(WASHINGTON) — After the Food and Drug Administration’s vaccine advisory panel rejected a plan on Friday to offer Pfizer COVID-19 booster shots for all Americans, White House chief medical adviser Dr. Anthony Fauci defended the White House’s earlier plan to begin rolling out the shots this month.
“The plan was that we have to be ready to do this as soon as the decision is made and when you have a plan, you put a date on it and you say we want to be able to get ready to roll out on the week of September the 20th,” Fauci said Sunday. “So giving that date, I don’t think was confusing. We needed a date to be able to say, let’s get ready to roll this out, pending the decision of the deliberation by the FDA and ultimately the (Centers for Disease Control and Prevention).”
ABC “This Week” co-anchor Martha Raddatz pressed Fauci on whether the White House’s premature announcement created any confusion.
“You yourself have said how important consistency and messaging can be, and you mentioned earlier President Biden talked about planning for a September 20th rollout for all Americans. I know he said ‘planning,’ I know he said it depends on the FDA, but isn’t a timeline like that just confusing to people?” Raddatz asked.
“These are the kinds of things that when you make a decision, you don’t snap your finger and it gets rolled out the next day and that’s, I think, the thing that the people in the United States need to understand,” he responded.
The panel did suggest that extra Pfizer shots should be given to those 65 and older or those at high risk of severe COVID-19. The panel also said it supports giving boosters to health care and other front-line workers, including teachers. A final decision is expected within days.
Additional vaccine doses, although not quite a booster, had 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.
Fauci said on Sunday that in three to four weeks — as more data from Israel and the U.S. emerge — the FDA advisory panel will continue to reexamine and modify recommendations for boosters.
“The story is not over because more and more data is coming in and will be coming in,” Fauci said.
He also said data on potential booster shots from Moderna and Johnson & Johnson vaccines is only “a couple of weeks away” and that the information will be examined in the same manner as Pfizer’s data.
COVID-19 cases in the U.S. continue to soar. The country has reported more than 1.02 million cases over the last week and the U.S. recorded more than 10,000 confirmed COVID-19 related deaths in one week, according to federal data.
With many students back in the classroom in person, pediatric COVID-19 cases and hospitalizations remain at one of their highest points of the pandemic and Raddatz asked Fauci when a vaccine might be available for children.
“It will certainly be this fall,” Fauci responded. “What we’re going to almost certainly see is that sometime in the next few weeks — as we get into October — we’ll be able to see the vaccines for children get enough data to be presented for safety and immunogenicity.”
“But in the fall, you know, rather than specifically saying what week, sometime in the mid- to late-fall, we will be seeing enough data from the children from 11 down to 5 to be able to make a decision to vaccinate them,” Fauci added.
(NEW YORK) — When Dr. Keila Rodriguez comes home, her 3-year-old daughter knows she has to wait to hug her mom.
“After the pandemic started, I would tell her, ‘You can’t hug mom right now, I have to shower and I have to change because I was around sick people all day and I don’t want to get you sick,” the Texas pediatrician told ABC News. “She knows now — I come home and she says, ‘Mom, how are you? I’m so happy to see you.’ But she’ll stay far away and she’ll say, ‘Go shower and change because I want hugs.”
Rodriguez’s hometown of McAllen, in the Rio Grande Valley, was especially hard-hit by COVID-19. Multiple people in her father’s family died from the virus, she said.
“It quickly became personal for everybody in the community,” she said. “Almost everybody knew somebody who had been very, very sick or died.”
Just as the family started to regain a sense of normalcy, the delta variant surged.
In recent weeks, record numbers of COVID-19 cases in children have been reported and pediatric intensive care units in parts of the country are reaching levels not seen before during the pandemic — just as children are heading back to the classroom.
Rodriguez, like many pediatricians across the country, is worried and overwhelmed, and trying not to get angry.
The pediatricians with children ABC News spoke to said they have fears about the current surge not only for patients but their families, especially as other communicable diseases spread. And they are using their platforms to try to get out the word about vaccination and mitigation.
“It’s such a difficult time emotionally, mentally, physically,” Rodriguez said.
Record cases in children
COVID-19 cases in children are at record levels. There were over 243,000 pediatric cases reported between Sept. 2 and Sept. 9, the second-highest figure reported during the pandemic, according to the most recent report from the American Academy of Pediatrics and the Children’s Hospital Association. The highest number of weekly cases was reported the prior week, topping 251,000, according to the organizations. Hospitalizations have also soared.
“When you tell a parent their child is positive for COVID, you see the fear in their eyes,” Dr. David Reeves, a pediatrician for Memorial Hospital at Gulfport in Gulfport, Mississippi, told ABC News. “Luckily, most children are not that ill with it, but we’re certainly seeing more severe illness with the delta wave.”
Still, children continue to be at lower risk for getting seriously ill or dying from COVID-19, a recent U.S. Centers for Disease Control and Prevention study found, noting that an increase in pediatric hospitalizations this summer has coincided with the rampant spread of the virus. The CDC said it could not determine with the available data whether the rise in hospitalizations was due to an increase in COVID-19 transmission or any greater illness caused by delta.
The American Academy of Pediatrics and the Children’s Hospital Associations have warned there is an urgent need to collect more data on the long-term consequences of the pandemic on children, “including ways the virus may harm the long-term physical health of infected children, as well as its emotional and mental health effects.”
‘Worse place than we were last year’
Dr. Rebekah Diamond has cared for children hospitalized with COVID-19, and then multisystem inflammatory syndrome in children, or MIS-C, since the start of the pandemic as a hospital pediatrician at Columbia University / NewYork-Presbyterian Morgan Stanley Children’s Hospital in New York City. She’s also seen the impacts on children’s mental health and loss of social supports tied to the pandemic.
“There’s a lot of talk about if COVID is bad for kids, which I just think is kind of an unhelpful and kind of really frustrating question because we know COVID is bad for kids. We know the pandemic is bad for kids,” she told ABC News.
Diamond, who has a 3-year-old daughter, said she felt a “huge amount of anxiety” caring for COVID-19 patients at the beginning of the pandemic, worried she might bring the virus home or spread it to her family.
“Navigating this pandemic, as a doctor, as a parent, I haven’t met a single doctor who has said, Yeah, it’s been a breeze,” Diamond said. “I certainly haven’t met a single parent, who, especially at this point, isn’t feeling some level of just extreme fatigue or stress or burnout, or just a variety of emotions — anger, grief, anxiety, it’s all there. And I would say, I’m right there with everyone.”
As COVID-19 cases have risen across the country due to the highly transmissible delta variant, the past few weeks “have been so destablizing,” Diamond said.
“It feels like we’re in almost a worse place than we were last year with our kids,” she said.
Navigating childcare continues to be especially fraught. Diamond said it is “really breaking my heart as a parent and the pediatrician” as parents continue to navigate difficult choices during the pandemic around childcare and school.
“It feels like we can’t control everything, but the degree to which we are having this crisis right now is largely preventable,” she said. “And I just know that parents feel totally let down. I can’t blame them.”
More concerned ‘than ever’
Dr. Katherine King, a pediatric infectious disease physician scientist who works at Baylor College of Medicine and Texas Children’s Hospital in Houston, Texas, has seen cases surge in her area, just as she was preparing for the new school year.
“I have to say that I’m more concerned about the situation now than I ever have been because the rates of infection in our community are higher than ever,” she told ABC News.
King said she has done “everything we can to try to limit exposures.” She pulled her 8-year-old daughter out of summer camp as COVID-19 cases were increasing in the community and masking and social distancing practices were subpar. Instead of a big party for her daughter’s birthday this summer, they had something small in their backyard.
But two weeks before the start of school, her daughter was exposed after a fully vaccinated neighbor tested positive, King said.
“I went through the whole concern and worry that she might test positive and would she be able to start school on time,” said King, noting that her daughter ultimately tested negative twice.
“I felt like I was really going through it with everyone else in terms of all the anxiety about the many exposures that are happening in the community right now and all the concerns we have about whether our kids can be in school,” she said.
The worries have only continued since school started amid a delta surge in Houston. On the second day of school, King got an email from her daughter’s school that someone in the class had been exposed to COVID-19, who ultimately tested negative. On a recent Friday, the school sent students home with a go-bag in case they weren’t able to return the following Monday.
By two weeks into the school year, King had already heard of two nearby schools needing to shift to remote due to COVID-19 cases.
“Unfortunately I think we’re in this place right now where there’s so many cases and so many contacts that it’s becoming really impractical for the schools to stay open, and particularly in the areas of town where masking has not been made a requirement,” she said.
Since the week ending Aug. 8, there have been over 126,000 COVID-19 cases in students reported from Texas public schools — including over 40,000 during the week ending Sept. 5.
“I am expecting that this school year we’re going to have more disruptions than we did last,” King said. “So as a parent, this means that we’re constantly kind of on edge.”
Using their platforms
Rodriguez, King and Diamond have been using their platforms as pediatricians to help educate and inform people during the pandemic and push back against misinformation.
Rodriguez published a children’s book last year, “When the World is Sick: A Story About Staying Safe and the Coronavirus,” about talking to children about COVID-19 and how to stay safe, and plans to write more books.
“It fills my cup, the way people say about things that fulfill them,” she said. “It just really makes me happy and fulfilled to help the community.”
Both Rodriguez and Diamond have taken to Instagram to engage with parents and their questions throughout the pandemic.
“It’s been really gratifying for me to put myself out there and show parents that as pediatricians, we really do know what you’re going through,” said Diamond, who has a forthcoming book, “Parent Like A Pediatrician.” “Not everyone’s struggles are the same, but we’ve seen you throughout this pandemic, I’ve seen parents throughout this pandemic, and I think what it does is it just makes me feel all the more protective and even angry on behalf of parents because I’ve seen that journey, not just for me, since last March.”
King has advocated for vaccination to reduce transmission and prevent prolonged illness related to COVID-19 infection. She plans to have her daughter vaccinated as soon as she is eligible.
“I was one of first to get the vaccine myself, and I hope my daughter will be one of the first children to get it when it becomes available,” King said, noting that that could come before the end of the year. “We will be eager to have her vaccinated as soon as we can. We can see the direct effects of vaccination, ZIP code by ZIP code in the United States.”
Masking mandates have become a lightning rod issue this school year. Though mask use is crucial to prevent the spread of the virus, particularly for those still too young to get the vaccine, the doctors said.
“The only thing that will traumatize kids about masks for the next few months is continuing to make it a debate conversation, when the conversation really should be — what kind of safety and support are we giving children for the next few months so that they feel safe in home, they feel safe in school, they feel that if they get COVID they will do well, that will keep the hospitals open and staffed appropriately,” Diamond said. “The things you can control are how you frame your own peace of mind and your own comfort and safety and how you model all of this to your kids.”
King urges people to “buckle down again” amid surging COVID-19 cases and hospitalizations, to which she has a front-row seat.
“It’s so hard to sometimes really incorporate statistics and numbers into our lives and really feel what that means, but it’s really easy for me because I go to work every day and I can see with my own eyes what coronavirus can do to a child and the impact it can have on a family,” she said. “So it’s very clear to me how valuable it is to try to control this virus and to try to avoid it.”
ABC News’ Arielle Mitropoulos contributed to this report.
(WASHINGTON) — Federal advisers on Friday voted 18-0 in favor of recommending Pfizer booster shots for anyone over 65 or anyone who is at high risk of severe disease from COVID-19. However, the panel declined to recommend boosters for all Americans as young as 16 who took the Pfizer vaccine more than six months ago.
If the Food and Drug Administrations agrees with the plan, which is likely, it’s possible that booster shots would roll out as early as next week to these populations. The Centers for Disease Control and Prevention would weigh in first though with more specific recommendations on who exactly should take the third shots.
Members of the FDA’s Vaccines and Related Biological Products Advisory Committee scrutinized new data from Israel and questioned whether boosters are really necessary, particularly among younger populations.
The largest sticking point was the lack of data on the effect boosters could have on young people, particularly because 16- and 17-year-olds weren’t included in the trial. Myocarditis, a heart inflammation condition, occurred mostly in young men, though very rarely, after their second mRNA dose, so members wanted to see more data on the effects of a third shot.
While many Americans have already opted for third shots, with doctors allowing them as an “off-label” practice, it’s up to federal regulators to decide how the vaccines are labeled and administered.
The debate has become unusually charged, in part because of White House involvement. President Joe Biden said he would only act on rolling out boosters if the FDA and CDC agreed. But his public pronouncement that the rollout would begin as early as Monday suggested the decision was a foregone conclusion, leading to accusations by some scientists that the Biden administration was pressuring independent regulators.
Following FDA approval, the CDC will determine who exactly should get a booster. After that CDC recommendation is made, booster shots would be available through any of the nation’s 40,000 pharmacies, doctors offices and other sites already offering the Pfizer vaccine.
The CDC has said vaccines still offer extraordinary protection against hospitalization and death, with more than 90% of patients hospitalized with COVID-19 being unvaccinated. At Friday’s FDA briefing, a CDC official said vaccine effectiveness against hospitalization in adults age 75 and older remained at about 88% through July.
But there were other signs that immunity waned with time.
A new Israeli study published in the New England Journal of Medicine found 11.3-fold lower rates of infection and 19.5-fold lower rates of severe COVID-19 among people older than 60 who got a booster dose. Also, an Israel Ministry of Health analysis estimated approximately 10-fold improved protection against infection and severe COVID-19 among people who got a booster.
Sharon Alroy-Preis, head of public health services at Israel’s Health Ministry, said Israel became concerned when it saw cases of fully vaccinated residents infecting other members of their households and – at times — winding up hospitalized.
“We definitely see that cases that are vaccinated — doubly vaccinated — that are no longer fresh” six months from their second dose, Alroy-Preis said. These vaccinated cases “are infecting other people. It’s obviously less than non vaccinated. But we’re seeing that, especially in their household.”
ABC News’ Sony Salzman contributed to this report.
(ATLANTA) — Despite the persistent pleas by public health officials to get vaccinated as coronavirus infections continue to surge, a staggeringly low number of pregnant people have been vaccinated against the virus nationwide.
Just 25% of pregnant people in the United States between the ages of 18 and 49 are currently vaccinated with at least one dose, according to data through Sept. 11 compiled by the Centers for Disease Control and Prevention.
The decision to not get vaccinated has resulted in a growing number of pregnant people ending up in intensive care wards, many severely ill with COVID-19. This worrisome uptick has been particularly evident in Mississippi, where state health officials have been sounding the alarm not only about the influx of fetal and maternal deaths, but also about several reports of pregnant women being turned away from getting the shot.
“Some of the patients had reported to us that they had gone to be vaccinated, and were turned away because they were pregnant. Those were people who were just sharing their experiences at pharmacies and other areas around the state,” Dr. Michelle Owens, a maternal-fetal medicine specialist at University of Mississippi Medical Center, told ABC News.
Owens, alongside other state health officials, reported this week that not all of their patients had been vaccine-hesitant, but instead were turned down after disclosing that they were expecting.
“People are kind of adverse to pregnant patients when they come in. They’re hesitant to give pregnant patients medications, and certainly, vaccinations kind of fall into that,” said Dr. Marty Tucker, chair of obstetrics and gynecology at UMMC, during a press conference on Thursday.
In light of the concerning reports, State Health Officer Dr. Thomas Dobbs issued a standing order last week for women to receive COVID-19 vaccines during pregnancy, “to give the pharmacy some reassurance for the places that it’s OK and recommended for pregnant women to get immunized at any stage in pregnancy.”
Owens added that health officials and physicians were all working together “to help reduce barriers to vaccination for pregnant women, and we just really tried to amplify this information so that wherever a pregnant person goes in order to receive care or to receive a vaccine that they are welcomed with open arms and that they receive that vaccine.”
In Mississippi, 72 patients have experienced late pregnancy loss and 15 pregnant women have succumbed to the virus, more than half of whom have died since the end of July. None of the pregnant women who died was fully vaccinated, and the majority were overweight, according Dobbs.
“There are NICUs all over this country that are filling up with babies who will not get to know their moms, and that’s devastating. There are families who are losing their matriarchs, and then, there are women who have been infected by this virus who won’t ever be the same,” Owens said.
Since the onset of the pandemic, more than 21,000 pregnant people have been hospitalized nationwide, and at least 155 have died as result of COVID-19, according to federal data. Additionally, there have been at least 266 pregnancy losses nationwide, and approximately 10.3% of patients have had to deliver prematurely.
“When we lose a mom, especially something that could be prevented, it is a tragedy. It does not discriminate, we see it in people with and without co-morbidities. We see it in people as young as 23 years old, so it is a bad actor across the board,” Tucker said.
Earlier in the pandemic, pregnant women at UMMC were not becoming as severely ill with COVID-19, but following the spread of the delta variant, Owens said, it became evident patients were becoming severely ill and deteriorating more quickly.
“We are seeing women, who may not have other co-morbid conditions, being affected at an earlier gestational age. Most of the people who we’re seeing now, are affected in the middle of their pregnancy, and they have a much more aggressive form of the disease,” Owens said. “The next thing you know, they end up progressing very quickly to need intubation.”
Pregnant people are at an increased risk for severe illness from COVID-19 when compared to non-pregnant people, according to the CDC. In addition, they are also at increased risk for preterm birth and other poor pregnancy outcomes.
The CDC and other leading health organizations, including the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, have issued guidelines calling on all pregnant people to get vaccinated against COVID-19.
“CDC encourages all pregnant people or people who are thinking about becoming pregnant and those breastfeeding to get vaccinated to protect themselves from COVID-19,” CDC Director Dr. Rochelle Walensky said in a statement about the updated guidance last month. “The vaccines are safe and effective, and it has never been more urgent to increase vaccinations as we face the highly transmissible Delta variant and see severe outcomes from COVID-19 among unvaccinated pregnant people.”
The updated guidance from the CDC was based on further research that found pregnant people can receive an mRNA vaccine with no increased risk to themselves or their babies.
“[It] is really the most important thing to give pregnant women an opportunity to still be able to live to fight another day,” Owens said. “It’s really imperative that women get the good information to know that the COVID vaccine is safe, approved and recommended, and that it makes a big difference in whether or not a patient has severe disease, or potentially, could die.”
(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.
