Moderna asks FDA for authorization of its vaccine for children under 6

Moderna asks FDA for authorization of its vaccine for children under 6
Moderna asks FDA for authorization of its vaccine for children under 6
Xavier Lorenzo/Getty Images

(NEW YORK) — The vaccine company Moderna on Thursday announced it submitted its request for the Food and Drug Administration to authorize its vaccine for children ages 6 months to 6 years, marking a hopeful development in the long journey for parents who are desperate to get their young kids vaccinated.

“I think for these little children, they really represent an unmet medical need,” Paul Burton, chief medical officer for Moderna, told ABC News. “I would be hopeful that the review will go on quickly and rigorously — but if it’s approvable, this will be made available to these little children as quickly as possible.”

Once the FDA reviews the data, it will call a meeting of its independent panel of advisors to publicly discuss the safety and efficacy of the vaccine before taking a vote. The FDA would then take the panel’s consensus into account and decide whether to authorize the vaccine.

After that, the process heads to the Centers for Disease Control and Prevention for its advisors to review the data and for the CDC director to recommend the vaccine to the public.

But questions remain about how soon the FDA will be able to authorize Moderna’s vaccine, and whether regulators would prefer to review it alongside Pfizer’s vaccine, which is expected to be submitted for review in the coming weeks.

Dr. Peter Marks, who oversees vaccines for the FDA, said on Tuesday that the FDA would put out a timeline for the review within the next week.

Marks couldn’t clarify whether the FDA would review both vaccines together or not until the agency had seen the data from the companies, but said that the FDA would move “quickly” once that data is in. Burton, with Moderna, stressed that kids under 5 currently have no vaccine options.

“I think every day that [kids] are without a vaccine is obviously another day that somebody can get infected, can get hospitalized. So I would hope that, you know, they can move as quickly as possible,” Burton said.“Typically, they seem to take about a month, so I’d be hopeful for that kind of timeline, but you know, they’ll do the very best job necessary.”

Moderna, which is a two-shot vaccine, is different from Pfizer’s vaccine, which is a three-shot vaccine, and because Pfizer hasn’t finished gathering its data yet, it’s not yet clear which shot will be more effective.

Moderna’s data, which is in, found that the shots generated a strong immune response with no significant risks found. The vaccine generated an antibody response roughly equivalent to the antibody response seen in adults, the company said.

At the same time, experts have questioned the low efficacy numbers against infection. During the omicron surge, two doses of the vaccine were roughly 51% effective against COVID-19 infection, including asymptomatic and mild infections, for children 6 months to 2 years old, and 37% effective among kids 2 years to 6 years old.

But Burton defended the vaccine’s efficacy against infection, arguing that omicron led to more breakthrough infections, but that the shot produced an antibody response that was even stronger in the young kids than it was in the 18- to 24-year-olds.

“I think moms and dads and caregivers, doctors and nurses should be reassured by this result,” Burton said.

“The antibody levels that we saw here were high, and we can translate that to what we see in adults where we get really good protection against severe disease and hospitalization,” he said.

Asked about Moderna’s plan for a third shot for kids, which would then put it on par with Pfizer, which is planning on submitting data for a three-shot vaccine, Burton said that Moderna intends to give children a booster with a variant-specific vaccine in the fall or winter, if a booster is necessary.

“We’re working on a variant-specific booster, we released some data a couple of weeks ago. We’re still working on even another booster candidate that will cover omicron, as well as the original virus. And if these little kids do need an additional booster, I think that’s the one that we would likely offer them in the fall or winter,” Burton said.

The company is currently testing boosters across all age groups.

But Burton said he was confident in the two-dose regimen Moderna is putting before the FDA.

“If these children need an additional booster dose, a third dose later in the winter, we’ll have those data on hand and we can discuss that with regulators then, but I think everybody can be well reassured of the result here,” Burton said.

None of the children in the Moderna study became severely sick, so the company was unable to provide an efficacy estimate for its ability to prevent severe illness.

Pfizer is expected to submit its data in the coming weeks. The company’s CEO, Anthony Bourla, said in a recent interview that he expected authorization sometime in June. Many experts expect the vaccine to be strong because data has consistently shown more immunity from third shots, or boosters, in adults.

For parents, the authorization of vaccines for the youngest population in the country has been a stressful, arduous wait.

The expected timeline for shots has slipped twice in the past year.

While children 5 and older have had a vaccine since the fall, younger kids have weathered the delta and the omicron waves without them. And a lot of them are too young to wear masks, which experts only recommend for kids over 2.

A CDC report on Tuesday revealed that the lack of vaccination has made young kids a bigger target for the virus. Around 75% of kids and adolescents under 17 have had COVID, according to a nationwide study — the highest percentage of people who’ve had COVID-19 of all the age groups.

Still, CDC Director Rochelle Walensky said it’s vital for everyone, including children, to get vaccinated when they’re eligible, regardless of prior infection.

“Those who have detectable antibodies from prior infection, we still continue to encourage them to get vaccinated,” Walensky said.

“We don’t know … when that infection was, we don’t know whether that protection has waned. We don’t know as much about that level of protection than we do about the protection we get from both vaccines and boosters,” Walensky said.

Copyright © 2022, ABC Audio. All rights reserved.

Fauci said the US is ‘out of the pandemic phase.’ What does that mean?

Fauci said the US is ‘out of the pandemic phase.’ What does that mean?
Fauci said the US is ‘out of the pandemic phase.’ What does that mean?
EMS-FORSTER-PRODUCTIONS/Getty Images

(WASHINGTON) — The worst days of the COVID-19 pandemic may be over in the United States, Dr. Anthony Fauci, the nation’s top infectious disease expert, said this week. Some experts urged caution, however, and said the pandemic is still a threat in the long-term.

“We are certainly right now in this country out of the pandemic phase,” Fauci told PBS NewsHour Tuesday. “Namely, we don’t have 900,000 new infections a day and tens and tens and tens of thousands of hospitalizations and thousands of deaths. We are at a low level right now.”

He continued, “So, if you’re saying, are we out of the pandemic phase in this country, we are.”

Some public health experts stressed Fauci is not saying the pandemic is over, which he also later clarified to CBS News, but rather that the virus is no longer having the same impact in the U.S. as it was a few months ago.

In fact, Fauci stressed at the end of the PBS interview, “So, if you look at the global situation, there’s no doubt this pandemic is still ongoing.”

This doesn’t just mean fewer cases, hospitalizations and deaths being reported but also fewer school closures and staffing shortages in hospitals as well as people resuming activities again, they say.

“We’re not having mass closures of hospital beds like we did in January 2022,” Dr. Cameron Wolfe, an associate professor of infectious diseases at Duke University School of Medicine, told ABC News. “We’re still seeing staffing shortages, but they’re not to the same extent that they were for the last couple of years. Activities are coming back online, so I’m at an in-person meeting for the first time in two years.”

Wolfe said the danger of overwhelming hospitals and high death rates is greatly reduced because of the number of Americans who’ve been vaccinated as well as previously infected.

According to the Centers for Disease Control and Prevention, 82.4% of the eligible U.S. population — those aged 5 and older — have had at least one COVID-19 vaccine dose and 70.3% are fully vaccinated.

What’s more, a new CDC analysis released Tuesday estimated three out of every five Americans have antibodies from a previous COVID-19 infection, up from one-third before the omicron wave.

“We’re in a phase right now that the number of vaccinations, and also frankly the number of people who have been infected, where our community level of immune protection is good enough that there’s not as many infections taking place as we saw in January.” Wolfe said. “So, the impact that has on the way our community ticks along becomes less.”

Wolfe said another reason the U.S. is doing well handling COVID-19 is because there are more treatments available for people who contract the virus.

During the first wave of the pandemic, there were few treatments approved or authorized for emergency use by the U.S. Food and Drug Administration.

But, over time, several treatments were developed and they are now more widespread. Currently, COVID-19 patients can receive monoclonal antibodies, which is an infusion of antibodies in a lab that mimic antibodies generated by the body, or pills developed by Pfizer and Merck.

These treatments have been shown to not only reduce the number of days a person is experiencing symptoms but also dramatically lower the risk of hospitalization and death, preventing healthcare systems from becoming overwhelmed.

“We’re in a much better state in terms of having treatment availability,” Wolfe said. “Having access to good medicines that are liberally now available and do a good job in terms of preventing the severe outcomes from COVID I think is a real bonus that we just didn’t have six months ago.”

However, other experts are not sure the U.S. is out of the pandemic phase.

“We have the potential for spread of new variants across this country, and it tells us that we are not necessarily out of this pandemic phase,” said Dr. John Brownstein, an epidemiologist at Boston Children’s Hospital and an ABC News contributor. “This virus has global impact and it means that we see spread in one part of the world.”

He continued, “We will likely see a surge here. And so as much as we want to head towards that normal life, I think we’re still months away from fully understanding whether we’re in a position where this virus is not disrupting our daily lives.”

ABC News’ Arielle Mitropoulos contributed to this report.

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Measles outbreaks possible amid ‘perfect storm’ of conditions, WHO and UNICEF warn

Measles outbreaks possible amid ‘perfect storm’ of conditions, WHO and UNICEF warn
Measles outbreaks possible amid ‘perfect storm’ of conditions, WHO and UNICEF warn
Yalonda M. James/The San Francisco Chronicle via Getty Images

(NEW YORK) — The World Health Organization and UNICEF are warning of a “perfect storm” of circumstances fueling the potential for large-scale measles outbreaks, underscoring worrying signs of increased risk as infections around the globe this year are far above what they were this time last year.

In the first two months of 2022, reported measles cases worldwide increased by nearly 80%, compared to the same timeframe in 2021, the organizations said in a joint news release, adding that conditions are “ripe” for serious outbreaks of the vaccine-preventable illness.

“Pandemic-related disruptions, increasing inequalities in access to vaccines and the diversion of resources from routine immunization are leaving too many children without protection against measles and other vaccine-preventable diseases,” the organizations said, adding that the risk for large outbreaks “has increased as communities relax social distancing practices and other preventive measures for COVID-19 implemented during the height of the pandemic.”

Almost 17,338 cases of the highly contagious disease were reported worldwide in January and February 2022, compared to 9,665 during the first two months of 2021.

Brewing humanitarian crises have inflamed the issue.

“With millions of people being displaced due to conflicts and crises, including in Ukraine, Ethiopia, Somalia and Afghanistan, disruptions in routine immunization and COVID-19 vaccination services, lack of clean water and sanitation, and overcrowding increase the risk of vaccine-preventable disease outbreaks,” the organizations said.

“The agencies are concerned that outbreaks of measles could also forewarn outbreaks of other diseases that do not spread as rapidly,” WHO and UNICEF said, noting that besides its direct effect on the body, which can be lethal, the measles virus also weakens the immune system and makes a child more vulnerable to other infectious diseases such as pneumonia and diarrhea for months after the measles infection — among those who survive.

This is not the first time global health agencies have warned of lagging pediatric immunizations being an issue of urgent address.

In an April meeting, the WHO’s Strategic Advisory Group of Experts noted that disruptions to routine immunization programs puts “millions of children at risk of disease outbreaks,” and “large and disruptive outbreaks of measles have occurred in at least 19 countries during the past 12 months.”

And in the U.S., as ABC has reported, vaccination coverage for kindergarteners fell below the nationwide target during the 2020-2021 school year, according to CDC data, raising concerns about vaccine-preventable diseases such as measles, mumps and whooping cough.

Experts worry pandemic disruptions could inadvertently lead to a growing number of vaccine-preventable illnesses among children.

In 2020, 23 million children missed out on basic childhood vaccines through routine health services, the highest number since 2009 and 3.7 million more than in 2019, the WHO and UNICEF said Wednesday.

As of April 1, 57 vaccine-preventable disease campaigns in 43 countries that were scheduled to take place since the start of the pandemic are still postponed, impacting 203 million people, most of whom are children, the agencies said. Nineteen of those postponed are measles campaigns, putting 73 million children at risk of measles due to missed vaccinations.

In Ukraine, the measles catch-up campaign of 2019 “was interrupted due to the COVID-19 pandemic and thereafter due to the war,” the WHO and UNICEF said. “Routine and catch-up campaigns are needed wherever access is possible to help make sure there are not repeated outbreaks as in 2017-2019, when there were over 115,000 cases of measles and 41 deaths in the country — this was the highest incidence in Europe.”

As of this April, the agencies said there have been 21 large and disruptive measles outbreaks around the world in the last 12 months. Most of the measles cases were reported in Africa and the East Mediterranean region.

Countries with the largest measles outbreaks since the past year include Somalia, Yemen, Nigeria, Afghanistan and Ethiopia.

The figures are likely higher, as the pandemic has disrupted surveillance systems globally, with potential underreporting, the agencies said.

The agencies cited insufficient measles vaccine coverage as the primary reason for the outbreaks “wherever they occur.”

“Measles is more than a dangerous and potentially deadly disease. It is also an early indication that there are gaps in our global immunization coverage, gaps vulnerable children cannot afford,” UNICEF Executive Director Catherine Russell said in a statement. “It is encouraging that people in many communities are beginning to feel protected enough from COVID-19 to return to more social activities. But doing so in places where children are not receiving routine vaccination creates the perfect storm for the spread of a disease like measles.”

ABC News’ Sony Salzman contributed to this report.

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Parents of kids under 5 fed up with lack of FDA action on a vaccine

Parents of kids under 5 fed up with lack of FDA action on a vaccine
Parents of kids under 5 fed up with lack of FDA action on a vaccine
Courtesy Emmie Fital

(NEW YORK) — Parents eager to vaccinate their toddlers and preschoolers last fall were told a COVID shot for the youngest age group was on its way, with data expected by the end of the year. That deadline slipped. Then it slipped again.

Now, with summer travel just around the corner, parents of kids under 5 are fed up. They describe feeling stuck in a kind of cruel pandemic time warp, even as much of the country moves on and people have stopped wearing masks, including on airplanes.

Many parents are ready to assign blame.

“I want you, Joe Biden, to call the FDA (US Food and Drug Administration) and tell them that they need to act with all possible speed because every day they delay there are children being infected and some of those children could die,” said Sarah Liebman, a mom outside Portland, Oregon, whose 2-year-old remains too young for a shot.

Emmie Fital, a mom of two boys ages 4 and 1, living outside Philadelphia, has opted to keep her kids home from school because her oldest son’s asthma has resulted previously in a hospital stay after he contracted the common cold.

“We’ve been kind of living in Groundhog’s Day, every day for two years … It is ludicrous what we are having to deal with as parents right now,” Fital told ABC.

In coming weeks, the nation’s two big vaccine makers — Pfizer and Moderna — are poised to deliver key pieces of data that the FDA needs to authorize a vaccine.

Moderna was expected by week’s end to submits its official request for FDA authorization for its 2-shot version. Pfizer says it expects to have final data on its three-shot version by the end of June.

How soon though regulators will give either shot a green light remains unclear. Government and industry officials say the data sets for vaccine trials can be complex, and Moderna will likely submit additional information on a rolling basis even after its official request is made.

The FDA has declined to comment on pending vaccine applications — necessary to avoid legal hot water — but suggested its hands are tied until company officials submit their data. The agency also has promised to make public a new tentative timeline for advisory committee meetings, a final step before authorization of any vaccine.

“Just remember that we can’t actually finish our reviews until we actually have complete applications in the FDA,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told a Senate panel on Tuesday.

Parents though say they are frustrated by these kinds of cryptic comments and that they seem to be learning more about the vaccine’s progress from press leaks than regulators. Last week, a Politico report suggested the FDA might wait on Moderna’s authorization request until Pfizer could offer more data on its version.

In an interview with CNN+, Biden’s top medical adviser Dr. Anthony Fauci confirmed there were concerns within the FDA about authorizing the two different vaccines — with different amounts of dosing and shots — on separate timelines. Authorizing them together would give parents a side-by-side comparison before they made their choice, some officials thought.

“What the FDA wants to do is to get it so that we don’t confuse people,” Fauci said.

His comments sparked swift pushback from frustrated parents, including Liebman.

“We were told over and over that the best shot was the first one to get into your arm,” she said. “So I don’t understand why the FDA seems confused. I am not confused. I’m not at all confused.”

Fatima Khan, who helped to start up a grassroots advocacy group and Facebook page called “Protect Their Future,” which advocates for swift authorization of a pediatric vaccine, said she wishes the FDA was more transparent about what it needs from vaccine makers and what concerns it has.

“I feel like we’ve been getting yanked around a lot. You know, no one really gives anyone a clear answer, and it shouldn’t be that difficult,” said Khan.

Still plenty of questions remain, including whether at the FDA should send parents down the path of a two-dose vaccine if an alternative three-dose is found to be more effective just a couple of weeks later.

Moderna has said its two-dose vaccine produced the same level of immune response as seen in adults. But because none of the participants in the study became severely sick, Moderna couldn’t give an estimate of how effective the vaccine is at preventing severe illness.

Dr. Julie Morita, a pediatrician who has advised the Centers for Disease Control and Prevention in the past, said premature or complex data can make speaking openly difficult for regulators.

“You want to be careful about what information you’re sharing because you don’t want to have misunderstandings. Because once you the information is out there it’s really hard to pull it back,” said Morita, executive vice president of the Robert Wood Johnson Foundation.

Overall, children are at significantly less risk of hospitalization and death of COVID-19 compared to adults.

Still, the number of children who became infected in recent weeks due to the omicron variant is staggering. The American Academy of Pediatrics estimates that nearly 124,000 kids were infected in the past month alone.

Since the pandemic began two years ago, 468 children have died as a result of complications from the virus.

Fital said she is irked hearing public health officials say repeatedly that the best way to protect yourself and others is to get vaccinated, when so many kids can’t.

“What do you say to the 20 million children that have no option?” she asked. “They have nothing.”

ABC News’ Sony Salzman contributed to this report.

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New research reveals sleep disorder may be linked to Parkinson’s

New research reveals sleep disorder may be linked to Parkinson’s
New research reveals sleep disorder may be linked to Parkinson’s
EMS-FORSTER-PRODUCTIONS/Getty Images

(NEW YORK) — New research on the connection between sleep and Parkinson’s disease is being hailed as a “first step” toward curing and preventing the condition, a brain disorder that causes uncontrollable movements.

The research, led by the Parkinson’s Progression Markers Initiative, funded by The Michael J. Fox Foundation, is working to make a concrete connection between Parkinson’s and REM sleep behavior disorder, or RBD, which causes a person to “physically act out vivid, often unpleasant dreams” during deep sleep, according to the Mayo Clinic.

Studies have found that up to 41% of Parkinson’s patients experience RBD before their diagnosis, with 65-75% of these patients being men. Researchers say they are hoping that a concrete connection between Parkinson’s and RBD can help us learn more about Parkinson’s.

“People who live with RBD can help researchers understand how and why Parkinson’s comes on from the very earliest moments so that we can work on getting to that cure and even preventing the disease from happening,” said Dr. Rachel Dolhun, a board-certified neurologist and movement disorder specialist and the head of medical communications for The Michael J. Fox Foundation.

“It’s one of our first steps toward curing and preventing Parkinson’s, something that we can’t do today,” she said of the research.

Parkinson’s is currently incurable and there is no way to diagnose the condition through blood or laboratory tests. The diagnosis is based mainly on clinical symptoms, how it presents and the history of the disease in the patient.

An estimated one million people in the United States are affected by Parkinson’s, according to The Michael J. Fox Foundation.

Gary Rafaloff is one of those one million people. He said he was diagnosed with Parkinson’s a decade ago after suffering for years from sleep issues, later diagnosed as RBD, that included making strange noises and waking up while violently lashing out during dreams.

“It’s a terrible symptom that is really not spoken about a lot, and there’s not a lot of research on it,” said Rafaloff. “I’m lucky if I average three hours of good sleep at night.”

Rafaloff said that after years of sleep issues, it was a shock to be diagnosed with Parkinson’s.

“When I was first diagnosed, I really didn’t know much about Parkinson’s disease, so, of course, you hear something like that and you think it’s the worst,” he said. “And I didn’t have any idea what life expectancy was going to be, what life would be like.”

Parkinson’s disease occurs when nerve cells in the area of the brain that control movement and release the brain chemical dopamine become impaired and/or die, according to the National Institutes of Health.

While symptoms differ in everyone, common symptoms may include tremors in the hands, arms, legs and head; muscle stiffness; slowness of movement; difficulty with balance and a tendency to fall; difficulty swallowing; and chewing and skin problems, according to the NIH. Non-motor symptoms may also include constipation, depression and memory problems.

Most people first develop Parkinson’s around age 60, but about 10 to 20% of people experience early-onset Parkinson’s before age 50.

With no blood or lab test for diagnosis, doctors usually diagnose Parkinson’s through a person’s medical history and a neurological examination, according to the NIH.

Copyright © 2022, ABC Audio. All rights reserved.

Over 120,000 pounds of ground beef recalled over possible E.coli contamination

Over 120,000 pounds of ground beef recalled over possible E.coli contamination
Over 120,000 pounds of ground beef recalled over possible E.coli contamination
David McGlynn/Getty Images

(NEW YORK) — Over 120,000 pounds of ground beef products are being recalled over possible E.Coli contamination.

The affected products come from Lakeside Refrigerated Services, located in Swedesboro, New Jersey, and were produced between Feb. 1, 2022, through April 8, 2022, and distributed to locations nationwide, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced Wednesday.

The E.Coli contamination was discovered during routine testing, according to the FSIS, and no illnesses have been reported.

What products are subject to the recall?

The FSIS posted a complete list of beef products subject to the recall as well as labels that appear on the impacted ground beef products to help consumers identify affected products. See the label list here.

Brands including Thomas Farms, SE Grocer’s Naturally Better, Tajima, Marketside Butcher and Weis by Nature are among those impacted.

The FSIS urges consumers to throw away or return affected products. Learn more here.

Lakeside Refrigerated Services is available to answer consumer questions via email (customercare@lakesiderefrigerated.com) or by phone (800-493-9042).

What are the symptoms of E.Coli bacteria?

People can become ill two to eight days after consumption of E.Coli bacteria. Symptoms of E.Coli bacteria include vomiting or diarrhea that worsens over several days, according to the Centers for Disease Control and Prevention. Most people recover within a week; some may develop a more severe infection.

Copyright © 2022, ABC Audio. All rights reserved.

No Americans should die of COVID-19 with treatments available, experts argue

No Americans should die of COVID-19 with treatments available, experts argue
No Americans should die of COVID-19 with treatments available, experts argue
skaman306/Getty Images

(NEW YORK) — As mask mandates are lifted, and mitigation measures are increasingly dropped across the nation, a stark reality continues to hinder the nation’s return to a pre-pandemic sense of normality. Hundreds of Americans are still losing their lives to COVID-19 every day.

However, with the growing availability of coronavirus vaccines and antiviral treatments, many health experts assert that, given the United States’ tremendous medical advancements in the fight against the virus at this point in time, few Americans should still be dying of COVID-19.

“It should be pretty close to ‘no one,” Dr. Shira Doron, an infectious disease physician and hospital epidemiologist at Tufts Medical Center, told ABC News.

Infectious disease experts say that the vast majority of those still dying are the unvaccinated. In February, unvaccinated adults were 10 times more likely to die of COVID-19 compared to vaccinated individuals and five times more likely to require hospitalization.

When compared to fully vaccinated and boosted adults, unvaccinated people were about 20 times more likely to die of COVID-19 and seven times more likely to require hospitalization.

“We have vaccines that, for people with normal immune systems, are about 90% effective at preventing hospitalization, and, for those who get COVID-19 and have even a single risk factor for progression to severe disease, we have treatments, like Paxlovid and Bebtelovimab, that are 90% effective at preventing progression to hospitalization,” Doron said. “Add those together and not only should no one be dying, but no one should be getting hospitalized, if we are using those tools as we should.”

Despite widespread medical approval of the drugs, federal officials say that many of those resources, in more than ample supply, are not being used as widely as they should be, and as a result, thousands of lives are being unnecessarily lost.

On Tuesday, the White House announced that it would take new actions to increase access to Paxlovid, Pfizer’s antiviral COVID-19 pill.

“We now have more tools than ever before to protect people from the virus, including highly effective treatments,” the Biden administration said in a statement Tuesday.

Paxlovid, which reduces the risk of hospitalization and death by 90%, currently gets prescribed to about 55,000 Americans a week, which is about 2.5 times more than a month ago. But over the past week, the U.S. has seen an average of 44,000 new infections each day.

The administration’s plan is to double the number of pharmacies that stock the drug to 40,000 sites nationwide in the coming weeks, as it was previously limited to 20,000 due to insufficient supply.

Officials will also work to provide physicians with more guidance and tools to understand and prescribe the treatments.

Despite the plan to increase the availability of critical drugs to combat COVID-19, some health experts are concerned that it will still not be enough to save lives, given the many barriers that stand in the way of ensuring that those drugs and treatments are widely accessible to all those who need them.

Issues of access remain critical

Although therapeutics and vaccines will be important tools to prevent serious illness and deaths, experts say decreasing the number of daily COVID-19 fatalities will also be a function of equitably increasing access to these preventive measures and treatments.

“Equitable access is a huge barrier at this point in time, especially to effective treatments such as Paxlovid,” Colleen Kelley, an associate professor in the division of infectious diseases at Emory University School of Medicine, told ABC News.

Lack of access to transportation to proper pharmacies can have major consequences for public health.

According to ABC News’ analysis last summer of pharmacy locations across the country, there are 150 counties where there is no pharmacy, and nearly 4.8 million people live in a county where there’s only one pharmacy for every 10,000 residents or more.

Based on Census data, there are far fewer pharmacies per person — especially chain pharmacies — in rural parts of the country compared to urban areas.

In addition, the access inequities underscore the racial gap prevalent throughout the country in both rural and urban areas, with more pharmacies per person in whiter and wealthier neighborhoods than in poorer, predominantly nonwhite neighborhoods.

Persisting disparities throughout the pandemic have also resulted in a higher likelihood of death from COVID-19 for Black and brown Americans.

According to federal data, adjusted for age and population, the likelihood of death because of COVID-19 for Black, Asian, Latino and Native American people is about one to two times higher, compared to white Americans.

Although some minority communities initially lagged behind in the nation’s vaccination efforts, the rates of Black and brown Americans have significantly caught up proportionally to their respective populations.

A recent report, produced by the Poor People’s Campaign in collaboration with the U.N. Sustainable Development Solutions Network, also revealed the “devastating and disproportionate” impact of the virus on low-income communities in the U.S.

The report found that death rates in the lowest income group were double the death rates of those in the highest income group

“Widespread equitable access would drive hospitalization and death rates way down,” Doron said, adding that not enough individuals know that treatments are available and end up in the hospital.

“Those who are more medically literate and do their own research know how important it is to suspect COVID at the first sign of symptoms, have easier access to testing, and know to call their doctor for a prescription for an antiviral or for an infusion of monoclonal antibody or remdesivir,” Doron said.

Education pertaining to treatments as well as widespread, equitable access to COVID-19 vaccines, tests and effective treatments are critical to boosting our way out of the pandemic by ultimately driving down hospitalizations and death rates, Dr. Jay Bhatt, an internist and adjunct faculty at the UIC School of Public Health, told ABC News.

“This would likely reduce spread and cases of chronic disease triggered by COVID-19 infection and likely hospitalizations and death,” Bhatt said.

COVID-19 funding will play an important role in treatment access

Equitable access to drugs also remains critical for the millions of Americans who are moderately or severely immunocompromised and thus have a weakened immune system, putting them at increased risk of severe COVID-19 illness and death, according to the Centers for Disease Control and Prevention.

According to physicians, a large proportion of the few fully vaccinated Americans who are getting breakthrough infections and dying are those with underlying conditions or those who are being treated with immunosuppressive drugs.

“There may be a small number of individuals with chronic disease and those that are immunocompromised infected with COVID-19 that may not survive infection even though they have had appropriate treatments and be vaccinated. It is also possible that COVID-19 flares chronic conditions that may lead to complications and death,” Bhatt said.

Matthew Cortland, a disability rights advocate, stressed the importance of getting those drugs to those at higher risk.

“If you are at higher risk, having a reduced viral load can only benefit you,” Cortland said. “There’s still a shortage and a scarcity mindset. Paxlovid has to be readily available basically everywhere.”

The push to make treatments more widely available only further underscores the need for COVID-19 funding, Cortland added.

“Congress will need to fund more purchases” of these treatments, Cortland said. “That’s the only way that we get to as few COVID deaths as possible.”

Copyright © 2022, ABC Audio. All rights reserved.

Life expectancy in Chicago declined during first year of COVID pandemic, especially for people of color

Life expectancy in Chicago declined during first year of COVID pandemic, especially for people of color
Life expectancy in Chicago declined during first year of COVID pandemic, especially for people of color
Scott Olson/Getty Images

(CHICAGO) — Life expectancy in Chicago fell by nearly two years during the first year of the COVID-19 pandemic, in line with national trends, a new report finds.

The data, released Monday by Mayor Lori Lightfoot and the city’s Department of Public Health, showed Chicagoans had a life expectancy of 75.4 years in 2020, down from 77.3 years in 2019.

The figure is one of the steepest declines in life expectancy recorded in a single year for Chicago. What’s more, the sharpest drops were seen among communities of color, particularly Black and Hispanic residents.

“COVID has taken a terrible toll on the health and well-being of our city’s residents, particularly those who are Black and Latinx,” Lightfoot said in a statement. “Without formally acknowledging this detrimental impact, and its roots in structural racism, we will never be able to move forward as a city.”

The data showed that life expectancy for Black residents fell below 70 years for the first time in decades, with a drop from 71.8 years to 69.8 years. Additionally, the life expectancy gap between Black and white Chicagoans widened to 10 years, up from 8.8 years in 2017.

Although the COVID-19 pandemic was a significant driver of the Black-white life expectancy gap in 2020, it was only the second leading cause of death. According to officials, the main driver was chronic diseases, including heart disease, cancer and diabetes.

The city also saw sharp increases in deaths caused by homicides and accidents, including drug overdoses and car crashes.

Meanwhile, Hispanic residents saw the steepest drop of any racial/ethnic group from 79.1 years to 75.9 — a decrease of 3.2 years. The data also found that Asian/Pacific Islanders saw a life expectancy decline of two years while white residents saw a decrease of one year.

In addition, death rates increased from 2019 to 2020 for all races and ethnicities, with people of color making up a disproportionate number of deaths. Black residents only represent one-third of Chicago’s population but accounted for half of the city’s deaths.

Overall deaths in Chicago rose by 30%, according to the report. Officials recorded about 6,000 more deaths than predicted and approximately 4,000 of those were due to COVID-19.

CDPH said it is working to narrow the racial life expectancy gap through a program called Healthy Chicago 2025 to address the root causes of these disparities such as structural racism.

Among the top priorities is increasing access to health care. The department’s Health Chicago Survey found that in 2020, 35% of Black residents lost health care coverage compared to 19% of white residents and 27% of Hispanic residents were unable to access health care compared to 8% of white residents.

What’s more, 27% of Hispanic residents and 26% of Black residents said they missed urgent medical appointments while only 9% of white Chicagoans reported similar circumstances.

The action plan also includes investing money to increase access to housing, food and childcare for minorities.

“The life expectancy gap isn’t just about the causes that show up on the death certificate most often, but what drives those causes,” CDPH Commissioner Dr. Allison Arwady said in a statement. “There is no miracle cure, no shortcut to closing the life expectancy gap.”

The statement continued, “Collectively, the City and its partners must do the work to fundamentally transform the conditions in which people live — by ending the pandemic and by addressing its impacts on access to services, housing, education, and economic opportunities, as well as people’s mental health.”

Neither the mayor’s office nor the CDPH immediately replied to ABC News’ request for comment.

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Americans who haven’t had COVID are now in the minority following omicron surge

Americans who haven’t had COVID are now in the minority following omicron surge
Americans who haven’t had COVID are now in the minority following omicron surge
VALERIE MACON/AFP via Getty Images

(ATLANTA) — A new CDC analysis estimates that at least three out of every five Americans have antibodies that indicate a prior COVID-19 infection. Prior to the omicron-fueled surge in cases from December 2021 to February 2022, only an estimated one-third of people in the U.S. were estimated to have a prior infection.

“This is the first time that population seroprevalence is over 50%,” Dr. Kristie Clarke, co-lead for the CDC’s COVID-19 Epidemiology & Surveillance Taskforce Seroprevalence Team, told reporters on a press call this afternoon.

Clarke said she had expected a post-omicron increase in seroprevalence — antibodies that show previous COVID-19 infection — but not this much of an increase.

About 58% of adults had detectable antibodies as of February — but that rose to nearly 75% among children and teens under 17.

“We had 43% in January and I did expect it to increase. I didn’t expect it to increase quite this much, but we follow the data and we look at the data and this is what the evidence is showing us and so this is why we want to get this message out to the U.S. population as soon as possible,” Clarke said.

The jump in antibody protection, both from infection and from vaccines and boosters, is part of the reason why the CDC went ahead with its recent decision to use new metrics for masking and community warnings, CDC Director Rochelle Walensky said.

“We do believe that there’s a lot of protection in the community both from vaccination as well as from boosting and from prior infection,” she said.

But Walensky and Clarke repeatedly emphasized how important vaccination still is. There’s very little information on how long immunity from a case of COVID lasts, but a lot more data on how long immunity from vaccines and boosters lasts.

“I can’t underscore enough what Dr. Clark said, which is those who have detectable antibody from prior infection, we still continue to encourage them to get vaccinated,” Walensky said.

“We don’t know … when that infection was, we don’t know whether that protection has waned. We don’t know as much about that level of protection than we do about the protection we get from both vaccines and boosters,” Walensky said.

Clarke said this study cannot be interpreted to mean 60% of Americans have protection against reinfection.

“Reinfection happens and infection after vaccination can happen,” Clarke said.

Nor does the percentage mean we’ve reached some kind of herd immunity.

“There’s also no known threshold of the population where once you get above X percentage will completely stop community transmission of COVID. So all of that is really important to know,” Clarke said.

Still, there is continued good news on the BA.2 variant, which has yet to cause a significant jump in severe illness or death, Walensky said, though there are a few counties in the Northeast that the CDC now categorizes as orange.

“There are some areas of the country, particularly in the Northeast, where we’re seeing higher number of cases and we’re starting to see some hospitalizations tick up. You know, we’re watching this carefully,” Walensky said.

But she noted: “We haven’t seen them tick up as much as we might have expected in prior times during this pandemic, thanks to, I believe, a large amount of protection in the community both from disease and infection, as Dr. Clark has articulated, as well as vaccine protection.”

The hospital stays that the CDC is monitoring have also not been as severe as in the past, she said.

“We’re seeing less oxygen, use less ICU stays. And we haven’t, fortunately, seen any increase in deaths associated with them. So we are hopeful that positive trends will continue that we will not see as a result of these increasing cases, any further severity of disease,” Walensky said.

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Aspirin no longer recommended to prevent first heart attack, stroke for most adults over 60

Aspirin no longer recommended to prevent first heart attack, stroke for most adults over 60
Aspirin no longer recommended to prevent first heart attack, stroke for most adults over 60
Tetra Images/Getty Images

(NEW YORK) — For years, doctors recommended people in their 50s start taking baby aspirin every day to protect against heart attacks and stroke. But in recent years, with new evidence of the possible harm of daily aspirin, health experts shifted those recommendations.

In major new guidance, an influential physician task force no longer recommends daily aspirin to prevent a first heart attack or stroke among people 60 and older. Meanwhile, the new guidance said people 40 to 59 should only take it if they have a high risk of cardiovascular disease, and in consultation with a doctor. There is little benefit in continuing aspirin beyond the age of 75 years old, experts concluded.

The new guidance comes from the United States Preventive Services Task Force (USPSTF), an influential physician group that helps guide medical best practices.

Heart disease and stroke are the leading causes of death in the United States, accounting for more than one in four deaths. While daily aspirin use has been shown to lower the chance of having a first heart attack or stroke, it can also increase the risk for bleeding in the brain, stomach and intestines. Although the absolute risk of a bleeding event is low, the risk increases with age.

“Based on current evidence, the task force recommends against people 60 and older starting to take aspirin to prevent a first heart attack or stroke,” task force vice chair Dr. Michael Barry, professor of Medicine at Massachusetts General Hospital, told ABC News. “Because the chance of internal bleeding increases with age, the potential harms of aspirin use cancel out the benefits in this age group.”

“People who are 40 to 59 years old and don’t have a history of cardiovascular disease but are at higher risk may benefit from starting to take aspirin to prevent a first heart attack or stroke,” task force member Dr. John Wong, interim Chief Scientific Officer and Professor of Medicine at Tufts Medical Center, told ABC News. “It’s important that they decide together with their healthcare professional if starting aspirin is right for them because daily aspirin does come with possible serious harms.”

“It is important for the public to understand that for the vast majority of Americans without pre-existing heart disease, aspirin does not provide a net benefit. The harms are approximately equal to any benefits. The USPSTF is just catching up with this widely accepted scientific viewpoint. For nearly 20 years the FDA has advised against routine use of aspirin for prevention in patients without heart disease,” Dr. Steven Nissen, cardiologist at the Cleveland Clinic, told ABC News.

The new recommendations were aimed at people who have not yet started taking a daily aspirin. The panel of experts did not issue guidance for people who are already taking a daily aspirin, and the updated news does not necessarily mean people should stop taking it if prescribed by a doctor.

“We want to emphasize that these recommendations are focused on starting aspirin to prevent a first heart attack or stroke. Anyone who already takes aspirin and has questions about it should speak with their healthcare professional,” Wong said.

The new guidelines do not change for people who have had a heart attack, stroke or other major cardiovascular issue. The recommendation for using aspirin to protect them from a second event remains strong.

Recommendations on daily aspirin to prevent disease have shifted in recent years. In 2016, the preventive services task force recommended people in their 50s at risk for heart disease take baby aspirin to prevent both cardiovascular disease and colon cancer. But updated recommendations based on additional research found benefits may not outweigh the risk, concluding the best colon cancer prevention is routine screening beginning at the age of 45.

Dr. Chineze Akusoba is an Internal Medicine resident at the Mayo Clinic Rochester, Minnesota, and a contributor on the ABC News Medical Unit.

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