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(NEW YORK) — An at-home treatment for COVID-19 that can prevent serious illness was authorized by the Food and Drug Administration on Wednesday, offering a note of optimism for the future of the pandemic as the world faces the omicron variant.
When taken early, Pfizer’s pill was 89% effective at reducing the risk of severe illness and death from COVID-19, according to the company, and was effective against omicron.
Pfizer CEO Albert Bourla estimated that 1,200 deaths and 6,000 hospitalizations would be prevented for every 100,000 COVID-19 patients who take the pills.
The FDA said the pill, Paxlovid, was authorized for the treatment of mild-to-moderate coronavirus disease in anyone 12 years and older who weighs at least about 88 pounds. Patients must test positive and be at high risk for progression to severe COVID-19, including hospitalization or death.
Paxlovid will be available by prescription only and should be started as soon as possible, ideally within five days of symptom onset, the FDA said.
“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release.
The treatment course requires taking several pills, twice per day, for five days.
The government has ordered 10 million pills of Pfizer’s Paxlovid and another treatment pill, Merck’s Molnupiravir, which has yet to be authorized.
The order will come in as it’s produced, with some doses available upon FDA authorization, White House COVID coordinator Jeff Zients told governors on a call Tuesday.
The federal government has already contracted with Pfizer to purchase the pills at $530 a course, or $5.3 billion.
There is not expected to be any direct cost to patients.
The pills offer hope, particularly as the omicron variant spreads rapidly across the U.S.
Vaccination and booster shots are the best defense against omicron, offering up to 80% protection by some estimates, and unvaccinated Americans will be hit hardest by the surge. But there will also be more breakthrough infections among vaccinated people because of omicron’s mutations.
“While not a replacement for vaccines, the emergence of new variants has highlighted the need for new therapeutic lines of defense,” said Dr. John Brownstein, an epidemiologist at Boston Children’s Hospital and ABC News contributor.
“The combination of low friction access and high efficacy means that we finally have a therapy that can make a real impact on the trajectory of this pandemic,” he said.
Public health experts and the pharmaceutical companies who make the pills also have been firm that the treatments alleviate illness — they do not prevent it. Vaccines do, and they’re still the safest, most effective option to stay out of the hospital.
“I want to emphasize that no one should use the existence of the pill as an excuse to avoid vaccination,” Bourla, Pfizer’s CEO, said.
The U.S. will also likely face some hurdles in the initial rollout — another reason they shouldn’t be relied upon as an alternative to vaccination.
One concern is that the pills need to be taken early, which means patients will need a positive test and a doctor’s appointment very soon after they get sick. Testing delays and overburdened hospital systems could make that more challenging.
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.”
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,” Bourla said.
ABC News’ Dr. Navjot Kaur Sobti contributed to this report.
(ATLANTA) — Life expectancy in the United States decreased by nearly two years in 2020, mainly because of the pandemic, a new federal report suggests.
In 2019, Americans had a life expectancy — the average number of years a person is expected to live — of 78.8 years.
But new data from the Centers for Disease Control and Prevention’s National Center for Health Statistics (NCHS) found this figure fell to 77.0 years in 2020, marking the biggest drop seen since World War II.
“The thing that stands out to me is just this staggering decline,” Dr. Robert Anderson, chief of mortality statistics at the NCHS, told ABC News.”I know 1.8 years doesn’t seem like a whole lot but, on a population scale, that’s a huge decline in life expectancy.”
This is the biggest decrease seen since World War II, when life expectancy fell by 2.9 years from 66.2 years in 1942 to 63.3 years in 1943.
Although the report lays bare the impact that the virus has had on life expectancy, the team behind the report said other factors also played a role, including an increase in deaths due to diabetes and accidental injuries, such as drug overdoses.
Diabetes deaths topped 100,000 for the first time, Anderson said, and accidental or unintentional injury deaths, such as drug overdoses, topped 200,000.
However, he said that COVID-19 is undoubtedly the biggest reason for the decline.
According to the report, there were more than 3.38 million deaths in the U.S. last year, about 530,000 more than there were in 2019.
Of that 3.38 million, more than 350,000 deaths were attributed to COVID-19, meaning 10.4% of all deaths in 2020 were caused by the virus.
“I can tell you it’s the primary driver in the decline in life expectancy and the increase in mortality,” Anderson said. “We’re talking about 350,000 deaths. That accounts for the bulk of the increase in morality — the overwhelming majority.”
Men saw a bigger decrease in life expectancy, losing 2.1 years — from 76.3 in 2019 to 74.2 in 2020 — compared to a decline of 1.5 years — from 81.4 in 2019 to 79.9 in 2020 — for women.
COVID-19 was the third leading cause of death in 2020, responsible for 85 deaths per 100,000 people.
Anderson said it is the first time a new disease has entered the top 10 leading causes of death so quickly.
“A disease that comes out of nowhere and ends up in the top 10 or top five? You’d have to go back to the early days of the HIV epidemic to see something similar.”
He said HIV never got higher than the eighth-leading cause of death and, even then, it took a few years after the virus was first identified before it reached the top 10.
“This is sort of similar, but even more dramatic, because in one year it goes from nothing to the third-leading cause of death,” Anderson added. “Remarkable.”
(NEW YORK) — With millions of Americans set to travel and gather for Christmas and the New Year, families across the country are scrambling to try to ensure they are adequately protected against the coronavirus.
Experts suggest a confluence of factors is likely driving the country’s case rate up amid the surge of the omicron variant, most notably the millions of Americans who remain unvaccinated.
Many of those who have yet to get the shot are children, despite the fact that in the U.S. anyone over the age of 5 is eligible for the vaccine. Pfizer shots were authorized by the Food and Drug Administration for those 5 to 11 at the end of October, 12 to 15 in May and are fully approved for those 16 and older.
Since the emergence of the delta variant, children have been a significant driving factor behind the nation’s latest coronavirus surges, accounting for about a quarter of the nation’s reported weekly COVID-19 cases. Since July, more than 3.3 million have tested positive for the virus, representing 1 in every 4 cases, according to data from the American Academy of Pediatrics and the Children’s Hospital Association. In addition, the U.S. has not seen a week with fewer than 100,000 new pediatric cases since early August.
Now, given the potential for the highly transmissible omicron variant to cause an even greater wave of infections, experts say it is more critical than ever for children to be vaccinated in order to protect them and those around them, from severe disease and hospitalization, despite the fact that severe illness remains generally uncommon among children.
“[Omicron’s] increased transmissibility makes it possible that we’ll see very high case numbers in children, especially if they remain unvaccinated,” Dr. Kristin Moffitt, an infectious disease specialist at Boston Children’s Hospital told ABC News. “Even if severe infection remains relatively uncommon in children, if case numbers in children skyrocket, we’ll see many more pediatric hospitalizations.”
Earlier this week, the Centers for Disease Control and Prevention reported that models, which estimate the epidemic trajectory of coronavirus in the U.S., suggest that the new COVID-19 infections are likely to surge in the weeks to come and could exceed previous peaks, due to omicron.
“One of the fundamental drivers of ongoing community transmission is that there remains a significant portion of our population that is not immune to COVID,” C. Buddy Creech, director of the Vanderbilt Vaccine Research Program and associate professor of pediatric infectious diseases, told ABC News.
More than 90 million Americans are currently unvaccinated — including 51 million children under the age of 18.
Child COVID-19 cases on the rise again
Since the onset of the pandemic, nearly 7.4 million children and adolescents have tested positive for coronavirus, and in the last week alone, approximately 170,000 pediatric cases were reported, according to a new report from AAP and CHA, released on Monday.
“I think it is concerning to see these rates increasing,” Dr. Lee Beers, the AAP president, told “GMA3” on Tuesday. “It’s been a long, almost two years, and everyone is tired and everyone is frustrated and that’s all the more reason for us to be coming together to work together to really try to beat this thing and I think our kids are struggling.”
Since the first week of September, there have been nearly 2.3 million child cases — nearly a third of the total pediatric cases reported since the onset of the pandemic — and over the last month, pediatric COVID-19 related hospital admissions have increased by 33%, according to federal data.
“As children make up a larger portion of the unvaccinated population, they will account for a higher percentage of cases,” added Moffitt.
Although young people have largely been spared from acute COVID-19 illness, experts stress that children are not immune from the virus. According to the CDC, children are as likely to be infected with COVID-19 as adults and the virus now one of the top 10 causes of death for children ages 5 through 11 years.
There continues to be the misconception, among some, that children and teenagers may not be as severely affected by COVID-19 as adults, explained Creech. While that seemed to be the case early on in the pandemic, the delta variant proved otherwise.
“We began to see far more infections in children, some of which were severe. In addition, we continue to see long COVID, myocarditis, and multisystem inflammatory syndrome in children who appear to have very mild symptoms at the outset,” said Creech.
Pediatric COVID-19 vaccination rates continue to lag
With less than a third of the pediatric population — those under 18 — fully vaccinated, officials, health experts and pediatricians alike have been urging parents to get their children vaccinated.
“If your child is five years of age and older, please get them vaccinated. We need to protect the children,” Dr. Anthony Fauci, chief medical adviser to the White House, told George Stephanopoulos on ABC News’ “This Week” earlier this month. “This idea that children are not vulnerable at all is not so.”
President Joe Biden echoed Fauci’s sentiment on Tuesday, pleading with all families to get their “children protected today.”
“If your children are not vaccinated, please get them vaccinated,” Biden said. “If you’re a parent, understandably you waited – to see how the first shots went with other kids, before getting your own kid vaccinated, you can stop waiting.”
However, 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 Kaiser Family Foundation poll, conducted before the discovery of omicron.
The safety profile of the Pfizer vaccine for eligible children remains “very reassuring,” added Moffit.
Earlier this month, CDC Director Dr. Rochelle Walensky told ABC News that real-world monitoring revealed vaccines are safe for young children.
Notably, the agency has yet to identify any concerns with the temporary heart inflammation known as myocarditis, a potential side effect of mRNA vaccines seen in rare circumstances in teenagers and young adults.
“We haven’t seen anything yet,” Walensky told ABC News Chief Medical Correspondent Dr. Jennifer Ashton. “We have an incredibly robust vaccine safety system, and so if [problems] were there, we would find it.”
Concerns over omicron
There is still not enough data to indicate how omicron will affect children, or whether it will potentially cause severe illness, compared to earlier variants.
Preliminary evidence indicates that omicron spreads at a rate two to three times faster than the delta variant, which experts say could result in a surge in COVID-19 cases, particularly among the unvaccinated.
“With delta, and now with omicron, we see the virus seeking and finding those who are either unvaccinated or whose circulating antibody levels have waned,” Creech explained.
Preliminary data from South Africa estimates that children had a 20% higher risk of hospitalization in the country’s omicron-driven fourth wave, given the fact that so many children were still unvaccinated, and therefore, unprotected.
In addition to the significant number of children and teenagers who are still unvaccinated, there is a large number of children under the age of five who are not yet eligible for the vaccine.
Late last week, the potential timeline for vaccines for children under 5 was pushed back after early data suggested that two lower doses of the Pfizer vaccine was not as effective for kids ages 2 to 5 as it was for the 16 to 25 population. Thus, scientists will add a third dose and see if the vaccine is as effective. Authorization for those 5 and younger may not come until the second quarter of 2022.
Experts therefore say it is critical for all those eligible to get vaccinated, in order to protect children who are still too young to get the shot.
“Vaccination will prevent infections, and fewer infections will mean lower transmission. Vaccinating everyone in a household who is able to be vaccinated will bring an added layer of protection to the entire household,” said Moffit.
(NEW YORK) — Medical researchers say there is renewed promise in reducing COVID-19-related hospitalizations and deaths by increasing the use of convalescent plasma treatments early on in a coronavirus infection.
And some medical experts are pushing the federal government to allow more patients to receive the treatment, as lab-based monoclonal treatments such as Regeneron have seen lessened effectiveness against the omicron variant.
Researchers at John Hopkins University on Tuesday released the results of a 16-month nationwide study on convalescent plasma use on COVID-19 patients and found it had a 54% relative risk reduction in COVID-19-related hospitalizations.
Dr. Arturo Casadevall, one of the study’s co-authors and chair of the department of molecular microbiology and immunology at Johns Hopkins Bloomberg School of Public Health, told ABC News that the results are promising, especially if the plasma is used early on in the infection period.
“The results show a 54% efficacy in reducing hospitalization if you give it up to day nine. It is clear and highly significant,” he said. “If you look to less than five days, the efficacy is much, much higher.”
Researchers observed 1,181 adults who contracted COVID-19, half of whom were given polyclonal high-titer convalescent plasma that contained a concentrated mixture of SARS-CoV-2 antibodies. The other half were given placebo control plasma with no COVID-19 antibodies,
None of the patients who received the convalescent plasma died, and only 17 were hospitalized within 28 days of their infection, the study said, whereas three patients who received the placebo died, and 37 were hospitalized within 28 days of their infection, according to researchers.
After the Food and Drug Administration granted emergency use authorization for monoclonal treatments made by Regeneron and Eli Lilly, the use of plasma treatments for hospitalized coronavirus patients decreased.
Unlike plasma treatments, monoclonal treatments are not derived from the blood of COVID-19 survivors but instead are a cocktail of lab-created antibodies. Those monoclonal treatments were shown to be very effective at preventing worsening symptoms and deaths in infected patients.
However, Casadevall, warned that plasma treatment options need to be more strongly considered as the omicron variant has made monoclonal antibody treatments less effective.
George Yancopoulos, the president and chief scientific officer at Regeneron, told ABC News his company does have a collection of antibodies that are effective against the omicron variant, but it will take at least a few months before it is authorized and shipped.
“People that are high risk who come down with COVID who receive plasma in lieu of monoclonals hopefully stay out of the hospital,” Casadevall said. “And so plasma holds the line until Regeneron comes out with a new set of monoclonals.”
The John Hopkins study comes two weeks after the World Health Organization advised against the use of treatments that use COVID-19 survivors’ plasma. The WHO said it used data from 16 trials involving more than 16,000 patients around the world and determined that the treatment did not “improve survival nor reduce the need for mechanical ventilation.”
Casadevall told ABC News that the WHO did not use the data from the John Hopkins research in its decision.
“We hope that they reverse their recommendation against convalescent plasma in light of the Hopkins study results, since this therapy is inexpensive and available in resource-poor countries where plasma can provide a major tool to reduce hospitalizations and mortality,” he told ABC News.
Andrea B. Troxel, a professor of population health and the director of the division of biostatistics at NYU School of Medicine who has also written studies on convalescent plasma treatments for COVID-19 patients, told ABC News that previous studies on the effectiveness of plasma treatment have been mixed, but she found the results of the John Hopkins University study to be very encouraging.
Troxel said the issue with plasma treatments is determining the right time for their use during the infection period, and the data in the new study gives doctors a better idea of its effectiveness.
“This is the sweet spot for plasma, early enough in the infection the plasma can do what it needs to do. For other studies, it maybe was a little late,” she told ABC News.
Casadevall said the Food and Drug Administration should extend its emergency use authorization for plasma treatments to the outpatient space to ensure the treatment is given at the right time.
Troxel echoed this call and said plasma treatments should be more widely used for infected patients
“There is a strong benefit for these patients in receiving plasma,” she said. “It is safe and there is no reason not to trust this evidence.”
(NEW YORK) — The U.S. Food and Drug Administration (FDA) has approved the first-ever long-acting injectable drug for HIV prevention.
Until this week, the only FDA-licensed and approved medications for HIV pre-exposure prophylaxis, most commonly known as PrEP, were daily oral pills containing the HIV treatment drugs tenofovir and emtricitabine, which slow the progression of an HIV infection in the body.
PrEP is taken daily so that it builds up in your system, to the point that if there is an HIV infection, it prevents the virus from replicating and spreading throughout the body.
When taken as prescribed, PrEP services reduce the risk of getting HIV from sex by about 99%, according to new data from the CDC. Now, individuals who feel at-risk of HIV infection have the option of taking the daily pill, or the new shot every two months, after two initiation injections administered one month apart.
“This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option,” the FDA said in a statement.
According to Dr. Darien Sutton, Emergency Medicine Physician, in an interview with “Good Morning America,” “This is a game-changer in the world of HIV prevention.”
“Patients often have difficulty complying with any oral medication, so a bi-monthly injection can truly change the landscape in terms of HIV prevention. Having a bi-monthly treatment also serves as an opportunity to interact with a patient, share risk reduction sexual health education and complete necessary screenings.”
“Patients on PrEP can often feel stigmatized with taking daily medication,” he told “GMA.” “Some have shared with me that they fear simple actions, like picking up their medications from the pharmacy due to fear of stigmatization. This stigma unfortunately doesn’t stop at the pharmacy, as many also fear being seen carrying their preventative medications in public.”
Sutton added, “The study was also inclusive, including transgender women, which allows better applicability with diverse patient populations.”
CDC data shows that an estimated 34,800 people in the United States acquired HIV in 2019, the most recent year for which data are available.
Men who have sex with men, transgender women who have sex with men, and Black cisgender women are among those disproportionately affected by HIV in the U.S.
Heterosexual people made up 23% of all HIV diagnoses in the U.S. and six dependent areas in 2019. Specifically, heterosexual men accounted for 7% of new HIV diagnoses and heterosexual women accounted for 16%.
The FDA approval comes on the heels of a CDC recommendation this month that there be an expansion of HIV prevention medication to close the gap on PrEP implementation.
In a release, the National Institute of Allergy and Infectious Diseases (NIHAID) also made a nod to the FDA approval, saying in part, “These medications are highly effective at preventing HIV when taken daily as prescribed, however, taking a pill daily while feeling healthy can be challenging.” Adding, “Long-acting injectable cabotegravir PrEP is a less frequent, more discreet HIV prevention option that may be more desirable for some people.”
(NEW YORK) — As Americans brace for the possibility of another difficult winter ahead in the nation’s fight against coronavirus, there is a renewed sense of urgency to get as many people inoculated and boosted as quickly as possible, given the emergence of the highly contagious omicron variant — now dominant in the U.S.
An ABC News analysis of federal and state data found that since July, there has been an acceleration of the number of breakthrough coronavirus cases, thus, of individuals who test positive after being fully vaccinated.
While federal data from the Centers for Disease Control and Prevention (CDC) is incomplete, only accounting for a subset of states, the analysis found that between April and November, more than 16,700 vaccinated people had died — the vast majority since the start of the delta variant’s surge, earlier this summer. Similarly, nearly all — approximately 96% — of the 1.8 million breakthrough cases — have come during the same time period.
Comparatively, in those select states, at least 5.8 million unvaccinated Americans had tested positive, and just under 64,000 unvaccinated Americans had died, during the same time period.
Despite the increase in coronavirus infections among vaccinated people, experts say vaccines are holding strong in their ability to dramatically reduce the risk of severe illness.
“Just because you have a breakthrough infection doesn’t mean the vaccine does not work and isn’t giving you huge benefit,” Dr. Justin Lessler, professor of epidemiology at University of North Carolina at Chapel Hill, told ABC News.
The analysis of state data reveals that the percentages of fully vaccinated individuals testing positive, requiring hospitalization, or dying of coronavirus remain quite low when compared to the percentage of unvaccinated Americans experiencing severe illness because of the virus. Since the rollout began last winter, only a small fraction of fully vaccinated people in the United States have experienced a breakthrough infection, and an even smaller percentage have been hospitalized or died.
“I think if you look at the data, it’s clear the vaccine is working,” Lessler said.
Breakthrough infections captured by the available data have been predominantly still associated with the delta variant. However, as concerns grow over the potential impact of the omicron variant, preliminary data suggests the new variant may be more likely to cause infections among vaccinated people.
Breakthrough cases becoming more common, data shows
Many vaccines lose their power over time and are not nearly as effective even initially as the COVID-19 vaccines. The tetanus vaccine, for example, requires a booster shot every 10 years. Other vaccines, like the flu shot — which, according to the CDC, reduces the risk of flu illness by between 40% and 60% among the overall population — are needed on a yearly basis.
When the COVID-19 vaccines were first launched last December, experts did not know how long their protection would last and how the evolution of the virus might impact vaccine efficacy. At the time, Pfizer and Moderna both estimated that their vaccines were more than 90% effective.
By late May, several weeks after the vaccine program became open to the general adult population in mid-April, about half of Americans had been fully vaccinated against COVID-19. But in the summer and fall, as the highly-transmissible delta variant became dominant, the nation began experiencing a marked increase in infections, including among vaccinated people, as the efficacy of the vaccines began to wane.
“We do have some evidence of vaccine effectiveness waning a bit,” Ellie Murray, an assistant professor of epidemiology at Boston University School of Public Health, told ABC News. “Vaccinated people start to have a higher chance of being infected than they did closer to the date of their vaccine.”
However, reporting from health officials and data revealed that infections in inoculated individuals tended not to be severe, thanks to underlying protection from the vaccines against acute illness.
CDC data, sourced from more than two dozen states, shows that between April and June, a total of 77,000 breakthrough cases and 1,500 breakthrough deaths were recorded, compared to more than 1.74 million breakthrough cases and 15,000 deaths recorded between July and the first week of November. It is unclear exactly how many of these people had also been boosted.
The federal data was pulled from 27 states, which regularly link their case surveillance and immunization information.
State-level data for breakthrough COVID-19 cases, hospitalizations and deaths is not publicly available in every state. But data obtained by ABC News from 41 states — which extends to December — echoes findings from federal data that even though the acceleration trend in breakthrough infections has continued over the last two months, the percent of fully vaccinated Americans who have experienced a breakthrough case remains low.
“An important thing to think about with breakthrough infections is not simply the number of [breakthrough cases], but what percentage of people who are vaccinated are having breakthrough infections and whether that percentage is changing in a meaningful way,” Murray explained.
Like the federally compiled data, state-level data from January to December also shows that infections among vaccinated people were still relatively uncommon. Meanwhile, it remains exceedingly rare for a vaccinated person to die of COVID-19.
Data for breakthrough infections, cases, and hospitalizations varies greatly by state. Some states provide data for all three variables, while others only offer statistics for one or two variables.
Data from 36 of the states showed that approximately 1.37% of those fully vaccinated have experienced a breakthrough infection between January and December. Similarly, data from 34 of the states showed that about 0.05% of those fully vaccinated Americans have experienced a breakthrough case that required hospitalization, and data from 36 states showed only 0.01% of those fully vaccinated have died of COVID-19.
In October, unvaccinated individuals had a 5 times greater risk of testing positive for COVID-19 and a 14 times greater risk of dying from it, as compared to fully vaccinated individuals, according to data compiled by the CDC. Additionally, unvaccinated individuals had a 10 times greater risk of testing positive for COVID-19 and a 20 times greater risk of dying from it, as compared to fully vaccinated individuals with a booster.
Breakthroughs do not mean vaccines are not working, experts say
With more people getting vaccinated, and protection declining over time since the initial vaccination series, breakthrough cases are to be expected, experts concurred.
“With waning immunity, new variants and increased population mobility, it’s no surprise that we are seeing a surge in breakthrough cases. While breakthrough cases will be for the most part mild or even asymptomatic, any new case only furthers community transmission and prolongs the pandemics,” said John Brownstein, Ph.D., an epidemiologist at Boston Children’s Hospital and an ABC News contributor.
Although vaccines remain overall, “very, very effective,” and “extremely effective” against hospitalization and death, there does indeed appear to be a decline in protection against infection, over time, Lessler explained.
“Even if we’re seeing a lot of breakthrough infections, those people are going to be less likely to end up in the hospital clinic compared to somebody who is [unvaccinated],” Lessler added.
Murray and Lessler both likened the COVID-19 vaccine to a seatbelt, explaining that even if an individual were to get into a car accident, the seatbelt can often, but not always, help prevent significant injury or death.
“Breakthrough infections are not evidence that vaccines don’t work anymore than the fact that car crashes [that] are still sometimes fatal is evidence that seatbelts don’t work. We use prevention tools because they help reduce our risk of serious disease or death, not because they are guaranteed to 100% always keep us safe,” Murray said. “If we held to that latter standard, we’d never use any preventive measures because nothing is perfect, and the result would be much more death and disease and disability.”
According to data from Peterson-Kaiser Family Foundation’s Health System Tracker, from June to September, the large majority of breakthrough hospitalizations affected older Americans, as well as those with comorbidities. Further, their average stay at the hospital was shorter than those who were unvaccinated.
The unknown of omicron
Over the last three weeks, concerns over omicron have rapidly traversed the globe. Data from the CDC shows that in the U.S., the presence of the omicron variant, now the dominant variant domestically, has increased by 70% over the last two weeks.
“With omicron displaying increased transmissibility, breakthrough cases will unfortunately become even more normalized,” Brownstein said.
Experts concurred that although much is still unknown about the omicron variant, it could also potentially cause more breakthroughs than past variants.
“Omicron is going to be more than a major player. It is going to be the main story,” Lessler said, adding that the U.S. may see a significant wave of infections, which could cause significant systemic challenges for hospitals.
Preliminary data suggests that omicron not only spreads at a rate two to three times faster than the delta variant, but also, may be more likely to cause infections among vaccinated people. Despite this, vaccines and additional booster shot protection still appears to dramatically reduce the risk of severe illness.
Ultimately, personal responsibility will play a major role in preventing additional spread, experts agreed.
Boosters and vaccines remain the key to slowing the spread of the infections, and ultimately to turning the pandemic around, particularly when combined with social distancing, masking and other preventative measures, according to the CDC.
“We have the right tools to limit breakthrough cases. Testing before traveling or attending a gathering can help prevent risk to both vaccinated and unvaccinated people. Similarly, boosters when eligible can dramatically reduce the risk of transmission,” Brownstein said.
The CDC currently recommends that everyone ages 16 and older receive a booster shot six months after their Pfizer or Moderna vaccines or two months after the Johnson & Johnson shot.
(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.
