(NEW YORK) — With the FDA gearing up to decide if all Americans need booster shots, some researchers are pointing to preliminary data suggesting that mixing different vaccines could offer an even stronger immune boost.
For now, data is too sparse to support a mix-and-match strategy, experts say. But scientists are learning more about just how strong the immune response can be for someone who has previously been infected with COVID-19 then gets the vaccine — a phenomenon called “hybrid immunity.”
“The best thing we can hope for is that three vaccine doses will emulate the super immune response, found among those previously infected with the virus,” said Dr. Paul Goepfert, an infectious disease physician and director of the Alabama Vaccine Research Clinic. “This [type of immunity] will protect against variants in the future.”
With the nation still slogging through the pandemic and contending with the delta variant’s threat of breakthrough infections, “super immunity” becomes an appealing concept.
In one review recently published in Science, people with that hybrid immunity see an immediate and “striking” improvement in protection — up to a 100-fold increase in their antibody response as compared to what they built up after their COVID-19 infection — Dr. Shane Crotty, review author and virologist at the La Jolla Institute for Immunology, said.
Experts are also discovering these hybrid antibodies appear to be more versatile and recognize more variants, including those as distant as the original SARS virus, Crotty said.
One yet to be peer reviewed study of previously COVID-19 positive patients who were then vaccinated at least six months later found participants were able to fight off both variants of concern tested: delta, the most infectious, and beta, the most lethal.
“With prior infection, their antibodies are able to recognize numerous variants, but with the addition of the vaccine, they are able to generate a large number to have a stronger effect against the virus,” Crotty said.
Like an exercise regimen that pairs weight lifting with cardio, Crotty explained that these individuals benefit from the combination of quantity and varied quality of the immune response they build. And that could indicate promising signs for boosters.
Scientists are seeking to replicate that strong protection, but without people having to contract COVID-19, as it’s universally agreed that infection is not an optimal immunization course.
Instead, they’re hoping booster doses of vaccines could convey a similar effect.
But timing is key when it comes to additional doses, whichever vaccine is given. Researchers say that exact right interval when immune response has matured — but before protection begins to wane — is the ideal target.
“Our immune system is built to have repeated exposures to the same antigen,” which will “substantially” enhance immune protection, Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center said.
Experts are still gleaning what exactly is the benefit of this enhanced immunity, though it’s not novel to coronavirus.
Flu vaccines, for example, are “boosted” for children receiving them, while adults receive one dose, yearly.
“This is because of hybrid immunity. Adults have already been exposed to influenza and have primed their immune response,” Goepfert said.
“What we have seen is that waiting six months does mount a better immune response later,” he added. “It seems that our immune system likes to rest and develop antibodies, and then mount a stronger response when it sees the same pathogen again later on.”
There is not enough data yet to say if the mix-and-match approach of priming one vaccine and boosting with another is going to offer better or more durable protection. But while the jury remains out, experts are hopeful.
“The mix-and-match approach in vaccine administration has been studied for decades, but unfortunately not for COVID,” Barouch said. “while larger studies are underway, it is best to stay with the same vaccine for the booster, if approved.”
(NEW YORK) — On Friday, an advisory panel for the Food and Drug Administration will weigh in on a debate that has been broiling since the Biden administration announced last month that the country would begin to roll out booster shots against COVID-19.
This panel, which is independent of the FDA and the Biden administration, will look at the data recently submitted by Pfizer on booster shots and make a recommendation. The FDA will then decide whether they will formally amend their current vaccine approval for Pfizer, and the Centers for Disease Control and Prevention, which has its own advisory committee, will review the information and make a decision.
But the back-and-forth leading up to this process, and the president’s involvement in an otherwise non-political decision, has left many Americans confused about who really needs boosters and when.
Do I need a booster shot, and if so, when?
Unfortunately, there’s no clear answer to this question yet. But it will come sometime in the next week, as the FDA and CDC’s advisory committees discuss the available data.
For now, the one thing to know is that the vast majority of vaccinated people are still well-protected by their vaccines.
“If you have a good immune system, I would certainly not go out and get a booster before anything is recommended. I feel strongly that we have to go by the scientific consensus, which really hasn’t been played out yet,” said Dr. Paul Goepfert, director of the Alabama Vaccine Research Clinic at the University of Alabama.
The latest CDC data found that over 90% of people hospitalized with COVID are still unvaccinated.
And while breakthrough infections happen, particularly as protection against mild infection wanes, the vaccines continue to protect Americans from ending up in the hospital with COVID, as well as vastly reducing their likelihood of death.
The only group that’s potentially at more risk of a serious breakthrough infection are older people who got their vaccines early on in the rollout. Recent studies by the CDC showed that protection against hospitalization for people over 65 has decreased to around 76-80%.
“At the end of the day, the purpose of the vaccines is to prevent hospitalizations and deaths, and they’re doing that very effectively still,” said Dr. Carlos Del Rio, executive associate dean of Emory University School of Medicine.
“Maybe a little less effective for people over the age of 60 or with comorbidities, but still, if you look around the hospitals, the people hospitalized today are people who haven’t received the vaccine.”
Additional vaccine doses, although not quite a booster, have already been approved by the CDC for the roughly 7 million immunocompromised Americans who didn’t have an optimal response to the first round of mRNA vaccines. Nearly 2 million Americans have gotten an additional shot since the FDA and CDC approved them in August for that subset of people.
The CDC officially recommended a third dose of an mRNA vaccine for immunocompromised Americans in August, allowing the approximately 7 million Americans who didn’t get an optimal immune response to their initial vaccine doses of Pfizer or Moderna to gain more protection.
There’s been a lot of debate as the process plays out. What’s the controversy?
When the Biden administration announced that it would roll out a booster shot program beginning Sept. 20, the White House’s COVID response team said it was to get ahead of the virus.
“You don’t want to find yourself behind, playing catch up,” Dr. Anthony Fauci, the nation’s top infectious disease expert, said when announcing the plan. “Better stay ahead of it than chasing after it.”
The White House has relied heavily on Israel’s progress. Data from the country, where the vaccine process began sooner than in the U.S., shows that vaccine protection against serious disease has now begun to wane.
But quickly, career scientists pushed back on the White House’s announcement, saying there wasn’t enough U.S. data to support boosters yet — all the current evidence shows vaccines still protect most Americans against serious disease.
For experts in that camp, the focus usually narrows in on the 80 million Americans who aren’t vaccinated at all. Increasing protection across more of the country would stamp out transmission.
“We’re spending way too much time talking about boosters when we need to be spending time talking about the people that haven’t been vaccinated,” said Del Rio.
But on the other hand, studies do show that general protection against mild infection is waning, even if it’s staying strong against hospitalization.
“We need to reinforce the armor,” said Dr. Todd Ellerin, an ABC News medical contributor and the director of infectious diseases at South Shore Health in Massachusetts.
Ellerin predicted a triple threat ahead: a surge of delta infections, higher transmission during the winter months and close to half the country remaining unvaccinated.
“I think there are strong arguments for both sides and we just have to see,” Ellerin said.
The FDA’s independent advisory committee meets all day on Friday, and plans to vote in the late afternoon. For now, they’re only meeting about Pfizer, the first vaccine to submit its data.
If the FDA panel votes to move forward with boosters, the CDC’s advisory committee will meet almost a week later to nail down the details: who gets boosters and how soon.
The FDA and CDC committees are looking at Pfizer booster shots. What’s the deal with boosters for people who got J&J or Moderna?
Both Johnson & Johnson and Moderna are expected to follow Pfizer and run their data by the official FDA and CDC channels in the coming weeks in an effort to get approval for booster shots.
But both companies maintain protection is still strong against severe infection.
Moderna, in an analysis of various studies released on Wednesday, even made the case that the company’s original vaccine appears to generate the strongest protection among the three currently authorized vaccines.
Nevertheless, Moderna President Stephen Hoge told ABC News in an interview on Wednesday that “protection is not permanent” and “we’re not going to be able to defy gravity forever.”
Newly published data from Moderna’s booster shot trial showed a lower risk of breakthrough infections among people vaccinated eight months ago compared to people vaccinated 13 months ago.
Unlike Pfizer, Moderna’s third booster will be a half-dose. They say their data shows that boosting with a half-shot seems to generate more than enough immune response.
For J&J, the one-shot series chosen by about 14 million Americans, a study found that the vaccine still provided a durable immune response at least eight months later, even without a booster dose.
Another study, not yet peer reviewed, found more good news: The J&J booster dose actually boosted antibody levels higher than they were after the initial shot.
And while it will be a few weeks before there’s more concrete news on the J&J booster shots, there’s room in the timeline. Most Americans didn’t receive the J&J vaccine until late spring of 2020, since it was approved after the mRNA vaccines. That means the J&J boosters won’t be widely necessary until November at the earliest — if the FDA and CDC decide they’re needed at all.
There is not enough data yet on mixing and matching vaccines, though the CDC is actively researching it.
And for all three of the vaccines, recipients have a common question: will I need to get a booster routinely? Experts, wary of predicting anything about the unpredictable global pandemic, said it’s possible, but unlikely.
“My prediction is that as long as the COVID rates are going down, we will not need a continuous boost,” Goepfert said. That could change, however, if a new viral strain requires a newly tailored vaccine.
Are booster shots safe?
Pfizer, the only vaccine so far to have its data reviewed by the FDA, found no safety concerns among the 300 trial participants who were part of its clinical trial. Pfizer followed the participants for up to three months after getting their third shot.
Peoples’ reactions to the booster shots were not significantly different from their reactions to a second dose, FDA and Pfizer both wrote in their separate briefing documents.
“No deaths, vaccine-related serious adverse events, or events of myocarditis, pericarditis, anaphylaxis, appendicitis, or Bell’s palsy were reported among study participants who received the … booster dose,” the FDA wrote in a review of Pfizer’s safety data.
Moderna and J&J have not yet had their data reviewed by the FDA, but have said they found no safety concerns in their clinical trials of booster shots.
Anjelica Lat, 26, instructs her students in New York City. – (Anjelica Lat)
(NEW YORK) — Sophie Oleniacz, an elementary school English teacher in California, took a leave of absence right before the COVID-19 pandemic began in early 2020 and went back to work in the fall. With her classes fully remote, she expected a different experience.
“It’s assumed that [virtual] is easier than teaching in the classroom and that you’re at home so you have time to provide and plan all these other things for kids,” Oleniacz, 27, told Good Morning America.
But, she said, the boundaries between her professional and personal life “fell apart.”
“I was home so I felt like I was always working,” Oleniacz said. “I definitely felt extremely burnt out.”
For her, the biggest shift during the pandemic was not being able to provide support to students the way she would’ve in a classroom setting. To do that, she would’ve had to work well past her hours.
“It takes more time to check in with each kid,” Oleniacz said. “You can’t just walk around and do a quick check. I don’t have time to pull small groups of kids aside, but that was the expectation.”
The school year brings further concerns for teachers
Oftentimes, teachers tirelessly work beyond a standard school day’s hours creating lesson plans, grading students’ work and preparing for the days ahead. During the pandemic, that has only gotten worse, leading to feelings of burnout, anxiety and stress.
According to the 2021 State of the U.S. Teacher Survey conducted by the RAND Corporation, job-related stress, burnout and symptoms of depression seem to be almost universal among teachers. Of those surveyed, one in five said they weren’t coping well with job stress, one in four said they were experiencing symptoms of depression and half felt burnt out.
Lisa Dishongh, a middle school history teacher in the Houston area, described the last two school years as exhausting.
“When I got home, I would want to shut down,” Dishongh, 55, told GMA. “I’d go home and sleep a lot. It seems like I slept more than I normally do just to give my brain a mental break.”
She taught hybrid classes, with students in the classroom and at home learning simultaneously. While it gave her a chance to experiment with her teaching style, keeping both sets of students engaged was the biggest challenge.
“One day I was talking to the kids that were sitting in class and I said, ‘You guys have the additional resource of having me present so I can help you,’” Dishongh said. “While I was saying that, not one of them was looking at me — they were watching me through the computer.”
It’s another concern for Dishongh, who also notes the additional responsibilities teachers have taken on.
“The schools are putting a lot on us, and I’m not really sure I’m equipped to deal with all that,” she said. “I’m overwhelmed with some of the things they expect us to do.”
“Two years ago, they started teaching us how to be first responders and how to treat gunshot wounds. I never signed up to be a first responder when I became a teacher, but with school shootings, that’s become the new reality,” Dishongh added.
Reality for many teachers also includes the politicization of masks in schools. Several states have issued executive orders banning school districts from requiring the use of masks. A number of districts are fighting back by issuing mask mandates anyway and some states are suing over the orders. Similarly, in Utah, Iowa and South Carolina, parents are taking matters into their own hands and filing lawsuits themselves.
While the lawsuits are handled in court, some districts are getting around the mask mandate ban through creative solutions. Some districts, for example, are requiring all students to wear masks by including them as part of the dress code. They’ll also be required in L.A., where the Los Angeles Unified School District Board of Education unanimously voted to require the COVID-19 vaccine for all eligible students ages 12 and up.
“We’re in a situation right now where kids are getting sick,” Dishongh said. “I am really, really concerned about their safety more than anything else. I feel like we’re under more of a threat this year than we were last year.”
Policy enforcement and uncertainty present more problems
For some teachers, they’re caught between the desire for normalcy and a fear for their students’ safety.
David Finkle, a ninth-grade English teacher in Florida, is teaching fully in-person classes and said he’s eager to see his students and connect with them in the classroom.
“It’s been really nice to see them all,” Finkle, 54, told GMA. “Building relationships with your students was one of those things that was a strain last year, and that’s not the case this year. Now you can walk around and relate to the kids.”
Of last year, he added: “I was kind of trapped behind my desk because I didn’t want to neglect the online students, but then I couldn’t go out and really interact with the classroom students as much as I wanted to.”
The lack of interaction meant students weren’t as lively or willing to participate, which in turn made it more challenging to teach.
“You want a certain level of energy back from the kids,” he said. “It was difficult to keep your energy up even though you weren’t getting much back.”
Finkle is worried about his students, as some are too young to get the vaccine and others have families who won’t allow them to do so.
“I’m scared for the kids,” he said. “COVID is hitting them more now.”
Even in states where mask use is required in schools across the board, such as New York, the issue of enforcing the mandate is still an issue.
“Masks are required, but is that necessarily enforced?” Anjelica Lat, a New York City music teacher, told GMA.
Lat, 26, is conflicted about the return to school, feeling both excited to see her students but worried about the level of uncertainty that comes with it.
“Part of being a teacher is being flexible,” Lat said. “But I feel like this pandemic is really testing how flexible anyone can be.”
Previously, Lat’s classes were hybrid and as a music teacher, it wasn’t easy for her to instruct her students virtually. Normally, Lat corrects her students’ work based on what she hears in class, but that wasn’t possible during virtual classes, because they all had to be muted.
“It was so difficult when we started,” she said. “I had to shift my teaching — having to see them through a screen and figure out what was happening on the very limited view that I had was challenging.”
Guidelines from the Centers for Disease Control and Prevention prevented Lat and her students from using instruments when they met in person.
“A lot of my students were upset about that,” she said. “Trying to find ways of doing the songs and the games that I still liked to do and wanted them to do was hard.”
Supporting educators
According to Oleniacz, if schools listened to their staff, burnout and unnecessary stress could be prevented.
“I know they have pressure put on them from the districts,” she said. “But it’s hard when teachers are saying, ‘Hey, this isn’t a possibility’ or ‘We’re doing our best,’ but aren’t listened to.”
The expectations for teachers and students have been raised in a time of crisis when they shouldn’t be, and there needs to be more consideration for both groups, Oleniacz added.
“Sometimes it felt like I was doing a lesson for high school students,” she said. “I definitely had to fight some people on things at school like, ‘They’re 9, so we’re going to do this, but it’s going to look different because they’re small and they’re not in the classroom.'”
Less micromanagement and more trust is key, Oleniacz and Finkle agreed.
“It’s so hard when no one is giving me space to do my job,” Oleniacz said. “No one is allowing for that to happen.”
“Stop trying to micromanage us and let us meet the students where they’re at, because students are in all different places,” Finkle said.
The ever-changing landscape in a COVID world doesn’t allow teachers to plan in advance, which only makes their job more difficult, Lat noted. Schools need to clearly communicate what their plans are if a positive case occurs ahead of time, so that teachers have insight into what would happen if that occurred and can have things ready rather than having to figure it out on the go.
“I don’t know quite how to prepare for each year,” Lat said. “I feel like I don’t have anything to fall back on in terms of my curriculum or things I like to do with my students because every year has been so different.”
For much of the last two years, schools with any form of in-person learning quickly pivoted to remote if someone tested positive. They would then return to in-person only to repeat the process once another case broke out.
“We can’t be waffling around with a health crisis,” she said. “It makes it hard to plan and prep … teachers can only do so much. There needs to be a better setup.”
(NEW YORK) — There is a high school sophomore from Texas who wakes up at 6 a.m. on the weekends when she knows her parents are asleep, so she can secretly and quietly make calls as an ambassador for a teen pro-vaccine group, fighting off vaccine misinformation.
The reason for all the cloak and dagger secrecy? The 15-year-old, who asked to be called Rain (not her real name), is the daughter of QAnon followers who hold strident views against mask wearing, social distancing and the coronavirus vaccine.
Rain is part of a growing generational divide, experts say, in a nation where adults and their children are consuming two entirely different streams of information about the unfolding COVID-19 pandemic, with many holding sharply different views about how they should respond to it.
“Students are thinking for themselves,” said Dr. Douglas Diekema, a University of Washington Medicine Professor of Pediatrics and Seattle Children’s Physician. “Kids spent an entire year, in most places, not being able to go out and now, they want to go to school, they want to see their friends and they know that the quickest way to do that and the safest way to do that is to get vaccinated.”
“And they’re mad about the fact that they can’t accomplish that without their parents’ permission,” Diekema said.
Rain works with Teens For Vaccines, an organization started in 2019 by Arin Parsa, a teenager from California who — as a sixth-grader– developed an interest in vaccine law and public policy at the height of the measles outbreak. The two connected after Rain took to social media publicly to express her frustration at local attitudes toward vaccination.
She said her social media post “was getting a lot of hate comments from conservatives when Teens For Vaccines reached out to me and said I was very brave,” Rain told ABC News. “And since joining them, I’ve seen that there’s a lot of teens in my shoes who can’t speak out, so I want to be a voice for them.”
Parsa’s interest in vaccine hesitancy predates the pandemic. He was inspired by Ethan Lindenberger, a teenager who gained national attention in 2019 when he posted on Reddit that he had never been vaccinated because his mother believed that vaccines are dangerous.
Lindenberger testified before a Senate committee about how misinformation that appears on Facebook, Twitter and other social media fuels the anti-vaccination movement.
Since then, Parsa began reaching out to teens with anti-vaccine and vaccine-hesitant parents on Reddit to answer their questions, guide them through state consent laws and help them educate and convince their parents to allow them to get vaccinated.
As misinformation, vaccine hesitancy and anti-vaccine sentiment have consumed the debate over a global pandemic response, the rift between some teens and their parents has increased. Teens For Vaccines has 30 state ambassadors like Rain across the country and has partnered with GENup, another teen organization with more than 4,000 student members.
The work of the organization has garnered national interest, with most recently, Parsa being invited to a back-to-school virtual event with Dr. Anthony Fauci, chief medical advisor to the White House and Douglas Emhoff, Vice President Kamala Harris’ husband, to encourage youth vaccinations.
“We are seeing a groundswell of teens from across the nation speaking up for public health and science in an era where truth and facts are being combated from all sides,” Parsa said.
Youth vaccination across the country
The Centers for Disease Control and Prevention expanded the COVID-19 vaccine eligibility in May to everyone in the U.S. 12 years and older. However, a Kaiser Family Foundation survey from August found that for parents of unvaccinated teens, their top concerns about the COVID-19 vaccine are around the potential for long-term or serious side effects.
The survey noted that the vaccination status of children “closely mirrors that of parents” with “larger shares” of Democrats, and those with higher incomes and college degrees saying their child is vaccinated, while nearly four in 10 Republican parents and half of parents who are unvaccinated themselves say they will not get their eligible children vaccinated.
And while 12-to-17-year-olds continue to be the least vaccinated eligible age group in the country, the vaccination rate among adolescents is growing faster than any other age group, White House coronavirus response coordinator Jeff Zients said in late August.
According to the White House, 50% of 12-to-17-year-olds now have at least their first shot.
But for the adolescents who are eligible to be vaccinated and cannot do so because their parents are vaccine-hesitant or anti-vaccine, there aren’t many options.
“Pretty much all states have created situations in which a minor can provide consent but they’re pretty limited to the treatment and diagnosis of sexually transmitted diseases, the treatment and diagnosis of pregnancy and pregnancy-related conditions, the provision of psychiatric and substance abuse care,” said Diekema “But vaccinations have never fallen into that category or those categories.”
“So in most states, vaccinations require parental consent and the COVID vaccine today is no exception to that,” Diekema said. “It’s kind of messy and it’s definitely different from state to state.”
As of May, teenagers ranging from 11 to 16 can consent to being vaccinated in Alabama, the District of Columbia, Oregon, Rhode Island and South Carolina, an analysis by the Kaiser Family Foundation showed. In Arizona, although parental consent is required, a child can be vaccinated if a court order is obtained.
A few states, said Diekema, have a “mature minor doctrine” in place that allows adolescents to give consent for medical care but not all include vaccination. Arizona, Idaho and Tennessee are among the states with mature minor doctrines in place.
In August, North Carolina, one of the states with a mature minor doctrine, passed legislation requiring minors to have approval from a parent before receiving the COVID-19 vaccine.
“Generally speaking, if you are in a state where parental consent is required for medical treatment for vaccines specifically or medical treatment, generally, then you are kind of out of luck if your goal is to be vaccinated and your parents are opposed to it,” said Brian Abramson, a vaccine law professor at Florida International University.
Abramson told ABC News that from a legal perspective, he believes some state vaccine laws that don’t permit children to give their own consent to be vaccinated are “not based in reality” because in some cases, minors who have children or are married can make their own health decisions.
“If a minor gets married, that certainly doesn’t demonstrate that they have the capacity and the maturity to make those decisions,” Abramson said. “Sometimes it demonstrates the opposite. But that’s the way the law is.”
“If you have a minor of a relatively mature age and they are seeking to be vaccinated to protect themselves from an infectious disease that has spread all over the country,” Abramson added, “that by itself is kind of an indication that they have a degree of maturity sign that they understand the consequences of their actions because they’re seeking to receive a vaccine that’s recommended by all the federal agencies and state agencies and by science.”
Because of how difficult it is for an adolescent to get vaccinated without their parents’ consent, Parsa said that a lot of his work is focused on helping teens educate their parents and addressing concerns.
“We always try convincing parents first,” Parsa said. “If nothing works, we show them the minor consent laws for their state and help them find a local pharmacy. But ultimately, we need to be able to have a law that says high schoolers should be able to consent to all the vaccines.”
In Texas, where Rain lives, minors need parental consent to be vaccinated.
“I’m probably going to have to deal with the fact that I can’t get vaccinated for COVID until I turn 18,” Rain said. “Going to school is scary but I try my best to wear my mask, sanitize my hands after every class and stay away from large groups of people even though it’s hard.”
(WASHINGTON) — The Food and Drug Administration on Wednesday released new data from Pfizer’s submitted application to approve booster doses of its Covid-19 vaccine. In it, Pfizer demonstrates what it sees as proof that third shot will be both safe and necessary for most Americans to take, arguing that immunity wanes over time — regardless of any new variant of concern.
It comes two days ahead of a critical juncture in the COVID-19 vaccine booster approval process: Friday, the Food and Drug Administration’s independent advisory committee (VRBPAC) is set to convene to review and discuss the latest data on potential booster doses of the Pfizer vaccine. The committee will be asked to vote on whether a booster dose is safe enough for widespread use — and whether it’s necessary and effective at improving protection levels.
In mid-August, the FDA authorized boosters of Moderna and Pfizer for the roughly 7 million immunocompromised Americans who didn’t get an optimal immune response to their initial vaccine doses.
Pfizer/BioNTech, which partnered to develop the nation’s first fully approved vaccine, has said it has early data suggesting a booster dose anywhere from six to 12 months after the second dose will help maintain a high level of protection; Pfizer asked the FDA to approve booster doses of its vaccine in late August by submitting an application and data. On Wednesday morning, the FDA made that data public.
While the independent members of the VRBPAC’s votes are not binding, the agency takes its recommendations under serious advisement in deciding whether to grant vaccines new authorization or approval. If and when a recommendation does come to green light booster shots, several additional steps must follow before it’s time for more Americans to role up their sleeves a third time.
First, the FDA would need to formally amend its current vaccine approval for Pfizer; then the Centers for Disease Control and Prevention’s advisory committee (ACIP) will weigh to whom, and when, expanded booster shots should begin. Then, the CDC director must formally sign off on whether to recommend the vaccine to the public, including who it will be recommended for and at what time period. It’s expected to be authorized for anyone eight months after their second dose. Authorization for Moderna and Johnson & Johnson may not be far behind.
The new data — and proximate committee vote — also come days before the Sept. 20 date set by the White House as the target to begin deploying booster shots for a wider pool of Americans.
The question of whether America’s immunity is waning has become an urgent question in recent months with the rise of the delta variant and large pockets of the country still unvaccinated.
FDA acting Commissioner Janet Woodcock and CDC Director Rochelle Walensky — both White House appointees — endorsed President Joe Biden’s Sept. 20 plan.
However, it has been getting some pushback, with health experts criticizing the Sept. 20 boosters-for-all timeline as premature and prior to any ruling from their advisory groups.
Two top FDA officials who are leaving the agency later this year publicly waded into the booster debate on Monday, splitting from the agency and arguing in a scientific journal that it was too soon to give booster shots to the general public since the vaccines still offer strong protection against serious disease.
One of them is scheduled to attend Friday’s VRBPAC discussion.
“The message that boosting might soon be needed, if not justified by robust data and analysis, could adversely affect confidence in vaccines and undermine messaging about the value of primary vaccination,” the officials wrote, backed by other worldwide organizations.
For their part, the Biden administration has emphasized that science will lead and federal regulators will have the final say — and that their call to push out booster shots is motivated by wanting to “stay ahead” of the virus.
“You don’t want to find yourself behind playing catch up,” Dr. Anthony Fauci said when announcing the plan. “Better stay ahead of it than chasing after it.”
(NEW YORK) — As companies continue to ramp up vaccine mandates to combat the contagious delta variant, some institutions are giving employees a chance to opt-out of getting the vaccine if they have a medical exemption.
However, medical experts who have been keeping track of COVID-19 vaccines and their effectiveness, say there are very few situations and conditions which would force a patient to put off getting vaccinated.
Dr. David Dowdy, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, told ABC News that the large and growing data on the three coronavirus vaccines shows there are no immediate health issues or side effects for most people with pre-existing medical conditions.
“Other than age, there are no major exemptions that cover large groups of people,” he told ABC News.
The current guidance from the U.S. Centers for Disease Control and Prevention, said the two-dose mRNA vaccines and the one dose Johnson & Johnson vaccine are safe for almost all patients.
The only major contraindication to the vaccines listed by the CDC is a severe allergic reaction to the first dose. In those cases, the person is advised to consult a physician and hold off on their second dose, according to Dowdy.
“We’re not talking about some people who had pain at the site of injection or a rash, we’re talking about anaphylactic shock,” he said.
Dowdy said the data so far shows this severe allergy is rare, and less than one in 1 million people experience it.
Dr. Jeff Linder, the chief of general internal medicine and geriatrics at Northwestern University Feinberg School of Medicine, told ABC News that research so far shows that those who have a severe allergic reaction are likely triggered by polyethylene glycol (PEG), a component in the vaccines.
“An allergy to that is pretty rare,” he told ABC News. “It would have to be documented, as a moderate or severe allergy, before I would consider giving a medical exemption.”
Overall, the COVID-19 vaccines are safe for people with “moderate to severe immune compromise,” underlying conditions, pregnant women, women trying to get pregnant and breastfeeding mothers, according to the CDC.
Linder said these populations are most vulnerable to severe illness and death from the coronavirus and it is important that they get their shot.
“Anyone who says, ‘I have a medical condition,’ that is more of a reason to get vaccinated,” he said.
The CDC has some extra precautions in place for people with certain medical conditions. For example, people with a history of heparin-induced thrombocytopenia (HIT), are advised to get an mRNA vaccine if they are within 90 days of illness, the CDC said. Women over 50 are also warned about a potential risk of thrombosis with thrombocytopenia syndrome (TTS) if they chose the Johnson & Johnson vaccine, according to the CDC.
The agency currently advises holding off on immediately getting the vaccine under two circumstances.
If a person is currently diagnosed with COVID-19 or under quarantine for a suspected case, they are advised from getting their shots until the quarantine period is over, according to the agency’s guidelines. If a patient is receiving monoclonal antibodies or convalescent plasma for COVID-19 treatment, they are advised to hold off on their vaccine appointment for 90 days, the CDC said.
Dowdy said neither scenario should stop someone from getting any of the vaccines once they’re eligible.
“People ask, ‘If I’ve gotten COVID in the past can I get the vaccine?’ The answer is yes, getting the vaccine adds additional protection,” he said.
Dr. Jay Bhatt, an internal medicine physician, an instructor at the University of Illinois School of Public Health and an ABC News contributor, added that special care should be taken for patients who are awaiting an organ transplant, recently received an organ transplant or are receiving metastatic cancer treatment. Those patients should talk with their physicians and set up a timetable for the earliest and safest time to get their shots.
“It’s less about not being vaccinated, it’s more about when they want to do it,” he said. “If they’re in the midst of treatment…you want to make sure they’re situated appropriately.”
Researchers say it’s highly unlikely that that list of medical exemptions will change in the near future. Over 178 million Americans over 12 have been fully vaccinated since December and there have been no reports so far of any adverse effects to patients who have medical conditions, according to Linder.
“The idea that we’re missing something that’s even rare or severe seems very unlikely to me,” he said.
Linder recommended that anyone who is still hesitant about getting the vaccine over a medical issue should consult their doctor and review the data that has overwhelmingly shown the vaccines are safe.
“The risk for COVID is still high,” he said. “At the end of the day, we know the COVID vaccines are highly effective at preventing hospitalization and death.”
Anyone who needs help scheduling a free vaccine appointment can go to vaccines.gov.
(NEW YORK) — Natalie Tapio has been living with a chronic seizure disorder, but with her service dog Dexter by her side, managing her condition has become a little easier.
He will alert her when she’s about to seize.
Tapio started experiencing catatonic seizures, a form of epilepsy, in 2014, which caused periods of semi-consciousness that rendered her unable to move. Eventually, she was suffering multiple, potentially debilitating seizures a day, that would happen at any time. Tapio’s doctors soon identified abnormal brainwaves after performing an EEG.
“The seizures were so unpredictable and silent, usually, and so there always has to be someone very attentive close by,” Tapio said. “[My] mom and I were basically inseparable. She would come into the bathroom with me when I needed to bathe or do anything. Really … wherever I went, she went.”
Her life changed three years ago after she learned about seizure alert dogs and eventually met Dexter.
“[Dexter] will alert me and then dial a dog phone, which has my parents’ phone numbers on it, and then [he] retrieves a pouch which will have any necessities for me, like medication, water [and] my cell phone,” she said.
Lisa Tapio, Natalie Tapio’s mother, found out about seizure alert dogs through a family member and began to research them, eventually coming across Little Angels. After Natalie Tapio submitted her medical information, she was accepted into the program.
Once Dexter was paired with Tapio, his first task was learning to paw her leg, alerting her when she was on the verge of a seizure. To do this, Lisa Tapio was asked to collect her daughter’s “seizure scent” by swabbing Natalie’s hands and the inside of her cheeks before, during and after a seizure. Dexter was trained with those scents and in 2018, he was ready to meet his new owner.
Dexter was raised by what some might consider an unlikely group of trainers: inmates at the California Correctional Women’s Facility in Chowchilla, California. Some of the inmates there are volunteers with Pups Uplifting Prisoner’s Spirits, or PUPS. The prison program is run by the non-profit Little Angels Service Dogs, a nationwide team that trains service dogs to help people living with disabilities and disabling conditions.
It was at the prison that ABC News met the group of women, all convicted felons, who’ve been training the dogs that might one day save people’s lives. Many of the women said the program has presented them with an opportunity for personal redemption.
“This isn’t just about training a dog,” said Amy Davis, an inmate at the prison. “[We] are training service dogs that save lives, and it’s about what the service dogs do to us to help us grow and continue to grow, and to heal our own wounds. You can’t be in this program and not grow. It doesn’t work [like that].”
Through the PUPS program, inmates have helped train dogs that have assisted medical technicians, people with autism, people with psychiatric conditions and those who are deaf or hard of hearing.
Dana Froomin, the prison program manager for Little Angels Service Dogs, admitted that she was initially concerned for the dogs safety when she was tasked with starting the PUPS program in 2017. Her concerns waned, she said, when she met the inmates, and has found the work to be rewarding.
The dogs graduate from their training after 12 to 18 months and then are sent to one of two Little Angels ranches in San Diego, California, or New Hampshire. Once they arrive, they go through advanced training to perfect their skills before they are eventually paired with a recipient or released from the program.
Any inmate can apply to participate in the program, says Froomin. Once they submit an application, they are selected based on three main criteria: physical and mental health, commitment level and their interests. Once selected, inmates sign on for a two-year commitment where they care for and train a dog.
“When I got here, I realized that these are women with stories, and they’re heart-wrenching stories, and they were so open and honest,” said Froomin. “It changed me because I realized that the dogs weren’t just changing the recipients’ lives, they were changing [the inmates’] lives, and then they changed mine.”
Inmate Amber Ingram, the lead trainer in the program, believes that PUPS helps her to deal with the guilt and shame she feels after she was convicted for the second-degree murder of her 5-year-old son, Braeden. Ingram said she her son was killed by an abusive boyfriend.
Ingram said that she protects the dogs no matter what and it is her way of not only remembering her son but honoring him, too.
“I can’t allow anything bad to happen to this dog,” she said. “If someone were to want to kick my dog, I’m jumping in front of it.”
To Natalie Tapio, Little Angels and the women at the PUPS program are saving lives, she said.
“People with epilepsy often have this constant kind of cloud over their head or worry in the back of their mind of, ‘When will the next seizure happen? Where will I be? What will I be doing,’” she said. “I don’t need to have that anymore, and so that’s very freeing.”
(NEW YORK) — Children and young people around the world are experiencing increasing anxiety over the fate of the planet — specifically climate change and how lawmakers are handling the looming crisis, according to new research.
Scientists who surveyed 10,000 young people, ages 16 to 25, across 10 countries, found “widespread psychological distress” among them, and, for the first time, discovered that the anxiety was significantly related to perceived government inaction, according to a study published Tuesday in Lancet Planetary Health.
Nearly half of all young people surveyed, more than 45%, said their feelings about climate change negatively affect their daily life and functioning, according to the study.
Another 75% of those surveyed said they feel the future is frightening, while 64% said governments are not doing enough to avoid a climate catastrophe.
Of the young people surveyed, 58% said governments are betraying hem, while 61% said governments are not protecting them, the planet or future generations.
The study is the largest to ever research climate anxiety among children and young people and is the first to investigate how government action on climate change is related to widespread psychological distress among the youngest members of society, according to the authors.
“Climate change has significant implications for the health and futures of children and young people, yet they have little power to limit its harm, making them vulnerable to increased climate anxiety,” according to the researchers.
The results of the study were not surprising and indicate a lack of trust toward the government as well as the perception of institutional betrayal, Lisa Van Susteren, a general and forensic psychiatrist and co-author of the study, told ABC News. The findings are also “as much a measure” of climate denial among adults as they are a measure of kids’ anxiety, Van Susteren said.
“Kids are very media savvy. They’re not living in a cave,” Van Susteren said. “They have heard about what the future looks like. They’ve heard the warnings.”
Scientists warned of the dire situation the planet faces in the annual Intergovernmental Panel on Climate Change (IPCC) report released last month.
“This report tells us that recent changes in the climate are widespread, rapid and intensifying, unprecedented in thousands of years,” said IPCC Vice Chair Ko Barrett, senior climate adviser for the U.S. National Oceanic and Atmospheric Administration.
Young people have been at the forefront of the climate fight for some years — with 18-year-old activist Greta Thunberg becoming a household name in 2018, and hundreds of thousands of young people around the world taking part in an organized global climate strike in 2019.
As an expert witness, Van Susteren performed psychological evaluations on the young people who were plaintiffs in Juliana V. United States, the 2015 federal lawsuit brought about by 21 youths who accused the government of failing to adequately combat climate change. She described it as “one of the most difficult experiences” in her career.
“You can clearly see that theirs depths of despair just are off the charts and are in part attributed to the sense that the future holds little promise,” Van Susteren said.
The case was dismissed in January 2020, but lawyers representing the plaintiffs intend to appeal the dismissal, they announced in February.
The researchers concluded that climate change and inadequate governmental response are associated with climate anxiety and distress in children and young people globally. Continued government inaction on climate change could lead to a public health crisis among the youth, the researchers warned.
Van Susteren described a “healing effect” that could take place if lawmakers and industry professionals were to do “the right thing” to significantly curb greenhouse gas emissions.
“They’re not going to heal with words alone,” she said. “They’re going to heal because of actions that are taken.”
(NEW YORK) — When Lt. Nathan Brashear saw the call for National Guard service members to help as hospitals were reaching a crisis point during Kentucky’s delta surge, he didn’t hesitate to volunteer.
For about two weeks, Brashear, a member of the Kentucky Army National Guard, has been leading a team of 30 National Guard members at The Medical Center at Bowling Green, doing “everything little thing” they can to help give the hospital staff a much-needed break.
“That’s one thing that makes this mission so important to us as soldiers,” Brashear, who was a deputy jailor before he went on active-duty orders, told ABC News. “We live and work in these communities. So for us to be able to support the communities is something that really impacts us.”
In recent weeks, several states have deployed hundreds of National Guard service members to help overwhelmed and understaffed hospitals, as COVID-19 hospitalization rates have reached points not seen during the pandemic.
The service members are not doing clinical work, but instead offering administrative and logistical support so hospital staff can focus on patient care. That could be anything from taking patients to appointments to cleaning beds to serving and clearing food.
“This is really the latest in demonstrated need that we’re seeing, obviously across the state and nation, that a lot of these hospitals are feeling the strain — both increased patients and a decrease in the available personnel to really help take care of everybody,” Lt. Col. Stephen Martin, director of public affairs for the Kentucky National Guard, told ABC News. “Our main mission there is really just to offload the logistical and administrative support that those hospitals have so that the full-timers there can better care for the needs of the patients that are coming in.”
The Kentucky National Guard was winding down its pandemic response, which has included helping set up drive-through COVID-19 testing sites and assisting food banks, when, about three weeks ago, it was called for the first time during the pandemic to assist hospitals overburdened by COVID-19 patients — most of them unvaccinated.
The size of National Guard teams and length of their deployment varies by hospital size and demand, and will stay as long as they can in whatever capacity is needed, Martin said.
“We as Guardsmen fancy ourselves as Swiss Army knives. We’ve got multiple skillsets, not only in what we’re trained on but being able to accomplish the mission before us,” he said. “We can send a small team into the hospital and say, ‘Here’s your left and right limits, these are the things that we want you to focus on and provide support to, and more than anything, just help these folks out.'”
“They’re in a bad way and we’re really just helping to alleviate that workload for a little it, let them catch their breath and catch up and really focus on the needs of the patients in the hospital,” he added.
Over two-thirds of Kentucky hospitals have critical staffing shortages as they’re overrun with COVID-19 patients, and doctors are “quickly approaching” the point where they would need to ration care, Gov. Andy Beshear told CNN on Wednesday.
More than 100 soldiers and airmen had already been deployed to four hospitals, including The Medical Center at Bowling Green, when Beshear announced Friday that over 300 more will be sent to 21 additional hospitals in the state’s largest-ever National Guard deployment for a health crisis.
“Our hospitals are at a breaking point,” Beshear said during a COVID-19 briefing Friday. “We have 93 total ICU beds left statewide. That is one of the lowest numbers, I think they would tell you, in our lifetime.”
The announcement came a day after Kentucky set new records for its statewide COVID-19 testing positivity rate, reaching 14%, and the number of patients on ventilators, the governor said.
Kentucky is not the only state to turn to the National Guard for COVID-19-related hospital support in recent weeks.
Late last month, Idaho Gov. Brad Little announced the state was deploying up to 150 Guardsmen, among other personnel, to help overwhelmed hospitals.
More than 600 patients are hospitalized with COVID-19 in Idaho, the highest on record for the state, as the number of intensive care unit beds dwindles and hospital staff are stretched thin. On Tuesday, Idaho public health leaders announced they had activated “crisis standards of care” for the state’s northern hospitals, enabling them to ration care.
In Oregon, Gov. Kate Brown announced last month she was deploying up to 1,500 National Guard members to hospitals around the state to provide support.
The service members have been met by applause by grateful health care workers as they’ve arrived at their hospitals.
Over the past few weeks, they’ve helped with nonclinical tasks, including screening visitors at hospital entrances, manning COVID-19 hotlines and changing patients’ bedding in the ICU.
Some have even used their talents to boost morale. Senior Airman Skadi Freyr of the Oregon National Guard has been playing piano during her lunch break while working at Oregon Health & Science University in Portland.
“A beautiful moment of someone in uniform who was blessing us on her break with some beautiful music, which really was grounding for me, to remind me of the beauty and the good in the midst of this really hard time,” OHSU oncology social worker Jen Smith told the Oregon National Guard last week.
Freyr said she doesn’t have any plans to stop playing after seeing the impact on staff.
“Now that I’ve seen that it has such a good sort of healing effect on people, it makes me more driven to do it, because I know that it’s really gonna just help them,” she said. “And I really like to be of service.”
(WASHINGTON) — U.S. Surgeon General Vivek Murthy defended President Joe Biden’s new actions to combat COVID-19, calling it an “ambitious” and “thoughtful” plan to increase vaccinations as the country has faced more than 100,000 cases a day for the past four weeks and roughly a quarter million new cases being reported among children.
“The requirements that he announced are not sweeping requirements for the entire nation,” Murthy told ABC “This Week” anchor George Stephanopoulos. “These are focused on areas where the federal government has legal authority to act.”
Reaching a milestone this week, 75% of American adults have now received at least one dose of a COVID-19 vaccine, but Murthy warned that the delta variant is a “tough foe” that has “thrown curve balls” at any progress made and said Biden’s actions “have to be taken” to help get through the pandemic.
Biden on Thursday announced his furthest measures yet to combat the delta variant — unveiling a six-part strategy that includes a new Occupational Safety and Health Administration rule for private businesses with over 100 employees to either require workers to be fully vaccinated or face weekly testing, covering roughly 80 million workers.
“We know that these kinds of requirements actually work to improve our vaccination rates,” Murthy said. “Tyson Foods, for example, which put in a vaccine requirement recently saw that its vaccination rate went from 45% to more than 70% in a very short period of time and they’re not even at their deadline yet.”
The president’s mandate on private businesses received swift criticism and legal threats from Republican governors, including Florida Gov. Ron DeSantis who called it “fundamentally wrong” for someone to lose their job for not being vaccinated.
Murthy pushed back against opposition, saying Sunday that “there are requirements that we put in workplaces and schools every day to make sure that workplaces and schools are safe,” such as mandatory vaccines for children to attend school.
“This is not an unusual phenomenon. What it is, is I think an appropriate response for us to recognize that if we want our economy to be back, if we want our schools to stay in session, we’ve got to take steps to make sure workplaces and learning environments are safe and these requirements will help do that,” he continued.
The surgeon general also defended the administration’s actions against legal challenges, saying it “wouldn’t have been put forward if the president’s administration didn’t believe that it was an appropriate, legal measure to take.”
“The COVID virus is a dangerous virus,” he continued. “It makes our workplaces and our schools, far less safe than they should be. So this is an appropriate action, we believe, and it’s certainly from a public health perspective — most importantly — will help keep workers safe.”
This is the first time OSHA will create a rule requiring vaccinations and White House press secretary Jen Psaki said Friday that they are hoping the rule making proceeds “as quickly as possible.”
The vaccine mandate is now also required for 17 million health care workers and 4 million federal government employees and contractors, but they won’t have the option to undergo weekly tests.
