(NEW YORK) — The recent rise in COVID-19 cases has come at an important time for millions of American families, particularly ones who avoided gatherings during last winter’s surge.
However, doctors and medical experts said this year’s holiday celebrations don’t necessarily need to be outright canceled if eligible family members are vaccinated and stick to protective protocols.
“I think it can be very different than last year,” Dr. John Brownstein, an epidemiologist at Boston Children’s Hospital and an ABC News contributor, said. “We didn’t have vaccines, we didn’t have pervasive testing. With these new tools, we can celebrate in a different way.”
Brownstein and other health experts said vaccinations and booster shots are the best tools to ensure that families are safe. The health data has shown that fully vaccinated people are less susceptible to the severe symptoms of the virus, are less likely to be hospitalized and less likely to die from COVID.
The booster shots have also been shown to provide strong protection from severe symptoms.
“The vast majority of breakthrough cases will be mild or asymptomatic,” he said.
Brownstein also emphasized social distancing before traveling to see families as it would reduce the risk of catching the virus from someone outside their household.
While there are long lines at testing sites and shortages of tests around the country, medical experts told ABC News that getting a test will give families peace of mind and prevent spread if they gather.
Dr. June McKoy, a professor at Northwestern University’s Feinberg School of Medicine, told ABC News that even fully vaccinated individuals should get a test and avoid gatherings if the test comes back positive.
McKoy emphasized that the virus is still dangerous for children under five, the elderly and those with immunocompromised systems.
“Families need to be open before they have visitors,” she told ABC News. “They need to know if you are putting someone at risk.”
McKoy recommended that indoor gatherings be kept to a small number, especially if it’s difficult to ventilate the room. She also urged family members to wear masks inside if there is an unvaccinated child or very elderly to ensure they are protected.
Removing the masks during meals is OK, according to McKoy, who said she plans on wearing a mask when she visits her family this week.
Ultimately, McKoy said it will come down to a person’s own sense of risk aversion and willingness to adhere to vaccinations and protective protocols.
She did note that holiday gatherings with family are important for one’s mental health and said taking such steps to enjoy the company of family during the holidays would be worth the sacrifice.
“We’ve all been waiting for [the holidays] and this is the important one. We all have to make sure to make it safe,” she said.
Anyone who needs help scheduling a free vaccine appointment can log onto vaccines.gov.
(NEW YORK) — Just three weeks after it was first discovered in the United States, the U.S. Centers for Disease Control and Prevention now estimates that the highly transmissible omicron variant is the dominant variant in the United States, representing 73% of new coronavirus cases, as of Dec. 18.
The variant has now been detected in all but two states — Oklahoma and North Dakota. In some parts of the country — including the New York, New Jersey area, much of the South, the upper Midwest, and the Pacific Northwest, the omicron variant now accounts for more than 90% of new cases.
The significant increase is 70% higher than just one week ago, and more than 72% higher than two weeks ago, when omicron, also known as B.1.1.529, was estimated to account for just 0.4% of all new cases.
“This sharp rise in omicron was expected and is similar to what has been seen worldwide,” the CDC said in a statement Monday. “We know layered prevention strategies can slow the spread of COVID-19.”
The World Health Organization and the CDC have both identified omicron as a variant of concern.
Health officials and experts alike have warned that the omicron variant is a more infectious version of the disease, and is likely to cause a significant COVID-19 surge in the weeks and months to come.
“This virus is extraordinary. It has a doubling time of anywhere from two to three days,” Dr. Anthony Fauci, chief medical adviser to the White House, said on Sunday during an appearance on CNN’s State of the Union.
The country’s latest COVID-19 resurgence comes just a week before Christmas and the New Year, as millions of Americans are set to gather and travel for the holidays.
The U.S. is currently averaging more than 130,000 new cases a day, more than double the average from two months ago. Nationwide, nearly 70,000 Americans are currently hospitalized with COVID-19, and just under 1,200 Americans are still being reported lost to the virus every day.
Health officials continue to urge the public to get vaccinated and boosted as soon as possible, given concerns over waning immunity.
Early data from Moderna on Monday found that its current vaccine booster candidate increases antibody levels against omicron 37-fold. Earlier this month, Pfizer reported that its booster increased antibody levels 25-fold.
(CHICAGO) — When Autumn Carver was in her darkest days fighting off complications from COVID-19, which she contracted while pregnant with her third child, she said she still had hope she would make it home to see her kids and husband.
Now, the 35-year-old is savoring every moment of being home with her family after being discharged from the hospital in time for Christmas.
“We have a lot to be thankful for, for Christmas and celebrating the birth of Jesus and us being together,” she told Good Morning America. “It’s not so much about the presents and all that jazz, we’ll just be happy to be able to be all together for Christmas.”
Carver, of Indiana, was hospitalized in August with COVID-19 and gave birth on Aug. 27 in an emergency C-section while 33 weeks pregnant.
Her son, Huxley, was born healthy, but Carver would not meet him for the first nearly two months of his life.
Shortly after giving birth, Carver was placed on an extracorporeal membrane oxygenation, or ECMO, machine, which removes carbon dioxide from the blood and sends back blood with oxygen to the body, allowing the heart and lungs time to rest and heal.
She spent around two months on the machine, and was only taken off of it in late October, when she was also finally able to meet her son for the first time.
“That day was precious,” she said, recalling the day she met Huxley.
Several weeks later, on Dec. 1, Carver left Northwestern Medicine in Chicago and returned home for the first time in 100 days.
It was the first time she was able to see her older daughters, ages 5 and 4, since being hospitalized, and it was the first time ever the Carvers were together as a family of five.
“It’s been awesome, better than expected,” said Carver, adding that her daughters were “shocked” to have her home. “The kiddos are still young enough that they’re resilient, but it’s taking them some time still to adjust,” she said.
Carver’s husband, Zach, spent nearly all the past 100 days of her hospitalization by her side while both sets of grandparents took care of their three children.
“Having my whole family under one roof for the first time was, I don’t have words to put on that,” he said. “Happy and joyful, they don’t compare to what I really feel. We’re just all so happy to be together, especially right before Christmas.”
The Carvers said they are especially grateful for every day that Autumn Carver is at home because of all the near-death moments she faced during her battle with COVID-19.
Carver’s husband said he was told multiple times over the 100-day journey that his wife may not make it. Just weeks ago, the couple said they were preparing for Carver to undergo a lung transplant.
“We would just pray together and use that to stay motivated,” said Carver. “We would look forward and we were just taking one day at a time.”
When Carver was discharged on Dec. 1, she was able to walk out of the hospital on her own and did not need oxygen support.
“I think using the word ‘miraculous’ is a very appropriate word,” said Dr. Ankit Bharat, chief of thoracic surgery at Northwestern Medicine, who treated Carver. “She’s not going to get her lung function back to where it was before COVID hit her, but she’ll be able to lead a normal life.”
Carver’s lung capacity is currently at 40% due to the damage done by COVID, according to Bharat.
“Even though her recovery has been miraculous, she’s still 40% and that’s significant,” he said. “It’s a reminder that this virus can affect anybody, whether you’re young or healthy, and you cannot take this lightly.”
Carver had no preexisting conditions and was doing CrossFit workouts right up until she started feeling COVID-19 symptoms. She said she hopes to be strong enough to workout again at some point, but her focus is getting strong again for herself and her family.
“We just totally have a renewed outlook on life,” said Carver. “As much as nobody wants to get up in the middle of the night [with kids], it’s easier for us to just count it as a blessing.”
Speaking of how it’s changed them as parents, she added, “We just take the time and sit down and do whatever they want us to do because we missed that so much for so long.”
Carver said her experience has also changed how she lives her own life daily, noting that she gives more hugs to the people she loves and tells them she loves them.
“I tell our girls every morning to be kind and to make somebody smile,” she said. “Our world could use a lot more kindness and forgiveness and joy.”
(NEW YORK) — As rates of COVID-19 infections rise during the holidays and omicron cases surface across the United States, drug companies Pfizer and Merck are preparing to launch the first COVID-19 pills. If authorized by the Food and Drug Administration, these at-home treatments could be prescribed by doctors and picked up at your local pharmacy to reduce the risk of becoming severely ill.
“In early clinical research studies, both [drugs] demonstrated a significant decrease in the progression of COVID-19 in high-risk patients,” said Dr. Roy M. Gulick, chief of the Division of Infectious Diseases at New York-Presbyterian/Weill Cornell Medical Center.
Both drug companies emphasize that their medications will likely be effective against the omicron variant.
Public health officials remain concerned about a pending winter surge. People with higher risk factors — the unvaccinated, immune compromised, elderly and those with chronic conditions — need the pills most and may benefit the most, said Dr. Arthur Kim, an infectious disease specialist at Massachusetts General Hospital.
But with both pills on the cusp of potential FDA authorization, physicians have expressed concern about uptake and access. One concern is that the pills need to be taken early — within the first three to five days after diagnosis.
They are most effective “before a person becomes critically ill,” said Dr. Paul Currier, director of the Respiratory Acute Care Unit at Massachusetts General Hospital. “Once a patient becomes critically ill, the virus has already caused a lot of inflammation in the body that likely cannot be stopped by medicines that only target the virus itself.”
That could pose a logistics challenge, experts said, as people with mild symptoms are currently encouraged to stay home to avoid spreading COVID-19 to others.
At first, the pills will only be available with a doctor’s prescription, and with health care resources still strained, “delays in testing and capacity will reduce their effectiveness in the real world,” Kim said.
Both treatments require patients to take several pills twice per day for five days.
But pharmaceutical executives are optimistic that the pills will make a significant dent in the pandemic.
Pfizer’s pill has the “potential to save the lives of patients around the world,” said Pfizer CEO Albert Bourla.
Bourla estimated that 1,200 deaths and 6,000 hospitalizations would be prevented for every 100,000 COVID-19 patients who take the pills.
But pharmaceutical companies say emphatically these pills should be used as a last resort and for patients who are already sick. Getting vaccinated is by far the safest and most effective way to prevent getting COVID-19, or becoming severely sick if you do.
“I want to emphasize that no one should use the existence of the pill as an excuse to avoid vaccination,” Bourla said.
“The best way to prevent getting seriously ill from COVID-19 is to use the strongest preventative measures we have: wearing masks and getting vaccinated,” Currier said.
When taken early, Pfizer’s treatment was 89% effective at reducing the risk of severe illness, hospitalization and/or death from COVID-19, according to the company. Merck’s pill, meanwhile, reduced the risk of severe illness, hospitalization and death by 30%, it said.
If authorized by the FDA, Merck and Pfizer’s COVID-19 pills could be available as early as next month.
Dr. Navjot Kaur Sobti is a cardiovascular disease fellow physician, rising interventional cardiology fellow and board-certified internal medicine physician at New York Presbyterian Hospital/Weill Cornell Medical Center. She is a member of the ABC News Medical Unit.
(NEW YORK) — Dr. Deborah Levine has been a pediatric emergency medicine physician in the New York City area for over two decades. In recent years, she has observed an increase in the number of mental health emergencies in adolescents — which only got worse during the pandemic.
“The problem has always been there. The pandemic, we felt it even more so,” said Levine, who practices at NewYork-Presbyterian Komansky Children’s Hospital and is an associate professor of clinical pediatrics and emergency medicine at Weill Cornell Medicine.
Last week’s surgeon general’s advisory on the youth mental health crisis during the pandemic didn’t come as a surprise to hospitalists like Levine, who continues to see the impact as demand still outpaces access 21 months later.
“We’re seeing it on the ground,” Levine said. “We’re looking for ways to help ameliorate the crisis and in the meantime, we’re actively treating these children who need help.”
Hospitals are often a “safety net” for people experiencing mental health emergencies, she said, and that’s only become more pronounced as outpatient clinics and offices continue to be overwhelmed.
“I think this crisis is so significant that we just can’t meet the demand,” she said.
Some hospitals are trying to meet the immediate demand by increasing bed capacity. Though greater access to psychiatric care is needed to help prevent mental health issues from escalating to emergencies in the first place, experts said. At the same time, an existing shortage of behavioral health professionals is compounding the problem, they said. Telemedicine, which proliferated during the pandemic, can also continue to increase access, particularly vulnerable youth in more rural areas, where specialists are in shorter supply.
The surgeon general’s advisory came on the heels of a coalition of pediatric groups declaring children’s mental health challenges amid the COVID-19 pandemic a “national emergency” earlier this fall. The medical associations pointed to research from the Centers for Disease Control and Prevention (CDC) that found an uptick in mental health-related emergency department visits for children early in the pandemic when compared to 2019, as well as a 50.6% increase in suspected suicide attempt emergency department visits among girls ages 12 to 17.
Depression and suicide attempts in adolescents were already on the rise before the pandemic, the surgeon general’s advisory noted.
“I am worried about our children,” Dr. Vivek Murthy, the surgeon general, said during a recent White House briefing. “[Our] kids have been struggling for a long time, even for this pandemic.”
Continued increase in demand
When the pandemic disrupted access to schools, health care and social services, Texas Children’s Hospital saw adolescents who had received prior treatment for issues such as anxiety and depression come back, along with “tremendous increases of new-onset problems,” Chief of Psychology Karin Price told ABC News.
Even as schools and services have gone back online, the volume “hasn’t let up at all,” she said.
“Our numbers of referrals on the outpatient side continue to increase — general referrals for common mental health conditions in children and adolescents,” she said. “Unfortunately, we’ve also seen increases in the demand for crisis services — children and adolescents having to come to the emergency center for crisis evaluations and crisis intervention.”
During the previous fiscal year, behavioral health had the third-highest number of referrals throughout the Texas Children’s Hospital system — behind ENT surgery and orthopedic surgery — much higher than it typically is, Price said.
“That has been very striking within our system and really demonstrating the need,” she said.
The Children’s Hospital of Philadelphia has seen more than a 30% increase in emergency department volume for mental health emergencies compared to the year before, according to Psychiatrist-in-Chief Dr. Tami Benton.
“We’re starting to see more kids who were previously well, so they were youngsters who were not having any specific mental health conditions prior to the pandemic, who are now presenting with more depression, anxiety,” she said. “So things have definitely not been heading in the right direction.”
The hospital has also been seeing adolescents with autism who lost services during the pandemic seeking treatment for behavioral problems, as well as an increase in girls with suicidal ideation, she said.
As the need has gone up, the number of services hasn’t necessarily followed, she said.
“It’s the same services that were challenged before, there are just more young people in need of services,” she said.
Adapting to the need
Amid the demand for psychiatric beds, CHOP converted its extended care unit to treat children in the emergency department while they wait for hospitalization, Benton said. The hospital also shifted clinicians to provide emergency outpatient services.
“We’ve had to make a lot of changes in our care practices to try to accommodate the volume to try to see more young people,” Benton said.
CHOP was already planning pre-pandemic to expand its ambulatory practices, though the increased demand has only accelerated the project, Benton said. The hospital is also building a 46-bed in-patient child and adolescent psychiatry unit. Both are slated to open later next year, “but as you can imagine, that’s really not soon enough,” Benton said.
Some hospitals have been looking at ways to prevent children from needing crisis services in the first place. Texas Children’s Hospital has developed a behavioral health task force that, for one, is focused on supporting screening for mental health concerns at pediatric practices, Price said. Levine is part of a team researching the pandemic’s effect on pediatric mental health emergencies with one goal being to prevent repeat visits to the emergency department.
“We’re trying to see if we can target certain areas that are at high-risk,” Levine said.
As far as increasing access, telehealth services have been invaluable during the pandemic, especially for reaching more rural populations. Though access may still be limited due to a family’s means, Levine said. Demand also continues to be high amid a workforce shortage, Price said.
“Behavioral health professionals have a lot of different opportunities now,” she said. “Any kind of behavioral health clinicians that didn’t already have full caseloads before certainly have them now.”
According to the American Academy of Child and Adolescent Psychiatry, every state has a high to severe shortage of child and adolescent psychiatrists.
With those challenges in mind, engaging community partners will be key to addressing the mental health crisis, Benton said.
“The most important thing for us to do right now really is focused on expanding access, and I think the quickest way for us to do that is for us to partner with other communities where kids are every day,” she said. “Greater partnerships with schools and the primary care practices is a way to do that … and get the biggest bang for our buck.”
ABC News’ Cheyenne Haslett contributed to this report.
(ATLANTA) — The CDC’s advisory committee recommended Thursday that people who have a choice should get an mRNA vaccine, either Pfizer or Moderna, over the single-shot Johnson & Johnson vaccine after a review of new CDC data on rare blood clots linked to J&J.
The rare blood clots are not a new safety concern, and the J&J vaccine has already become far less common in the U.S. after it was given an FDA warning label about the clotting condition. But more data that confirmed a slightly higher rate of clotting cases and deaths than was previously reported caused the CDC and FDA to take another look at the data this week.
The CDC has now confirmed a total of at least 54 cases and nine deaths from the severe clotting event, which is called thrombosis with thrombocytopenia or TSS, out of the 17 million people who have gotten the J&J vaccine in the US.
Though it’s very rare, the data led CDC experts to favor mRNA vaccines by comparison, particularly because there are so many mRNA vaccines available in the US and people are less likely to be limited.
There could also be more cases and deaths, because TSS is under-diagnosed and could be underreported, the CDC said.
The clotting is more common among women in their 30s and 40s but has also been seen in adult men and women of all ages.
The experts were very clear, however, that the J&J vaccine should not be taken off the shelves and is still far more beneficial than not getting any vaccine at all.
In certain parts of the U.S., particularly among prison populations, people dealing with homelessness, or rural parts of the country, the J&J vaccine is most common. And outside of the U.S., J&J has played a huge role in vaccinating populations in low-income countries — a growing priority as it becomes clear that variants will continue to emerge until vaccination is widespread around the globe.
“In the setting where there are no alternative COVID-19 vaccines, the benefits of the J&J vaccine outweigh the risk. This is important in global situations where there may not be other COVID vaccines available,” CDC’s Dr. Sara Oliver said in a presentation to the committee on the cost-benefit analysis of J&J vaccines.
With the Pfizer and Moderna vaccines, though, the protection against COVID was considered better and the side effects less severe, the CDC analysis found.
“Due to both higher vaccine effectiveness of the mRNA vaccines and the severity of safety issues seen with J&J vaccines, in the setting of widely available mRNA vaccines in the U.S., the benefit-risk balance of the mRNA vaccines is more favorable than for the Janssen vaccine,” she said.
There was also discussion about the recovery from TSS, which often leads to brain bleeding and can be a harder recovery than myocarditis, the heart inflammation condition linked to the mRNA vaccines that is also a rare safety concern.
“It’s important to note that there are differences in the severity of these vaccine associated events. In myocarditis after mRNA COVID-19 vaccines … at a three-month follow up, over half reported no symptoms and over 90% were fully recovered by cardiologist or health care provider, and there have been no confirmed deaths,” Oliver said.
“For TTS after the Janssen COVID vaccines, there’s around a 15% mortality rate and 17% required discharge to a post-acute care rehabilitation facility,” she said.
The experts on the committee were largely in agreement with the recommendation, supporting a push toward Pfizer or Moderna over J&J when available but continuing to offer J&J as opposed to no vaccination.
“I recognize the drawbacks of the Janssen vaccine. However, I look at this as an issue of the trolley problem in ethics, where you’re driving the trolley and you have to decide whether you’re going to go down one track and have one person die or go down a different track and have 10 people die,” said Dr. Jamie Loehr, a doctor in Ithaca, New York.
“If we take away the Jansen vaccine, and people … cannot get the mRNA vaccine, we have all these complications from getting COVID disease. And so even though there are significant risks to the vaccine, if it’s the only one that is an option, I want it to be available,” he said.
Dr. Beth Bell, a professor of public health at the University of Washington, said she thought the “preferential recommendation” would make it very clear that experts were concerned about the side effects but wanted to maintain individual choice.
“I would not recommend the Janssen to my family members. On the other hand, I think we do have to recognize that different people make different choices and if they are appropriately informed, I don’t think we should remove that option,” she said.
Some were more determined to avoid it, however.
“I just have a real problem with a recommendation for anyone to give a vaccine that 1 per 100,000 women ages 30-49 years old will have a condition with a case fatality rate of 15%,” said Dr. Pablo Sanchez, a pediatrician at The Ohio State University Nationwide Children’s Hospital.
“And so I really have a problem. I’m not recommending it to any of my patients’ parents and I tell them to stay away from it,” Sanchez told the committee.
For its part, J&J said it remained very confident in the positive impact of its vaccine, particularly in low-income countries.
“Let me just state at the outset that based on the data we are confident in the positive benefit-risk profile of our vaccine. It is saving lives here in the U.S. today and on every continent around the globe,” Dr. Penny Heaton, global head of vaccines for J&J, said at the meeting.
“Our vaccine is different, it’s long lasting, it offers high levels of protection and it provides breadth of protection. Our vaccine has flexible dosing, it’s easy to store and transport. In many low- and middle-income countries, our vaccine is the most important and sometimes the only option, even in the U.S.,” Heaton said.
(NEW YORK) — The COVID-19 pandemic has shifted Americans’ perceptions of health care, and not for the better, according to a new survey.
Nearly half of Americans say the pandemic has worsened their perceptions of the U.S. health care system, with many describing it as “broken” or “expensive,” according to the West Health-Gallup survey released this week, the largest survey conducted on U.S. health care since the start of the COVID-19 pandemic.
The high price of health care was a major factor, with a staggering one-third of Americans intentionally delaying or declining medical care over cost concerns.
In the midst of a pandemic, 14% of people with COVID-19 symptoms reported that they didn’t seek medical care because they worried they wouldn’t be able to afford it, a Gallup poll from April 2020 found.
In the new survey, nearly all sectors of society reported deep concerns about the health care system, including the insured and uninsured, wealthy and poor. The pandemic has also raised awareness of the unequal impact on Black, Hispanic and other non-white groups.
The survey found nearly three out of four Americans believe that their household pays too much for the quality of health care they receive, and an estimated 58 million U.S. adults find health care costs to be a major financial burden for their families.
One survey respondent, a white, Republican woman in her 60s, told researchers, “It’s hard when you have three or four kids and you’re trying to juggle the cost, and you’re deciding should I go to the emergency clinic or can we wait another day.”
Avoiding treatment due to rising costs is a problem facing both poorer and richer Americans. Around 34% of people with household incomes of less than $24,000 reported not seeking care in the prior three months due to cost. Twenty percent of people in high-income households (earning more than $120,000 annually) reported the same.
One in five U.S. adults reported they or a member of their household had a health problem worsen after postponing their medical care due to concerns about cost.
“Postponing care is only going to create higher costs in the long run,” said Dr. Blythe Adamson, founder of Infectious Economics LLC and affiliate professor at the University of Washington. “If we’re detecting cancer later on, that patient will have worse outcomes and more expensive care.”
The West Health-Gallup survey found that 60% of Americans reported the pandemic has made them more concerned about unequal access to quality health care services. Among Black Americans and Hispanic Americans, this concern was higher at three-fourths and two-thirds, respectively.
“We get brushed aside, African Americans, a lot of times,” said one survey respondent, a Black, Democrat woman in her 40s. “Things that we say, we feel it gets brushed off, they’re not really taking it seriously, like, oh, she’s just complaining again or it’s not serious, that kind of thing.”
Essential workers, who have lower income on average, continue to face greater COVID-19 risks than those with higher-income, more Zoom-friendly jobs.
“We continue to see low-income workers having high COVID-19 exposure at their job and not having insurance,” Adamson said. “These people are more likely to be hospitalized and thrown into bankruptcy.”
While some Americans have benefited from expanded access to telemedicine, inequities remain.
While other countries have government-backed health care, the US still relies on a mix of public and private health care insurers, which can create confusion and unequal pricing, according to Adamson.
Plus, as Adamson pointed out, “There are still many low income people that don’t have reliable internet, smartphones or computers that they can use in a telemedicine visit.”
Collectively, the survey shows that the pandemic appears to have worsened people’s views on the U.S. health care system.
“What’s changed in people’s minds is value in health care. Are we really getting a good value for every dollar we’re spending on prevention, on treatments, on hospitalization in this system?” Adamson asked.
Many of the challenges of the existing health care system were exposed under the strain of the COVID-19 pandemic.
“Our current system is unsustainable, especially for the poor,” Adamson said.
Nicholas Nissen, M.D., is an author, host of the “Brain Health with Dr. Nissen” podcast and a contributor to the ABC News Medical Unit.
(WASHINGTON) — Two senators are taking aim at the widespread issue of fake and ineffective masks flooding the U.S. market.
A new bill announced Thursday and obtained exclusively by ABC News will grant more authority to the Food and Drug Administration to enforce and punish counterfeiters in the mask industry. It’s a bipartisan effort by Sens. Chris Murthy of Connecticut, a Democrat, and Mike Braun of Indiana, a Republican.
It is the first piece of legislation in a large pandemic response package that will be rolled out by the Senate Committee on Health, Education, Labor and Pensions in the next few weeks.
The wide-ranging bipartisan package, which the committee has been working on for months, will target various holes in the nation’s pandemic response infrastructure by improving the supply chain for medical equipment and addressing health inequities that have put minority populations at higher risk, among other measures.
The legislation announced Thursday, called the Protecting Patients from Counterfeit Medical Devices Act, comes as public health experts are urging Americans to renew their vigilance on masking in the face of omicron, a quickly-spreading COVID-19 variant of which infections have increased sevenfold in the U.S. over the last week.
New York, California, Illinois, Nevada and several other states have recently reimposed indoor mask mandates.
“In looking at early data on transmissibility of omicron from other countries, we expect to see the proportion of omicron cases here in the United States continue to grow in the coming weeks,” CDC Director Rochelle Walensky said at a White House briefing on Wednesday.
“What does this mean for individuals and families as we head into the winter months? A time when families may be gathering with one another over the holidays?”
“It means that it is vital for everyone to get vaccinated and boosted if they are eligible. Given the increase in transmissibility, this also means continuing to be vigilant about masking in public indoor settings, in areas of substantial or high community transmission. And as of now, this represents about 90% of all counties in the United States,” she said.
The new bill is also aimed at protecting health care workers who could face a surge of patients this winter.
Last February, the Department of Homeland Security announced it seized 10 million counterfeit 3M N95 masks, including some possibly headed for hospitals.
Since the start of the pandemic, Customs and Border Patrol has seized more than 34 million counterfeit masks, and nearly 60% of the counterfeits were seized in 2021, according to the FDA.
Earlier this year, the FDA asked for broader powers to seize and punish counterfeiters, telling Congress that the agency is currently limited to destroying certain fakes.
The current ability to enforce the rules around fraudulent PPE “is incomplete and there will be limited deterrence for the selling of counterfeit devices, especially domestically,” the FDA said in its 2022 budget request.
“The revisions proposed will help keep counterfeit devices like these out of the United States and facilitate enforcement actions against those that find their way into interstate commerce,” the FDA said.
(ATLANTA) — As the delta variant of COVID-19 spread across the United States this summer, the virus appeared to take a particular toll on unvaccinated pregnant people, with deaths dramatically increasing in the summer months.
The number of pregnant people who died of COVID-19 spiked sharply in August and September, with more than two dozen deaths recorded in each of those months, according to data released this week by the U.S. Centers for Disease Control and Prevention (CDC).
More than 40% of the 248 deaths among pregnant people since the start of the pandemic occurred since August, the data shows.
The number of pregnant people who contracted COVID-19 also increased sharply over the summer months, according to CDC data, reaching numbers of cases not seen since before the vaccine was made widely available earlier this year.
Now, as the omicron variant spreads across the U.S., with what is believed to be a high degree of transmissibility, the director of the CDC said she is “very concerned” about those who remain unvaccinated.
“I can tell you, when I hear about a pregnant woman in the community who is not vaccinated, I personally pick up the phone and talk to them,” CDC Director Dr. Rochelle Walensky told ABC News’ chief medical correspondent, Dr. Jennifer Ashton, in a Dec. 8 interview.
“It’s just shocking,” she said of the number of pregnant people who died specifically in August, one month after the delta variant became the predominant variant in the U.S.
Risks to unvaccinated people and the fetus
More than 25,000 pregnant people have been hospitalized since the start of the pandemic, and more than 150,000 cases of COVID-19 have been confirmed in pregnant people, according to the CDC.
Pregnancy is included in the CDC’s list of underlying medical conditions that make a person more likely to experience severe illness from COVID-19.
The virus causes a two-fold risk of admission into intensive care and a 70% increased risk of death for pregnant people, and increases the risk of a stillbirth or delivering preterm, or earlier than 37 weeks, according to the CDC.
COVID-19 is especially dangerous in pregnant people because their immune systems are already less active as they are supporting their growing fetus. For the same reason, their hearts and kidneys are working harder, Dr. Laura Vricella, a maternal fetal medicine physician at Mercy Hospital in St. Louis, told ABC News in August, as her hospital and others experienced a spike in pregnant patients with COVID-19.
Pregnant people must also keep their oxygen levels higher in general to support their fetus, which can be a herculean task to do when COVID-19 is in the body, according to Vricella.
And in addition to pregnant people with COVID-19 being more likely to deliver prematurely, Vricella said her hospital also saw more COVID-positive pregnant patients deliver stillbirths, even with mild COVID cases.
“COVID-19 begins as a respiratory illness, but can affect the entire body and also seems to increase the risk of thrombosis or blood clots,” she said. “We suspect that this decreased oxygen to the fetus may be responsible for the stillbirths that we are seeing, though we need further research.”
Vaccination rate remains low
In September, the CDC issued an “urgent health advisory” calling on pregnant people to prioritize getting vaccinated against the virus.
As of Dec. 4, the most recent data available, the vaccination rate among pregnant people remains below 40%, compared to nearly 61% of the general population, according to the CDC.
The vaccination rate for Black pregnant people, who already face disproportionate health risks in pregnancy and postpartum, is even lower, at just over 20%, CDC data shows.
“This is one where I feel like we have to do more,” Walensky said of the low vaccination rate overall among pregnant people. “We have to do better.”
“The vaccines are safe, they are effective and they are even more important in pregnant women,” she said.
In addition to the CDC, the nation’s two leading health organizations focused on the care of pregnant people — American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) — have issued guidelines calling on all pregnant people to get vaccinated against COVID-19.
Vaccines shown to be safe
Though pregnant people were not recruited for the initial clinical trials of the COVID-19 vaccines, data over the past several months, since vaccines have been widely available, has shown them to be safe for pregnant people.
In its health advisory urging pregnant people to get vaccinated, the CDC pointed specifically to new data showing the vaccines did not increase the risk of miscarriage. The vaccines are also not believed to have any “significant impact” on fertility.
Both the Pfizer and Moderna vaccines use mRNA technology, which does not enter the nucleus of the cells and doesn’t alter the human DNA. Instead, it sends a genetic instruction manual that prompts cells to create proteins that look like the virus, as a way for the body to learn and develop defenses against future infection.
They are the first mRNA vaccines, which are theoretically safe during pregnancy because they do not contain a live virus.
Vaccine experts interviewed by ABC News said although pregnant women are advised against getting live-attenuated virus vaccines, such as the one for measles, mumps and rubella, because they can pose a theoretical risk of infection to the fetus, the Johnson & Johnson vaccine doesn’t contain live viruses and should be safe. Instead the Johnson and Johnson vaccine uses inactive viruses.
Health experts said that with or without the vaccine, pregnant people need to continue to remain on high alert when it comes to COVID-19 by following safety protocols, including mask wearing, social distancing and hand washing.
(NEW YORK) — One year ago, on Dec. 14, 2020, Sandra Lindsay, an intensive care nurse from Northwell Health, became the first American to roll up her sleeve and receive a COVID-19 vaccine, following the green light from federal authorities.
“That day, when that needle pierced my arm, all I felt was this huge boulder, this weight just roll off my shoulders. I’m always optimistic, but my light got even brighter that day,” Lindsay told ABC News.
Lindsay’s image rapidly circulated across the country, a symbolic representation of the light at the end of the tunnel after the pandemic had forced families apart, shuttered businesses and schools and confined millions of Americans to their homes.
“I just felt hopeful for myself, for the entire country, for the world — that yes, the day that we’ve waited so long for healing is coming,” Lindsay said.
The country’s unprecedented creation and rollout of the vaccine was once considered a nearly impossible feat, given that vaccine development is often a long and arduous process, requiring years of regulatory and manufacturing hurdles to be overcome before it can be made available to the general public.
However, leaning on years of prior research on vaccine technology and with support from the federal government, the process was expedited, allowing for emergency authorization of the shots less than a year after work began.
“When the vaccine first became available a year ago, it seemed miraculous that a vaccine could be developed, rigorously tested in large clinical trials and ready to go in less than a year after the virus was identified,” Dr. Stephen Morse, professor of epidemiology at Columbia University, told ABC News. “That’s an amazing accomplishment considering that we really didn’t have the infrastructure for a rapid national mass vaccination campaign when we started.”
Nevertheless, hundreds of millions of Americans are now inoculated — but tens of millions of others remain completely unvaccinated, an ongoing hurdle that experts say will likely result in the loss of tens of thousands of more lives.
Millions vaccinated but hundreds of thousands still lost to COVID-19
Nearly two years after the vaccine companies first raced to study the virus genome, around 600 million vaccine doses have been distributed and more than 200 million Americans — about 61% of the population — have been fully vaccinated.
“Overall, I think that the vaccine rollout has been a major success over the past year,” Dr. Cindy Prins, a professor of epidemiology at the University of Florida, said. “This took a lot of effort and flexibility, with public health professionals in different states tailoring the rollout to the needs of their own populations. … Looking back, I’m really in awe of what the U.S. has achieved in the past year.”
Pfizer, along with its partner BioNTech, was the first company to receive U.S. regulatory emergency use authorization for its COVID-19 vaccine. Reflecting on the one-year anniversary of the rollout, Pfizer CEO and Chairman Albert Bourla told ABC News he feels proud of what the company has accomplished over the last two years.
“I’m proud and proud for the people at Pfizer. I’m proud for everything that we’re able to do. They [made] the impossible possible, in the way that they manufactured, they brought the treatment, they brought the vaccine,” Bourla said, later adding, “We have the tools to control the situation and go back to our normal way of life.”
However, the road to vaccinate the country has not been easy.
Even with the Trump administration’s multi-billion dollar initiative, Operation Warp Speed, created to speed up the development, manufacturing and distribution of COVID-19 vaccines, as well as a subsequent push from the Biden White House to acquire vaccines and get Americans vaccinated, there have been inconsistent ebbs and flows of interest in the shots.
Over the last year, an average 1.3 million shots — including first, second and third doses — have been administered every day. Comparatively, an average of more than 1,300 lives have been reported lost to the virus each day.
When the first COVID-19 vaccines were administered last December, many hoped the shots would herald a return to normalcy. However, even with vaccines, the U.S. continues to lose thousands of lives every week.
The one-year vaccine anniversary coincides with yet another pandemic sobering milestone: 800,000 Americans reported lost to the virus. Since the first shots went into arms a year ago, approximately half a million Americans have died of the virus.
Of those lost in the last year, just shy of half — 230,000 — have died since mid-April of 2021, when President Joe Biden announced that the vaccine was widely available to every American over the age of 18.
“Since the unvaccinated are most likely to get serious disease and end up in the hospital, vaccination is lifesaving,” Morse said. “This week, we will reach 800,000 confirmed COVID-19 deaths in the U.S. At least a quarter of these deaths, and probably more, were preventable and didn’t have to happen if these people had been vaccinated.”
According to federal data compiled in September 2021, unvaccinated individuals had a 5.8 times greater risk of testing positive for COVID-19 and a 14 times greater risk of dying from it, as compared to vaccinated individuals.
Vaccine hesitancy an ongoing obstacle
Across the country, the issue of vaccine hesitancy remains an ongoing obstacle in the country’s fight against COVID-19.
About 93 million Americans remain completely unvaccinated, including 73 million Americans who are currently over the age of 5, and thus, eligible for a shot.
“I think we were unprepared for the ferocity of the negative response and how many were adamantly opposed,” Morse said.
According to a Kaiser Family Foundation poll released earlier this month, one in four adults remain unvaccinated, with about 14% saying they will “definitely not” get vaccinated. An additional 3% said they will only get the shot if they are required to do so for work, school or other activities.
In addition, despite the fact that all children above the age of 5 are now eligible to receive a shot, millions of youth remain unvaccinated.
About two-thirds of parents of elementary school-aged children are either holding off on getting their younger children vaccinated or refuse to do so, according to another recent KFF poll, conducted before the discovery of omicron.
Coronavirus infections among children continue to surge, currently accounting for about a quarter of all new cases.
“The challenge with having so many people remain unvaccinated is that the virus will circulate most efficiently among those people,” Prins said.
Issues of access still a roadblock for many Americans
Minority communities in the U.S. have faced disproportionate hardships in the pandemic. According to federal data, adjusted for age and population, the likelihood of death because of COVID-19 for Black, Latino and Native American people is approximately two to three times that of white people.
Vaccination rates among Black and brown Americans have notably improved since the first months of the pandemic, though some groups are still lagging behind in the rollout.
Despite representing 12.4% of the U.S. population, Black Americans currently account for 10.1% of those fully vaccinated against COVID-19.
“It’s OK to have questions, but go to trusted sites,” Lindsay, who has become a vaccine advocate, said. “Everyone knows that we are scarred from historical events. But you’ve got to put that aside. So much has happened since all those terrible things. Safeguards have been put into place to ensure that these terrible experiments don’t happen again.”
Issues of access, particularly in minority communities, remain a significant hurdle for many to get vaccinated.
“The access issues still exist, and I think that they can be even more challenging now, because a lot of the mass vaccine clinic and mobile clinic efforts have given way to vaccines being distributed by pharmacies or doctors’ offices,” Prins said. “There are many neighborhoods in the U.S. where people don’t have access to a pharmacy or physician’s office and may not have good transportation to be able to get to one easily.”
According to an ABC News’ analysis of pharmacy locations across the country conducted earlier this year, 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.
“While it is important to celebrate the incredible science, engineering and public health expertise that went into designing and delivering so many vaccines this past year, we must also remember the lack of equity both nationally and internationally in who has been vaccinated,” said Samuel Scarpino, managing director of pathogen surveillance at the Rockefeller Foundation. “As we move forward, it is critical that we address the systemic barriers preventing more equitable delivery vaccines.”
‘Now is the time to take action’
Ultimately, experts concurred that the country’s vaccination efforts are far from over.
“If we had controlled the virus early on, we could have avoided this. More recently, if everyone had been vaccinated, we could have prevented many deaths and much suffering. Too late now, but still not too late to use the vaccine to soften the landing,” Morse said.
With the waning of immunity over time and the potential that the omicron variant could chip away at efficacy, experts are urging Americans to slow the rise of infections by getting vaccinated and boosted.
“The virus isn’t going anywhere,” Lindsay added. “Now is the time to take action, get informed and make the right decision for yourself and for your loved ones.”
ABC News’ Sony Salzman and Chris Donato contributed to this report.
