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Thursday, December 24, 2020

AIM ImmunoTech's Ampligen trial in COVID-19 'long haulers' proceeds

 

Inovio up on positive peer-reviewed data for COVID-19 jab

 

  • Inovio Pharmaceuticals (NASDAQ:INO) has climbed 9.0% in the premarket after the medical journal, The Lancet, published the Phase 1 clinical trial data of its COVID-19 vaccine candidate, INO-4800.
  • In June, the company announced positive interim Phase 1 data for INO-4800 indicating 94% of immunogenicity of 40 healthy trial participants aged 18 to 50 years.
  • According to the journal report, 38 trial subjects have received both doses, and 100% (38/38) of them have achieved the immunogenicity with excellent safety and tolerability profile, with either or both humoral or cellular immune responses.
  • Phase 1 data have suggested the vaccine could be a safe booster, and one of the volunteers in the 1.0mg dose group has become seropositive at baseline due to prior infection with COVID-19. Notably, despite receiving both doses, the individual has not developed any adverse events.
  • Yet, the report highlights the need for a larger sample size and the inability to conclude the length of the vaccine-driven immunity.
  • Early December, Inovio announced the initiation of the Phase 2 portion of Phase 2/3 trial for the vaccine in a trial involving 400 individuals aged 18 years or older.
  • https://seekingalpha.com/news/3647358-inovio-is-up-9-in-premarket-on-peer-reviewed-data-for-covidminus-19-jab

Wednesday, December 23, 2020

Floridians 65 and older will get coronavirus vaccine first: DeSantis

  Floridians 65 and older will be the first in the general population to be vaccinated for COVID-19, with the first doses administered as soon as Monday, Gov. Ron DeSantis said Wednesday.

DeSantis signed an executive order ensuring that older Floridians will be the first in the general population to receive vaccines. Health care workers and people in long-term care facilities, who are most vulnerable to the virus, are being treated already, and DeSantis said the state has administered 70,000 shots already.

Florida coronavirus cases by age group

Doctors say older people are at a greater risk to developing severe symptoms from COVID-19, which makes Florida especially vulnerable.

With more vaccines arriving, DeSantis said the state was ready to expand the vaccines to people over the age of 65.

The treatments will be administered by hospitals and county health departments as early as Monday, but DeSantis did not say how people could sign up to be vaccinated. He said those details will be available closer to Monday.

“Bear with us,” he said.

Those health departments won’t include Tampa Bay on Monday, though. A spokesman for the Hillsborough County Department of Health said vaccines for the area will be available “in the coming weeks,” but they won’t have them available on Monday.

On Tuesday, DeSantis said he wanted to vaccinate the more than 3 million Floridians over the age of 70 over the next six weeks, giving them priority over essential workers and younger people with underlying health conditions.

“The vaccines are going to be targeted where the risk is going to be greatest, and that’s in our elderly population,” DeSantis said Tuesday. “We are not going to put young, healthy workers ahead of our elderly, vulnerable population.”

https://www.tampabay.com/news/florida-politics/2020/12/23/floridians-65-and-older-will-get-coronavirus-vaccine-first-desantis-orders/

Bad News: Cold Weather Increases Fomite Spread of SARS-CoV-2

 The holiday season is still not done delivering bad news. With ICUs at 0% capacity in some parts of the United States, Public health officials wonder if the seasonal change alone will affect the transmission of SARS-CoV-2. A recent research study has studied the influence of temperature and humidity on the properties of individual virus-likes.

When it comes to fighting the spread of this virus, you kind of have to fight every particle individually. And so you need to understand what makes each individual particle degrade. People are also working on vaccines and are trying to understand how the virus is recognized? All of these questions are single particle questions. And if you understand that, then that enables you to fight a hoard of them.

 

The results indicate cold weather could have a preserving effect on the virus. The first study to evaluate the mechanics of the virus at a single particle stage, found that other coronaviruses tend to infect more people during the winter months.
Source: CNN; Johns Hopkins University

"You would expect that temperature makes a huge difference, and that's what we saw. To the point where the packaging of the virus was completely destroyed by even moderate temperature increases," said Michael Vershinin, assistant professor at the University of Utah and co-senior author of the paper. "What's surprising is how little heat was needed to break them down -- surfaces that are warm to the touch, but not hot. The packaging of this virus is very sensitive to temperature."

The SARS-CoV-2 virus is typically transmitted by spreading respiratory particles (e.g. sneezing or coughing), which ejects droplets of the microscopic aerosols from the lungs. These mucus droplets have a high volume-to-surface ratio and dry fast, so that wet and dry virus particles come in contact with a surface.

Scientists examined virus-like particles on both dry and humid glass surfaces. They found relatively little variation between humidity levels on the surfaces. But scientists point out that humidity potentially matters when the particles in the air by impacting how easily the aerosols dry out.

https://smosa.com/bad-news-cold-weather-will-help-the-spread-of-sars-cov-2/

Millions of U.S. vaccine doses sit on ice, putting 2020 goal in doubt

 Millions of COVID-19 vaccines are sitting unused in U.S. hospitals and elsewhere a week into the massive inoculation campaign, putting the government’s target for 20 million vaccinations this month in doubt.

As of Wednesday morning, only 1 million shots of the Pfizer-BioNTech COVID-19 vaccine had been given, about one-third of the first shipment sent last week. Over 9.5 million doses of vaccines, including Moderna’s, have now been sent to states, according to the U.S. Centers for Disease Control and Prevention.

While hospitals have started giving out Moderna’s vaccine, the CDC has not yet reported that data and there may be a lag in reporting shots given of both the Pfizer and Moderna vaccines.

The slow pace has barely picked up from the first week when 614,000 shots were given although nearly 2.9 million were shipped.

Hospitals said the first COVID-19 vaccinations started slowly last Monday as they navigated preparing the previously frozen shots for use, finding employees to run the vaccination clinics, and ensuring proper social distancing both before and after vaccination. Some said they did only about 100 shots the first day.

They were contending with a COVID-19 surge, as cases around the United States surpassed 18 million with 323,000 deaths.

The Trump administration promised to vaccinate 20 million by the end of the year while providing little funding to achieve the goal.

That’s nine days to give out nearly 19 million shots or over 2 million people vaccinated a day including on Christmas Day.

Almost 5.9 million doses of Moderna Inc’s vaccine should go out this week and an additional 2 million doses from Pfizer and partner BioNTech.

“The commitment that we can make is to make vaccine doses available,” U.S. Operation Warp Speed chief adviser Dr. Moncef Slaoui said on a Wednesday press call. He noted the rate of people getting a shot in their arm is “slower than we thought it would be.”

Two more vaccines may be approved in February from Johnson & Johnson Inc and AstraZeneca Plc.

The government’s goal is 100 million Pfizer and Moderna shots in arms by March 1.

Operation Warp Speed’s General Gustave Perna, who is leading the vaccine distribution effort, on Monday said that the CDC data reflects a reporting lag and that the number of vaccinations will catch up as time goes on.

The CDC said its data may also reflect a lag between vaccine dosing and state reporting. Most nursing home vaccinations only began in mass this week, and the CDC data does not specify how many doses from the first shipment were being held by states for that group.

STAFF STRETCHED THIN

Margaret Mary Health, a 25-bed rural hospital in Indiana, built a drive-thru vaccination clinic at a local fire station and one at a local recreation center to vaccinate healthcare workers in the surrounding counties, according to Chief Executive Officer Tim Putnam.

Putnam, who has done traffic control at the clinic’s drive-thru, said they have used about 400 of 1,100 doses received.

“We’re asking for volunteers from our staff, volunteers from the local community college to step in and build this process from the ground up,” he said.

Some of the largest U.S. hospitals inoculated more than 1,000 people per day, having done dry runs of the vaccine delivery and rollout.

Vermont, Delaware and Idaho were among states that confirmed their states had given only thousands of doses - a fraction of those available to them - during the first week.

Jason Schwartz, assistant professor of health policy at Yale School of Public Health, described the initial tally as “discouraging” and said “the challenges of getting vaccines out as quickly as we’re able to manufacture them will only grow.”

Johnson & Johnson’s one-shot vaccine could speed deployment because it requires a conventional refrigerator and has no specialized procedures to thaw out and administer, said Claire Hannan, executive director of the Association for Immunization Managers trade group. AstraZeneca’s two dose vaccine also can be stored in a refrigerator.

“When it’s refrigerator-stable and a one-dose regimen, it can’t get any easier than that,” Hannan said.

HOSPITALS START SLOWLY BUT SPEED UP

Dr. Saul Weingart, the chief medical officer of Tufts Medical Center in Boston, said the hospital had given about 750 doses of the around 3,000 available as of Friday. It started with 100 shots per day and worked up to about 450, he said.

He said experts at the hospital modeled that giving Pfizer’s COVID-19 vaccine would take 10 minutes, about two to three times as long as a flu shot, due to the procedures needed because the vaccine is stored in a deep freeze. Patients need to socially distance before and after being given the vaccine and be monitored for allergic reactions.

The United States gives 170 million flu vaccinations each year within a few months, but for the COVID-19 pandemic, the United States must give about three times that number of shots - the Pfizer and Moderna shots are two doses - to reach most Americans by July. At its current pace, the U.S. appears to have the capacity to administer less than a third of the shots that are shipped in a given week, underscoring the gap.

A spokesperson for Houston Methodist, a hospital in Houston, Texas, said it had given 8,300 employees the vaccine as of Monday with about 7,000 doses left from the first shipment.

The University of Southern California’s Keck Medicine medical school has vaccinated over 3,000 employees and said it will take six weeks for everyone, similar to its flu vaccination schedule.

States and health departments need federal money to hire staff, from data center workers to track inoculations to call center employees to field questions, said Adriane Casalotti, chief of government and public affairs of the National Association of County and City Health Officials.

The U.S. Congress’s current coronavirus aid package sets aside more than $8 billion for vaccine distribution but is delayed.

“You can’t hire someone in December and train them up if you don’t know you can pay them in January,” Casalotti said.

https://www.reuters.com/article/us-health-coronavirus-vaccines-distribut/millions-of-u-s-vaccine-doses-sit-on-ice-putting-2020-goal-in-doubt-idUSKBN28X2J6

COVID immunity lasts at least 8 months: new data

 Australian researchers have revealed—for the first time—that people who have been infected with the COVID-19 virus have immune memory to protect against reinfection for at least eight months.

The research is the strongest evidence for the likelihood that vaccines against the virus, SARS-CoV-2, will work for long periods. Previously, many studies have shown that the first wave of antibodies to  wane after the first few months, raising concerns that people may lose immunity quickly. This new work allays these concerns.

The study is the result of a multi-center collaboration led by Associate Professor Menno van Zelm, from the Monash University Department of Immunology and Pathology, with the Alfred Research Alliance between Monash University, The Alfred hospital and the Burnet Institute, and published today in the prestigious journal, Science Immunology. The publication reveals the discovery that specific cells within the  called memory B cells, "remembers" infection by the virus, and if challenged again, through re-exposure to the virus, triggers a protective immune response through rapid production of protective antibodies.

The researchers recruited a cohort of 25 COVID-19 patients and took 36 blood samples from them from Day 4 post infection to Day 242 post infection.

As with other studies—looking only at the antibody response—the researchers found that antibodies against the virus started to drop off after 20 days post infection.

However—importantly—all patients continued to have memory B cells that recognized one of two components of the SARS-CoV-2 virus, the spike and nucleocapsid proteins. These virus-specific memory B cells were stably present as far as eight months after .

According to Associate Professor van Zelm, the results give hope to the efficacy of any  against the virus and also explains why there have been so few examples of genuine reinfection across the millions of those who have tested positive for the virus globally.

"These results are important because they show, definitively, that patients infected with the COVID-19 virus do in fact retain immunity against the  and the disease," he said.

"This has been a black cloud hanging over the potential protection that could be provided by any COVID-19 vaccine and gives real hope that, once a vaccine or vaccines are developed, they will provide long-term protection."

More information: Rapid generation of durable B cell memory to SARS-CoV-2 spike and nucleocapsid proteins in COVID-19 and convalescence, Science Immunology  22 Dec 2020: Vol. 5, Issue 54, eabf8891, DOI: 10.1126/sciimmunol.abf8891 , immunology.sciencemag.org/content/5/54/eabf8891

https://medicalxpress.com/news/2020-12-covid-immunity-months-reveals.html

Neutralising SARS-CoV-2 RBD-specific antibodies persist at least 6 months independent of symptoms severity

 Angelika Wagner, Angela Guzek, Johanna Ruff, Joanna Jasinska, Ute Scheikl, Ines Zwazl, Michael Kundi, Hannes Stockinger, Maria R. Farcet, Thomas Kreil, Eva Hoeltl, Ursula Wiedermann