(NEW YORK) — Kayley Reese first noticed what seemed like a growing bump in her stomach over a year ago.
“The reason I really noticed it was because I own a clothing store and am in all the photos and it got to a point where I could see it in every single photo,” Reese, of Richmond, Virginia, told Good Morning America. “It looked like I was pregnant.”
Reese, 23, said she did not notice any other physical symptoms, so she did not do anything about it.
“On social media I would see some things like it’s your uterus protruding or everyone has it, it’s a protective layer,” she said. “So I kind of made it normal in my head.”
It was not until June when Reese flew home to Orlando, Florida, that she began to feel symptoms and sought treatment.
“I was nauseous and dizzy and my appetite wasn’t normal and I had shortness of breath, painful urination, all that,” said Reese. “My mom asked to feel the spot that I was complaining about and said, ‘That is not normal.'”
Reese went to a local emergency department, where she underwent testing that found a large cyst near her left ovary.
“The [doctors] weren’t sure how long it had been there but they said the symptoms I was having were from that,” she said. “At 23, I had no idea this could ever happen to me.”
Reese underwent a two-hour surgery to remove the cyst, which she said was eight inches in length, seven pounds in weight and was filled with two liters of fluid.
The cyst was diagnosed as a paratubal, or paraovarian cyst, a type of cyst that forms near an ovary or fallopian tube but does not adhere to an internal organ, like an ovary.
“It was the best possible case scenario because they were able to save both my ovaries,” she said. “When I went into surgery they said they were likely going to have to take out an ovary and my fallopian tube.”
“I saw someone else’s TikTok about having something similar and all the comments on her video were like, ‘That’s normal. Everyone has it,'” said Reese. “I thought this was exactly why I didn’t think much of my own [stomach bump].”
Reese posted a now-viral video sharing her own story, explaining, “I feel like if I had seen my own TikTok, I would have gone to the doctor a lot earlier.”
She said she was overwhelmed by the response, both from women thanking her for the information and women who also had paratubal cysts.
“When it started to get picked up I was very nervous because I’m like I’m not a doctor, but I saw that it brought awareness to a lot of women,” said Reese. “I got messages from women who had the same situation and they said was the first time they heard anyone even talk about it, so it was super emotional.”
The type of paratubal cyst Reese had differs from the more well-known ovarian cyst because a paratubal cyst does not attach to the ovary or fallopian tube.
While most paratubal cysts do not cause symptoms, some develop and become extremely large before causing symptoms including abdominal pain, frequent urination and feelings of fullness in the abdomen.
(NEW YORK) — The American Medical Association and the American Nurses Association have joined up with over 50 other health care organizations to call for mandatory vaccinations in their industry, citing rising COVID cases and their trust in the vaccine.
“Due to the recent COVID-19 surge and the availability of safe and effective vaccines, our health care organizations and societies advocate that all health care and long-term care employers require their workers to receive the COVID-19 vaccine,” the organizations wrote in a joint statement on Monday morning.
Between them, these health care organizations represent millions of physicians, nurses and other health care workers across the country, including pediatricians, oncologists and pharmacists.
And they don’t think the health care industry should be the only one to require vaccines. They also called on other industries to follow suit.
“As the health care community leads the way in requiring vaccines for our employees, we hope all other employers across the country will follow our lead and implement effective policies to encourage vaccination,” the joint statement said. “The health and safety of U.S. workers, families, communities, and the nation depends on it.”
According to the Centers for Medicare and Medicaid, just 58% of nursing home staff are vaccinated. According to one estimate in late May, 1 in 4 health care workers were unvaccinated in the U.S. In some places, like Florida, the rates were as low as 40%.
Nationwide, the U.S. is struggling to increase its vaccination rates past 50% of the total population, including children, and missed President Joe Biden’s goal to get 70% of adults vaccinated with one shot by July Fourth. As of Monday, about three weeks later, still just 69% of adults had met that goal, while 60% of adults were fully vaccinated, according to Centers for Disease Control and Prevention data.
The influential statement has the potential to move the needle on an issue that, so far, has held up in court and proven to be effective at increasing vaccinations, at least in the health care field. Over the winter, Houston Methodist became the first hospital to require vaccines for its staff, and many hospital systems around the country have followed suit. In Houston, the hospital was sued, but won a lawsuit over the requirement and saw the vast majority of its 26,000-person staff get vaccinated, while around 150 quit or were fired for not adhering to the policy.
That decision spurred a recent statement from another massive health care organization, the American Hospital Association, to call for mandatory vaccinations in hospitals and paved the way for even more to get on board as they did on Monday.
“I think it’s incredible to see these organizations come together and make the bold statement to mandate vaccinations, which we know are safe and effective,” said Dr. Jay Bhatt, the former chief medical officer for the AHA and an ABC News contributor.
“We know, as Americans, it’s hard for folks to agree on a lot of things. So if we’re seeing big organizations agree on vaccinations, we should be paying attention to it,” Bhatt said.
In defending their reasons, the groups that came out in support of vaccine mandates on Monday said it was necessary for caregivers to protect patients who might be immunocompromised or not yet eligible for a vaccine, and for their own health.
The organizations emphasized their confidence in the vaccines, which are safe and effective, and hinted at the fact that the vaccines would be fully approved by the FDA soon, which will also bring more employer mandates. Currently, the vaccine is authorized under an Emergency Use Authorization, which is a temporary approval.
“As we move towards full FDA approval of the currently available vaccines, all health care workers should get vaccinated for their own health, and to protect their colleagues, families, residents of long-term care facilities and patients. This is especially necessary to protect those who are vulnerable, including unvaccinated children and the immunocompromised,” the joint statement said. “Indeed, this is why many health care and long-term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.”
Also on Monday, the Department of Veteran Affairs announced that it would mandate the vaccine for its doctors and nurses. The decision came after four unvaccinated employees of the department died in recent weeks. The mandate will go into place in two months.
Department of Veterans Affairs Secretary Dennis McDonough said the mandate is “the best way to keep veterans safe, especially as the Delta variant spreads across the country.”
While there is a risk of pushback that could lead to people leaving their jobs, particularly in parts of the country where there is more refusal to get the vaccine, the rising levels of the delta variant, which currently makes up 83% of all cases in the U.S., could also hit hospital workforces hard, particularly for doctors and nurses on the frontlines of the pandemic.
“Either way, there’s a risk of them not being in the workforce. And I would say the cost of getting COVID is great enough that it warrants vaccination,” said Bhatt.
But for those who can’t be vaccinated because of medical reasons, which the groups estimated to be “a small minority of all workers,” they should be evaluated individually.
(WASHINGTON) — As pressure grows for the Food and Drug Administration to give full approval for the vaccine, a move that could drive up vaccinations by allowing vaccine mandates in places such as the military and schools, the agency told ABC News on Monday that reviewing the vaccines is among its “highest priorities.”
“The FDA recognizes that vaccines are key to ending the COVID-19 pandemic and is working as quickly as possible to review applications for full approval,” FDA spokesperson Alison Hunt said in a statement.
But critics maintain that full approval of the Pfizer and Moderna vaccines, beyond the temporary approval that they currently have, needs to happen quicker. The argument is that the vaccine has proven to be safe and effective, and full FDA approval could increase Americans’ confidence in the vaccines at a time when the country is teetering dangerously at just 50% full vaccination while up against the fast-spreading delta variant.
“I think a lot of us are baffled why the FDA is taking so long,” Dr. Ashish Jha, dean of the Brown University School of Public Health, said on ABC’s Good Morning America on Monday.
The FDA will surely approve of the vaccines, Jha said, but needed to “move a bit faster now.”
So what do we know about the timeline?
Full approval of a vaccine under priority review, as both Pfizer and Moderna are, usually takes six months. The FDA has said it intends to complete it much quicker than that, and Dr. Anthony Fauci, chief medical adviser to the White House, recently said he expected full approval for Pfizer in a month or so, by August, and Moderna to follow thereafter.
Pfizer submitted for full approval on May 7, almost three months ago, and Moderna on June 1, almost two months ago. So, the decision should not be too far off.
And what does FDA say about the criticism that it’s moving too slowly?
Asked by ABC News on Monday if the review is moving slower than anticipated, the FDA stood by the process.
FDA spokesperson Alison Hunt said that reviewing the vaccines is “among the highest priorities of the agency, and the agency intends to complete the review far in advance of the PDUFA Goal Date.” The goal date is January 2022, though that’s a regulatory deadline and not when it’s expected.
“The FDA recognizes that vaccines are key to ending the COVID-19 pandemic and is working as quickly as possible to review applications for full approval,” Hunt said.
The FDA also emphasized that the current authorization — an Emergency Use Authorization — was conducted thoroughly, signaling that it stands on solid ground and should be fully approved.
“Although an authorization is not an FDA approval, the FDA conducted a thorough scientific evaluation of each of the authorized vaccines and can assure the public and medical community that the vaccines meet FDA’s rigorous standards for safety, effectiveness and manufacturing quality,” Hunt said.
Some have also argued that the FDA has to take its time so that any vaccine mandates that follow the full approval go as smoothly as possible. Any cracks in the approval process or accusations of rushing, could lead to even more pushback. That’s already played out over the last few months, as hesitant Americans have refused to take the vaccine because they fear it was given emergency authorization too hastily.
That was White House press secretary Jen Psaki’s defense on Monday.
“The FDA is the gold standard in our view, and they move at the speed of science,” Psaki said to ABC News Chief White House Correspondent Cecilia Vega, who asked why the FDA hadn’t yet given full approval of the vaccines.
“It wouldn’t be responsible to expedite that process at a faster speed than the science and data allows.”
(WASHINGTON) — New Hampshire residents cannot be required to get a COVID-19 vaccine in order to “access any public facility, any public benefit, or any public service” according to a new bill signed into law by Republican Gov. Chris Sununu.
The so-called “medical freedom” bill does not override state vaccine law, which “requires that all children enrolled in any school, pre-school, or child care have certain immunizations to protect them and those around them from vaccine preventable diseases,” according to the New Hampshire Department of Health and Human Services.
The COVID-19 vaccine is not currently listed as a requirement for attending school, nor is it approved for children younger than 12.
Other exceptions to the new law include correctional facilities, such as jails and prisons, where immunizations can be mandated “when a direct threat exists,” as well as county nursing homes and medical facilities operated by the state.
The governor’s office did not immediately respond to ABC News’ request for comment.
New Hampshire’s law stands in contrast to some other parts of the Northeast, which have edged toward mandatory vaccinations in recent days.
In New York City, Mayor Bill de Blasio announced Monday that COVID-19 vaccination would be compulsory for all city workers, including police officers, firefighters and teachers, starting Sept. 13. City workers will have the option of getting tested weekly for COVID-19 if they choose not to get vaccinated.
“We’re doing this out of a sense of urgency,” de Blasio said. “It is about protecting the workforce, their health and safety, and the people they serve.”
New Hampshire’s vaccination rate is slightly higher than the national average. As of Sunday, 64% of residents had received at least one dose, and 58% were fully vaccinated, according to the Centers for Disease Control and Prevention. By comparison, 57% of Americans have gotten at least one shot, and 49% are fully vaccinated.
ABC News’ Aaron Katersky contributed to this report.
(LOS ANGELES) — Pfizer and Moderna are expanding the size of their COVID-19 vaccine studies in children ages 5 to 11, according to a new report.
The decision, which came after a push from the Food and Drug Administration, according to The New York Times, is intended to detect rare side effects in young people under the age of 30, such as myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart). The original size of the studies was too small to detect those rare side effects.
Pfizer declined to comment on The Times’ report to ABC News and pointed to a vaccine timeline the pharmaceutical company had previously released. Testing on 5- to 11-year-olds began in early June, Pfizer said, and on kids younger than 5 on June 21. The company anticipates having initial Phase 2 and 3 results for 5- to 11-year-olds in September.
Moderna told ABC News in a statement: “It is our intent to expand the trial and we are actively discussing a proposal with the FDA.”
It’s unclear what effect these changes might have on the timeline for emergency use authorization for COVID-19 vaccines in children. “The objective is to enroll a larger safety database which increases the likelihood of detecting rarer events,” according to Moderna. “Timelines are regularly reevaluated based on agency discussions and requests.”
Moderna said it expects to seek emergency use authorization by the end of 2021 or in early 2022.
“Some of the advisory committee members have said they’d like to see a longer median follow up time after vaccination – more than the 2 months used to support FDA’s emergency use authorizations for older age groups – in the trials in the younger ages, which is something that the agency intends to take into consideration, though it is not bound by the recommendations of advisory committees or statements from advisory committee members during the course of scientific discussions,” the FDA said to ABC News in a statement last week.
(NEW YORK) — Although reports of breakthrough COVID-19 cases occurring among fully vaccinated Americans are garnering much attention, as the country experiences a viral resurgence, new data illustrates just how rare these breakthrough infections are likely to be, and further shows that the vast majority of those becoming severely ill are the unvaccinated.
“While anecdotal cases and clusters can conjure concern around the vaccine, when put in the larger context of how many people have been vaccinated and the sheer volume of cases in the unvaccinated population, we recognize that the vaccines are working and how rare breakthroughs actually are,” said Dr. John Brownstein, the chief innovation officer at Boston Children’s Hospital and an ABC News contributor.
With more than 156 million Americans fully vaccinated, nationwide, approximately 153,000 symptomatic breakthrough cases are estimated to have occurred as of last week, representing approximately 0.098% of those fully vaccinated, according to an unpublished internal Centers for Disease Control and Prevention document obtained by ABC News. These estimates reflect only the adult population and do not include asymptomatic breakthrough infections.
Substantial vaccination coverage amid increasing COVID-19 case rates are driving an increase in “expected” symptomatic breakthrough infections in recent weeks, the CDC wrote in the document.
Experts stress that no vaccine can provide 100% protection, but they are still very effective at preventing severe illness and death.
“The risk to fully vaccinated people is dramatically less than that to unvaccinated individuals. The occurrence of breakthrough cases is expected and, at this point, is not at a level that should raise any concerns about the performance of the currently available vaccines,” Matthew Ferrari, director of the Center for Infectious Disease Dynamics at Pennsylvania State University, told ABC News.
“Some vaccinated folks may still get infected, some may still transmit. And the more vaccinated people there are, the more breakthrough cases we’ll see,” he added.
Coronavirus cases are now at their highest point since early May, according to CDC data, with the U.S. average nearly quadrupling since June to 47,000 new cases a day, largely driven by the highly infectious delta variant, which now accounts for more than 83% of new cases nationwide.
Virus-related hospitalizations have also increased, with more than 27,000 patients hospitalized around the country, though that number is still significantly lower than in January, when over 125,000 patients were receiving care at one time.
According to the White House COVID-19 Task Force, severe breakthrough infections remain rare, and nearly all of these hospitalized patients — 97% — are unvaccinated.
Earlier this week, the popular summer destination of Provincetown, Massachusetts, was thrust into the spotlight after at least 430 COVID-19 infections were confirmed, many of them breakthroughs, following a busy July Fourth weekend.
Confirmed cases among Massachusetts residents, stemming from the Provincetown cluster, have been found to be predominantly symptomatic, with 69% of affected individuals reported to be fully vaccinated, according to local officials. Apart from three hospitalizations — two in state and one out of state — symptoms from cases associated with this cluster are known to be mild and without complication, Alex Morse, the town manager for Provincetown, said.
“The transmissibility of the delta variant raises the likelihood of sporadic ‘super spreader’ events among vaccinated people, especially when indoors and in close proximity without masks. These events raise the risk to those unvaccinated while the vast majority of the breakthrough cases will be mild or asymptomatic,” Brownstein added.
Statewide in Massachusetts, state health officials report there have been at least 5,166 breakthrough infections as of July 17. More than 4,800 of these infections resulted in no hospitalization or death. A total of 80 of these breakthrough cases resulted in death, representing 0.0015% of individuals fully vaccinated — and 272 cases resulted in hospitalization, representing 0.006% of those fully vaccinated.
The hospitalizations and deaths that do occur among fully vaccinated individuals tend to occur among people who are older or those with serious underlying medical conditions for whom the vaccines may have reduced efficacy, experts said.
Ankoor Shah, principal senior deputy director at the Washington D.C. Department of Health, said during a Thursday press conference that the district had 200 fully vaccinated breakthrough cases of COVID-19, out of a total record nearly 376,000 fully vaccinated people, representing “only point .05 percent, which just strengthens our confidence on how great these vaccines are.”
And in New Jersey, the total number of breakthrough cases, so far, is 5,678 out of a total of 4.8 million people vaccinated by July 12, according to state data. Forty-nine fully vaccinated individuals have died as a result of COVID-19.
“It is important to point out that 49 deaths due to COVID-19 among 4.8 million fully vaccinated state residents is slightly greater than one in 100,000 fully vaccinated individuals. That means vaccines are about 99.999% effective in preventing deaths due to COVID-19,” Dr. Ed Lifshitz of the New Jersey Department of Health said in a statement to ABC News.
Additionally, 27 of these individuals had pre-existing conditions, Lifshitz said, and many had more than one condition.
Of concern to some experts is the decline in daily COVID-19 tests, which makes it more difficult to track the spread of the virus. The nation is now recording just under 600,000 COVID-19 tests a day, which has ticked up slightly in recent weeks but is still much lower than at the country’s peak in January, when U.S. was recording over 2 million tests a day. In addition, the CDC has, since May, ceased reporting asymptomatic or mild breakthrough cases.
According to Brownstein, the combination of the overall testing decline, the mild nondescript nature of breakthrough infections, and the general perception that vaccines are protective, means that any count of breakthrough infections is likely an underestimate.
Hence, he said, “given the efficacy of the vaccines, we recognize that even more cases will be asymptomatic, so these data only show part of the story. While asymptomatic cases are not of clinical relevance, they do help understand important patterns of transmission in the community.”
Experts concur that even with lower case levels than this past winter, the pandemic is not yet over, and it is critical to track the disease in order to attempt to slow its spread.
In a recent editorial in the Journal of the American Medical Association, experts urged the CDC to “re-energize” its testing services in light of the highly transmissible delta variant, “because without vigorous testing, the nation cannot be sure whether declining cases are a function of decreased numbers of infections or reduced numbers of tests.”
“As long as the virus is circulating, with or without causing illness, it can change and mutate, including into new strains that may be even harder to control,” Samuel V. Scarpino, managing director of pathogen surveillance at the Rockefeller Foundation, told ABC News.
“To get ahead of the pandemic we need to track the virus more closely and collect high-quality information on how and where COVID-19 is changing,” he said. “This high-quality, detailed information is crucial for COVID-19 and future pandemics.”
(NEW YORK) — As cities around the world start to reopen after COVID-19 lockdowns, the effects of the pandemic are starting to show on people’s faces.
Experts in cosmetic medicine say they have begun to notice an uptick in Botox treatments among younger generations. They say people, particularly women, in their early 20s — aged from the pandemic and wearing less makeup than before — spent so much time looking at themselves during Zoom meetings that they started to notice their “imperfections,” and for the first time, turned to Botox and fillers.
“I would say that my average age of patients shifted down considerably this year, and it’s now early 20s,” Skinly Aesthetics founder Dr. Dmitriy Schwarzburg said. “And they’re coming not just for Botox, but for all kinds of procedures that they would otherwise consider at a much later point in their lives.”
Amy Shecter, the CEO of Ever/Body said, “The Zoom effect is real, and it has definitely been a catalyst for increased interest in cosmetic dermatology treatments.”
According to Stacy Garrity, a nurse practitioner at Ever/Body, many of their clients over the past year have admitted that they only started to notice their fine lines because of Zoom, and now that things are opening up, they’re anxious to get out of their quarantine funk and look and feel better.
The number of patients in their early to mid 20s “is a phenomenon that was not seen five years ago,” Garrity said.
Schwarzburg said the pandemic accelerated what was already happening with people’s interest in Botox. He said the median age of patients at his clinic has actually been declining for about four years, “and it’s 100% because of social media — especially filters.” Schwarzburg said patients often come to him with photos of themselves with Instagram filters on and ask him to make them look that way. His biggest requests this year: “smooth skin, full lips, nice cheeks, sharp jawline.”
Priya Patel, a physician assistant and Botox expert at Plump, agreed social media is to thank for the younger audience, and for the slow but steady de-stigmatization of Botox and cosmetic procedures in general.
“You can easily go on Instagram or TikTok and watch the procedures being done and realize like, ‘Oh, it’s not really what I thought it would be,'” she said. “And you can also follow those posts and see what their results look like.”
But what’s different about this younger population of first-time Botox users, Schwarzburg said, is that many of them are choosing to embrace wrinkle relaxers before their “dynamic lines” turn “static.” In other words, it’s all “preventative,” whereas some years ago, it was used purely to treat an already existing “problem.”
He explained that all Botox — a protein approved by the Centers for Disease Control and Prevention and the Food and Drug Administration — does is temporarily paralyze one’s muscle receptors so that even when the brain sends the muscle a signal to move, it stays put. It takes about 12 weeks for the Botox to have full effect. Researchers also believe that the injections give the skin a chance to produce collagen to erase whatever fine lines may have developed over time. That’s why those lines disappear. So, by using Botox early, millennials and Gen Zs are essentially taking control of how they age — at least externally.
“What millennials want is for those dynamic lines to be less expressive, so they never reach the point of static lines. And they start early, so they never have to worry about developing static lines,” Schwarzburg said. “That’s a huge shift, I would say.”
Botox clinics are adapting to this younger population
Dr. Carolyn Treasure, the co-founder of Peachy, opened the Botox clinic in New York’s SoHo neighborhood at the peak of the pandemic, but has already secured a cult-like following of younger fans, including influencers, who love her services. This is not because Peachy is the only place in Manhattan to get wrinkle-relaxers — there are hundreds — but because clinics like hers are catering to a younger audience by making the experience of cosmetic procedures feel more trendy and casual than scary, taboo and hospital-like.
Also, Peachy uses a technology to apply Botox that was made precisely for the digital times we’re living in. When a patient goes into the clinic, the nurse or doctor who will deliver the treatment first takes photos of the patient’s face using an iPad. Then, Peachy’s own Botox app will analyze the photos and suggest the number of Botox units that should be applied to each of the three FDA-approved points: forehead, frown lines and crow’s feet. Of course, those numbers can be tweaked depending on the patient’s desired look.
After the procedure — which takes about five minutes — the patient can sit down in the clinic’s cozy, pink relaxation room, enjoy a complimentary sparkling water, ice their Botox points and take selfies on the many mirrored walls.
“Our mission at Peachy is really balancing fun and approachability with clinical excellence and scientific rigor,” Treasure said. “I really try to fight against the ‘Botox bar’ stereotype in that we do have a clinically excellent environment and phenomenal providers and nurse practitioners who are really here to educate people on wrinkle prevention, and particularly prevention that doesn’t alter or change how you naturally look. And it’s a novel model of health care delivery.”
Peachy, Plump, Skinly Aesthetics and Ever/Body — with their pastel-colored decor, bright white lights ideal for photos and stylish waiting rooms — look more like spas you want to post on Instagram than clinics where you get injected in. At the same time, many of the doctors and nurse practitioners who deliver the treatments have become social media stars, and often run in the same circles as fashion influencers or celebrities.
Treasure, who graduated from Harvard Medical School and was previously a resident at Brigham and Women’s Hospital in Boston, said Peachy is like no other health care environment she’s ever worked in, and that is exactly the draw. Young patients see getting Botox as a fun experience they want to brag about, whereas their parents likely believed in the myths associated with the procedure and thought it taboo.
The FDA does not recommend Botox cosmetic use in people under 18, and says any side effects are generally minor, such as redness, headache or nausea, according to the medication guide.
One common misconception is that Botox gives you a plastic or “deformed” look, but experts said that is actually the result of too much filler — which is not the same. Another myth is that Botox is bad for the health, but Garrity said, “Neuromodulators are FDA-approved and have been used cosmetically in the U.S. since 1991. When injected judiciously and by a skilled medical provider, there is very little risk to people of any age.”
Schwarzburg, at Skinly Aesthetics, said those are the exact misconceptions that caused the yearslong stigma against Botox, and which millennials and Gen Zs are helping to eliminate.
“I can tell you that most of the 40-plus patients keep it to themselves or to a very close circle of friends, while 20-year-olds could be posting it as I’m doing it and then they’ll tell everyone and that will generate more traffic,” Schwarzburg said. “It’s a lifestyle kind of achievement.”
The experts also agreed that while Zoom, Instagram and TikTok have certainly pushed younger people to try out Botox for the first time, so have they. Now that medical professionals have different platforms, health, skin care and scientifically backed cosmetic procedures have begun trending.
“People are now more interested in what is results-oriented — what has data behind it. Because in this space there’s historically been a lot of pseudo-science, and that’s what we’re fighting against,” Treasure said.
(NEW YORK) — A Centers for Disease Control and Prevention panel once again warned consumers this week not to use commercial antibody tests to check whether or not they are immune to COVID-19. These tests, the panel said Thursday, are not consistent and can’t be used to measure protection against the virus.
Antibody testing is primarily used to determine if a person has previously been infected with the COVID-19 virus. Early reports suggested that people who tested positive for antibodies after either a known or asymptomatic infection had some level of immunity. Now, most health officials agree that having a positive antibody test does not mean a person is immune to contracting the virus.
“Antibodies after a period of time start to come down again, that’s not a bad thing,” said Dr. Todd Ellerin, director of infectious diseases at South Shore Health. But the presence of antibodies is only part of the story when it comes to immunity.
“Your antibodies are only one part of the immune system. You have other parts of the immune system as well, such as T-cells,” said Ellerin. “T-cell response is probably very important to protecting against severe disease because they can attack the virus directly.”
With high-profile breakthrough infections among sports teams and Olympians, many are wondering if they still have the same level of protection against the delta variant as when they first got their vaccines.
But scientists are still searching for a so-called “correlate of protection” — a marker in the blood that would reliably indicate protection. And they don’t necessarily think it’s antibodies. That means the presence of antibodies — or even more specific antibody levels — does not necessarily correlate with a person’s level of protection.
“The correlates of protection are not known, and so it is not known whether a positive antibody test after COVID-19 infection represents protection against any variant, including the delta variant,” said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center.
The Food and Drug Administration strongly warns against antibody tests as a way to check for immunity among people who are fully vaccinated, writing in May that “currently authorized SARS-CoV-2 antibody tests should not be used to evaluate a person’s level of immunity or protection from COVID-19 at any time, and especially after the person has received a COVID-19 vaccination.”
Experts agreed that this warning might be confusing for some consumers. After all, antibody testing is routinely done to test for immunity against other viruses such as hepatitis B, measles, mumps, rubella and varicella.
But COVID-19 is different, experts said.
“It is generally not recommended to use commercial antibody tests to monitor responses to vaccines, because the meaning of these assays has not been well defined in terms of whether they can predict vaccine protection or not,” said Barouch.
We know the COVID-19 vaccines work not because of a blood test, but from large clinical trials that compared a group of unvaccinated people against a group of vaccinated people, finding that unvaccinated people were overwhelmingly more likely to become infected and fall seriously ill with COVID-19.
“What we generally think is that all of the vaccines get you to high-enough levels where even if they wane, you’re still protected against hospitalization,” Ellerin said. “Because the vaccines have done such a great job, all of them, at preventing hospitalizations, we think, based on some of the modeling studies, that you only need 3% of your average neutralizing antibody response to keep you out of the hospital.”
Unfortunately, there is no commercially available antibody test that can tell us if we are truly immune to COVID-19 or how long any immunity gained through natural infection or vaccine-mediated will last.
According to the CDC and FDA, the only acceptable time to use an antibody test to check for immunity is if you have volunteered for a carefully monitored clinical study. Some people with immune compromised conditions — like cancer or autoimmune diseases — don’t mount a good response to vaccines.
People with those medical conditions are being monitored for antibody levels using very specific antibody tests, and under the close supervision of doctors. And early data suggests that for some, a third shot might help.
No vaccine is 100% effective in preventing infections, but health officials continue to recommend vaccination as the best way to prevent COVID infections.
“Even if we find a correlate of immune protection, we want it to have clinical relevance, not just in vitro or test tube relevance,” said Ellerin. “The national guidelines and I do not recommend antibody testing for the general public, but for immunocompromised patients that’s a different story.”
Odelia N. Lewis, M.D. is a recent graduate of SUNY Downstate’s Family Medicine Residency Program and a contributor to the ABC News Medical Unit.
(NEW YORK) — Maryland Gov. Hogan announced earlier this month, the launch of the $1 million VaxU scholarship program. The effort is to incentivize those eligible, kids between 12-17 to get vaccinated against COVID-19, the governor said. Anyone between those ages who was vaccinated in the state is automatically entered to win.
Winners will receive a $50,000 scholarship for any public, in-state institution of higher education. As of July 12, the state began randomly selecting two winners and will continue with weekly drawings through Labor Day, when they will then pick four winners.
“The virus, and its variants are a dangerous threat to you,” Hogan said. “Getting vaccinated is the only way to protect yourself and to continue on our recovery.”
“The winners will receive a Maryland 529 prepaid college trust contract, which locks in today’s tuition rates for the future, or a Maryland 529 College invest plan,” said Gov. Hogan. “And the winner, if they decide down the line…. [that they] would like to attend a private institution or school that’s outside of the state of Maryland, they can actually transfer the scholarship to the school of their choice.”
The funding behind these scholarships comes from the American Rescue Plan which distributed more than $360 billion in emergency funding to state and local governments.
“Promotions like these are just one more way that we are reinforcing the importance of getting every single Marylander that we can vaccinate against COVID-19, especially our young people,” said Gov. Hogan. “But those who are unvaccinated do remain at risk, especially with the new highly transmissible variants, including the delta variant which is currently circulating.”
“According to our state health department, 95% of all new COVID cases reported last month were people who have not been vaccinated [and] 93% of all new covid deaths in the month of June were Marylanders who were unvaccinated,” said Gov. Hogan.
The incentive comes as the delta variant spreads rampantly throughout the U.S. and vaccination rates across the nation continue to fall.
Centers for Disease Control and Prevention Director Rochelle Walensky told lawmakers Tuesday that the delta variant now makes up 83% of COVID cases, up from 50% at the beginning of this month.
Since vaccinations have become widely avaiable states have used lotteries, college scholarships and other rewards as ways to intice people to get vaccinated.
In May, Joseph Costello was announced the winner of a full-ride scholarship in Ohio’s Vax-a-Million lottery. Costello’s name was randomly drawn from nearly 105,000 entries among vaccinated 12 to 17-year-olds.
That same month, the mayor of Lancaster, California, offered a raffle scholarship that included a grand prize of $10,000 for teens who get the COVID-19 vaccine.
(NEW YORK) — Adding to the many challenges parents faced during the COVD-19 pandemic, vaccines remain unavailable for young children leading to questions about the need for kids to wear masks.
The issue has come to a head as kids start to return to school and even different schools within the same school district may have different mask policies.
On the national level, the Centers for Disease Control and Prevention has said immunized adults and teens can go without a mask, including inside schools.
The public health agency has also said that schools can still embrace universal masking if they can’t verify vaccinations or have large numbers of students too young to qualify. Children under the age of 12 are currently not eligible for a COVID-19 vaccine.
At least eight states, including Arizona, Georgia and Texas, have banned mask mandates in schools.
Meanwhile, the American Academy of Pediatrics, an organization of nearly 70,000 pediatricians, this week called for schools to enforce universal masking mandates.
“AAP recommends universal masking because a significant portion of the student population is not yet eligible for vaccines, and masking is proven to reduce transmission of the virus and to protect those who are not vaccinated,” the AAP wrote in a statement. “Many schools will not have a system to monitor vaccine status of students, teachers and staff, and some communities overall have low vaccination uptake where the virus may be circulating more prominently.”
Good Morning America spoke with two pediatricians from Columbia University to help clarify for parents all the advice coming in on face masks and kids.
Here are their takeaways for parents.
1. All kids above age 2 should wear face masks at schools:
Both pediatricians, Dr. David Buchholz and Dr. Edith Bracho-Sanchez, agreed with the AAP’s recommendation that all people above age 2 should wear masks inside schools, regardless of vaccination status.
“It makes it simple and it makes it flawless and protects everybody,” Buchholz said of a universal policy. “Wearing a mask protects yourself and it also protects others. It’s a great benefit.”
Both Buchholz and Bracho-Sanchez pointed out that the AAP’s and CDC’s seemingly different policies can be explained by the focus of their work.
“The CDC is in general making recommendations for the whole country,” said Bracho-Sanchez. “The APA, they’re pediatricians and their first thought is what makes sense for children? They’re looking granularly at kids and what makes sense for them.”
2. Masks matter because kids are at risk for COVID-19:
“Our understanding of COVID-19 in children has changed dramatically [since the start of the pandemic] and it absolutely can be a very serious illness in children,” said Bracho-Sanchez. “Since the start of the pandemic, there have been over 4 million children who have contracted COVID-19 and hundreds who have unfortunately passed away from it and another large amount of children who are suffering long-term COVID-19 symptoms after having had the initial illness.”
COVID-19 cases have nearly tripled in the United States over two weeks, according to The Associated Press. The virus is also on the rise among children, with more than 23,000 new pediatric cases diagnosed in the U.S. last week, twice as many as the end of June, according to the AAP.
The CDC reports that among recent cases of COVID-19, 99.5% of hospitalizations are people who weren’t immunized.
In addition to protecting children from COVID-19, face masks also help prevent the spread of other viruses like respiratory syncytial virus (RSV) and influenza, noted Buchholz.
3. Masks allow children to learn in person:
After more than one year of learning entirely online for many students, wearing face masks is an easy measure that will allow kids to learn in person, according to Bracho-Sanchez.
“Children have absolutely suffered from being isolated from their peers, from their friends, from other people,” she said. “But that is because they have been away from other people, not because they have been wearing masks.”
“You can be around other people and socializing and wear masks, or not wear masks and potentially get very sick and have to go back to learning online,” added Bracho-Sanchez. “It’s in my mind a no-brainer. I would mask my own child. I would ask the adults around my child to wear masks.”
4. Masks should be used along with other safety practices:
In addition to supporting their kids in wearing face masks, parents should pay attention also to the other safety recommendations that have been in place throughout the pandemic, including hand washing and social distancing, according to both doctors.
They also urge parents to continue to screen themselves and their children for symptoms each morning and to stay home from school and-or work if they are sick.
5. Kids may have bigger feelings around returning to school:
Bracho-Sanchez said that parents will want to listen to their kids in case their possible resistance to or anger over having to wear a mask is about something deeper, like anxiety over returning to school.
“We are very focused on COVID and masking but this back-to-school season is going to be about so much more than COVID-19,” she said. “Some kids are really nervous. Some kids have truly fallen behind. Some kids have not been around people, so at the same time we’re having these conversations, we also have to remember that we have to protect children in so many ways.”