(NEW YORK) -- As more infectious COVID-19 variants become dominant in the U.S., there are renewed signs that COVID-19 cases may be back on the rise across parts of the country.
The national resurgence comes as the number of children testing positive for the virus also sees an increase again.
New infections among children had been on the decline since May, however, for the first time in nearly two months, there has been an uptick in the weekly total of pediatric COVID-19 cases.
Last week, nearly 76,000 children tested positive for the virus, up from the 63,000 pediatric cases reported the week prior, according to a new report from the American Academy of Pediatrics and the Children's Hospital Association.
Overall, totals remain significantly lower than during other parts of the pandemic. However, the organizations said that child cases are still "far higher" than one year ago, when just 12,100 cases were reported.
Many Americans, who are taking at-home tests, are also not submitting their results, and thus, experts said daily case totals are likely significantly higher than the numbers that are officially reported.
Approximately 13.8 million children have tested positive for the virus, since the onset of the pandemic. Approximately 5.9 million reported cases have been added so far this year. Children represent about a fifth of all reported cases on record.
COVID-19 related hospitalizations among children are also on the rise, with admission levels also reaching their highest point since February, federal data shows.
Late last month, all children, six months and older, became eligible for the COVID-19 vaccine — a welcome development in the fight against the pandemic that many parents had been eagerly awaiting.
Although it is still unknown how many children between the ages of six months and four years old have been vaccinated, data shows that the vaccine rollout in older children continues to lag.
Over 25 million children, over the age of five, who have been eligible for a shot since November, are still unvaccinated.
"It is critical that we protect our children and teens from the complications of severe COVID-19 disease," Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said in a statement last month. "Vaccinating this age group can provide greater confidence to families that their children and adolescents participating in childcare, school, and other activities will have less risk for serious COVID-19 illness."
Despite continued encouragement from scientists and federal health officials, overall, less than half of children ages 5 to 17 — about 44.4% that age group — have been fully vaccinated.
An even small proportion — 38.6% — of children over 5, who are eligible for a booster, have received their supplemental shot.
The American Academy of Pediatrics and the Children's Hospital Association noted in their report that there is an "urgent" need to collect more age-specific data to assess the severity of illness related to new variants as well as potential longer-term effects.
"It is important to recognize there are immediate effects of the pandemic on children's health, but importantly we need to identify and address the long-lasting impacts on the physical, mental, and social well-being of this generation of children and youth," the organizations said.
(ATLANTA) -- A listeria outbreak that caused one death in Illinois and sickened at least 23 other people has been linked to a Florida ice cream brand, according to the Centers for Disease Control and Prevention.
The CDC advises consumers to discard Big Olaf Creamery brand ice cream they have at home. It also recommends cleaning any containers, utensils and areas that may have touched a Big Olaf ice cream product.
The brand is only sold in Florida but the outbreak spread across 10 states.
The CDC is advising retailers to remove Big Olaf ice cream products from shelves and notes that the Sarasota-based company is “voluntarily contacting retail locations to recommend against selling their ice cream products until further notice.”
Listeriosis is an infection typically caused by eating food contaminated with the bacterium “Listeria monocytogenes,” the CDC states on its site. When the bacteria spreads beyond the gut to other parts of the body, it can cause severe illness.
Symptoms can start as early as the same day or up to 70 days after eating the contaminated food.
The CDC says listeria typically affects pregnant women, newborns, older adults and people with weakened immune systems. It is rare for people in other groups to get the illness.
Symptoms vary based on the person and the part of the body affected – including fatigue, muscle aches, fever and more.
(NEW YORK) -- The Supreme Court's decision to overturn Roe v. Wade, leaving it up to individual states to decide whether to allow abortion procedures, has prompted abortion-rights advocates to urge women using period-trackers, and other digital apps that track reproductive health, to delete them.
“If you are using an online period tracker or tracking your cycles through your phone, get off it and delete your data. Now,” tweeted lawyer Elizabeth McLaughlin, founder of the female empowerment non-profit Gaia Project for Women's Leadership.
McLaughlin’s message, which was posted on the day Politico reported the leak of the Supreme Court’s draft opinion on Roe v. Wade in early May, has since been retweeted more than 59,000 times. The Supreme Court handed down its official decision on Roe v. Wade on June 24.
Abortion-rights advocates are ringing alarm bells not just about the use of menstruation-tracking apps, but the potentially incriminating digital trail of geo-location data, online transactions and web-search histories.
“It's not just that we're going back to a time before Roe v. Wade,” Leah Fowler, professor of health law and policy at the University of Houston, told ABC News’ “Start Here” podcast. "We're doing it with the surveillance apparatus in place that we couldn't have imagined even then,” she said.
Fears about criminal prosecution have grown among abortion-rights advocates as states with abortion bans institute penalties, which include possible fines and imprisonment, for abortion providers. For example, Arkansas has made performing or attempting to perform an abortion a felony punishable by up to 10 years in prison and a fine of up to $100,000. The only exception is if the mother's life is in danger.
Kentucky and Louisiana have had courts issue temporary blocks on their bans, which had stated anybody who performs or attempts to perform an abortion will be charged and face prison terms and/or fines.
And the data could also be at risk in civil litigation, Fowler said, through “discovery requests or other civil investigative demands,” that are not necessarily part of a criminal investigation.
“You don't only have to be in a place that has made [abortion] a crime or considers it homicide to be subject to potential legally valid requests for information,” said Fowler.
These period-tracking apps have millions of users every month who utilize the technology to better understand and help control their reproductive health. The apps can tell you when to expect your next period, if you might be pregnant and how far along you are, when you are the most fertile for conceiving and what sorts of symptoms you usually experience.
In June, politicians released a statement asking President Joe Biden to “clarif[y] protections for sensitive health and location data” as part of a larger call to protect abortion rights.
This week, Axios reported that Biden plans to ask the Federal Trade Commission to protect consumers’ data privacy specifically in the context of Roe v. Wade being overturned.
As part of the settlement, the app agreed to an “independent review of its privacy practices” and committed to “get app users’ consent before sharing their health information.”
In the settlement, Flo "neither admit[ted] nor denie[d] any of the allegations."
On the day that Roe v. Wade was overturned, the company tweeted that it would soon be launching “Anonymous Mode,” which “removes your personal identity from your Flo account, so no one can identify you.”
A number of other period-tracking companies reacted to the decision.
The astrology-focused period-tracker app Stardust sent out a tweet two days after the Supreme Court decision that “we absolutely want to protect our users from bad actors, hackers and even our own government overreaching into our privacy.”
The company announced it had implemented an “encrypted wall” to protect users' data and that it was “working on an option for users to completely opt out of providing any personal identifiable information.”
The app Clue, which is based in Europe and beholden to more stringent privacy laws, said in a statement that “no data point can be traced back to any individual person.”
In response to the question of how companies’ privacy policies could protect consumers’ data in the face of a warrant, Fowler said, “you can’t turn over what you don’t have.”
“There are limits on the types of things that law enforcement can do when they're trying to get information from a company,” said Fowler. “That can inform how people might want to select period trackers.”
(NEW YORK) -- One person in Illinois died after being infected with listeria, in a new outbreak that has infected a total of 23 people across 10 states, the Centers for Disease Control and Prevention said. The CDC said all but one of those infected were hospitalized.
Listeria is an illness that typically affects pregnant women, newborns, older adults and people with weakened immune systems, according to the CDC. It is rare for people in other groups to get the illness. Listeria is treated with antibiotics.
Symptoms vary based on the person and the part of the body affected. A rare version can cause fever and diarrhea.
Listeria outbreaks are typically traced back to one source, such as contaminated food products. The CDC said it is too soon to know the source of the outbreak, but said that most of the people who got sick lived in or traveled to Florida about a month before their illness. It is not clear if that is a coincidence, the CDC said.
For people who suffer a severe illness called invasive listeriosis, where the bacteria has spread beyond the gut, symptoms vary based on whether they are pregnant or not. Pregnant women usually experience fever and flu-like symptoms including fatigue and muscle aches. For others, symptoms include headache, stiff neck, confusion, loss of balance, convulsions, fever and muscle aches.
Symptoms of severe illness usually start within two weeks after eating food contaminated with listeria, but could also start as early as the same day or as late as 70 days after.
It is usually a mild illness for pregnant women, but it can cause severe illness in fetuses and newborn babies. Infections during pregnancy can lead to a miscarriage, stillbirth, premature delivery or life-threatening infection in the newborn.
Five pregnant women became sick during the recent outbreak, one of which resulted in the loss of the fetus.
People ages 65 and older and people with weakened immune systems could develop severe infections in the bloodstream, possibly causing sepsis, or in the brain. Other parts of the body could also be affected, including bones, joints and sites in the chest and abdomen.
The CDC said anyone suffering listeria symptoms should call their local health department and report the case.
(NEW YORK) -- In the early days of the coronavirus vaccine rollout, scientists were hopeful it might herald the long-awaited turning point of the pandemic, not only bringing the threat of severe disease, hospitalization and death to an end, but also completely halting the spread of the disease.
Dr. Anthony Fauci, chief medical adviser to the White House, said in December 2020 that if the nation's COVID-19 vaccine campaign went well, the U.S. could approach herd immunity by summer’s end and “normality that is close to where we were before” by the end of 2021.
A series of events last summer, including a widespread COVID-19 outbreak that hit highly vaccinated Provincetown, Massachusetts, soon swayed those hopes, as evidence emerged that vaccinated people were contracting the virus more frequently than initially expected and transmitting it to others.
In the months that followed the Provincetown outbreak, breakthrough infections would shift from a statistical anomaly to a regular occurrence.
Experts say current vaccines are still doing their most important job - dramatically reducing people’s risk of severe illness and death. But they are no longer hopeful vaccines will stop the virus in its tracks, now that it's clear vaccinated people can develop mild disease and transmit illness to others.
The astoundingly high levels of protection against infection that was initially observed, especially for the mRNA vaccines, created by Pfizer and Moderna, have largely dissipated, especially for those with one or two doses combined with extremely transmissible variants.
“When it comes to vaccines and COVID-19 infection, there’s good news and bad news,” said Dr. Shira Doron, an infectious disease physician and hospital epidemiologist at Tufts Medical Center. “The good news is the vaccines are still doing an amazing job at preventing serious illness, hospitalization and death. The bad news is that effectiveness at preventing infection is a lot lower in the omicron era, and wanes quickly after vaccination.”
Despite the increase in the number of breakthrough infections, per capita data shows that unvaccinated Americans continue to have a greater risk of developing severe disease or death from COVID-19, than their vaccinated counterparts.
“Variant evolution and even subvariant evolution within omicron have shown that accumulation of mutations result in limited cross-protection when it comes to infection risk,” said John Brownstein, Ph.D., an epidemiologist at Boston Children's Hospital and an ABC News contributor. “The main question continues to be does infection matter in a world where serious outcomes are averted.”
But health experts say that despite mild outcomes for many vaccinated and boosted people, waning immunity and easily transmissible variants, high caseloads have the potential to strain public health systems and put the vulnerable at risk. In addition, long COVID-19 remains a risk, although vaccinated people are less likely than unvaccinated to suffer from it.
How protected are we really?
Although the vaccine's protection against hospitalization remains strong, data collected in the U.K. found that being vaccinated was no longer enough to protect against mild or asymptomatic infection by June 2022.
Although effectiveness against severe disease remains relatively strong across all vaccines, emerging evidence suggests that that protection also wanes over time, and in the face of newly evolved variants. A CDC analysis found three shots was roughly 90% effective against emergency room or hospital visits in the months after the third shot, but that declined to 66-78% by four to five months out.
Given mounting evidence of the benefits of three doses, the CDC recommends an additional booster dose for adults and children 5 and older.
A recent study published in the New England Journal of Medicine also found that as the virus continues to evolve, each new omicron subvariant is increasingly likely to lead to reinfection or breakthrough infection.
Researchers found lower antibody responses against new omicron subvariants BA.5 and BA.5 - now dominant - compared to prior omicron subvariants.
Thus, as evolving variants continue to escape protection, Doron stressed that widespread protection against infection is likely unrealistic.
“I believe it is not reasonable to expect the current vaccines to prevent infection,” Doron said. “The effectiveness isn’t high, and it is short-lived. It is not feasible to revaccinate people as often as would be needed to maintain any kind of level of protection from infection.”
Amid concerns of a renewed COVID-19 resurgence, federal officials are now in the process of deciding what type of vaccines should be made available in the fall, in order to better address variants that are increasingly getting better at eluding the immune response triggered by the vaccines.
The Food and Drug Administration said this week that it is asking the vaccine companies to produce shots for this fall that will give Americans the broadest and strongest protection against COVID-19 for its upcoming booster campaign.
The manufacturers have been advised to create vaccines that include two strains of COVID-19, the original strain and the most recent omicron BA.4 and BA.5 strains that are currently dominant in the U.S.
Although the FDA’s group of advisers voted earlier in the week in support of moving forward with the new vaccine design, some reminded Americans that these new-and-improved shots will also not be able to offer total protection from mild infections.
Although scientists say they are not giving up on finding a vaccine that can prevent all infections, they creating such a vaccine is more difficult - a feat that very few other vaccines have accomplished.
Herd immunity no longer the goal
In the first months of the pandemic, reaching herd immunity was frequently discussed by public health experts as an important long-term goal in achieving national protection against COVID-19 and returning to normalcy in the face of a deadly and mysterious disease.
However, when the occurrence of breakthrough infections became more common, despite mass vaccination, the likelihood of herd immunity began to slip away.
“The more our understanding of COVID-19 has improved, the more we’ve realized that the theoretical end state of herd immunity is unachievable,” Brownstein said. “There will likely be a continuous race between the evolution of the virus and the background immunity achieved either through infection or vaccination. Unfortunately, evolution continues to outpace our ability to gain protection.”
Doron said that she believes that “eventually” the nation will have enough immunity to treat COVID-19 like other viruses that circulate regularly, when hospitalizations and deaths are not as widespread.
“I think we will have enough immunity as a population to treat COVID-19 like we do other respiratory viruses, where we stay home until we feel better and don’t structure our lives around the virus. Immunocompromised people will still need to be careful as they always are about catching infections,” Doron explained.
Providing clear goals and outlining the benefits of vaccination remains critical to encouraging uptake among the hesitant.
“Public health has to be more clear about the goals of vaccination programs,” Brownstein said.
Many health experts agree that the goal of the nation’s current vaccine drive cannot be to prevent every infection, as providing robust protection from hospitalization and deaths remains the most critical goal in the nation’s fight against COVID-19.
“If COVID-19 had always caused only the kind of infection that we currently see in boosted people, we wouldn’t have let it upend our lives the way we did. Ultimately, what’s most important is prevention of hospitalization and death,” Doron said.
However, Brownstein noted that it is important to consider the continued risks of long-COVID, which even with less severe forms of infection.
“While prevention of hospitalization and deaths remain the priority, post-acute conditions like long COVID-19 challenge this paradigm,” Brownstein added. “Muddied messaging has led to extreme divides between those who feel protected and those who still worry about long term impacts of infection especially with unknown variants around the corner.”
(NEW YORK) -- With Independence Day approaching, and plenty of associated picnics and barbecues on the way, the U.S. Department of Agriculture is warning of the dangers of foodborne illness and providing some helpful tips to keep people safe.
Four easy steps can help you avoid food poisoning: clean, separate, cook and chill.
First, find out if there is a clean water source before you grill or eat outdoors. If not, pack water for food preparation and cleaning as well as clean cloths, alcohol-based moist wipes, and hand sanitizer to clean hands and surfaces.
"If you are grilling out at a public park, and [they] have grills and tables there, be sure to check the grill and use a grill brush to scrub off any excess debris. You can also make sure to bring some disinfecting wipes to disinfect any kind of patio furniture, tables, and chairs that you may be using, especially if they're going to be in contact with food," said Kenneth King, a USDA food safety expert.
Keep raw meats, poultry, seafood, and eggs separate from any other ready-to-eat foods to avoid cross-contamination. Use a separate cutting board for fresh produce and another one for raw meat products.
Always use a food thermometer to ensure that all foods are cooked to a safe minimum internal temperature.
"For hamburgers, you want to insert the food thermometer through the side of the patty until the probe reaches the center ... the temperature should read 160F [when] your hamburger is safe to eat," King said. "For hot dogs, they need to reach 165F and you can do this by sticking the thermometer into the end of the hot dog all the way until the probe reaches the center."
If you're transporting food in a cooler, make sure it is stocked with ice or frozen gel to keep perishable food cold. The "danger zone" in which bacteria grow rapidly is in between 40 degrees Fahrenheit and 140 degrees Fahrenheit.
Additionally, you should avoid leaving any food out longer than two hours, or one hour if the outside temperature surpasses 90 degrees Fahrenheit. Keep any pack beverages in a separate cooler from perishable food.
"The scary thing about bacteria is that we can't really see it, the food may look okay, but in actuality, it's not," King said. "We always recommend to people [that] when you're out grilling, and you have some food sitting out on the table too long and no one's eating it, please be sure to put that food back into a refrigerator. Or if you're grilling outside, and you have a cooler with some ice, nestle that food under some ice in the cooler to keep it cold."
An estimated 48 million people in the U.S. -- 1 in 6 Americans -- get sick from foodborne diseases each year, according to the Centers for Disease Control and Prevention.
Certain groups are at risk of more serious illness from food poisoning. Adults aged 65 and older, children under the age of 5, those with weakened immune system due to health conditions or medicine, and pregnant people should take extra care when eating food.
The CDC also recommends that those at higher risk should avoid undercooked or raw food from animals, raw or lightly cooked sprouts, unpasteurized milk and juices, and soft cheese that has not been made with pasteurized milk.
Symptoms of food poisoning include upset stomach, stomach cramps, nausea, vomiting, diarrhea, and fever. Visit a health care provider if you or a loved one develops severe symptoms such as bloody diarrhea, a high fever, frequent vomiting, signs of dehydration and diarrhea that lasts more than three days.
The USDA Meat and Poultry Hotline can be reached at 1-888-674-6854. You can also chat live at ask.usda.gov. Representatives can help address any food safety questions people might have from 10 a.m. to 6 p.m. ET, Monday through Friday.
"We recommend that while you're preparing for the July 4 weekend, make sure to give us a call if you have any questions. Or you can look up our website at foodsafety.gov," said King.
(NEW YORK) -- The Fourth of July rings in the peak of summer quite literally as fireworks fly into the sky from cities to backyards alike.
While the celebration is often colorful and exciting, it is also a time that can be very loud and frightening for dogs around the country, causing it to be the weekend more pets go missing than any other time of the year, according to the American Kennel Club.
It is common for dogs to suffer from noise phobia and fireworks are usually a big trigger. The noise of fireworks causes dogs to enter survival mode, according to Kitty Block, president and CEO of The Humane Society of the United States. This can leave dogs feeling panicked, and can even cause "dogs considered to be very laid-back" to bolt from their owners and destruct their home.
"It is a logical response if you think of it from the dog’s perspective," Block explains. "They hear extremely loud noises that often make the ground vibrate and see bright flashing lights. They don’t know it’s a holiday or a celebration, often they don’t even know where the sound is coming from, so their desire to get away or hide is understandable."
There are some overt signs that your dog could be getting anxious, such as whining, pacing, and running away. However, dogs can also show more subtle signs of anxiousness, which can look like presenting "a general restlessness when the fireworks are happening," explains Nick Hof, chair of the Association of Professional Dog Trainers.
The anxiety dogs have from fireworks can also be acquired over time or after a traumatic incident, which Hof’s dog, Lanie, experienced after losing her canine brother.
"One of my dogs a few years ago lost her brother and actually gained an anxiety for the Fourth of July when we no longer had her brother here as well," Hof shares. "It took me by surprise because she had previously been totally fine."
"When the Fourth of July came the year after, she became very panicked, would cry and whine, completely unable to settle down or relax," Hof added.
Hof said he did everything he could to try and help her in that difficult situation, such as "turning on relaxing music to mitigate the sounds of fireworks" and "offering tasty, high-value treats" in an effort to make the experience less scary for her, which are a few of the many useful ways to ease your dog’s anxiety.
However, something unique and hopeful about this time of the year is that there is always a definite day these particular fireworks are planned to go off, which means we can prepare for it. Experts believe we have improved over time as a society with how we handle our dogs with care on the Fourth of July.
From anti-anxiety sweaters known as "Thunder Shirts" to desensitization CDs that help utilize the sound of thunderstorms, there are many different ways of dealing with anxiety in animals, said Dr. Klein, chief veterinary officer at the American Kennel Club.
There has also been an improvement in veterinary medicine with the types of medications that are offered for dogs with anxiety and noise phobia.
"We are moving away from medications that were just purely sedative and moving more towards ones that have anti-anxiety components that can help reduce the actual anxiety that the dogs are feeling," said Hof.
Here are 6 ways to treat your dog with care on July 4 to lessen anxiety and panicking:
1. Create a sense of calmness and compete with the noise by turning on a radio or television.
2. Place a cotton ball in their ears while the fireworks go on (just remember to take them out!)
3. Stay with your pet or have a family member or friend dog-sit for the day to give them a sense of security.
4. Take your dog out on a leash when they need to use the bathroom so they are not alone and cannot run away at the noise of fireworks.
5. Play fetch with them, put on some relaxing music, and reward them with treats.
6. Most importantly, keep them far away from the fireworks show!
(SILVER SPRING, Md.) -- The Food and Drug Administration on Thursday said it had advised COVID-19 vaccine companies to produce an updated vaccine for this fall, an aim to give people broader and stronger immunity in an upcoming booster campaign ahead of the winter.
It’s the latest step in the FDA’s strategy to better keep up with the virus, moving quicker to address variants and working to make booster doses more effective.
The announcement comes after the FDA's advisers met earlier this week to discuss the various options for updated vaccine designs. In keeping with the advisers’ recommendations, the FDA selected a vaccine that will include two strains of COVID, the original Wuhan strain and the most recent omicron sub variants, BA.4 and BA.5, which is currently making up the majority of cases.
“The COVID-19 vaccines that the FDA has approved and authorized for emergency use have made a tremendous difference to public health and have saved countless lives in the U.S. and globally,” said Dr. Peter Marks, the FDA’s vaccine chief, in a statement Thursday.
But the virus has “evolved significantly,” Marks said, making it necessary to better match the vaccines to the variants.
“As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19,” Marks said.
The hope is that updating the vaccines to more closely match the current variants will give people stronger protection for a longer period of time, and that including multiple strains of virus in the vaccine could give broader protection against new variants that are likely to arise in the future.
Still, the next few months will carry a lot of uncertainty, as manufacturers race to produce hundreds of millions of doses and the virus likely continues to mutate.
As the chair of the FDA’s advisory committee noted on Tuesday, planning vaccines ahead of time to try to protect against unknown COVID-19 variants is “unchartered territory.”
“Unfortunately -- looking in the past doesn't help us a great deal to look in the future for this virus, which has baffled a lot of us and made predictions almost irrelevant,” said Arnold Monto, the committee chair.
But experts are hopeful that updating the vaccines to bring them closer to the latest variants will still be beneficial, even if it won’t be a perfect match by fall.
The government has already purchased $3.2 billion worth of vaccines from Pfizer, which amounts to 105 million doses. The order includes doses for adults, adolescents and children.
The contract came with an option to order an additional 195 million doses, bringing the total to 300 million, which would nearly cover the U.S. population.
But for now, the White House has run into funding troubles.
After months of Congressional gridlock over a request for $22.5 billion for COVID preparedness, the White House pulled $10 billion from other COVID efforts, including testing, to buy $5 billion worth of vaccines and another $5 billion of therapeutics.
The government is likely to also contract with Moderna, which could increase the available doses, but in the meantime the White House has so far only secured enough doses to boost the country’s most vulnerable people, White House COVID coordinator Ashish Jha said Wednesday.
There are around 118 million Americans over the age of 50, 55 million of whom are 65 and older — the highest risk group for the virus. The Pfizer order alone could cover this group, if manufacturing all goes to plan.
But there are over 258 million Americans over the age of 18, and the White House said it’s committed to securing doses for everyone “who may benefit.”
“As we warned Congress months ago, our fall vaccine order will not be sufficient to make a vaccination available to every adult who may benefit from these new booster shots and comes with trade-offs,” Jha said, calling on Congress to act.
“We lack funding to purchase enough vaccines to cover all Americans who may want this protection.”
Of course, it remains to be seen how many Americans that will be. Only 105 million Americans have gotten their first booster dose, about half of the people who got their initial series, which could be a sign that demand for boosters will continue to be low this fall.
Both Pfizer and Moderna plan to have doses available by October and November.
Before that happens, the companies will submit their data on these vaccines to the FDA, which will issue an authorization if it finds them to be safe and effective.
The FDA has not asked the companies to alter their designs for primary doses — the initial two shots for mRNA vaccines — calling this year a “transitional period” and saying that the primary series still gives good protection against hospitalization.
ABC News' Arielle Mitropoulos contributed to this report.
(NEW YORK) -- New York City's COVID-19 test positivity rate is skyrocketing, indicating that a sixth wave of the virus could be around the corner.
As of June 26 -- the latest date for which data is available -- the test positivity rate hit 10.05%, according to the city's Department of Health & Mental Hygiene.
It marks the first time the rate has surpassed 10% since Jan. 22, when the omicron wave was still hammering the Big Apple.
Experts previously suggested the true test positivity rate could even be higher due to the number of people testing positive with at-home rapid tests and not reporting their results to health officials.
This reflects trends also being seen on the national level, data from the Centers for Disease Control and Prevention shows.
As of June 26, the seven-day average for the COVID test positivity rate in the United States was 15.65%, the highest figure recorded since Feb. 3.
Additionally, COVID-19 cases are also on the rise, with the seven-day average sitting at 3,216, city data shows -- a 9% percent increase from the 2,946 average recorded two weeks ago.
However, hospitalizations are continuing to fall while deaths remain flat.
The majority of COVID-19 cases continue to be among the unvaccinated. As of June 11, the case rate among the unvaccinated was 1,046.04 per 100,000, data from the New York health department shows.
Comparatively, the rate among those who are vaccinated and boosted was four times lower at 259.4 cases per 100,000, while the rate among those vaccinated but not boosted even lower at 156.4 per 100,000.
Earlier this week, Dr. Jay Varma, an infectious diseases physician and former Mayor Bill de Blasio's senior advisor for public health, tweeted this is likely the beginning of a wave caused by BA.5, an omicron subvariant.
"BA.5 was [around] 17% of cases two weeks ago so [it's] likely much higher now," he tweeted. "Experience from other countries means there will be another big increase in NYC COVID-19 infections, including among those who have had omicron in [the] past few months."
Varma added, "Unclear from lab data [and] elsewhere how much this will increase hospitalizations & deaths. At a minimum, I can be confident predicting that BA.5 will lead to more days when people are out of work, kids home from school/camp and more people suffering from long COVID."
Across the U.S., BA.5 makes up 36.6% of all COVID-19 cases, CDC data shows, which is more than double the prevalence from two weeks prior. Combined with another subvariant, BA.4, they make up more than half of all cases.
Meanwhile, BA.1 -- the original omicron variant -- accounts for no cases, according to the data.
"BA.4 and BA.5 have come out of nowhere the last two weeks." Dr. Roy Gulick, chief of the division of infectious diseases at NewYork-Presbyterian and Weill Cornell Medicine, told ABC News. "They are more transmissible than the other recent variants we've seen, they're less susceptible to antibodies both from previous infection or from vaccination -- but they don't seem to cause more severe disease."
In response, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration, announced Thursday the agency is asking COVID-19 vaccine developers, including Pfizer-BioNTech and Moderna, to develop a booster shot that can target the subvariants.
"As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19," Marks said in a statement.
In light of the rise of cases, Gulick recommends people still keep following known mitigation measures that work including avoiding large crowds and wearing a mask if crowds are unavoidable.
(WASHINGTON) -- Eli Lilly has announced the U.S. government is buying an additional 150,000 courses of the only monoclonal antibody therapy left that still holds up against all COVID-19 variants of concern, including BA.2.
The new purchase of the therapy, called bebtelovimab, is costing the government roughly $275 million.
This comes after the White House has repeatedly warned the money is running out to buy new vaccines and treatments, including antiviral therapies like Paxlovid and the monoclonal antibodies, without additional relief funds.
This new purchase was paid for out of the $10 billion in COVID funding, which the White House diverted earlier this month to pay for more vaccines and treatments.
Officials said at the time they were left with "no choice" but to shift those dollars, since Congress has not yet approved additional funding.
That redirected $10 billion included $300 million to buy more monoclonal antibody treatments -- a cache now all but exhausted by Wednesday's purchase.
The U.S.'s existing supply of this treatment, including the new purchase, is expected to meet present demand through late August, an Eli Lilly spokesperson told ABC.
Previously this spring, and before the White House diverted the $10 billion in funds, President Joe Biden said the U.S. could run out of monoclonal supplies "by the end of May," if further funding wasn't secured, and that planned orders would have to be canceled.
In March, ABC News obtained internal documents showing the administration planned to start significantly cutting the number of viral treatments available to states, and would begin reclaiming and reabsorbing unused doses for later redistribution, in light of the relief funding that had stalled in Congress.
Delivery of this new order of 150,000 courses is supposed to finish no later than Aug. 5, Eli Lilly said. That's the date Lilly will get them to the Health and Human Services Department, which will then be responsible for allocating doses to states.
There is an option in this new purchase agreement for the government to order an additional 350,000 doses, which would need to be exercised "no later than Sept. 14," Eli Lilly said.
“Lilly and its collaborators have partnered closely with the federal government throughout the pandemic to ensure broad and equitable access to our monoclonal antibodies,” Eli Lilly's chair and CEO David Ricks said in a statement to ABC News. “While Congress works toward additional COVID-19 funding, Lilly and the U.S. government will continue to work together to support the availability of bebtelovimab to maximize equity and accessibility in the U.S. market.”
(NEW YORK) -- A spike in internet searches for abortion pills may indicate women in the United States will try to obtain the medication without a doctor's oversight, a new study finds.
Researchers from Bryn Mawr College in Pennsylvania and the University of California, San Diego examined online searches following a leaked draft opinion on May 2 from the Supreme Court indicating Roe v. Wade would be overturned. The court eventually did so on June 24.
The team analyzed Google search trends that mentioned "abortion pill" or "abortion medications" from Jan. 1, 2004 -- when the search engine first began collecting data -- through May 8, 2022.
Results showed the week following the leaked draft opinion corresponded with a record-high number of searches on Google in the U.S. with 350,000 searches from May 1 to May 8.
When the team looked at the data based on hourly trends, they found that in the 72 hours following the leaked opinion, there was a 162% increase in online searches relating to abortion medications.
At-home medication abortions involve someone taking two pills to end a pregnancy and are approved by the U.S. Food and Drug Administration for use up to 10 weeks after conception.
The first pill is mifepristone, which was authorized by the FDA in 2000. It works by blocking the hormone progesterone, which the body needs to continue a pregnancy.
This causes the uterine lining to stop thickening and break down, detaching the embryo. The second drug, misoprostol, taken 24 to 48 hours later, causes the uterus to contract and dilates the cervix, which will expel the embryo.
Lawmakers in at least 12 states have introduced bans or restrictions on medication abortion in 2022, including barring the mailing of pills and preventing them from being accessed via telehealth, according to the Guttmacher Institute, a research group that focuses on sexual and reproductive health, and further reporting.
Results also showed states with more restrictions on abortion had higher search volumes than states with fewer restrictions.
Nebraska had the highest search volume, followed by Iowa and Missouri, respectively.
The team said its study is limited because it cannot confirm any searches for these medications were linked to abortion attempts.
But residents of these restrictive states trying to obtain abortion medications that traditionally require a prescription is an alarming trend as it suggests that they will attempt unsafe abortions with potentially unregulated, counterfeit pills and without physician oversight.
"Elevated interest in abortion medications should alert physicians that many of their patients may pursue this option with or without them," the authors wrote.
(NEW YORK) -- After the U.S. Supreme Court ruled to overturn Roe v. Wade, many pregnant people living in states where abortion is now illegal are expected to turn to medication abortion, also known as the abortion pill. For now, it is still legal in most states to receive this medication by mail.
A medication abortion consists of two pills, mifepristone and misoprostol. This combination of pills can be used to end an early pregnancy, up to 10 weeks.
These medications are prescribed by a health care provider and can be taken wherever people feel comfortable. The abortion pill is one of two ways to safely end a pregnancy, the other option being an in-person procedure. In the U.S. currently, medication abortion accounts for half of all abortions, according to the Guttmacher Institute, a research group that focuses on sexual and reproductive health.
Now, with in-clinic abortion services banned or threatened in more than half of U.S. states, the abortion pill is expected to become an even more important option.
Are these medications safe?
The Food and Drug Administration and major physician groups have found these medications to be safe and effective.
“Medication abortion within the first 10 weeks of pregnancy has been demonstrated to be so safe that sonograms are no longer needed to detect ectopic pregnancies before the medication is administered,” said Dr. Jacques Moritz, a board-certified OB/GYN and medical director at Tia, a healthcare system centered around female-related care.
“Medication abortions pose no increased risk to the mother’s health nor impacts future pregnancies," Moritz said. "Medication abortion can be likened to undergoing a spontaneous miscarriage in terms of the expected effects of the procedure.”
This medication should not be used by those with bleeding conditions, long term steroid therapy and adrenal failure, or people who have a contraceptive IUD present in the uterus.
How are these medications taken?
When terminating a pregnancy, 200 mg of mifepristone is taken orally; 24 to 48 hours after taking mifepristone, 800 mg of misoprostol is taken buccally (in the cheek pouch). About seven to 14 days after taking mifepristone, patients should follow-up with their health care provider.
What should someone expect when having a medication abortion?
People undergoing a medication abortion can expect vaginal bleeding greater than normal as well as pelvic cramping and pain. The success rate of medical abortion is 95-98%.
Other common side effects of a medicated abortion include nausea, vomiting, diarrhea, fevers, chills, headache and dizziness. Typically, medications are needed for pain relief such as NSAIDs for most people.
What else are these medications used for?
Misoprostol can be used to induce labor by softening and opening the cervix in patients ready to give birth vaginally, prevents drug induced gastric ulcers and treats postpartum hemorrhage in combination with oxytocin.
Mifepristone can also treat persistently high blood glucose in patients with Cushing Syndrome.
How is the abortion pill different from Plan B or emergency contraception?
Emergency contraception is intended to prevent pregnancy from occurring after unprotected intercourse rather than terminating an already existing pregnancy.
Emergency contraception or Plan B is an oral medication that contains levonorgestrel, which prevents ovulation and fertilization of an egg. This treatment option does not affect existing pregnancies and cannot cause abortion.
The emergency contraception pills should not be used as a long-term contraceptive method since repeated use can cause menstrual irregularities and is not as effective as other known options, such as IUDs, depot shots and birth control pills.
What other abortion options are present?
Both medical and surgical abortions are available in both the first and second trimesters. In the first trimester, surgical abortion is called uterine aspiration and is offered up to 13 weeks of pregnancy. This procedure takes place under anesthesia, takes less than 15 minutes to complete and is greater than 99% effective, which allows for women to leave the medical center knowing their abortion is complete.
“Both are excellent options, and it really comes down to personal preference and sometimes logistics,” said Dr. Gariepy, the director of complex family planning at Weill Cornell Medicine. “We saw an increase in the number of abortions that were accomplished via medical abortion during the pandemic because of all the various health restrictions, lack of access to clinics, etc. during COVID.”
Although less common, the CDC found that in 2019, 7.2% of abortions happen in the second trimester or after 13 weeks.
In the second trimester between 13 and 20 weeks of pregnancy, a medical abortion is called an induction abortion, and is done in a hospital or clinic setting where monitoring can occur. A combination of misoprostol and mifepristone as well as anesthesia and pain medication are given, with the abortion usually taking 12 to 24 hours to complete.
Surgical abortion in the second trimester is called a dilation and evacuation (D&E). In a D&E, the cervix will be dilated with medication or dilator rods and then a suction device is used to remove all fetal tissue present in the uterus.
"The reasons someone may prefer a medication abortion is for privacy, the fact that you don’t have to have surgery, and the fact that you can take the pills at home with a loved one, and your heating blanket,” said Gariepy.
Erica Jalal, MD, is an internal medicine resident physician at George Washington University and a contributor to the ABC News Medical Unit.
Emma Egan is an MPH candidate at Brown University and a contributor to the ABC Medical Unit.
(WASHINGTON) -- The Food and Drug Administration issued a new alert this week, warning parents not to use baby neck floats on their children, particularly those with special needs, as part of a water therapy program because doing so could be fatal or lead to serious injury.
"Neck floats are inflatable plastic rings that can be worn around a baby's neck and allow babies to float freely in water," the FDA explained in a safety communication released Tuesday, adding that they are sometimes marketed for premature babies and babies as young as 2 weeks old, and as water-therapy products.
The FDA also said the "safety and effectiveness of neck floats to build strength, to promote motor development or as a physical therapy tool, have not been established."
According to the agency, neck floats "as therapy interventions" are especially hazardous for babies with developmental delays; birth defects or genetic disorders, such as cerebral palsy; Down syndrome; spina bifida; or spinal muscular atrophy (SMA) type 1.
"The use of neck floats in babies with special needs can lead to increased risk of neck strain and injury," the FDA said in a recommendation to parents and caregivers.
The FDA believes injury or death from neck floats is rare but noted that one baby who had been placed in a baby neck float had been hospitalized and another died. It also noted that there may be a chance other cases have gone unreported.
The American Academy of Pediatrics recommends that parents in general avoid using "floaties" or inflatable swimming aids on children as they can provide kids a false sense of security. They also note that floats and swimming aids are not adequate substitutes for life jackets.
"The market will keep coming up with ways to float infants and adults and market them. This is not a lifesaving device, not designed to be. We consistently say anything inflatable is only a toy; and can deflate. No child should be unsupervised or left alone in water, even with a personal flotation device or if wearing a US Coast Guard approved life jacket," Dr. Linda Quan, an AAP spokesperson, told ABC News in a statement.
The FDA asks individuals to file a report if they know of any baby or individual injured by a neck float through their online voluntary reporting form.
(NEW YORK) -- After testing positive for COVID-19 earlier this month, Dr. Anthony Fauci said Tuesday that he has joined a growing group of people experiencing a Paxlovid rebound, following treatment with Pfizer's antiviral.
Fauci, 81, said that when he first tested positive two weeks ago, he had very minimal symptoms. However, when he began to feel worse, "given [his] age," he was prescribed Paxlovid.
Other than fatigue and a bit of congestion, Fauci reported that he felt "really quite well," and after his five-day course of Paxlovid, he tested negative with a rapid test.
However, after testing negative for three consecutive days, Fauci said he decided to take one more test out of precaution and subsequently found himself positive again on the fourth day.
"It was sort of what people are referring to as a Paxlovid rebound," Fauci said during a remote interview with the Foreign Policy Global Health Forum on Tuesday.
Over the course of the next day, he began to feel "really poorly," and "much worse than in the first go around," he added.
Paxlovid is authorized in the U.S. for people with mild-to-moderate symptoms of COVID-19, who are at significant risk of progressing to severe illness.
Last month, the Centers for Disease Control and Prevention asked doctors to be on the lookout for the seemingly rare, but increasingly reported phenomenon.
"Paxlovid continues to be recommended for early-stage treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease," the CDC wrote in a health alert in May.
The rebounding phenomenon, which is described as a recurrence of COVID-19 symptoms or the development of a new positive viral test after having tested negative, has been found to occur between two and eight days after initial recovery. A brief return of COVID-19 symptoms may be part of the "natural history" of the virus, officials wrote, and may occur in some people, regardless of treatment with Paxlovid or vaccination status.
Just last week, Fauci told reporters during a White House COVID-19 briefing that he was feeling well after testing positive and taking his first course of Paxlovid.
"All is well with Fauci and thank you for asking," Fauci said. "I'm vaccinated. I'm doubly boosted. And I believe if that were not the case, I very likely would not be talking to you, looking as well as I look, I think, right now."
However, after his COVID-19 recurrence, Fauci was prescribed another course of Paxlovid, he said. As of Tuesday, he is on his fourth day of a five-day course.
"I am on my fourth day of a five-day course of my second course of Paxlovid. And fortunately, I feel reasonably good. I mean, I'm not complete[ly] without symptoms, but I certainly don't feel acutely ill," Fauci said.
Health officials have reported that while information is still limited, available data suggests that most people who experience the rebound are not likely to suffer from severe forms of disease.
At this time, CDC states that there is currently no evidence that an additional treatment of Paxlovid, is needed, following a rebound.
The Food and Drug Administration also says that “there is no evidence of benefit at this time for a longer course of treatment … or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course.”
The CDC currently recommends that doctors advise their patients with COVID-19 rebound to follow CDC’s guidance on isolation and take additional precautions to prevent transmission.
Patients should re-isolate for at least five days, and per agency guidance, can end their re-isolation period after five full days, if fever has dissipated for 24 hours and symptoms are improving, the CDC says. Physicians are also recommended to tell their patients to wear a mask for a total of 10 days after rebound symptoms started, the agency said.
"Regardless of whether the patient has been treated with an antiviral agent, risk of transmission during COVID-19 rebound can be managed by following CDC’s guidance on isolation, including taking other precautions such as masking," the agency wrote in May.
Earlier this month, Pfizer also reported new clinical trial data that showed that Paxlovid did significantly reduce the risk of going to the hospital or dying in people with standard risk of developing severe illness. However, the company said the treatment still works well in high-risk individuals.
(NEW YORK) -- Updated COVID-19 vaccines that could better match the more recent variants are on the way.
On Tuesday, the U.S. Food and Drug Administration's committee of independent advisors met and recommended that the vaccines should target the latest omicron variant, kicking off the process for distribution of the new vaccines this fall.
That could be good news for the fight against the virus. But the next few months hold a lot of uncertainty.
Many vaccine scientists agree that as the virus evolves, vaccines should be updated along with it. But scientists caution that planning ahead in this pandemic is challenging. A new variant could emerge by the fall, rendering even new vaccines old by then.
There's also a question of how many people will get the shot -- both because the government doesn't have enough funding to secure vaccines for everyone, and because less than half of eligible Americans have received their first booster shots.
That said, the vaccine companies have been testing different strategies for a new-and-improved booster shot.
On Tuesday, the FDA's advisers reviewed the data and favored a bivalent vaccine -- a type of vaccine that targets two strains of virus in the same shot. They recommended that it include the latest omicron subvariant and the original strain, generally supporting it because it could protect more broadly against future variants.
FDA leadership will announce the final decision sometime in early July, incorporating the advisers' discussion from Tuesday.
Health officials are aiming to roll out the newly designed vaccines in early October, said Dr. Peter Marks, who oversees the FDA's vaccine department.
The goal is to get ahead of a potential surge next winter.
"That combination of waning immunity, combined with the potential emergence of novel variants during a time this winter when we will move inside as a population, increases our risk of a major COVID-19 outbreak," Marks said.
"And for that reason, we have to give serious consideration to a booster campaign this fall to help protect us during this period from another COVID-19 surge," he said.
How much better will the new vaccines be?
Scientists cautioned that existing vaccines are still working well to prevent severe illness.
And while newer shots will help, they might not be significantly better at preventing more mild breakthrough illness.
"It will be better than what we have now, but I don't think we are going to see 94% again," said Dr. Paul Goepfert, professor of medicine at the University of Alabama at Birmingham.
The current vaccines, designed to match the original Wuhan virus, initially showed efficacy of 94% -- but that's now thought to be an untenable goal because of rapidly-evolving new variants, Goepfert said.
"It's essentially an arms race," said Dr. Dan Barouch, author on the recent study and director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston. "As the population becomes more immune, the virus becomes more and more immune evasive."
Updated vaccines "will be helpful," Barouch said, but are unlikely to be a "game changer" that end the need for future boosters.
The political snag getting in the way
The other major caveat to the rollout of new vaccines this fall is funding -- the battle over which has been stuck in a stalemate on Capitol Hill since the winter.
The White House has since pulled funds out of COVID test manufacturing and put it toward contract negotiations for the newest vaccines, but the decision leaves the US vulnerable to a testing shortage, and still doesn't fully do the job.
"It's very clear we're not going to have enough vaccines for every adult who wants one," Dr. Ashish Jha, the White House's COVID coordinator, said last week.
Jha called the decision to move money away from testing "incredibly painful," but necessary to avoid missing out on orders entirely as other countries placed theirs.
"Contract negotiators on behalf of the US government are going to enter into contract negotiations with Moderna and Pfizer with the resources that we've been able to … cobble together for vaccines for the fall," Jha said.
The government will purchase enough for high-risk Americans to get the latest vaccines, Jha said.
But it's unclear how the rest of the population will get access to the vaccines. On one hand, demand for vaccines has continued to drop since the initial doses. If that trend continues and fewer people want a vaccine, it's possible that the government's smaller order could still cover people who want one.
And some experts don't think everyone will need a booster in the fall, like Dr. Paul Offitt, the director of the Vaccine Education Center at Children's Hospital of Philadelphia, who said he thinks re-upping antibody levels ahead of a likely winter surge would be beneficial for high-risk groups, but not necessary for everybody.
Another option is for insurance companies to step in and cover vaccines, rather than the government distributing them for free. Jha dismissed this option, though, calling it too soon to switch to the private market because there's still too much competition for ordering doses among countries and insurance companies wouldn't have enough leverage.
"There is not a commercialization plan that somehow would be ready in time for this fall and winter," Jha said.
Yet vaccine companies have indicated that they're ready to distribute their vaccines through insurance companies and won't leave the American market behind.
Though it's still months away, both the White House and the vaccine companies have committed to devising a plan as fall draws closer.