FDA Approves First Ebola Treatment: What to Know

  • The Food and Drug Administration approved a new treatment for Ebola virus disease, which could help control ongoing and new outbreaks.
  • The treatment is called Inmazeb and made by Regeneron Pharmaceuticals.
  • It’s a combination of three monoclonal antibodies.

Last week, the Food and Drug Administration (FDA) approved the first treatment for Ebola virus disease in adults and children.

The treatment, called Inmazeb, is a combination of three monoclonal antibodies made by Regeneron Pharmaceuticals. The drug is approved to treat Zaire ebolavirus, one of six known types.

The average case death rate of Ebola is around 50 percent, according to the World Health Organization, although it has ranged from 25 percent to 90 percent in past outbreaks.

Inmazeb, along with a vaccine approved by the FDA last year, offers a new way to fight Ebola.

“Until now, we have not had much to offer in the way of treatment for this deadly virus other than supportive care and attempts to prevent spread to others,” said Dr. Katie Passaretti, medical director of infection prevention at Atrium Health.

“The approval of Inmazeb is an important step forward and offers hope as we face current and future outbreaks,” she said.

Triple antibody cocktail improves survival

The monoclonal antibodies included in Inmazeb target a glycoprotein on the surface of the Ebola virus.

The virus uses this glycoprotein to attach to human cells and fuse its own membrane with that of the host cell. This allows the virus to enter the cell and cause an infection.

By binding to the glycoprotein, the three antibodies can block the virus from attaching to and entering the host cell.

Leah Lipsich, PhD, who heads Regeneron’s global program for infectious diseases, told the Associated Press that using three monoclonal antibodies reduces the risk that the virus will become resistant to the drug.

The drug, which is given as a single intravenous dose, was tested alongside three other drugs in a randomized, controlled trial conducted during a 2018-19 Ebola outbreak in the Democratic Republic of Congo (DRC).

Of 155 people given Inmazeb, 33.5 percent died after 28 days, compared with 51.3 percent of 154 people who received another experimental triple monoclonal antibody drug.

The most common symptoms experienced by those who received Inmazeb included fever, chills, fast heart rate, fast breathing, and vomiting. These are also common symptoms of an Ebola infection.

Another group of participants received a single monoclonal antibody derived from an Ebola survivor. Of 174 people who received this drug, 35.1 percent survived after 28 days.

A fourth group of participants received Gilead Sciences’ broad-spectrum antiviral remdesivir. About half of them died from Ebola.

Remdesivir had shown better promise initially as a treatment for COVID-19. The FDA issued an emergency use authorization for it earlier this year for use against the new coronavirus.

But this month, a study from the World Health Organization found no evidence it prevented deaths.

When President Trump was hospitalized this month with COVID-19, he received several treatments, including remdesivir and a two-monoclonal antibody cocktail developed by Regeneron.

“Among a number of agents being studied to combat COVID-19, one of those received by President Trump recently was a monoclonal antibody like Inmazeb,” said Dr. Charles Bailey, medical director for infection prevention at St. Joseph Health and Mission Hospital in Orange County, California.

“As yet, we do not have a directly acting antiviral drug for Ebola to compare to the other drug received by President Trump: remdesivir,” he said.

New tools in fight against Ebola outbreaks

Ebola is highly contagious. It mainly spreads through the bodily fluids of a person who is sick or has died from the disease.

Symptoms include fever, fatigue, muscle pain, headache, and sore throat. Later symptoms include vomiting, diarrhea, and sometimes internal and external bleeding.

The FDA approved the first vaccine against the Ebola virus, Ervebo, in December 2019.

A preliminary analysis earlier this year found that the vaccine was 97.5 percent effective in people who were exposed to the virus at least 10 days after being vaccinated.

While the Ebola vaccine can help prevent future outbreaks, Inmazeb can be used to treat ongoing outbreaks, such as the one in Équateur Province of Congo. As of early September, this outbreak had reached 110 cases, with 47 deaths.

The Ebola virus was first identified in 1976 in the Democratic Republic of Congo. The largest outbreak occurred in West Africa between 2013 and 2016, and led to more than 28,000 cases and more than 11,000 deaths.

During this outbreak, 11 people were treated for Ebola in the United States.

In addition, two healthcare workers in Texas contracted Ebola infections after treating a man with Ebola who had traveled from Africa to the United States. The man died; both healthcare workers recovered.

The Associated Press reports that drugmakers commonly first seek FDA approval for tropical diseases such as Ebola because this can make it easier to get regulatory approval in Africa.

Parallels with search for COVID-19 vaccine

The U.S. government helped provide funding for the development of Inmazeb, reports the Associated Press, even though the risk of Ebola in the United States remains low.

However, ignoring highly infectious diseases just because they aren’t “knocking on our door” right now can lead to unnecessary illness and deaths, as we’ve seen with the COVID-19 pandemic.

“Future Ebola outbreaks are inevitable, and there are ongoing cases in the DRC as we speak,” Passaretti said. “With international travel and the interconnectedness of our world, we need to continue to maintain vigilance for this and other highly infectious diseases.”

The Ebola vaccine approved by the FDA in late 2019 took years to develop.

The Operation Warp Speed program — a partnership between pharmaceutical companies and the U.S. federal government — aims to shorten that timeline for a COVID-19 vaccine.

Bailey says the much larger impact of the COVID-19 pandemic — more than 40 million cases and more than 1 million deaths worldwide — compared to Ebola may help speed things up.

“Hopefully, a COVID vaccine or vaccines will become available around the 1-year anniversary of the first Ebola vaccine, Ervebo, last December,” Bailey said. “If so, it would be a remarkably rapid such accomplishment compared to the timeline for Ervebo and other vaccine development historically.”

Source: Read Full Article

Kids Are Getting COVID-19 at School and Spreading It to Families

  • Many schools around the country are cautiously beginning to allow children to return to in-person classes.
  • As children head back to school, parents may have questions about whether their families are at risk.
  • Experts say kids can develop COVID-19, and there have been cases where they’ve transmitted it to adults.
  • While it usually causes mild disease in children, it’s rarely fatal.
  • One basic way to help protect children is to emphasize the importance of handwashing, physical (social) distancing, and mask wearing.

With schools around the United States beginning to cautiously return their students to on-campus classes, many parents have questions.

They want to know whether their children will be prone to getting COVID-19.

In addition, there are concerns as to whether they might transmit it to their families, friends, and teachers.

Here’s what we currently know about COVID-19 and children.

Yes, children can get COVID-19

Dr. Lisa Gwynn, an associate professor of clinical pediatrics and public health sciences at the Miller School of Medicine at the University of Miami, said that yes, children can get COVID-19.

However, according to Brian Labus, PhD, MPH, an assistant professor in the School of Public Health at the University of Nevada, Las Vegas, the infection rates in children are low.

Adults over age 75 have 10 times the rate of infection of children, said Labus.

Adults under 45 have 5 times the rate of infection.

“When children do get infected,” explained Labus, “they tend to have a very mild disease compared to adults.”

They can also transmit it to adults

Gwynn said that children can transmit COVID-19 to adults.

She noted that children ages 10 and older are especially able to transmit the illness to the adults around them.

While there’s limited information regarding children younger than 10, the Centers for Disease Control and Prevention (CDC) released a report on September 18 indicating that younger children can transmit the virus to adults as well.

The report cited one case in which an 8-month-old child transmitted the SARS-CoV-2 virus, which causes COVID-19, to both parents.

Another child at the same day care facility who contracted the virus was 8 years old.

Both children had mild signs and symptoms, including runny nose, fatigue, and fever.

The report included information about 12 children who had developed COVID-19 at three different child care facilities.

Transmission, either confirmed or probable, was shown to have occurred to 46 people outside of the facilities, including one parent who had to be hospitalized.

Also, two children who had confirmed COVID-19 but were asymptomatic were shown to have transmitted the disease to adults.

COVID-19 is potentially but rarely life threatening in children

“For the vast majority of children, COVID-19 presents as a very mild disease or with no symptoms at all,” Gwynn said.

However, it can be serious for children with underlying health problems, she said.

Gwynn added that the COVID-19 death rate for children is very low. Only 71 of 190,000 deaths through the end of July occurred in children.

When children do die from COVID-19, it’s usually due to either complications from underlying conditions or a condition called multisystem inflammatory syndrome (MIS-C), according to Labus.

MIS-C is a condition in which multiple parts of the body, such as the heart, kidneys, lungs, skin, gastrointestinal organs, or eyes, become inflamed.

The CDC states that it’s unknown exactly what causes MIS-C, but it’s been linked to COVID-19.

Labus emphasized that MIS-C is quite rare. Through July, only 570 cases have been reported in the United States.

In addition, many children can recover from MIS-C with medical care.

Protecting kids as they return to school

Gwynn’s advice to parents is first to make sure children are following the basics of infection control.

They should be wearing masks properly (mouth and nose covered), maintaining physical distancing, and washing their hands, she said.

Labus suggested that parents look to the CDC’s guidance as children begin to return to the classroom.

While not an all-inclusive list, some of the recommendations made by the CDC include:

  • Check in with your child daily to monitor them for any signs of illness, such as a cough, fever, of vomiting.
  • Talk with your child about safety protocols, such as washing hands, wearing masks, and maintaining physical distancing.
  • Make sure your child is up to date on vaccines, including the flu vaccine.
  • Familiarize yourself with your school’s COVID-19 action plan.
  • If your child has had close contact with someone who has COVID-19, keep them home.
  • Make note where you can obtain testing in the event that your child does become sick.
  • Create a routine for your family to make sure they’re always prepared with items like hand sanitizer and spare masks.
  • Create a plan for how you’ll protect any household members who are at greater risk for severe illness.
  • Be prepared in the event that your school has to close or to impose a period of quarantine on your child.
  • Make sure the emergency information you have on file with your school is up to date.
  • Speak with your school about their plans for any special services that your child uses, such as speech therapy or tutoring.
  • Be aware that your child will need to wear a mask and maintain physical distancing if they’re riding the school bus or carpooling with other kids.

If COVID-19 hits your child’s school

While the hope is that everyone’s hard work in preventing COVID-19 will keep everyone safe and well, parents need to be prepared in the event that cases do develop.

Both Labus and Gwynn suggest looking to your school for guidance. They’ll be in the best position to tell you if your child is safe to return to school or will need to quarantine at home.

Labus noted, however, that just because there’s been a case at your child’s school, this doesn’t mean that your child has been exposed.

If your child does develop symptoms of COVID-19, Labus said it’s important to not send them to school.

“There is no need to rush to the doctor,” he added. “If you wouldn’t normally take your child to the doctor for their illness [mild to moderate symptoms], COVID-19 doesn’t really change that.”

But he added that if your child has underlying health problems, it’s important to talk with his or her doctor for advice.

Talking with your child’s doctor will ensure that you’re responding appropriately.

Once your child has recovered, speak with the school regarding their policy for allowing children to return to classes. They may require a doctor’s release before your child can go back to school.

Source: Read Full Article

How This Utah Woman with Diabetes, Asthma, and MS Beat COVID-19

We’ve been warned that COVID-19 can be more dangerous for people with underlying medical conditions such as type 1 diabetes, multiple sclerosis, asthma, and obesity.

What if you had all of them when you contracted the virus?

A woman from Salt Lake City, Utah, who checked all those boxes, has battled and survived her fight with COVID-19.

What put her on the road to recovery after her family said their possible goodbyes to her over the phone?

Kimberly Ishoy believes it was a combination of advocating for her care while being willing to do all the doctors’ asked.

She also credits attention to her medical conditions, prayer, and — perhaps mostly importantly — an active lifestyle that includes distance cycling and triathlons.

“My new saying is she’s last in the triathlon but first out of the ICU,” Chris Ishoy, Kimberly’s husband, told Healthline. “The doctors have no doubt her fitness helped her through.”

The diagnosis

It all started for Ishoy in late May when symptoms concerned her — gastrointestinal distress, a searing headache, an inability to eat (“even water tasted like dirt”), and all-consuming exhaustion.

“I was working from home and it was like ‘Weekend at Bernie’s’ the Kim edition,” Ishoy told Healthline. “I would prop myself up for a call and just get through it, put my head down, and fall asleep until it was time to be propped up for the next one.”

Still, despite some family members having contracted the new coronavirus, Ishoy felt she was battling something else because she had no fever.

She consulted with her primary care doctor by phone, who warned her that if it was COVID-19, things could get worse even if she thought she was getting better.

Source: Read Full Article

When Can I Start Hanging Out with My Friends Again?

  • As more states begin reopening, experts say socializing with a limited number of friends and family outside your home can be done if certain precautions are implemented.
  • That means physical distancing, wearing masks, and practicing good hygiene.
  • Experts advise avoiding large groups of people.
  • Instead, health officials recommend creating “social bubbles,” which are defined as a group of 12 people or fewer who don’t socialize with other bubbles for 3 weeks at a time.
  • Gatherings should be outdoors, such as a park or a backyard, and everyone needs to agree to follow the same rules.

While some parts of the country have been under shelter-at-home orders for almost 3 months, the social part of being human beings has been starved.

We’ve held virtual graduations, drive-by birthday parties, and stayed connected with families and friends over Zoom and other video conferencing apps.

But it’s not the same.

Now, as many parts of the country are loosening restrictions, people are wondering how to safely see their friends and family in person, without increasing all of our risks to the coronavirus.

A new social normal

On a recent Friday and again on Sunday, Thomas Plante and his wife hosted a “socially distant cocktail hour” each evening with a different couple. Their guests went directly into their backyard, brought their own drinks, glassware, and snacks, and the two couples sat more than 6 feet from one another and chatted for about an hour.

“This follows all the health precaution rules, and a lot of people — including myself — have gotten a bit tired of the Zoom cocktail party thing by now,” Plante, a licensed psychologist and adjunct clinical professor in the department of psychiatry and behavioral sciences at Stanford University School of Medicine, told Healthline.

In order for things to truly “get back to normal,” like having carefree dinner parties with dozens of guests sharing the same space and being unafraid to touch common surfaces, a vaccine is needed. And that vaccine needs to be effective and used widely.

Right now, only about 70 percent of Americans say they would get a coronavirus vaccine, if one were available, according to a recent Washington Post-ABC News poll.

Because there are no vaccines for any strain of the novel coronavirus on the market and no large scale manufacturing capacity for these vaccines yet exists, doing it for the first time “can be tedious and time consuming,” researchers from the Icahn School of Medicine at Mount Sinai reported in April in the journal Immunity.

So, until researchers have developed a safe and effective vaccine, experts like Plante say the United States and the rest of the world will be living in some kind of pandemic setting for some time.

“So, we all need to adapt and think in terms of a post-COVID-19 world relative to our previous pre-COVID-19 world, just like we had to do with 9/11, HIV/AIDS, and so forth,” Plante said.

That means taking precautions, such as physical distancing, wearing masks, and practicing good hygiene.

Be cautious and candid about where you’ve been and where you’re going

Dr. Nancy Gin, medical director of quality and clinical analysis for Kaiser Permanente in Southern California, says people have been incorporating best practices for 3 months now — it’s become part of everyday life. Now, she says, they’re doing some “cautious toe dipping” by stepping out of the house to be together in various settings.

“It’s an important element for people who need to nourish their souls by being with those they love,” she said.

But in order to do it safely, Gin says that means people have to be candid about their behaviors, such as if they’ve been around other people, especially if they’re in contact with vulnerable people. No matter where we are at with infection rates, that includes the elderly and the immunocompromised.

Above all, people need to avoid others if they’re not feeling well.

And being with other people may be more common recently, as millions of people around the world have been attending Black Lives Matter protests.

While it’s a healthy expression of First Amendment rights to come to the aid of those in the community who are victims of ongoing systemic oppression, it may have some people forgetting that we’re all in a global pandemic.

“We live in a society that does not have a good attention span,” Gin said. “We are nowhere near the herd immunity we need.”

That’s why non-protesting social gatherings still need to be kept small and intimate, and some orders from health officials are being loosened to allow them.

Creating your own ‘social bubbles’

As of June 9, three states — California, Kentucky, and New Jersey — and Puerto Rico have active statewide stay-at-home orders. Three others — New York, Oregon, and Pennsylvania — have variations of those rules and the rest of the states have county-by-county orders.

In Alameda County in Northern California, people are now allowed to create their own “social bubbles,” which health officials define as a group of 12 people or fewer who don’t socialize with other bubbles for 3 weeks at a time. Still, these gatherings should be outdoors, such as a park or a backyard, and everyone agrees to follow the same rules.

“Remember that your actions affect everyone in the group,” the Alameda County Health Department says in its “plain English” guidelines.

Neighboring Contra Costa County’s health orders now allow outdoor gatherings of up to 100 people for protesting and religious gatherings.

But those gatherings shouldn’t include the handshakes and hugs. Gin says elbow bumps or foot taps are the new forms of expressing that you’re happy to see someone. And those greetings should only be after good hand hygiene and given while wearing face masks.

And if it’s over food, experts still recommend people don’t dine-in together, but rather get separate takeout orders and enjoy them outside.

“We just want people to stick with the basics,” Gin said. “This coronavirus isn’t going anywhere for a while. We’re only 3 months in, but we have learned a lot.”

One thing Gin says she’s learned is that virtual reunions with friends and loved ones should stick around. She says she’s been able to be on Zoom calls with family all over the world, something that wouldn’t normally happen before.

But under our so-called “new normal,” we all have to remain extremely cautious about our contact with others, even as health officials loosen some restrictions.

Plante’s other recent socially distanced cocktail party was with his neighbors, who all kept their distance and talked loud enough to hear.

He says that kind of interaction is important — especially people who consider themselves extroverts — but remaining vigilant about the new rules will be critically important as we choose to come together. That includes younger people, who may feel they’re more invincible to the virus.

“We’re in a new world together, and so, we all have to adapt and get used to it,” he said. “Since we are in it for the long haul, we need to find ways to make this safe but sustainable. And we must be ready to say goodbye to our old world and way of being and hello to our new world and way of being.”

Source: Read Full Article

Mouthwash Can’t Replace a Mask for Stopping the Spread of COVID-19

  • Experts are looking at mouthwash to see if it can help stop the spread of COVID-19.
  • In labs, mouthwash may help kill the new coronavirus.
  • Other experts disagree and point out that the coronavirus can quickly multiply in the throat even after using mouthwash.
  • Masks and physical distancing are still the best ways to prevent spreading or developing COVID-19.

Frequent handwashing, following social or physical distancing rules, and using face coverings in mass transportation and shops are still some of the best ways to protect against the new coronavirus.

However, a new study finds that ingredients in commercially available mouthwash may damage the virus that causes COVID-19 in a way that makes it harmless. The report, recently published in the journal Function, suggests that there’s an “urgent need” to test the effectiveness of this approach in clinical trials.

Previous research has shown that interfering with the lipid envelope represents an effective strategy to target similar viruses. Although experts are not recommending people trade in masks for mouthwash.

“Information has emerged highlighting how important the throat and salivary glands are as a site of virus replication in early disease and also in people who don’t have symptoms and how they seem to be involved in transmission of infection,” lead author Valerie O’Donnell, PhD, director, division of infection and immunity and co-director of the Systems Immunity Research Institute at Cardiff University, told Healthline. “It seemed worthwhile to check if there was any potential for direct antiviral targeting of virus in the throat via damaging the membrane.”

SARS-CoV-2 has a vulnerable spot

According to researchers, the virus strain that causes COVID-19, called SARS-CoV-2, is an enveloped virus with a fatty (lipid) membrane.

This envelope comes from the infected cell, or host, in a process called “budding off,” according to the National Cancer Institute. During this process, newly formed virus particles become “enveloped” or “wrapped” in an outer coat made from a small piece of the cell’s membrane. The envelope may help a virus survive and infect other cells.

“We found that there is evidence from other people’s research that enveloped viruses like influenza, herpes simplex, and other coronaviruses are sensitive to common ingredients in mouthwash, but this evidence is from test-tube experiments — not from studies on viruses in the mouth, where their response may be different, and where little work has been done,” explained O’Donnell.

However, she cautioned, “It’s important to note that studies haven’t been done on this coronavirus because it’s new.”

Infection begins in the nose and throat

SARS-CoV-2 infection is believed to happen through respiratory droplets, and the virus particle is viable in aerosols for up to 3 hours.

“Dampening transmission by any means could be a preventative measure, and we don’t have any ways to do this currently,” said O’Donnell.

“CDC have recommendations for dentists where patients use mouthwash before procedures for preventing transmission of respiratory disease already,” she continued. But she added that this is based on theoretical benefit, not benefit proven through clinical trials, which haven’t been conducted yet.

O’Donnell concluded, “This is where research needs to be done, first to find out if these ingredients can inactivate this virus in the throat, and then if they can, whether this could reduce transmission.”

Mouthwash could have an unexpected effect on health

Post-exercise hypotension (PEH) is a common physiological process that lowers blood pressure after “acute exercise.”

But how this happens is still not fully understood.

Recent research finds that interfering with the bacteria in your mouth may affect your cardiovascular health. The study examined whether the “nitrate-reducing activity” of bacteria in our mouths is a key trigger for PEH.

Scientists used a randomized, double-blind, and crossover study design, which means neither the testers nor the participants knew who received mouthwash or a placebo.

Findings suggest that the participants who used mouthwash experienced significantly higher blood pressure after exercising than the placebo group, reducing an important benefit of cardiovascular exercise.

Of course, this doesn’t mean that mouthwash is bad for you or doesn’t provide important benefits.

COVID-19 researcher weighs in

“There is potential for mouthwash with alcohol to reduce, maybe slightly, short-term spread of virus to close household contacts. The alcohol might kill virus in the mouth surfaces temporarily — so might a shot of whiskey, rum, or tequila,” said Eric Bortz, PhD, assistant professor of biology, University of Alaska Anchorage.

But Bortz, who is currently researching the genome sequencing of COVID-19, pointed out, “If someone is actively infected, the infected cells in the throat will soon produce more virus.”

He added that the upper and lower respiratory tissues are very often infected and can produce transmissible virus. “So for most people with coronavirus, mouthwash will be of limited value in preventing spread of COVID19.”

“Face coverings [masks], social distancing, and limiting contact are the best public health measures. But good oral hygiene is good for health, so it’s good to maintain it [mouthwash use] anyway!” Bortz advised.

It kills the virus, but it’s not the best defense

Bortz agreed that anything that kills the virus in a test tube might kill the virus in the mouth, “But that doesn’t mean you should use it as a first line of defense. For example, bleach kills virus — but don’t drink it or wash your mouth with it because it might kill you too!”

“The coronavirus survives inside of cells mainly in the respiratory tract, not just the mouth,” he emphasized.

Mouthwash won’t cure anyone of COVID-19, concluded Bortz, “or prevent infection by coronavirus.” But he remarked that good oral hygiene is a part of good health: “So for adults non-alcohol or alcohol-based mouthwashes are great, but for children, no alcohol.”

Mouthwash company Listerine has urged consumers not to use mouthwash to fight COVID-19 during the pandemic. “LISTERINE mouth rinse has not been tested against the coronavirus and is not intended to prevent or treat COVID-19,” the company said in a statement.

The bottom line

Research finds that mouthwash ingredients have a potential role in the fight against COVID-19. They say that commercially available mouthwash could damage the new coronavirus in such a way to render it harmless.

Some scientists emphasize that since the throat is a major area of infection for COVID-19, then strategies, like mouthwash, that reduce the concentration of virus in mucous membranes could contribute to reduced transmission risk.

Other experts disagree and point out that the coronavirus can quickly multiply in the throat even after using mouthwash, and that masks and social or physical distancing are still the best ways to prevent spreading or developing the infection.

Source: Read Full Article