Health

With omicron’s explosive spread threatening to outpace current COVID-19 treatments, the race is on to find new options that will stand up to the variant.

The first oral antiviral treatment for the virus was authorized by the Food and Drug Administration Wednesday. Pfizer’s Paxlovid has proved effective against severe illness and death from COVID, and is expected to hold up against omicron. The news lent a glimmer of hope amid the latest surge, but supply is expected to remain limited for months as production ramps up.

Meanwhile, omicron’s high transmission rate is squeezing what was already a finite arsenal of COVID treatments. Of the currently authorized monoclonal antibody therapies — which have become a primary treatment for COVID to help keep patients out of the hospital — two of the main ones bought in bulk by the U.S. government have not been successful against the omicron variant.

The third option, one so far expected to remain effective against omicron, is in scant supply with federal health officials moving quickly to stockpile the drug, called sotrovimab, from Vir Biotechnology and GlaxoSmithKline.

Dr. Anthony Fauci, the nation’s top infectious disease expert, said the low supply of sotrovimab is “something we need to worry about” in a private call this week between the White House COVID response team and the nation’s governors obtained by ABC News.

The Biden administration is aiming to double its sotrovimab supply to more than 1 million treatment courses, making 300,000 doses available in January.

So far about 55,000 doses of sotrovimab have been allocated to states, with federal health officials promising shipments would arrive as soon as this week. But as the omicron variant rapidly advances — nearly three-quarters of all COVID cases are now omicron — health officials are bracing for a winter surge while potentially lacking ample defense from treatments that hold up against the new variant.

Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials, told ABC News that state leaders gearing up for omicron face a multi-pronged challenge: what was a “compelling tool” against the virus is now compromised, and what now works is still in limited supply. In addition, with hospital staffing shortages, there are looming concerns that manpower to administer the treatment will also be scarce.

“We can’t just hope it’s delta and give the older therapies,” he said. “Even if all of these monoclonal treatments still worked against all the variants, and we had an abundant supply, I’d worry we would get to a place where we just didn’t have the capacity to administer them.”

Evusheld, the pre-exposure monoclonal treatment from AstraZeneca, authorized earlier this month and expected to hold up against omicron is another treatment that could help out health officials. It can be given to a small subset of people for preventative use against the virus, such as those where the vaccines are not effective because of compromised immune systems.

“We’re in a very tight situation now where the virus is increasing faster than our access to the drugs that can treat it,” said Dr. Andrew Pavia, a fellow with the Infectious Diseases Society of America and a treatment guidelines panel member with the National Institutes of Health, told ABC News. “Once we have an adequate supply of sotrovimab, of Evusheld and of Paxlovid, we’ll have some pretty good tools for fighting omicron. But the virus is going to wash over the country before we have an adequate supply. So I’m worried January is going to be ugly.”

A spokeswoman for GSK told ABC News the company is “working with urgency and exploring options to expand our supply capacity in 2022,” including securing additional batches of the ingredients they’ll need to amp up sotrovimab manufacturing, and pushing up their next year supply plans to make more available sooner.

“The challenge is that the supplies [of sotrovimab] are still very limited,” Pavia said. “It’s going to require some very careful prioritization of who needs the drug the most.”

It’s not the first time new variants have hindered mainstay COVID treatments: for several months earlier this year federal health officials paused distribution of Eli Lilly’s monoclonal antibody treatment when it was shown to be ineffective against the gamma and beta variants. The Food and Drug Administration recommended health care providers use alternative authorized antibodies — like Regeneron and GSK — which had shown to hold up against the main variants of concern.

The government spent billions of dollars purchasing Regeneron and Eli Lilly’s monoclonal antibody cocktail to ensure there would be enough supply; GSK’s had not been as widely purchased and distributed. When delta became the dominant variant of concern and all three antibody therapies were effective against it, Eli Lilly’s authorization was renewed.

Health officials have increasingly turned to these therapies as breakthrough cases have ticked up and vaccination rates have not ticked up enough. These antibodies are synthetic versions of the body’s natural line of defense, meant for COVID patients early on in their infections and who are at high risk of getting even sicker in order to help keep them out of the hospital.

The currently authorized COVID-19 vaccines and their booster doses have still shown to be highly effective at preventing severe illness and death.

But as omicron gains steam, some hospitals, like Mount Sinai in New York, have already put a pause on using Regeneron and Eli Lilly’s treatments, given they are not effective against the variant. Some jurisdictions, however, are still clamoring for more supply amid the new crush of cases.

Miami-Dade County exhausted its supply of Regeneron’s treatment this week, shutting down its infusion site for a day while more was secured, a spokesperson for the mayor’s office told ABC News. They now have enough to last until Monday.

“What’s emerging is a realization that this virus is going to be with us for a while, and it’s going to be challenging,” Plescia said. “We’re just going to have to get through this as best we can and find new tools to meet that challenge.”

ABC News’ Eric M. Strauss and Cheyenne Haslett contributed to this report.

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(NEW YORK) — Urgent care chain CityMD announced it is temporarily closing more than a dozen of its 150 locations in New York and New Jersey amid a surge in COVID-19 cases and increased demands for testing.

The 19 shuttered clinics include 13 in New York City — impacting every borough except Staten Island — two on Long Island, one in Westchester County, and three in New Jersey.

“To preserve our ability to staff our sites, we are temporarily closing certain locations effective December 22,” a statement on CityMD’s website read. “It is our hope that closing sites now will best allow us to avoid future closures as this surge continues.”

It is not clear when the locations will reopen, with CityMD directing patients to visit nearby locations for testing in the meantime.

This is not the first time that CityMD has closed locations due to the pandemic.

During Thanksgiving last year, the urgent care chain announced all locations would close 90 minutes earlier, citing staff working longer hours than scheduled due to long COVID-19 testing lines

CityMD did not immediately respond to ABC News’ request for comment.

The closures come as states in the Northeast continue to report record-breaking numbers of COVID-19 cases.

On Wednesday, New York reported record-high infections for the fifth time over six days, with more than 28,000 people testing positive, state data showed.

Additionally, New York City has the country’s highest new case rate, with 1,019 cases per 100,000 people over the last seven days, according to data from the Centers for Disease Control and Prevention.

To meet the demand for testing, Mayor Bill de Blasio announced the city would be opening more than 20 testing locations this week.

Gov. Kathy Hochul also said the state intends to set up an online portal through which New Yorkers can order at-home rapid tests. The tests will mostly be sent to areas where vaccination rates are lagging and cases are rising.

New Jersey also reported a record number of COVID-19 cases on Wednesday, with 9,711 confirmed infections.

The state already has a program in place for residents to request a free COVID-19 test kit in the mail. The sample is then sent back to a laboratory with results available within 48 hours.

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(WASHINGTON) — D.C. Mayor Muriel Bowser announced Wednesday that certain establishments, including restaurants, bars, nightclubs, gyms, events and meeting spaces, will require proof of COVID-19 vaccination beginning in January.

Patrons above the age of 12 will be required to be partially vaccinated by Jan. 15 and fully vaccinated by Feb. 15.

“If you are a resident that is not yet vaccinated and you want to continue enjoying these activities, now is the time to get vaccinated,” Bowser said.

Citing new data from the Centers for Disease Control and Prevention reporting omicron as now the dominant strain in the U.S., D.C. Department of Health official Patrick Ashley said it was only “a matter of time” before that played out in the district, which currently has 25 confirmed cases of the new variant.

Ashley also pointed to huge spikes in the weekly and daily case rate in D.C. from a month ago, attributing them, in part, to the winter surge and the omicron variant.

A month ago, D.C. reported a daily case rate of 13.7 cases per 100,000 people. As of Wednesday, the rate had jumped nine times to 123.8 cases per 100,000 people.

Bowser noted that some exceptions to the new mandate will be made for patrons not staying long at a restaurant, for example, a patron picking up an order.

The move follows in the footsteps of other major U.S. cities like New York City, San Francisco and Los Angeles that have similar vaccine requirements.

Approved proof of vaccination includes vaccination cards or photos of vaccination cards, immunization records or verification apps like CLEAR and VaxYes.

Further guidelines on the requirements are still to come, Bowser said. Wednesday’s initial announcement of the new guidelines was made to give businesses enough time to prepare.

Bowser also announced that to meet the increased testing demand among residents, the district will order another five million rapid antigen tests, for a total of six million.

Students in D.C. schools will also have to be immunized beginning March 1, following regulations from the D.C. Council.

Bowser also encouraged residents to celebrate safe holidays and asked people to have small gatherings, wear masks and gather outdoors.

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(NEW YORK) — A month after the omicron variant was first identified, it has become the dominant strain in the United States, responsible for about three-quarters of new COVID infections.

As of Wednesday, cases have been identified in 49 states and Washington, D.C. South Dakota has not reported any omicron infections yet.

While there is still much to learn about omicron, more research is being done every day furthering health officials’ understanding of this highly transmissible variant.

Spreads more easily than any other variant

A growing body of evidence suggests the omicron variant may spread more easily than any other variant identified during the pandemic.

Health officials, such as Centers for Disease Control and Prevention Director Dr. Rochelle Walensky, say early data shows omicron doubles in prevalence every two to three days.

This is much faster than the delta variant which, at its peak, had a doubling time of about seven days.

“This is an incredibly fast-moving variant,” Dr. John Brownstein, an epidemiologist at Boston Children’s Hospital and an ABC News contributor, said. “We only identified it on Thanksgiving and it’s already the dominant variant in the U.S. The level of certainty we have in the U.S. that it is more transmissible than any variant before is high.”

Omicron partially impacts vaccines, but a booster helps

Omicron seems to evade — at least partially — protection offered by COVID-19 vaccines more easily than previous variants, but it’s unclear by how much. However, studies have been showing boosters help restore much of that lost protection

Preliminary data from Pfizer-BioNTech showed that people who received two doses of their vaccine had low levels of neutralizing antibodies against the variant.

Those who received their booster shot, however, saw their levels of antibodies increase 25-fold compared to pre-boost levels.

Additionally, early data from Moderna released on Monday showed its 50-microgram booster increases antibody levels 37-fold.

Two-dose vaccines still dramatically reduce the risk of severe illness and death, health officials say.

​​”It’s still an open question about what relative protection you get,” Brownstein said. “It appears vaccines still provide incredible protection around severe illness and death, especially if boosted.”

Additionally, it does not appear that previous COVID infection protects against reinfection from omicron the same way that it did against the delta variant.

A recent study from Imperial College London, which has not yet been peer-reviewed, suggests that the risk of infection with omicron is five times higher than with delta.

Monoclonal antibodies are less effective, but not pills

Treatments also appear to have been affected by the emergence of omicron.​​According to a readout of this week’s private call between U.S. governors and the White House, which was obtained by ABC News, two of three monoclonal antibody therapies used to treat COVID are less effective against the new variant.

The antibody treatments made by Regeneron and Eli Lilly are not as effective while the third option, made by Vir Biotechnology and GlaxoSmithKline, may be effective but in short supply.

Dr. Anthony Fauci stated that pills produced by Merck and Pfizer do not appear to be impacted by omicron, according to the readout.

Too early to tell if omicron causes severe illness

Health officials still do not know if omicron causes mild or severe illness.

Studies that have been published have offered conflicting findings. A study from South Africa found that the risk of hospitalization for adults was 30% lower compared to the delta-fueled surge during the fall.

But the study from ICL found that omicron did not show any signs of being milder than delta.

In a recent statement, the World Health Organization said it’s too early to say whether omicron causes more mild or severe illness.

So far, only one death from the omicron variant has been identified: An unvaccinated Texas man in his 50s who had previously been infected with the virus. It’s important to remember that not every COVID-related death is reported to health authorities.

Until we learn more about omicron, Brownstein said the best way to protect ourselves is to follow mitigation measures that are known to work, including vaccination and mask-wearing.

“The No. 1 thing that people can do is make sure they’re vaccinated and boosted. That is still our absolute No. 1 line of defense,” he said. “Use rapid tests as a way to identify if you may be contagious and wear a high-quality mask in indoor settings, especially if you’re around people with unknown vaccination status.”

ABC News’ Sasha Pezenik contributed to this report.

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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.

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(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.”

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(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.

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(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.”

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(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.”

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(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.

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