September 25 coronavirus news

By James Griffiths, Adam Renton, Joshua Berlinger, Melissa Macaya and Veronica Rocha, CNN

Updated 12:58 AM ET, Sat September 26, 2020
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12:36 a.m. ET, September 26, 2020

Health minister in Australian state of Victoria resigns after being blamed for mishandling quarantine hotels 

From CNN’s Angus Watson in Sydney

Jenny Mikakos speaks to the media on June 22 in Melbourne, Australia. 
Jenny Mikakos speaks to the media on June 22 in Melbourne, Australia.  Darrian Traynor/Getty Images

Victoria's Health Minister Jenny Mikakos has resigned in the wake of Premier Daniel Andrews’ testimony to the state’s hotel quarantine inquiry, in which he said she was responsible for the bungled scheme that resulted in a devastating second wave of the virus in the state.

In a statement posted on Twitter, Mikakos said she had written to Victoria’s Governor to resign as minister and will also be resigning from Parliament. 

“I have never wanted to leave a job unfinished, but in light of the premier’s statement to the board of inquiry and the fact that there are elements in it that I strongly disagree with, I believe that I cannot continue to serve in his cabinet,” she wrote. 

On Friday, Andrews said Mikakos was responsible for the hotel quarantine program, but didn't know who made the decision to use private security contractors to manage it. Mikakos said on Saturday she took responsibility for the department -- but it was not her responsibility alone.

A Board of Inquiry has heard evidence that Victoria’s second wave was started by leaks from the hotel quarantine scheme. Its final report is due on November 6. 

The situation in Victoria: Victoria is not Australia's most populous state, but it has reported around three-quarters of the country's 27,000 cases.

As of Friday, Victoria had recorded more than 20,000 coronavirus infections including 781 deaths, according to official data. The outbreak is centered in the state's largest city, Melbourne.

11:59 p.m. ET, September 25, 2020

US public service announcement narrated by Harrison Ford aims to recruit vaccine trial volunteers

From CNN Health’s Sierra Jenkins

Harrison Ford smiles during a press conference to present the film 'El Llamado Salvaje' on February 5, in Mexico City.
Harrison Ford smiles during a press conference to present the film 'El Llamado Salvaje' on February 5, in Mexico City. Adrián Monroy/Medios y Media/Getty Images

Actor Harrison Ford has narrated a new public service announcement that aims to recruit volunteers for Covid-19 vaccine clinical trials. 

Sprinkled among clips of President John F. Kennedy’s 1961 inaugural address, the ad features some of the 1,500 Covid-19 Prevention Network (CoVPN) registry participants who submitted video testimonies explaining why they volunteered.

“I’m not a doctor, but I am a citizen of this great country,” says one volunteer. “I want to do my part as an American,” adds another.

“We need to register a million more volunteers to complete the studies and possibly get a safe and effective vaccine to hundreds of millions of Americans,” Ford says in the ad.

“The vaccine trial needs Americans of every race, location and medical condition to help in one of the most important endeavours of our lifetime.”

Producers said they expect the PSA to air on major networks in the future. 

This PSA is not part of a previously announced federal government campaign.

 

11:25 p.m. ET, September 25, 2020

Health experts demand more transparency in open letter to FDA commissioner

From CNN Health’s Nadia Kounang

Dr.Stephen Hahn testifies during a Senate hearing on September 23, in Washington.
Dr.Stephen Hahn testifies during a Senate hearing on September 23, in Washington. Alex Edelman/Pool/Getty Images

Public health and regulatory experts signed an open letter to FDA Commissioner Dr. Stephen Hahn on Friday, demanding transparency and outlining steps to maintain the agency’s integrity. 

The 33 signees of the #ProtectTheFDA letter included Dr. Luciana Borio, former chief scientist for the US Food and Drug Administration; Dr. Aaron Kesselheim, head of the Program On Regulation, Therapeutics, and Law at Harvard Medical School and Brigham and Women’s Hospital; Dr. Peter Lurie, president of the Center for Science in the Public Interest; and Dr. Eric Topol, director of the Scripps Research Translational Institute. 

“The data and reasoning on which FDA bases its actions must be transparent and made reasonably available at the time the decision is made," the letter said.

If decisions are made on data that’s evolving quickly, the authors said, there should be “a clear follow-up plan” that explains how more data will be collected and the process for re-evaluating the decision. “The FDA must enforce these timelines and be ready to modify or reverse its initial decision if better data require doing so," the letter added.

The authors said that undermining the FDA by allowing political interference would harm the public. 

The letter listed eight points for the FDA to act on, including insisting that “the President and his White House advisers refrain from criticizing federal scientists, their scientific conclusions, measurements, or methodologies” and sharing “key data and consultation with scientists from … the NIAID, the NIH, the CDC, FDA’s Vaccines and Related Products Advisory Committee, and the Infectious Diseases Society of America” before making any decision on authorizing a Covid-19 vaccine. 

The signees of the letter also called on the FDA to “commit to publicly challenging claims by any government officials that are inconsistent with the evidence evaluated by FDA scientists in issuing its decisions.”

 

10:51 p.m. ET, September 25, 2020

A 9-year-old has been suspended after a teacher saw a gun in his bedroom during a virtual class

From CNN's Gisela Crespo

Ka Mauri Harrison, 9, pictured in his home participating in virtual learning.
Ka Mauri Harrison, 9, pictured in his home participating in virtual learning. Courtesy of Harrison Family

A 9-year-old Louisiana student was suspended and now has a weapons violation in his school record after a teacher said a gun was seen in his bedroom during a virtual class. 

What happened: Fourth-grader Ka Mauri Harrison was taking a rollover test in his bedroom on September 11 after being off school sick the day before, Chelsea Cusimano, the attorney representing the Harrison family, told CNN Friday. 

While Harrison was taking the test, Ka Mauri's brother -- who he shares a room with -- stepped or tripped on a BB gun that Ka Mauri had received as a gift. Ka Mauri picked up the gun and was out of sight from the screen for a moment before placing the BB gun next to him on his chair, Cusimano said. 

Ka Mauri -- who had muted the virtual class he was on so he could concentrate on his test -- continued working before noticing his teacher was trying to get his attention. According to Cusimano, the teacher was screaming and Ka Mari got kicked off the virtual classroom. 

After the incident: A behavior interventionist told Ka Mauri's family that, according to the teacher, Ka Mauri was out of sight for a few second sand came back with what looked like a rifle which he propped against his chair, according to Cusimano. The family was told Ka Mauri wouldn't be able to go back to school. 

At a hearing on September 22, it was determined Ka Mauri was guilty of displaying a facsimile weapon while receiving virtual education. Cusimano said a hearing officer determined it was a BB gun.

The school amended the recommendation for expulsion to school suspension for six days and social work assessment. Ka Mauri returned to school on Thursday, September 24.

The reaction: Cusimano told CNN the school parish "took an on-campus weapons policy and unilaterally determined that they were going to apply it to one of their students in a manner as if he was on campus and not consider any measures such as the privacy of his own home." 

Cusimano argues that schools should consider the things that take place in a private home when they enact policies in a virtual learning environment. 

"Now he's got a federal gun possession mark on his educational record for the rest of his career until he goes to college," she said.

Cusimano and the Harrison family want the charge to be cleared from Ka Mauri's record. The parish's legal counsel argued Ka Mauri doesn't have the right to an appeal because it was only a suspension, according to Cusimano. 

In a statement to CNN, the school parish told CNN: "We do not comment on individual student records. Regarding discipline, it is our policy that teachers and administrators may employ reasonable disciplinary and corrective measures to maintain order."   

Louisiana Attorney General Jeff Landry announced Friday his office is investigating the incident, saying it appears to be a "blatant government overreach by the school system."

9:27 p.m. ET, September 25, 2020

Any “hanky panky” around US vaccine approval is unlikely, Fauci says

From CNN Health’s Lauren Mascarenhas

National Institute of Allergy and Infectious Diseases Director Anthony Fauci on September 23.
National Institute of Allergy and Infectious Diseases Director Anthony Fauci on September 23. Graeme Jennings/Pool/AFP/Getty Images

It is unlikely that political interference will play a role in the approval process of a Covid-19 vaccine, Dr. Anthony Fauci, National Institute of Allergy and Infectious Diseases director, said Friday.

“The big elephant in the room is: Is somebody going to try and make a political end-run to interfere with the process? Let's call it the way it is,” Fauci told JAMA editor-in-chief Dr. Howard Bauchner in an online conversation. 
“If you look at the standard process of how these things work, I think you could feel comfortable that it is really unlikely that that's going to happen.” 

Fauci emphasized the role of the Data and Safety Monitoring Board, which will independently review a vaccine for safety and efficacy before it is approved.

“When a decision is made to approve or not a vaccine, to do an EUA or not, that's going to be public, so any kind of hanky panky there that people are worried about is going to be multiple checkpoints,” he said. “You start off with the Data and Safety Monitoring Board, you then go to the FDA – who we trust – then you go to the advisory committee to the FDA, and then you have the scientific community looking at the data.”
“I trust the career scientists of FDA, and I certainly trust the commissioner of FDA,” he added.

Fauci emphasized that the professionals at the US Food and Drug Administration (FDA) are experienced.

“You got to reassure people who have concern and skepticism there that these are professionals at the FDA that have been doing this their entire career. They really know what they're doing. This is what they do every single day," he said.

7:55 p.m. ET, September 25, 2020

IHME director warns of coming "surge" in Covid-19 cases

From CNN’s Shelby Lin Erdman

There’s concern about an explosion in coronavirus cases in the next few months as fall and winter set in, Dr. Christopher Murray, the director of the Institute for Health Metrics and Evaluation at the University of Washington, told CNN Friday.

The IHME model released new numbers Thursday that projected 371,509 deaths by Jan. 1 — a dip of 7,000 from the model’s projection last week. However, that’s 168,000 more deaths than the current US total of more than 203,000. The decrease in the projection from last week is attributed to an uptick in mask use in some states.

There are two things driving the expected winter surge, Murray told CNN’s Wolf Blitzer.

“First, as case counts have come down in some states, we tend to see that people become less careful, they tend to have more contact,” he said.

“But then the most important effect is the seasonality of the virus, that people go indoors, transmission happens more.”

“That seasonality is going to be driving the big winter surge that we expect to see,” Murray predicted. 

“That's why our model shows the huge surge that we really expect to take off in October and accelerate in November in December.”

“There's a real risk that winter surge has already started in Europe, you know cases are exploding there. So we know it's coming and we expect it to hit the US pretty soon. 

The IHME model also projected that if 95% of Americans wore masks in public, 100,000 lives could be saved by Jan. 1.

Watch:

7:23 p.m. ET, September 25, 2020

Here's the latest on Johnson & Johnson's Covid-19 vaccine

From CNN’s Andrea Kane

This September 2020 photo provided by Johnson & Johnson shows a single-dose COVID-19 vaccine being developed by the company. 
This September 2020 photo provided by Johnson & Johnson shows a single-dose COVID-19 vaccine being developed by the company.  Cheryl Gerber/Courtesy of Johnson & Johnson/AP

Early results from a Phase 1/2a clinical trial of Johnson & Johnson’s coronavirus vaccine shows that it was well tolerated and even one dose appeared to produce a strong immune response in almost all of the participants for whom data is available.

The study was posted Friday on MedRxiv, a preprint server, which means that it has not yet been peer-reviewed or published in a medical journal.

This interim analysis of the Phase 1/2a trial looked at the safety and side effects of two different doses of the vaccine in almost 800 participants, including about 400 18- to 55-year-olds and about 400 people 65 and older.  

The analysis also looked at the vaccine’s ability to produce an immune response in the 18- to 55-year-olds, plus a small subset of those in the 65 and older group, who are at much higher risk of getting very sick and dying from the virus. 

The researchers found that 99% of the participants age 18 to 55 in both dose groups had developed antibodies against the virus 29 days after getting vaccinated. Among the participants 65 and older, only 15 had antibody data available and 100% were seropositive. 

The analysis also found that most of the side effects were mild and resolved after a couple of days. The most common were fever, headache, fatigue, body aches and injection-site pain. The study authors note that the rate of side effects was lower in the older participants than in the younger ones — 36% compared to 64% — and this may mean that older people may not be having as strong an immune response.

Some of the participants from each age group and from both dose groups will receive a second shot of the vaccine as part of the trial, but the results published Friday are based on data after the first shot.

The vaccine – called Ad26.COV2.S – uses a non-replicating adenovirus to deliver the SARVS-CoV-2 spike protein; it’s the same technology used in J&J-developed vaccines for Ebola, Zika, HIV and RSV.

Based on the results of this study, Johnson & Johnson on Wednesday became the fourth company to begin large Phase 3 trials; the company says it plans to enroll 60,000 adult volunteers at more than 200 sites in the US and internationally. 

So far it’s the only Phase 3 Covid-19 vaccine trial in the United States that is testing a single-dose of the vaccine.

7:09 p.m. ET, September 25, 2020

Fauci: Covid-19 vaccinations may start by end of year, but it could be a while until we're back to normal

From CNN's Lauren Mascarenhas

Covid-19 vaccinations could very likely start in November or December, but it could be a while until we’re back to normal, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Friday. 

“The availability and starting vaccination could very likely start in November or December,” Fauci told JAMA Editor in Chief Dr. Howard Bauchner in an online conversation. 

“By the time you get enough people vaccinated so that you can feel you've had an impact enough on the outbreak, so that you can start thinking about maybe getting a little bit more towards normality, that very likely, as I and others have said, will be maybe the third quarter or so of 2021. Maybe even into the fourth quarter.”

Fauci noted that with the different vaccines being developed, the US could potentially have 700 million doses by April of 2021, but the availability of vaccines is not the only factor at play.

“In our society, it likely will be that many people will not want to get the vaccine right away and want to wait to see what happens with the first 10, 20, 30, 40, 50 million people,” he said. 

6:38 p.m. ET, September 25, 2020

Fewer than 10% in the US have antibodies to the novel coronavirus, study finds

From CNN’s Andrea Kane

A nationwide study of the blood of more than 28,000 people found that, as of July, approximately 9.3% in the United States had antibodies to the novel coronavirus. The numbers ranged from an average of 3.5% in the West to an average of 27% in the Northeast. 

“This research clearly confirms that despite high rates of COVID-19 in the United States, the number of people with antibodies is still low and we haven’t come close to achieving herd immunity. Until an effective vaccine is approved, we need to make sure our more vulnerable populations are reached with prevention measures,” one of the study authors, Dr. Julie Parsonnet, a professor of medicine at Stanford University, said in a statement.

For the study, which was published Friday in The Lancet, researchers led by Stanford University��s Dr. Shuchi Anand, analyzed samples of plasma — a component of blood — from more than 28,500 patients receiving dialysis in July at approximately 1,300 facilities in 46 states run by one lab.  

Why dialysis patients? “Patients receiving dialysis in the USA undergo routine monthly laboratory studies,” the researchers wrote, so there was no need for “considerable infrastructure and expense” to gather samples, nor were there other pandemic-related challenges. 

Additionally, the risk factors for getting infected with coronavirus and for developing severe disease — including advanced age, non-White race, poverty and diabetes — “are the rule rather than the exception in the US dialysis population.”

The overall percent of people who were positive for antibodies among those sampled was 8%. Because dialysis patients aren’t representative of the US population, the researchers standardized the results with respect to age, sex, race and ethnicity, and region, to get an estimate of 9.3% seropositivity for the US adult population.

They found that there was a wide variation by state: seven states had 0% seropositivity, while New York, an early pandemic hotspot, topped the list with 33%.  

The researchers were also able to see who was more likely to have antibodies. They found that, compared to the White population, residents of predominantly Black and Hispanic neighborhoods were two to three times more likely to be seropositive; people living in poorer areas were two times more likely; and those living in the most densely populated areas were 10 times more likely.

They also compared rates from their study with population case counts from Johns Hopkins University. From that, they estimated that only 9.2% of the patients with antibodies had been officially diagnosed by a test with Covid-19. 

But, as the authors of an accompanying commentary point out, questions still remain about how long the antibodies last and how protective they are. Still, they wrote, studies like this one can help find answers if they can be repeated over time.

The study authors indicated the same. “A surveillance strategy relying on monthly testing of remainder plasma of patients receiving dialysis can produce unbiased estimates of SARS-CoV-2 spread inclusive of hard-to-reach, disadvantaged populations in the USA. Such surveillance can inform disease trends, resource allocation, and effectiveness of community interventions during the COVID-19 pandemic.”