(NEW YORK) — As many children return to in-person learning and adults end a period of working from home, experts are concerned about the upcoming flu season and its implications for hospitals that are already pushed to the limits of capacity due to the COVID-19 delta variant.
Flu season usually runs from October to May, with experts suggesting the best time to get vaccinated is from early September to the end of October, although some major retail pharmacies have already begun advertising this year’s supply.
“We should always prepare for the flu season by planning to get vaccinated. This fall and winter there is likely to be circulation of COVID, influenza as well as other respiratory viruses,” said Dr. David Hirschwerk, an infectious disease specialist at Northwell Health in New York.
For some, that might mean getting vaccines for the flu and COVID-19 at the same time — either a booster shot or primary COVID-19 vaccination. Either way, the Centers for Disease Control and Prevention say it is safe to get the COVID and flu vaccines during the same visit.
“There is currently no contraindication to receiving both at the same time and for many people, this will be the most convenient way to handle it,” said Hirschwerk.
Experts say that with multiple viruses now circulating, every bit of protection helps.
Other seasonal respiratory viruses — such as RSV and adenovirus — have proven unpredictable, surging during the summer, a time typically outside their regular season.
By the same token, it’s not possible to predict the severity of the 2021-2022 flu season. Public health officials like to say if you’ve seen one flu season, you’ve seen one flu season — meaning every year starts and ends at different times, with different strains and different severities. Some worry the low number of cases last year during remote learning and work from home situations — as well as people wearing masks when they were in public — could be the calm before a very severe flu season this year.
Influenza activity during the 2020-2021 season was at a record low despite high levels of testing. Less than 1% of tested respiratory samples were positive for the flu. For comparison, the prior three flu seasons showed positive tests for influenza between 26% and 30%.
During the 2019-2020 season, 38 million people became sick with flu, resulting in more than 400,000 hospitalizations and 22,000 deaths.
A major contributor to the low cases of flu during 2020-2021 was a record number of flu vaccinations. An estimated 193.8 million doses were distributed in the U.S. during the 2020-2021 season.
Many primary care doctors, especially pediatricians, are playing catch-up when it comes to making sure that everyone is getting their routine vaccinations as the COVID pandemic resulted in many maintenance visits being canceled or rescheduled.
While children under 12 are not yet eligible for the COVID vaccine, those ages 6 months and older are strongly encouraged to get the flu vaccine. Many school districts insist on it.
“The first time a child gets the flu vaccine, it’s two doses, not just one, so people should plan for that,” said Dr. Eric Cioe-Pena, emergency medicine specialist at Staten Island University Hospital.
Annual flu vaccines are especially important for children ages 6 months to 4 years, adults aged 50 and older, nursing home residents, people with underlying health conditions such as heart disease and lung disease, people who are immunosuppressed and people who are pregnant.
By now, most people are aware that vaccines prevent serious illness for the individual getting the vaccine and for those around them who are more vulnerable to severe illness. In a typical year, hundreds of children die from the flu. The CDC estimates that an average of 36,000 adults have died of the flu each year over the past decade. The worst recent flu season was 2017-2018, when 61,000 people died, according to the CDC.
“It is very important that all children (6 months and older) receive the flu vaccine. This helps to reduce risk of infection, of severe complications from flu, and it protects the entire household and communities by reducing transmission to others,” said Hirschwerk.
To vaccinate as many individuals as possible, vaccine makers are producing large quantities of several types of flu vaccine. Flu vaccines are typically made using a process that involves eggs, but alternative vaccines will be available for people who have egg allergies.
Getting vaccination is a key step in preventing the flu and decreasing transmission, experts say. Continuing mitigation measures are also likely to keep any influenza surges at bay, especially as the country to struggles to cope with the devastation caused by COVID-19.
“Mask-wearing has significantly curbed the spread of influenza,” said Cioe-Pena. “Wash your hands, wipe down commonly touched surfaces like keyboards, phones and door knobs. Stay home when you are sick, and wear a mask.”
(NEW YORK) — The Centers for Disease Control and Prevention announced an investigation into an outbreak of Salmonella that may be linked to Italian-style meats.
They reported 36 illnesses and 12 hospitalizations across 17 states and found that most people ate Fratelli Beretta brand uncured antipasto trays before they became ill, according to a release on Thursday.
This does not include Italian-style meats sliced at a deli.
No deaths have been reported.
The CDC is advising people not to eat Fratelli Beretta brand pre-packaged uncured antipasto trays, including uncured salami, prosciutto, coppa or soppressata. The trays were sold nationwide and have “best by” dates on or before Feb. 11, 2022.
The investigation is ongoing to determine if additional products are linked to illness. ABC News has reached out to Fratelli Beretta for comment, but has not heard back at this time.
(CHESTERFIELD, Mo.) — Dr. Steven Brown is on the front line of the battle against the surge of COVID-19 cases. But for him, the front line is also the home front.
Working overnights, the 66-year-old critical care specialist manages hundreds of intensive care unit patients in hospitals across the Midwest, more than half of them COVID cases, many on ventilators. And he does it from his living room in suburban St. Louis.
Sitting before an array of four large computer screens and two laptops, he compares his work to that of an air traffic controller. He can read charts, scans, X-rays and even look in on patients with the help of sophisticated cameras in the ICUs.
“Each room has its own camera in it and I’m remotely operating it,” he told ABC News.
So despite being distant from his patients, his care is intimate. “I can look in a throat. I can look at how they’re using their muscles of respiration and whether they have disordered breathing. I’m able to do extreme fine-tuning of the ventilator settings for patients.”
And lately, more and more of his cases are COVID patients on ventilators. On his regular 12-hour shifts, he reports that the “amount of disease I am seeing is amplified. While some critical care doctors on a night shift might be managing eight or 10 patients with COVID-19 who are on ventilators for their shift, I’m managing 10 times as many because I’m managing patients in multiple sites.”
Remote care is not new for Brown, who had been working that way alongside colleagues at Mercy Virtual Care Center for more than 12 years. However, age and other factors put him at higher risk for COVID-19. So, when the pandemic struck, he got installed in his home the equipment needed to continue working there and has done so now for more than a year and a half.
“There are a lot of telemedicine physicians and providers and vendors out there,” Bethany Pope, spokesperson for Mercy Virtual, told ABC News. “There are likely very few who are doing critical care medicine from home.”
Working from home, however, does not mean working less. Brown forecasts that the surge in the disease will mean a surge in his already grueling work schedule, from 10 straight days of 7 p.m. to 7 a.m shifts to 12 days in a row or more.
But while the current situation is grim, he thinks a good outcome is still possible, perhaps even a Hollywood ending. “Initially this felt, at the end of 2020, as being like the end of the first original Star Wars movie,” he said. “We’re in the ‘Empire Strikes Back’ right now with the delta variant. And we’re going to have a happy sequel, but there’s a lot of work ahead for us.”
(ST. LOUIS) — A Missouri mom whose newborn son passed away after she gave birth to him while battling COVID-19 is speaking out in order to urge pregnant women to get vaccinated.
Vanessa Alfermann, a registered nurse from Franklin County, says she was 22 weeks pregnant with her second child when she contracted COVID-19 in November, before the first COVID-19 vaccine received emergency authorization from the Food and Drug Administration (FDA).
“My husband had symptoms and he tested positive and the next day I also tested positive,” Alfermann, 33, told Good Morning America. “I never had shortness of breath but was just really tired.”
Alfermann said she had more symptoms of COVID-19, like a loss of taste and smell and headaches, but never experienced the more serious complications she sees COVID-infected patients suffer from at the hospital, Missouri Baptist Sullivan, where she works.
Around 10 days after she first tested positive for COVID-19 though, Alfermann began experiencing back pain and cramps and went to see her OBGYN.
“The baby was fine [in an ultrasound] but my white blood cells were really high and they said I had an infection from COVID and gave me an antibiotic and some muscle relaxers to go home with,” she recalled. “The next morning at about 1:30 I got up and realized I was in labor.”
Because her husband was still isolating due to his own COVID-19 diagnosis, Alfermann’s mother-in-law drove her to Mercy Hospital in St. Louis, where she would quickly give birth to her son, whom she named Axel.
“Within a half hour from me getting there and getting up to the [labor and delivery] floor, Axel was born,” said Alfermann. “I didn’t even get to hold him. The NICU people held him and he took his breath with them and then he passed away.”
Alfermann said doctors told her she suffered a placental abruption, a pregnancy complication that happens when the placenta separates from the uterus. In her case, the abruption was caused by blood clots in the placenta due to COVID-19.
“It was mind-blowing because don’t think you’re going to get a blood clot on your placenta. [You think] you’re going to be put on a ventilator because you can’t breathe,” Alfermann said, referring to respiratory problems that were the most well-known COVID-19 complication at the time. “I went through all of these emotions but I also thought if this is what’s coming, what COVID does, it just scared me.”
Placental abruption can be a deadly complication for the mother. Alfermann said she is thankful she survived and is able to still be here for her family, including her husband, son and stepdaughter.
As she continues to walk through the grief of losing a child, Alfermann said she is sharing her story to help encourage pregnant people to get vaccinated against COVID-19.
“There’s so much misinformation out there that’s killing people and it’s frustrating,” she said. “I speak out about this for Axel’s legacy … because there shouldn’t be another Vanessa or Axel.”
Alfermann, who was vaccinated against COVID-19 in December, said she thinks about how her life may be different if the vaccine had been available during her pregnancy.
Describing the moment she received her first vaccine shot in December, Alfermann said, “I was so happy because I was protecting everybody else but I went upstairs to our bathroom and just cried because I thought ‘what if.’ What if five or six weeks earlier I could have gotten the shot? I could still be waiting to have my baby boy.”
“It’s very bittersweet,” she said.
Earlier this month, the Centers for Disease Control and Prevention (CDC) strengthened its recommendation for COVID-19 vaccination during pregnancy, stating that all women who are pregnant, breastfeeding or trying to get pregnant now or might become pregnant in the future should get a COVID-19 vaccine.
Still, 3 out of 4 four pregnant women in the U.S. have not yet received a COVID-19 vaccine, according to new data from the CDC.
The low vaccination rate among pregnant women combined with the more infectious delta variant spreading in the U.S. has led to an increase in hospitalizations among pregnant women, including in the St. Louis-based healthcare system where Alfermann works.
“We’re getting pretty desperate,” said Dr. Jeannie Kelly, a Washington University obstetrician at Barnes-Jewish Hospital in St. Louis, part of the BJC HealthCare system. “We have had to say no to transfers because we are completely full and that in my eyes is just unacceptable for American medicine in 2021 and it’s infuriating that we’re here at this point.”
“I think all of us who are taking care of pregnant patients at this point are really worried, are really concerned and are really scared,” she said. “It’s a really hard situation for a pregnant person who is in the ICU with a baby who is also sick because mom is so sick.”
Dr. Laura Vricella, a maternal fetal medicine physician at Mercy Hospital, where Alfermann was treated, said the hospital is also seeing record number of COVID-positive pregnant patients.
“In the past month we have seen the largest amount of pregnant people being hospitalized with COVID, and be critically ill with COVID, than we did at any time last year, said Vricella. “We have eight [pregnant people with COVID-19] in the hospital now, five are critically ill and virtually all are unvaccinated.”
Vricella, who was not involved in Alfermann’s care, said doctors and researchers are learning more and more now, as the pandemic continues, about the negative effects COVID may have on pregnant people.
“What we’re seeing right now is that COVID-19 seems to be much more dangerous for pregnant people than what we were seeing in the spring,” she said. “This is why the three national bodies [the CDC, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM)] are now recommending the vaccine in pregnancy regardless of timing.”
COVID-19 is especially dangerous in pregnant people because their immune systems are already less active in order to support their growing fetus and their hearts and kidneys are already working harder during pregnancy to support the fetus, according to Vricella.
Pregnant people must also keep their oxygen levels higher in general to support their fetus, which can be a herculean task to do when COVID-19 is in the body, according to Vricella.
And in addition to pregnant people with COVID-19 being more likely to deliver prematurely, Vricella said her hospital is also seeing more COVID-positive pregnant patients deliver stillbirths, even with mild COVID cases.
“COVID-19 begins as a respiratory illness but can affect the entire body and also seems to increase the risk of thrombosis or blood clots,” she said. “We suspect that this decreased oxygen to the fetus may be responsible for the stillbirths that we are seeing, though we need further research.”
Just as doctors are learning more about the complications of COVID-19 in pregnant women, they are also seeing more data about the safety of the vaccines, according to Vricella.
“The risks of COVID are much, much greater than the theoretical risks of the vaccine,” she said. “The overwhelming evidence indicates that the vaccine is safe.”
When the CDC strengthened its recommendation for COVID-19 vaccination during pregnancy this month, it did so citing new evidence of safety with the vaccines, a point that Kelly also stressed.
“I tell my patients that at this point, the [COVID-19] vaccine is one of the most studied medications, or interventions, during pregnancy,” said Kelly, noting that over 140,000 pregnant people have been vaccinated and doctors now have nearly nine months of data pointing to the vaccine’s success. “During pregnancy, we’re pretty excited when we see a study come out with a couple thousand women enrolled in it, and now we’re talking so many more numbers than we typically see for any other type of research in pregnancy.”
Both the Pfizer and Moderna vaccines also use mRNA technology, which doesn’t enter the nucleus of the cells and doesn’t alter human DNA. The two COVID-19 vaccines are the first mRNA vaccines, which are theoretically safe during pregnancy, because they do not contain a live virus.
“It’s never too late and it’s never too early,” Vricella said of when pregnant women should get vaccinated. “I think the fall could be a really terrifying time for pregnant people if we don’t increase their vaccination rates quickly.”
(NEW YORK) — Since the start of the coronavirus pandemic, one in five kids in the U.S. has experienced anxiety, according to data published this month in JAMA Pediatrics, a medical journal.
Now with most kids returning to school in-person this year amid the delta variant and as mask mandate debates continue throughout the country, it is to be expected that anxiety and stress levels may again be on the rise, experts say.
“We need to make space for the fact that kids may be experiencing very new things,” said Dave Anderson, Ph.D., vice president of school and community programs at the Child Mind Institute, an organization dedicated to mental health work with children and families. “It’s really important
to say, ‘Just because we’re excited to be returning to some sense of normalcy, what do I need to support you around? What might you be nervous about?'”
Leena and Sunil Saini, of Newtown, Pennsylvania, said they are in the midst of anxiety-inducing change as they send their daughters, Kirina and Ela, to school after socially isolating together for the past 18 months.
“We’ve been in this protective bubble until now and now we’re sending them out into the world,” said Leena Saini, whose husband, Sunil, is also returning to work in-person. “Sending them back to school now, it’s kind of anxiety-provoking, and what’s hard is we as parents are anxious, but don’t want to transfer that anxiety to our kids.”
Here are four tips from Anderson to help the anxiety families like the Sainis are experiencing in this time of big changes.
1. Stay calm and open with your child.
While parents like the Sainis’ may be worried about pushing their own anxiety onto their children, Anderson said it is okay for parents to talk to a certain extent with their kids about how they’re feeling.
“The answer is always something in moderation,” said Anderson. “We don’t want a parent to fully suppress everything that they’re feeling.”
When talking with their kids about school, parents should try not to ask leading questions, like, “Are you nervous about going back to school?” according to the Child Mind Institute’s back to school guide.
Anderson recommends parents listen to and validate their child’s feelings by telling them, “We know you’re going to have feelings. Those feelings are very valid. Let’s focus on the things that might you might be optimistic about this particular change, and then beyond that, we’re just going to take it as it comes.”
And parents themselves can help to ease their own anxiety by, first, taking a deep breath, according to Anderson. He noted that parents may also find it helpful to review the procedures their child’s school has put in place to help ease their worries.
2. Reassure your child you’ll still have time with them.
For many families, the pandemic lockdown meant more time together than they were used to spending. For some children, adjusting back to the routine of being apart during the day may prove difficult, according to Anderson.
“We can say to kids, ‘Even as I go back to the office, maybe those days where you see me less, know that I have valued this time where we’ve been able to see each other, and there will still be days when that rhythm is still kind of there,'” he said. “And I think kids get comforted by that.”
3. Talk to your child about things to do to stay safe.
Wearing face masks and taking other safety measures against COVID-19 may be anxiety-inducing for some students who are being asked by their parents to do so when their peers are not.
Especially when it comes to masks, which have become a heated debate in some school districts, parents should have conversations with their child ahead of time, according to Anderson.
“It’s going back and saying to the child, ‘Well, look, we’ve made the decision that you’re going to wear a mask. We’re going to find you a good fitting one,'” said Anderson, who added that parents can also talk to their child about when they can take mask breaks and the fact that some classmates may be unmasked. “And the reality is that any child who’s in a mixed-mask environment is going to feel comfortable fairly quickly with that norm, likely even more quickly than adults.”
4. Focus on sleep, diet and movement.
In addition to focusing on kids’ feelings, parents should also pay attention to what their kids are eating and how much sleep and movement they’re getting, according to Anderson.
Those elements of an overall healthy lifestyle can help children, and parents, cope with stress.
“It’s going back to basic wellness habits. Get some sleep, make sure you’re feeding yourself, make sure you’re moving your body in some way and that you’re getting some sort of social support,” said Anderson. “If you can check off those boxes a bit, you’re going to be better able to confront the challenges.”
Bonus tips:
Encourage flexibility.
A lesson from the pandemic is that anything can change at any time, so parents should prepare their children to be flexible and prepared for potential changes with school, according to the Child Mind Institute’s back to school guide.
“It’s helpful for kids to know that you’re prepared for changes that may occur. Let your child know that the whole family is going to have to be flexible,” the guide recommends.
Know when to seek help.
Parents can look for several behavior changes in their child that signal it is time to seek professional mental health help.
Those changes include having severe meltdowns at drop-off time for more than two or three weeks, and being unable to recover or to even stay at school, for more than three or four weeks, or having school-related worries that cause repeated headaches and stomachaches, constant visits to the school nurse, or refusal to go to school, according to the Child Mind Institute.
(NEW YORK) — In the midst of a delta variant surge, a new study finds that giving a booster dose of the Johnson & Johnson shot six months after primary vaccination results in a nine-fold increase of a crucial antibody response, according to a company press release.
Meanwhile, a prior study found that people vaccinated with the Johnson & Johnson vaccine still had a durable immune response at least eight months later, even without a booster.
Collectively, the findings could help inform the U.S. government’s recommendations about booster shots for the 14 million people who received the single-shot Johnson & Johnson vaccine.
Boosting after six months “appears to be safe, and boosts immune responses substantially,” Dr. Dan Barouch, Ph.D., director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, told ABC News.
The new data shows “a booster dose of the Johnson & Johnson COVID-19 vaccine further increases antibody responses among study participants who had previously received our vaccine,” said Dr. Mathai Mammen, Global Head, Janssen Research & Development, Johnson & Johnson, in prepared remarks.
“This data will likely be reviewed by federal health authorities in their discussions about recommending boosters,” Barouch said.
Scientists said emerging evidence suggests vaccine efficacy for all three vaccines wanes slowly over time. And in the face of the highly transmissible delta variant, more frequent mild breakthrough infections have been reported, but so far, evidence indicates that vaccines are still dramatically reducing the risk of hospitalization and death.
Still, this new phase of the pandemic means federal health officials are now likely to endorse booster doses.
“We are prepared to offer booster shots for all Americans beginning the week of Sept. 20 and starting eight months after an individual’s second dose,” said Centers for Disease Control and Prevention Director Rochelle Walensky, speaking at a press conference Wednesday.
But the Biden administration’s Wednesday announcement on booster doses only included people who received the Pfizer or Moderna shots, omitting a specific recommendation for those who received Johnson & Johnson. Walensky said data on Johnson & Johnson could be expected “in the next few weeks” and that “with those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.”
Pfizer and Moderna vaccines were authorized in December 2020, while Johnson & Johnson was authorized in February 2021. Because large clinical trials for the Johnson & Johnson vaccine began months later than the other two vaccines, data for this vaccine often takes a few weeks longer to be published.
The new data, which still has only been described in a press release and has not yet been peer-reviewed, will likely help inform recommendations about if, and when, booster doses will be needed for those who got the Johnson & Johnson shot.
“It’s some of the data people been asking for and waiting for and wanted to see,” Barouch said.
(NEW YORK) — Ellie Zeiler is known by her 10 million TikTok followers for her fashion hauls, beauty hacks and viral dance videos.
Although her feed often includes endorsements for major brands, her latest partnership came from the U.S. government, which asked her for help encouraging people to get the COVID-19 vaccine.
“They said they were starting this whole process of reaching out to influencers — people who were in the public eye … really wanting to stop these rumors and get the word out about the vaccine,” Zeiler told ABC News.
The 17-year-old, who was vaccinated in May, has continued to share her experience of getting the shot in an effort to ease the concerns of other young Americans, which are the least-vaccinated age group in the country.
“I feel great after. I feel like I have this armor around me,” she said. “I had no side effects.”
With the highly contagious delta variant continuing to impact communities and many children already beginning school, there is now a race to inoculate America’s youth.
Youth aged 12 to 15, 16 to17, and 18 to 24 have only 33.9%, 44% and 46.5% of their age group vaccinated, respectively, according to the CDC. Ages 25-39 have 50.8% of their demographic vaccinated.
President Joe Biden’s administration is reaching young people through their smartphones. They’ve enlisted some of the generation’s social media icons, like Olivia Rodrigo and Benny Drama to help get the word out.
Influencers like Zeiler are now helping inform the country about the realities of the vaccine.
“I think that that’s just the impact of social media — that anyone can do it — which is very, very special,” Zeiler said.
They aren’t just promoting vaccines, but fighting a growing tide of vaccine misinformation and unfounded conspiracies that have run rampant on social media.
“I was used to, in the beginning of the pandemic … being a friend for these people that followed me … giving them advice on whether it be fashion or friends or people … to [now, I] actually give them useful and straight up factual advice,” she said.
In an effort to encourage the vaccine and dispel misinformation, the Biden administration has organized interviews between Dr. Anthony Fauci, chief medical advisor to the president, and a plethora of creators across social media platforms.
Many creators often rely on paid posts for their income, but many of those who have been working directly with the White House on the vaccine push are doing it for free.
“They’re doing it because they believe in it,” Taylor Lorenz, a tech reporter for The New York Times, said.
However, it can’t be forgotten that “promoting vaccination and working with the White House is a status symbol,” Lorenz said. “Dr. Fauci is a hugely viral figure. And by the way, you know, doing an interview with Dr. Fauci, that generates enormous engagement on their social channels. So these influencers are getting a lot from the deal, even if it’s not direct payment.”
This is not the first time the government has tapped digital creators to get messaging out.
“It didn’t surprise me,” Lorenz told ABC News. “Obama actually leveraged YouTube to promote the Affordable Care Act and encourage people to enroll in their health care program back in the mid-2010s and, obviously, Trump also leveraged influencers. He had very high-profile meme accounts. … This is kind of becoming more and more of a trend among politicians, I think, as they recognize that the media environment has shifted and these influencers are undeniably impactful.”
This trend among politicians has given way for a new generation of creators to organize.
Aidan Kohn-Murphy founded Gen-Z For Change, one of the organizations that Biden’s administration collaborated with to promote the vaccine.
The group has most recently been partnering with MadeToSave, an organization helping share information about the vaccine, the U.S. Dept of Health and Human Services and the White House to combat misinformation and promote vaccination efforts.
Gen-Z For Change is an organization of over 500 creators, who have a combined following of about 432 million people and garner a total of 1.5 billion views a month.
Their efforts have gotten over 27.5 million views on COVID-19 related videos since the start of the pandemic.
“These numbers are huge, and I think for a long time, adults really struggled to contextualize them,” Kohn-Murphy told ABC News. “I think adults are realizing that these numbers … are actual things that you can put into action.”
Gen-Z For Change’s coalition of creators ranges from dancers to comedians to activists.
Missouri-based TikToker Alaysia Brandy, who goes by “Laysie B” online, has over 1.5 million followers. She began her online activism speaking out about social justice issues related to Black and LGBT communities. As the vaccine rolled out, she made it a point to ask Fauci about her community’s vaccination concerns.
“I know people do not trust the government,” she said, adding that she understands why there would be mistrust given the abuse that Black people have faced in the U.S.
“I understand the hesitation… But I also want to make sure that they are getting the research themselves and making sure they have reliable sources … even when I speak on these issues, I also leave [hyper]links in ways that you can go look at it yourself and see this information yourself.”
Brandy said she hopes to bridge the information gap that has resulted in concerns about getting the shot throughout communities of color. In her home state, fewer than 50% of the total population is fully vaccinated and only 28% of the Black community is part of that group.
“In my videos, I do speak in English and Spanish and make sure I have subtitles just because I want to reach the largest audience possible,” Brandy told ABC News. “And I want to make sure that you understand, like I completely understand where you’re coming from, and I’m not trying to make you feel any less than whatsoever. But I want to talk about this and I want to understand your concerns.”
She said she wants to make sure she addresses all the reasons someone might be wary of the vaccine.
“You can’t lump people in who are distrusting of the government because we have been treated so poorly our entire existence in this country, versus people who just don’t believe in science — because that’s two completely different groups,” Brandy said.
“It is definitely very hard to navigate,” she added. “But when it comes to people saying … ‘The vaccine is going to microchip you’ … you just want to immediately knock down and debunk the stuff that’s disinformation. … Let’s stop the fear mongering so they can actually address the real concerns.”
Lorenz pointed out, however, that the misinformation is only one part of the problem. She said there are influencers who also promote fallacies.
“The campaign is up against a huge tsunami of misinformation on social media. So you have people that are also influencers. They’re solely anti-vax influencers,” Lorenz said. “You have tons of other lifestyle influencers and other people who are promoting just absolute lies. … I mean, it’s actually shocking that people believe some of this stuff.”
She said that seemingly minor inaccuracies like explaining things out of context “can plant a seed of doubt in peoples’ minds, priming them for “absolutely crazy disinformation.” Gen-Z For Change makes it a point to coach its creators about different types of misinformation online. Kohn-Murphy said he brought misinformation and disinformation specialists to the organization, who taught them about the value of a “truth sandwich.”
“[It’s] kind of coming in with a very empathetic approach, explaining a little bit of the truth behind the vaccine and then kind of dislodging the rumors and the misinformation that the person might believe without making them feel small, because nobody ever wants to be told that they’re wrong,” Kohn-Murphy explained. “Then closing out with, again, an empathetic approach and linking them to sources where they can do their own research.”
Each creator that ABC News spoke to noted that some of the inaccuracies they saw online came from their followers’ own parents. Zeiler described this reality as “frustrating.”
“It kind of transferred over [from] what parents wanted, and what adults wanted, which I think [is] why the marketing strategy with the White House was so crucial and so important,” Zeiler said. “Now, I see my friends and people on TikTok who are scrolling through, and they get to be educated themselves before having … past thoughts about the vaccine that their parents created for them, and they get to make their own narrative.”
Brandy said that some of her followers are minors with anti-vax parents who still want to get the vaccine. She said they’ve had to try and convince their parents. “Just talking about how you can help your parents find this information on their own so that they receive it and being able to try to help ease their tensions,” she said.
Experts say it is an uphill battle for these creators. A study published in July by UC San Francisco researchers found that about one in four unvaccinated people aged 18 to 25 said that they “probably will not” or “definitely will not” get the COVID-19 vaccination.
Lorenz said pro-vaccine campaigns do well and can reach millions. However, she said “it’s no match for the stuff that Facebook, YouTube, Twitter, TikTok has allowed to spread rampantly for years.”
“They’re up against this very coordinated disinformation network,” she added. “It’s very hard. I think it might just be a drop in the bucket in the end. That’s not to say that it’s not worth doing, but that is all they have control over.”
Kohn-Murphy, on the other hand, believes that if they’re convincing “one person to get vaccinated” or “debunking one person’s misinformed belief” or helping one kid gather the courage to talk to their parents about getting vaccinated, then they’re successful.
A year from now, Brandy said she hopes the pandemic is a thing of the past. She said she wants to do whatever is necessary to make that happen.
“It’s definitely a motivation factor in constantly keeping a fire under me to make sure that I’m doing my part and using my platform and my voice to get that information out there to the audience,” she said.
Zeiler, meanwhile, expressed hope and purpose in the work that she’s been doing.
“I hope that I’m helping, especially when I get that one-on-one interaction where [someone tells me], ‘I got my first shot of the vaccine today because I saw your video,’ or, ‘Because I saw you,’ which is so crazy to say out loud,” she said. “But that is what makes me continue [to] want to do it.”
(NEW YORK) — When the Food and Drug Administration (FDA) granted full approval of the Pfizer COVID-19 vaccine for people ages 16 and older Monday, it did so with a warning to parents and medical providers.
The vaccine — the first covid-19 vaccine to transition from an emergency authorization status to full FDA approval — should not be given to young children as off-label use, according to FDA commissioner Janet Woodcock.
“We do not have data on the proper dose, nor do we have the full data on the safety in children younger than what is in the EUA, and so that would be a great concern that people would vaccinate children,” Woodcock said. “We are not recommending that children younger than age 12 be vaccinated with this vaccine, it would not be appropriate.”
“They are not just small adults,” she said of kids. “And we’ve learned that time and time again and so we really would have to have the data and the appropriate dose before recommending that children be vaccinated.”
Dr. Robert Frenck, lead investigator of the COVID-19 vaccine trials at Cincinnati Children’s Hospital, emphasized that clinical testing has not yet been done in 5 to 12-year-olds.
It’s likely that young children ages 5 to 12 will get a smaller vaccine dose. That’s not only because children are smaller, but also because they tend to have stronger immune responses than adults, Frenck said.
“In kids 5-12, we found that 10 micrograms, so one-third of the [adult] dose, gives you the same immune response,” Frenck said. “If they give it off label, and they give the 30 mg, I think they’re going to have kids in the 5 to 12-year-olds that are going to have a lot more reactogenicity. That means they’re going to have kids with fevers, headaches, and they’re going to feel bad.”
“As scientists we want to know,” Frenck said. “You don’t want to guess.”
The American Academy of Pediatrics (AAP) also urged caution, noting that while it is now “legally permissible” for doctors to administer the vaccine off-label for kids ages 11 and younger, the AAP “strongly discourages that practice.”
Pfizer’s COVID-19 vaccine was authorized for use in children ages 12 to 15 in May by the U.S. Food and Drug Administration (FDA).
The two other COVID-19 vaccines available in the United States, Moderna and Johnson & Johnson, are currently available for anyone 18 years and older in the U.S. Moderna filed for emergency use authorization with the FDA for its vaccine in adolescents in June but is still awaiting a decision.
Here is what parents may want to know about the COVID-19 vaccines and kids to help them make decisions.
1. What is the science behind the COVID-19 vaccine?
Both the Pfizer and Moderna vaccines use mRNA technology, which does not enter the nucleus of the cells and doesn’t alter human DNA. Instead, it sends a genetic “instruction manual” that prompts cells to create proteins that look like the outside of the virus — a way for the body to learn and develop defenses against future infection.
The Johnson & Johnson vaccine uses an inactivated adenovirus vector, Ad26, that cannot replicate. The Ad26 vector carries a piece of DNA with instructions to make the SARS-CoV-2 spike protein that triggers an immune response.
This same type of vaccine has been authorized for Ebola, and has been studied extensively for other illnesses — and for how it affects women who are pregnant or breastfeeding.
Neither of these vaccine platforms can cause COVID-19.
2. What is the status of vaccine eligibility for kids?
Pfizer has said it will submit vaccine safety data on 5- to 11-year-olds by the end of September. Moderna has said it will do so in the middle of the fall. It will then be up to the FDA on how quickly it grants the authorization.
In general, federal and industry officials said they expect the first vaccine shots for children ages 5-11 could happen by the end of this year or early 2022. Timing on a vaccine for children younger than 5 is less certain, but officials have said they hope a green-light for toddlers and infants will follow soon after.
Clinical trials are however still ongoing, and the FDA has signaled it wants to expand the pool of children signed up as volunteers. A larger pool of volunteers makes it more likely that even the rarest of side effects could be detected before it rolls out nationwide.
3. Why do kids need to be vaccinated against COVID-19?
While have not been as many deaths from COVID-19 among children as adults, particularly adults in high-risk categories, kids can still get the virus and just as importantly, they can transmit the virus to adults.
The American Academy of Pediatrics reported this week that children now make up 22.4% of all new weekly cases, and over 3.7 million children have been diagnosed during the pandemic.
“There are really two big reasons why kids need to get the vaccine,” explained Dr. Jennifer Ashton, ABC News chief medical correspondent.
“One of them is that it is possible that they could be infected and then unknowingly pass COVID-19 to someone with a serious or underlying, pre-existing medical condition,” she said. “And also, though it’s very uncommon and unlikely, it is still possible that children infected with COVID-19 could become seriously ill or worse. We have seen that.”
“It’s important to think in ripple effects, outside the box,” Ashton added. “It’s not just your home environment that you need to worry about.”
4. Will kids experience the same vaccine side effects as adults?
Adolescents experienced a similar range of side effects as seen in older teens and young adults — generally seen as cold-like symptoms in the two to three days after the second dose — and had an “excellent safety profile,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at a press briefing announcing Pfizer’s authorization.
“Based on all this available information, the FDA determined the Pfizer-BioNTech vaccine has met all of the criteria required to amend the EUA, which concluded that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the vaccines known and potential risks,” Marks said.
Marks encouraged parents who were hesitant to vaccinate their children to speak with their pediatricians, urging confidence in the trial and data.
Moderna said its COVID-19 study with teens ages 12 to under 18 identified no “significant safety concerns.” The most common side effects from the vaccine were injection site pain, headache, fatigue, muscle pain and chills, according to the company.
The FDA will scrutinize Moderna’s clinical data before authorizing the use in anyone under 18.
5. Have there been any vaccine side effects for teens and young adults?
There have been more than 300 confirmed cases of heart inflammation in teens and young adults who have received COVID-19 vaccines, but the nation’s leading health experts say the Pfizer and Moderna vaccines remain safe for use.
Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), said on “Good Morning America” in June the benefits of the vaccine for young people “overwhelmingly outweigh the risk,” echoing the findings of researchers at a CDC advisory committee meeting this week on vaccines.
Out of more than 26 million doses given to young people, the CDC has so far confirmed 323 cases of heart inflammation, called myocarditis or pericarditis, and is still monitoring more cases. Of the confirmed cases, the vast majority were temporary and resolved with monitoring and treatment.
“To put this in perspective, if we have a group of 12 to 17-year-olds who we’re working to vaccinate over the next four months and can vaccinate 1 million of them, which would be great strides, over the next four months we could expect 30 to 40 of these mild self-limited cases of myocarditis,” Walensky said on “GMA.” “And for that, if we were to vaccinate all 1 million we would avert 8,000 cases of COVID, 200 hospitalizations, 50 ICU stays and one death.”
The rare instances of heart inflammation occurred about 12.6 times out of every million second dose administered and were mostly among younger males about a week after the second dose of the Pfizer or Moderna vaccines, according to researchers at the CDC advisory committee.
Regulators at the Food and Drug Administration (FDA) say they are preparing a warning to go along with the Pfizer and Moderna vaccines to make young people aware of the very rare risk.
6. How effective are the vaccines in children?
Pfizer announced in late March that its clinical trials showed the vaccine was safe and 100% effective in children ages 12-15, similar to the 95% efficacy among adult clinical trial participants.
Marks confirmed on May 10 that after a trial with over 2,000 children, Pfizer found no cases of infection among the children who had been given the vaccine and 16 cases of infection among the children who received a placebo.
No cases of COVID occurred in the 1,005 adolescents that received the vaccine, while there were 16 cases of COVID among the 978 kids who received the placebo, “thus indicating the vaccine was 100% effective in preventing COVID-19 In this trial,” said Marks.
Moderna’s COVID-19 vaccine is 100% effective in children ages 12 to under 18, the company said last month, in announcing results of their latest clinical trials.
In addition to its efficacy, the vaccine showed “no significant safety concerns” in the trial of more than 3,700 adolescent participants, according to Moderna.
7. Will kids get the same dose of the vaccines as adults?
The FDA has authorized the same dosing for 12- to 15-year-olds as adults with the Pfizer two-dose vaccine.
Pfizer is currently testing smaller doses of the vaccine in children ages 11 and under.
8. Could COVID-19 vaccines impact puberty, menstruation?
There is currently no clinical evidence to suggest the vaccines can have long-term effects on puberty or fertility, according to Ashton, a practicing, board-certified OBGYN.
Ashton noted that while there has been anecdotal discussion of the emotional event of finally receiving the vaccine temporarily impacting menstruation for adult women, the idea of the cause being from the vaccine itself “defies science and biology.”
It is really important to understand basic biology here,” Ashton said. “Women can have changes in their menstrual cycle and also have gotten the vaccine, that does not mean that one caused the other.”
“Right now there is no puberty concern. There is no fertility concern,” she added.
9. Will the Johnson & Johnson COVID-19 vaccine be available for kids?
Johnson & Johnson announced in April that it had begun vaccinating a “small number of adolescents aged 16-17 years” in a Phase 2a clinical trial.
As of April, the trial was enrolling participants only in Spain and the United Kingdom, with plans to expand enrollment to the U.S., the Netherlands and Canada, followed by Brazil and Argentina.
10. Will COVID-19 vaccines be required by schools?
It will be up to each state’s government to decide whether a COVID-19 vaccine is required for school entry. Many colleges and universities in the U.S. have announced they will require students to be vaccinated from COVID-19.
Another study, published this month in the medical journal JAMA, found that two-thirds of U.S. children’s calorie intake comes from ultra-processed foods, defined as ready-to-eat foods that contain “little to no whole foods,” like frozen pizza, chips and cookies.
The greater the intake of processed foods, the more sugar a child is likely consuming, which can lead to lifelong health complications, including obesity and Type 2 diabetes, experts say.
“The added sugars for most kids are going to show up in the packaged, processed foods,” said Maya Feller, a New York-based registered dietitian and nutritionist. “For the most part, you don’t have tablespoons of sugar dumped into their homemade food, so it’s actually in whatever product they’re consuming.”
When LeVeque gave birth to her oldest son nearly three years ago, she said she was shocked to see how hard it is to control sugar intake in even young kids.
“I know firsthand that added sugars and too much even natural sugar in something like orange juice wreak havoc on us internally, on our metabolic goals, so when I became a mom, it was mind-blowing,” she said. “Even the [portable food] pouches available to children are all sugar.”
It’s a fight every day to keep the sugar, processed foods and inflammatory oils out of our homes. To the moms, my gatekeepers out there in the trenches….keep fighting the good fight for good health! These little brains, organs and bodies need an adult in the room. #saynotosugar
LeVeque recently launched a “Fab 4 Under 4” guide for parents that adapts the “Fab 4” principles she created to help adults support blood sugar balance in kids.
“We think that kids are not vulnerable to the effects of sugar, but in fact they’re more vulnerable,” she said, noting that blood sugar spikes caused by sugar can affect everything from a child’s mood to their ability to learn. “These are formative years for children and, in my opinion, they’re drugged with sugar, and it’s not their fault when we look at the increased access to processed foods in their pantry,”
Here are five tips from LeVeque and Feller to help parents reduce the amount of sugar in their children’s diets.
1. Balance sugar with protein, fat or fiber.
Parents can help reduce the impact of sugar kids consume by balancing it with other macronutrients, according to LeVeque.
“If you’re going to have sugar, even natural sugar in the form of fruit, you absolutely have to balance that with protein, fat or fiber,” she said. “That blood sugar response needs to be blended with other foods.”
A breakfast of pancakes and strawberries, for example, would cause a double spike in blood sugar, where serving pancakes with a protein like peanut butter or turkey sausage would help counter the blood sugar spike brought on by the pancakes.
2. Know what sugar your child is consuming at home .
Both Feller and LeVeque acknowledge it’s inevitable that children will consume sugar at celebrations like birthday parties or at friends’ houses, and that’s okay.
What parents can do, however, is make sure they keep the foods their kids eat daily at home low in sugar.
“Make sure that with every food in your house, you know where the sugar is,” said LeVeque. “My kids are going to have sugar but they’re not going to have sugar in their ketchup or their marinara or granola bars,” “We’re going to pull it out of the everyday things and be very strategic.”
3. Read food labels.
There are more than 70 ways that sugar can be listed on a food label, so parents need to not only read food labels, but read them carefully.
Look out for words that end in “ose” (like glucose, dextrose, sucrose), as well as words like juice concentrate, syrup, honey, maple, coconut sugar and agave, according to LeVeque.
“Sugar is sugar. It doesn’t matter what type it is,” she said. “I don’t care if it’s natural, organic, vegan, paleo, keto, look for the sugar.”
Feller echoes that parents should also be wary of food labels that feature healthy buzz words to advertise a product that nonetheless contains sugar.
“It’s challenging for parents in the current food landscape to figure out what constitutes a healthy pattern of eating,” she said. “When a parent goes to a grocery store and they see 100% carrot juice, sure it is a better choice than a sugar-sweetened beverage, but it would also be great to offer your child a carrot.”
4. Talk to your child about how foods make them feel.
LeVeque said she talks to her sons about what the foods they eat do for their bodies, like building muscle.
“I want my kids to have the foundation of knowing how healthy eating makes them feel and knowing the expectation of their family, that we eat to nourish our bodies,” she said. “So when they’re crying and having a meltdown after a sugar crash, it’s having the conversation, ‘I see that you’re upset now … I bet if you had a little bit of protein and a lot of water, you’d feel a lot better.’”
5. Encourage your child to eat what you eat.
“You don’t need kid foods,” said LeVeque, adding that the kids’ foods nearly always contain more sugar. “People think, ‘Oh, I need to get my kids the kids’ yogurt,’ but that’s just something you’re being told, that kids need kid food and kids need kids’ meals.”
When LeVeque’s sons begin eating solid foods, she serves them a portion of her own meal when they are out to eat, for example.
“I’ll order chicken and a side of veggies or a salad and order extra protein and put a little chicken on his plate with some avocado,” she said. “And when kids get to the age that they need another meal, order a real meal, take half of it home and you have lunch the next day. Not only did your kid eat healthier, but you have a healthier lunch for the next day.”
“Kids love to cook and they’re super capable,” said Feller. “Sometimes it takes time to prepare food with them, but we have to change our mindset and be okay with the idea that there will be times where we’re going to spend time preparing something.”
“You have to get your kids involved,” echoed LeVeque. “And get your kids involved in making the vegetables and the protein and the dip. They don’t care what they’re making with you. You believe that they’re going to be disappointed that they’re not making cookies, but they are so excited to make a vinaigrette with you, a kale salad with you, to barbecue with you.”
When LeVeque does bake with her son, she uses tricks like swapping bananas for sugar in their favorite blueberry muffin recipe.
“Swapping in bananas for even half of the sugar in the recipe helps,” she said. “Because the sugar in banana is wrapped up in fiber, there won’t be as much of a high blood sugar spike and crash.”
Try these low-sugar recipes from LeVeque and Feller
Ingredients:
1/4 cup coconut oil
1/3 cup unsweetened vanilla nut milk
2 bananas (smush them in the peel before placing in a bowl so you don’t have to fork them as long)
2 eggs
1 teaspoon apple cider vinegar
1 teaspoon vanilla extract
2 cups almond flour
1 scoop @bewellbykelly vanilla protein powder (or 1/4 cup coconut flour)
2/3 cup tapioca or arrowroot flour
1 teaspoon baking soda
1/2 teaspoon salt
1 1/2 cups blueberries
Directions:
Mix wet and dry ingredients, and place in a greased muffin tin (can grease with coconut oil).
Bake for 30 minutes at 350 degrees.
“I slather the muffins with almond butter and ghee, yum!” said Leveque.
(WASHINGTON) — The Food and Drug Administration on Monday granted full approval of the Pfizer COVID-19 vaccine, becoming the first covid-19 vaccine to transition from an emergency authorization status to full FDA approval.
The approval comes in a week prior to federal health officials’ earlier estimates that the agency would complete its review by Labor Day.
The full approval indicates that Pfizer has shown enough effectiveness and safety data to meet the stringent Biologics License Application (BLA) requirements, which includes at least six months of safety data from a majority of the volunteers in a large, final stage clinical trial.
“Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Albert Bourla, Pfizer CEO said in a statement to ABC. “Hundreds of millions of doses of our vaccine already have been administered in the U.S. since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans.”
This prioritized review entailed government scientists pouring over hundreds of thousands of pages of safety and efficacy data at a rapid-fire pace, conducting meticulous inspections of Pfizer’s manufacturing process.
Pfizer’s full and formal approval will now pave the way for further vaccine mandates in both the public and private sector, akin to existing vaccine mandates for other FDA-approved vaccines. Some businesses and state leaders have held off thus far, signaling they’d wait for full approval before imposing tighter requirements.
Federal, state and local health officials have also expressed optimism that full approval will help dissolve some of the lingering hesitancy around taking a shot that until now has been only authorized for emergency use — a forecast recent polling has also reflected.
U.S. Surgeon General Dr. Vivek Murthy, predicting on ABC’s “This Week” Sunday that full approval may “tip” some fence-sitters towards taking the shot, and prompt more workplaces and schools to move forward on requirements.
“I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity,” Bourla said upon Pfizer’s approval.
“Full approval could not come at a more important time, as the highly contagious Delta variant continues to drive up caseloads and deaths across the U.S.,” Dr. Rich Besser, former acting CDC director and president of the Robert Wood Johnson Foundation said. “I am hopeful that full approval will address any remaining concerns and will move many people to a ‘yes’ on vaccination.”
Pfizer was the first to request full approval in the U.S.; other Covid vaccine makers are likely to follow suit. All three authorized vaccines were granted emergency authorization based on massive clinical trials involving tens of thousands of volunteers.
Federal health officials have come under immense political pressure from all sides to get the approval done as soon as possible — as much of the country faces yet another surge, and the Delta variant threatens hard-fought wins in the fight against the virus.
In private calls with the White House Covid team obtained by ABC News, some of nation’s governors have recently expressed waning patience and frustration over the wait for full approval of the vaccine — saying the FDA either needs to act, or be transparent about how much longer there is to wait — given that the lack of full approval is a recurring reason they had heard among the hesitant for not taking the shot yet.
The FDA had made clear getting Pfizer’s vaccine to the approval finish line is a top priority, with an “all hands on deck approach” and “moving forward as rapidly as possible.”
ABC News learned in late July the agency would reprioritize some of its personnel and technology resources from “across the agency” and reshuffling other existing work, in order to finish the review faster, devoting those additional resources towards expediting the process for Pfizer’s approval.
“We recognize that for some, the FDA approval of COVID-19 vaccines may bring additional confidence and encourage them to get vaccinated,” an agency spokesperson told ABC in late July, promising any approved vaccine would meet “rigorous standards for safety, effectiveness, and quality.”
