of candidate vaccines supported through Operation Warp Speed are overseen by a common DSMB developed in consultation with ACTIV.
Adults who are interested in joining this study can visit Coronaviruspreventionnetwork.org or ClinicalTrials.gov and search identifier NCT04505722.
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 Operation Warp Speed:OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
About the National Institute of Allergy and Infectious Diseases: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 theNIAID website.
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
###
