(WASHINGTON) — Pfizer CEO Albert Bourla said on ABC’s “This Week” Sunday it’s possible to provide both COVID-19 booster shots as well as doses for people who have not yet been vaccinated.
“I think it is also not the right thing to try to resolve it with an ‘or’ when you can resolve it with an ‘and,'” Bourla told ABC’s George Stephanopoulos. “It’s not, ‘Shall we give boosters or give primary doses to other people.’ I think the answer should be, ‘Let’s give both boosters and doses for other people.’”
With millions more Americans now newly eligible for a booster COVID-19 shot from Pfizer, Bourla’s optimism punctuates what’s become a protracted, hot-button issue amongst the scientific community over who needs the boost and when.
Just after midnight Friday, Centers for Disease Control and Prevention Director Rochelle Walensky endorsed her independent advisory panel’s recommendation for seniors and other medically vulnerable Americans to get a booster shot of Pfizer’s COVID-19 vaccine six months after their second dose.
In a notable departure, Walensky partially overruled the panel by adding a recommendation for a third dose for people who are considered high risk due to where they work, such as nurses and teachers — a group the panel rejected in its recommendation.
The CDC’s final sign-off marked the starting gun for sleeves to start rolling up for a third shot at retail pharmacies and doctors’ offices across the country.
It also in part buttoned up what has become a seething scientific debate after the Biden administration announced there would be “boosters-for-all” before any review from the regulatory bodies or their independent groups. While the White House’s political appointees had endorsed President Joe Biden’s timeline, some of their career scientists and advisers vehemently objected to the incomplete data they were being asked to assess.
The booster debate has played out as the delta variant sweeps across states and threatens hard-fought gains against the virus here at home and as the World Health Organization continues to call for a moratorium on booster shots in the interest of more equitable distribution of primary vaccinations, as many still countries struggle with providing first and second doses.
Gathering world leaders virtually Wednesday on the U.N. General Assembly’s sidelines, Biden announced the U.S. would donate another half billion doses of Pfizer vaccine to lower-income nations.
Pfizer, the first vaccine maker to administer shots in the U.S. more than nine months ago, had cited data from Israel and elsewhere showing the vaccine’s robust protection began to wane with time. In April, Bourla predicted a third coronavirus dose was “likely” to be needed within a year of the primary two-dose course. In July, the company announced plans to ask the FDA to authorize a booster shot of the original vaccine six months after the second dose.
Earlier this month, Pfizer’s submitted brief to the FDA made the case that it’s time to “restore” full protection from the COVID-19 vaccines, even though they are still protecting most vaccinated people from being hospitalized.
(NEW YORK) — One week after getting her first COVID-19 vaccine shot, Bernadette Ann Bowen said she started her period one day early.
Then, Bowen, a 31-year-old Ph.D. student at Bowling Green State University, said she experienced some of the worst menstrual cramps of her life.
“I started getting a headache and then started feeling cramps coming on,” Bowen told Good Morning America. “My nausea and abdominal pain became so severe at the peak of my cramps that I could barely stomach a few sips of water, as I laid there feeling like I was going to pass out from it all.”
After Bowen saw people on TikTok discussing similar changes in their menstrual cycles after being vaccinated, she said she was “stricken with fear” over what could happen when she received her second dose of the vaccine.
“A lot of people I saw said their experience was after the second shot, so I was literally stricken with fear for a whole month wondering what would happen,” she said. “I was so afraid that it would continue.”
Bowen though, like most women who have reported menstrual changes after the vaccine, experienced only the one-time change to her period.
Nonetheless, she described it as “unacceptable” that people who menstruate did not know ahead of time that the vaccine may cause changes to the timing or severity of their menstrual cycles, even if temporary.
“Not getting a single warning is unacceptable,” she said. “It would be one thing if we were given a single consideration, but just knowing the design of medicine is so biased that this wouldn’t have been reported as a warning, it’s telling.”
Now, nearly one year after the COVID-19 vaccines began to be distributed in the U.S., the National Institutes of Health (NIH) has committed $1.6 million in funding to “explore potential links between COVID-19 vaccination and menstrual changes,” according a news release.
The funding, announced last month, comes as the U.S. Food and Drug Administration authorized Pfizer booster shots Wednesday for high-risk Americans and adults over age 65. FDA’s acting commissioner, Dr. Janet Woodcock, said the list of high-risk Americans should include health care workers, teachers and grocery story workers, all industries with largely female workforces.
The research funding also comes months after people began to share on social media their experiences of short-term period side effects after being vaccinated.
Tens of thousands of people documented their side effects in an online database created by researchers Katharine Lee, of Washington University in St. Louis, and Kathryn Clancy, of the University of Illinois Urbana-Champaign, who each said they experienced unexpected menstrual cycles after receiving the COVID-19 vaccine, and began to collect data.
The newly announced NIH funding, for which Lee and Clancy applied but were not selected, will go to researchers at five institutions: Boston University, Harvard Medical School, Johns Hopkins University, Michigan State University and Oregon Health and Science University.
The researchers will study everything from menstrual cycle changes reported on period tracking apps like Clue to menstrual changes in people with endometriosis and people trying to get pregnant, people who have not been vaccinated and teenagers. They will be examining how the vaccines may have affected flow, cycle length and pain, as well as exploring why COVID-19 vaccines may cause changes, according to Candace Tingen, Ph.D., program director of the Gynecologic Health and Disease Branch at the National Institute of Child Health and Human Development.
“Exactly like you’d see on a medication, that it may cause drowsiness, we want to say to women, ‘If you get a booster, if you get a vaccine, you might have a slightly heavier period for a cycle or two,'” Tingen said. “That’s what we want when we go in to get vaccinated, so we know how to prepare.”
Data on menstrual side effects was not widely collected during clinical trials for COVID-19 vaccines, which were conducted by the companies behind the vaccines, Pfizer and BioNTech, Moderna and Johnson & Johnson, according to Tingen.
She said the NIH was motivated to fund research both from reports of menstrual side effects as well as the misinformation that followed around menstrual changes and fertility.
“There was a lot of misinformation out there, and NIH sees its mandate as countering misinformation with accurate information,” Tingen said. “[Research] is something that we could do to step in and provide some real information about whether or not this is this is accurate.”
Experts in the medical community agree menstrual changes potentially linked to COVID-19 vaccines are likely to be temporary, and current evidence suggests that the vaccine has no impact on current or future fertility.
A possible explanation for temporary changes to period timing, flow and pain may have to do with how the body responds to physical and emotional stresses. Prior studies indicate that COVID-19 itself can be a stressor, leading to irregular menstrual cycles for some people.
Menstrual changes are also controlled by the hypothalamus and the pituitary gland in the brain, along with the ovaries, which use hormones as signals. These hormone signals can be disrupted when the body goes through changes that occur with an infection, and even a vaccine.
The research funded by NIH to help solidify these theories will include as many as 500,000 participants, some of whom are already involved in clinical studies, according to Tingen. She said because of the studies’ reach, transgender and nonbinary people will be included.
Dr. Laura Payne, director of the Clinical and Translational Pain Research Lab at McLean Hospital and an assistant professor in the department of psychiatry at Harvard Medical School, is one of the five researchers receiving NIH funding.
She is studying teens ages 14 to 19 to explore why the COVID-19 vaccines may cause changes in periods.
Specifically, Payne is looking at whether the vaccines cause inflammatory markers to be released, which then affect estrogen, which then affects menstrual cycles.
“Right now, the data on this particular mechanism is pretty limited to animal studies so we don’t really know how inflammation affects estrogen,” Payne said. “I think if we can show that inflammation has an effect on the menstrual cycle, that can help us just better understand the different things that affect the menstrual cycle.”
“In the bigger scheme of things, we’re just putting the menstrual cycle and menstrual health to the forefront as an important part of medical research, and it just hasn’t been,” she said. “It’s certainly an additional variable, but it’s really important and it’s important for women even if it’s not causing any kind of dangerous condition, it’s an important measure of health for women.”
Payne called it a “miss” that changes to menstrual cycles were not looked at during the vaccine trials, but said she is hopeful that the work being done now will help prioritize menstrual research in the future.
“In the vaccine trials, what I’m guessing is that they were just looking for indicators of pretty severe health complications that would land somebody in the hospital and they didn’t feel like changes in the menstrual cycle were part of that,” she said. “There’s certainly an argument to be made for that, but I think with the anecdotal reports and with the research that myself and the other [principal investigators] will be doing, hopefully this will inform future trials to say maybe this isn’t a life-or-death situation, but it’s important to women and it’s important to include.”
In addition to speaking out like so many people did when it came to menstrual changes with the vaccines, Payne said people can also volunteer for clinical research in order to move research on menstruation forward.
“Volunteering for clinical research is one of the best things that you can do to support the type of research that you want to see,” she said. “One of the biggest obstacles that we face in clinical research is finding ways to access participants, particularly participants from diverse backgrounds, and that’s something that we really are focusing on and NIH is really committed so we get an understanding from diverse samples of people.”
(NEW YORK) — A new study found that children whose mothers experienced depression during and soon after pregnancy are more likely to experience depression themselves.
While experts said more research is needed on the subject, they emphasized that this new finding reinforces the urgent need to identify and treat depression among pregnant women — not just for their sake, but potentially for the sake of their child as well.
“It’s definitely been proven that there’s genetic linkage for psychiatric disorders,” Dr. Gabrielle Shapiro, a child psychiatrist from the American Psychiatric Association, told ABC News. “And identifying [depression] in early childhood would be the best way to have an impact on … lifetime trajectory functioning” for children with mental illness.
In the study, researchers in the U.K. reviewed survey data from a large database of women who gave birth during the early 1990s. They focused on a subset of over 5,000 mothers and assessed their reported symptoms of depression, both during pregnancy and after they gave birth.
The children were also surveyed throughout childhood and young adulthood. Researchers found that children of depressed mothers not only had more symptoms of depression themselves but also that the symptoms escalated faster in them than they did in children without exposure to maternal depression.
“We found that the depression scores of offspring of mothers … increased at a greater rate over time — in other words, their scores went up by more points each year than offspring of non-depressed mothers,” Dr. Rebecca Pearson, co-author of the study, told ABC News.
The data also revealed a potential association between a father’s depression and childhood depression, though the study was not constructed to assess that relationship fully.
Although previous research has looked at the link between parental depression and childhood mental health, this study is the first to indicate that the timing of when a parent has depressive symptoms may contribute to a child’s mental health in a unique way.
In a press release, Dr. Joanne Black, chair of the Faculty of Perinatal Psychiatry at the Royal College of Psychiatrists, said the study “shows that the timing of depression in parents (during pregnancy, after childbirth or both) and if the mother, father or both were affected, are all important risk factors for the child’s future mental health.”
Exactly why this timing appears to be important is still unknown, but may point to the importance of screening for depression during the peripartum period and supporting mothers with mental health conditions. It also begs the question: Are genetic factors that lead to depression passed from mother to child in the womb?
Although the findings are intriguing, it remains unclear if the results are applicable to the population at large, as this study was conducted in a part of the U.K. with little socioeconomic or racial diversity.
This matters to Shapiro, who stressed the importance of recognizing racial disparities in childhood mental health.
“It’s even more important to screen our [Black, indigenous, people of color] population and make it more acceptable for them to have early intervention and be OK with treatment discussions,” she said.
Moving forward, the study’s findings may help health care providers identify and treat children through supporting families with mental health needs.
(NEW YORK) — The Centers for Disease Control and Prevention’s independent advisory panel has unanimously voted to recommend booster doses of Pfizer’s COVID vaccine for people aged 65 and older, along with long-term care facility residents, at least six months after their second dose.
The panel also voted to recommend booster doses for people between the ages of 50 and 64 years old who have underlying medical conditions, at least six months out from their second dose.
This recommendation roughly follows — but is slightly more specific — than authorization Wednesday night from the Food and Drug Administration, greenlighting the third shot for anyone 65 or older, as well as for people as young as 18, if they have a medical condition that puts them at risk of severe COVID-19 or if they work a frontline job that makes it more likely that they would get infected.
The vote also follows weeks of contentious back and forth amongst top health experts over who should get a booster dose and when — and whether it’s still premature to be asking the question. However, advisory panelists ultimately voted to recommend the booster shot, informed by data showing the gradually waning immunity from the vaccine impacting the elderly and high risk groups.
(NEW YORK) — Pfizer just released its first safety data about COVID-19 vaccines for children ages 5 to 11, reassuring parents that a safe and effective vaccine soon could be available for those younger than 12.
A trial of 2,268 children showed that a smaller dose of Pfizer vaccine — one-third the amount given to adults and adolescents — provided robust and adequate immune responses among those ages 5 to 11.
If the FDA agrees with Pfizer’s assessment, finally those younger than 12 can get vaccinated — in this case, if authorized, with the smaller dosage.
But that smaller dosage has led some parents to question the vaccine’s effectiveness compared with a larger dose.
“You’ve got to have a cutoff point and do something that’s logistically feasible,” Dr. Anthony Fauci said Monday, speaking on CNN. “Parents should not be confused or concerned about that.”
Other experts have stressed that size isn’t everything. Because the lower dose still mounts a strong and sufficient antibody response to COVID-19, even an 11-year-old who’s taller or weighs more than a kid over 12 should be protected.
And experts involved in the Pfizer trial strongly recommend adhering to available dosage data for 5-to-11-year-olds because clinical research shows doing so is safe and effective — a different dose would just be an educated guess.
“This is clearly an important — very important — first step,” said Dr. Evan Anderson, a professor of pediatrics and medicine at Emory University School of Medicine and one of the principal investigators of the Pfizer trial for children.
At this point in the pandemic, more than 5 million American children — most not eligible for vaccination — have tested positive for COVID-19. Children make up 22.2% of the U.S. population but accounted for almost 30% of new COVID-19 cases in a single week, based on early September data compiled by the American Academy of Pediatrics.
Prior clinical trials in adults and teens sought to identify a rough measure of vaccine efficacy, but because scientists already know vaccines are safe and effective, trials in younger children worked differently. Instead, this latest clinical trial focused on assessing children’s immune response based on analysis of their blood. These so-called immuno-bridging studies provide important information about the vaccine’s ability to mount immune responses for this group of children, none of whom could be vaccinated.
The Pfizer data showed that the smaller dose in younger children generated antibody levels comparable to 16-to-25 year-olds who received the standard 30-microgram doses.
“Despite the smaller dose, in the smaller children, the antibody response is as vigorous as what we find in older age groups. We’re seeing a robust antibody response meeting [a] protective threshold,” said Dr. Frank Esper, an infectious disease specialist at Cleveland Clinic Children’s.
In fact, researchers discovered that when 5-to-11-year-old children in the trial received the 30-microgram dose, they had more side effects. With the lower dosage, side effects mirrored those seen in teens and adults — pain at the injection site, headaches and fatigue.
Regardless of weight and size, children still should receive vaccine doses according to recommendations based on data, experts agreed, arguing it is better to stick to evidence rather than make an educated guess outside parameters of trials.
Dr. Robert Frenck, director of the Gamble Vaccine Research Center at Cincinnati Children’s and a principal investigator for the Pfizer trial, said the vaccine should not be given off-label with higher-than-recommended doses, citing the American Academy of Pediatrics and the Pediatric Infectious Diseases Society.
“I would stick with what the recommendation is for under 12 years of age,” he said. “I think it will be safe. I think it will be effective.”
(NEW YORK) — In the early days of the pandemic, experts kept a close watch on the number of new cases — one of the key metrics signaling success or failure of public health measures. But with new variants leading to more frequent breakthrough infections, mild COVID-19 cases will likely still persist, even if every person in the country is fully vaccinated.
“Even before any vaccines were authorized … we knew that this was going to be an issue,” said Dr. Lynn Goldman, dean of the George Washington University’s Milken Institute of Public Health.
“No vaccine is 100% effective at preventing infection,” added Dr. Kimberly Fisher, professor of medicine at University of Massachusetts Chan Medical School.
Now, public health and infectious disease experts are shifting their metric of success.
With vaccines still highly protective against severe illness, experts said we should focus less on cases, and instead on how many people are being hospitalized or dying.
“I think in some ways, the strong data around vaccines out of the gate created this illusion of perfection, which never was the case,” said John Brownstein, Ph.D., an epidemiologist and chief innovation officer at Boston Children’s Hospital and a contributor to ABC News.
“The major goalposts should have always been the hospitalizations and deaths,” he said.
Many experts point to countries like Singapore as an example of living “with” the virus, rather than eradicating it completely. With more than 80% of the population fully vaccinated, the island nation is still seeing more than 1,000 cases on average per day, but very few deaths due to COVID-19.
Although there may be “increases in cases,” Brownstein said, “that is not resulting in real impact in hospitalizations and deaths. … That sort of divergence is super important.”
In the U.S., a peek into COVID-19 intensive care units around the country reveals an important and recurring theme: ICU cases and deaths are overwhelmingly among the unvaccinated. A study by the health department in North Carolina found unvaccinated individuals are 15 times more likely to die from COVID-19 than the vaccinated. Washington state’s King County, which includes Seattle, tracks the numbers daily with unvaccinated people being 42 times more likely to die over the past 30 days.
Emerging data from the post-COVID-19 vaccine era underscored vaccine success will not necessarily be measured in prevention of COVID-19, but overwhelming success at keeping people alive if they do.
“It makes sense to focus on rates of hospitalization and death for COVID-19 — both of which the vaccine is very effective at reducing,” said Kathleen Mazor, a professor of medicine at University of Massachusetts Chan Medical School.
Public health experts hope that by focusing on this new metric for success, the nation can start prioritizing what’s important and readjust to the “new normal.”
Meanwhile, the overarching message to the vaccine-eligible population is clear: The vaccine is not simply intended to stop you from getting COVID, it’s so you live to talk about it if you do.
(LOS ANGELES) — Karen Notzon’s daughter, Callie, began her first year of middle school this fall by opting out of in-person learning after initially deciding to return to the classroom.
The Huntington Beach, California, mother told ABC News there were many reasons why her daughter changed her decision — including the rising number of COVID-19 cases across the U.S. linked to the delta variant — but one of the biggest ones was that a particular circumstance left Callie ineligible for vaccination in time for classes.
The pre-teen turns 12 in November, and is not eligible for the Pfizer COVID-19 vaccine like some of her other classmates who had birthdays before her this year, Notzon said.
Many students like Callie, who are entering sixth or seventh grade this year, are anxiously waiting to get their shots.
While medical experts say there is little that can be done for those soon-to-be 12-year-olds until the vaccines are approved for younger people, they say there are some tips that schools and families can take to ensure that each child is safe this year.
Annette Anderson, the deputy director for the Johns Hopkins Center for Safe and Healthy Schools, told ABC News that middle and high schools are dealing with a tough time going back to classes as there are scores of students who haven’t received their COVID-19 vaccines. As of Sept. 13, 52% of Americans between 12 and 15 have received at least one dose of a coronavirus vaccine, according to the U.S. Centers for Disease Control and Prevention.
Anderson, a former public school administrator and parent of a teenager, said the situation is very frustrating for those waiting for their child to age into the eligibility threshold, and could be harmful to students’ emotional and mental wellbeing.
“This is a tough time for schools. We’ve never been in a situation like this,” she said. “You are building the plane as you’re flying it.”
Notzon said she is more comfortable keeping Callie at home until she is fully vaccinated for that very reason and because they have an elderly member of the family living in the house.
“We’ve had high anxiety putting our daughter in a position like that. It seems like a risk,” she said.
Dr. Jessica Justman, an associate professor of medicine in at the Columbia University’s Mailman School of Public Health, told ABC News that parents with children on the cusp of vaccine eligibility that choose in-person classes will have a better chance of staying safe if the school sticks to strict measures, especially with masking.
Until more students receive their shots, indoor masking is the only line of defense from catching the virus, she said.
“It won’t be perfect, but whatever amount of time they spend wearing a mask is more time protected,” Justman said.
Katie Berkaw of Austin, Texas, told ABC News that her family is taking those same precautions seriously for her son, Connor, who turns 12 in October.
Although the hospitalizations and COVID-19 cases in Texas have been skyrocketing over the last few weeks, Berkaw said her family ultimately decided that it was best for her to attend classes in person during that wait.
“Being back on campus is important for his social engagement,” she said.
In the meantime, Connor has been wearing a mask, as is required by his school district, washing his hands and avoiding big indoor events until he gets his shot, according to Berkaw.
“There is always a little bit of nervousness that he could get it,” she said. “But he understands the level of cleanliness that is needed for himself.”
Sharon Gucker, a single mom from Nassau County, New York, told ABC News that her 11-year-old son, Owen, has also been cautious at school, wearing a mask and avoiding big crowds, but he is near the end of the tunnel.
The seventh-grader, who is the youngest of Gucker’s three sons, turns 12 this Saturday and has already scheduled an appointment to get his vaccine at a New York state vaccination center, she said.
This has been a moment the entire family has been waiting for, as they’ve been putting off many big activities due to the wait, including visiting family members on the West Coast.
“We’re still going to still wear our masks, but I think after that we will feel like a great weight off our shoulders,” Gucker said.
Justman and the other experts said practicing patience is the best things parents with kids who turn 12 later in the school year can do.
While it is certainly a question of when the vaccines will be made eligible for people under 12 and not if, Justman said parents can have some relief knowing that their seventh- or sixth-grader is in a classroom with some classmates who have some protection against the virus.
“You can look at this from a glass half full perspective,” she said. “It’s more fortunate for these 11-year-olds to be in a classroom with so many people who are vaccinated.”
Anyone who needs help scheduling a free vaccine appointment can log onto vaccines.gov.
(NEW YORK) — Sickle cell disease is an inherited red blood cell disorder that can cause debilitating pain and lead to lifelong complications. For years there have been limited improvements in awareness and treatment options, but that seems to be changing.
“My journey was kind of up and down like a roller coaster,” said Kim Jones, a 52-year-old woman in New York who shared her experience with ABC News about living with sickle cell disease since she was 3 years old. “When I was younger, I would get a lot of painful crises, usually in the joints, wrists, ankles.”
Jones became a second-grade teacher, but ultimately had to quit because her symptoms worsened due to the stressful demands of the job and what she felt was the lack of understanding and support from her school administration.
“There were days when I still went to work in so much pain. The doctor begged me to take days off and I couldn’t, I was scared I would lose my job. I ended up leaving that school,” she recalled.
Her experience with the disease has led her to advocate for sickle cell disease awareness and its scientific advancements.
September is Sickle Cell Awareness Month and Jones is sharing her experience so people become aware of the need to be screened, to raise the need for blood and bone marrow donors and to encourage the medical community to keep working on new medications and other treatments.
“In the past there has been very little support for people living with sickle disease, and minimal funding to research how to best treat it, at least in part due to racism in the medical system,” Dr. Susanna A. Curtis, assistant director of the Montefiore Adult Sickle Cell Center and assistant professor at Albert Einstein College of Medicine, told ABC News.
But just last week, Curtis at Montefiore Medical Center received a five-year grant from the NIH to investigate the efficacy and safety of a drug called dronabinol, a THC-containing pill normally for nausea and vomiting, to see if it could treat chronic pain in adults living with sickle cell disease. This grant will also allow them to determine if dronabinol can reduce inflammation, which Curtis said “is known to play an important role in sickle disease.”
Her research grant could determine if dronabinol could be added to the toolkit of sickle cell therapies, potentially improving the quality of life in patients with the disease.
Blood cells are normally round, but in people with sickle cell disease, they form into a C-shape, causing the cells to clump up, leading to severe pain.
Sickle cell disease affects millions of people worldwide, but disproportionately those of African descent.
Experts aren’t sure exactly why people of African descent are more likely to inherit the disease, but it may be linked to the fact that the abnormally shaped blood cells from which the illness gets its name have one potentially small but unexpected benefit: protection from malaria, a blood-borne disease.
“Sickle cell trait is protective against the effects of malaria, so people who lived in high malaria areas are more likely to reproduce and pass on that trait,” said Dr. Renee Crichlow, vice-chair of Health Equity at Boston University School of Medicine and chief medical officer of Codman Square Health Center. “So people with African ancestry are more likely to have the sickle trait.”
It affects approximately 100,000 Americans and occurs in one out of every 365 Black or African-American births, according to the CDC.
The only cure for sickle cell disease is a bone marrow or stem cell transplant. This is a hospital based-procedure that takes healthy stem cells from a donor and puts them into someone’s bone marrow, allowing the person to make new healthy cells. According to the NIH, the treatment has been successful in about 85 out of 100 children. However, it is a risky procedure that not a lot of people can tolerate. “It is only for patients with such severe disease,” Crichlow said. “The treatment can be highly toxic, and as a result, there are very few of these transplants that are done.”
Other treatment options vary for each person and depend on the symptoms. Treatments can include: receiving blood transfusions, staying hydrated and taking medications to help with the pain. Painful crises are often triggered by things like cold or dehydration, so part of managing the illness has to do with understanding those triggers.
“A person with sickle cell disease may need to take both chronic medications, like hydroxyurea, to help prevent crises, need occasional blood transfusions, and occasionally very heavy medications, including pain medications to treat the severe acute symptoms as a result of a sickle cell crisis,” Crichlow said.
Kim has been taking hydroxyurea for the past five years. This drug, originally used for chemotherapy, was FDA-approved for sickle cell disease in adults in 1998 and then in 2017 for children. So as she grew up, there were limited amounts of innovations in sickle cell therapies. “I had to start realizing environments that would trigger a sickle cell crisis, like the weather, if it’s too cold. I would get chills and have to not participate in certain activities,” Jones said.
Thankfully, efforts are being made to change this. In 2020, Congress released a proclamation to highlight the need for research and treatment of sickle cell disease.
Experts also said more could be done by the public. One way to bring more attention to the disease — and the need to find a cure for it — is simply to normalize talking about it.
“There is a tremendous cloak of shame covering sickle cell disease,” said Ginger Davis, the development and communication consultant for the Sickle Cell Thalassemia Patients Network.
The disorder can seem invisible to those who don’t have it. And for people who have it, there is often the emotional challenge of trying to explain what is happening while going through a very physically painful and draining experience. This was something that personally affected Jones.
“I went to school and college without telling anybody,” she said. “I was with a friend of mine and I got sick and she had no idea how to help me because I never told her I had sickle cell.”
Since 2006, all newborns in the U.S. are screened for sickle cell at birth. However, everyone can and should be tested for sickle cell.
“If you were born before newborn testing began in 2006, you could ask your doctor for a simple blood test to determine if you carry the sickle-trait,” Crichlow said. Continued research and public efforts towards the awareness treatment of sickle cell disease can benefit the thousands of people living with it.
(NEW YORK) — A second dose of Johnson & Johnson’s COVID-19 vaccine given two months after the first leads to stronger protection, according to the company.
The new data, announced in a press release, adds to a growing body of evidence suggesting that booster shots could enhance vaccine protection against breakthrough infections — though experts agree all three vaccines are still doing their job to protect against more serious illness.
Compared to the Pfizer and Moderna vaccines, Johnson & Johnson’s single-shot vaccine always had slightly lower efficacy. Peak efficacy from the two-shot Pfizer and Moderna vaccines was 95% and 94%, respectively, against symptomatic illness.
But two Johnson & Johnson shots, given two months apart, resulted in a similarly high effectiveness level: 94% protection against any symptomatic infection in the U.S., and 100% against severe disease.
With Pfizer’s booster shots now up for formal review from the Food and Drug Administration, and Moderna’s shortly to follow, the new data will likely factor into regulators’ decision about if and when additional shots are appropriate for the nearly 14.9 million people who received the Johnson & Johnson vaccine.
All three currently authorized vaccines are still working well to dramatically reduce the risk of being hospitalized, but as months pass and with the emergence of new COVID-19 variants, the vaccines are losing their power to prevent more mild breakthrough infections.
The new Johnson & Johnson data also raises questions about when to give an additional shot for the country’s only single shot vaccine. New data describing a booster two-months later found a marked increase in antibody levels. But prior data, already published, found that a booster shot given six months after the first dose results in even higher antibody levels.
“With the two-month boost interval, there was a four-fold increase in antibody titters. But when a booster was given after six months, it led to a 12-fold increase in antibody titers,” Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, whose lab helped develop the J&J vaccine, told ABC News.
“This suggests that the efficacy might be even greater when the booster is given at this later point in time,” Barouch said.
Regulatory authorities will need to weigh the available evidence and determine the appropriate timing for booster shots for all three vaccines.
In prepared remarks, J&J Chief Scientific Officer Dr. Paul Stoffels said the single-shot vaccine still provides “strong and long-lasting protection” while also being “easy to use, distribute and administer.””At the same time,” Stoffels said, “we now have generated evidence that a booster shot further increases protection against COVID-19 and is expected to extend the duration of protection significantly.”
According to Barouch, “the data supports the single-shot vaccine as the bedrock for providing robust and durable protection. But giving a boost two to six months later increases immune responses and augments protection to very high levels.”
(NEW YORK) — As millions of children across the country remain unvaccinated against COVID-19 due to their age, new data shows the Pfizer and BioNTech COVID-19 vaccine is safe and effective for children ages 5 to 11, according to the two companies.
“In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralizing antibody responses,” the companies said in a news release, sharing the results of a trial that involved more than 2,200 kids ages 5 to 11.
Pfizer and BioNTech also confirmed they plan to soon submit a request for emergency use authorization with the U.S. Food and Drug Administration (FDA).
The FDA approved the Pfizer vaccine for people ages 16 and older in August. It is currently authorized for emergency use in children ages 12 to 15.
The news from Pfizer and BioNTech about their vaccine comes as the U.S. faces a COVID-19 surge as the more contagious delta variant spreads and vaccination rates remain low for some age groups.
The surge is also happening as students are back in school and many remain unvaccinated, leading to a spike in pediatric cases.
More than 1.2 million children have tested positive for COVID-19 since they returned to classrooms in late July, according to the American Academy of Pediatrics and the Children’s Hospital Association.
The two other vaccines currently available in the U.S., Moderna and Johnson & Johnson, are currently available only for people 18 years and older.
Here are 10 questions answered about the COVID-19 vaccines and kids as families seek to make the best decisions.
1. What is the science behind the COVID-19 vaccine?
Both the Pfizer and Moderna vaccines use mRNA technology, which does not enter the nucleus of the cells and doesn’t alter human DNA. Instead, it sends a genetic “instruction manual” that prompts cells to create proteins that look like the outside of the virus — a way for the body to learn and develop defenses against future infection.
The Johnson & Johnson vaccine uses an inactivated adenovirus vector, Ad26, that cannot replicate. The Ad26 vector carries a piece of DNA with instructions to make the SARS-CoV-2 spike protein that triggers an immune response.
This same type of vaccine has been authorized for Ebola, and has been studied extensively for other illnesses — and for how it affects women who are pregnant or breastfeeding.
Neither of these vaccine platforms can cause COVID-19.
2. What is the status of vaccine eligibility for kids?
In general, federal and industry officials said they expect the first vaccine shots for children ages 5-11 could happen by the end of this year or early 2022. Timing on a vaccine for children younger than 5 is less certain, but officials have said they hope a greenlight for toddlers and infants will follow soon after.
NIH Director Dr. Francis Collins told “Good Morning America” in August that he expects kids ages 5 to 11 will get access to the vaccine in “late 2021.”
Pfizer said it plans to submit its authorization request for 5 to 11-year-olds to the FDA “with urgency.”
Moderna filed for emergency use authorization with the FDA for its vaccine in adolescents in June but is still awaiting a decision. The company said it will submit vaccine safety data on 5- to 11-year-olds this fall.
Pfizer and BioNTech said results from two other ongoing trials — one of children ages 2 to 5 and one of children 6 months to 2 years old — are expected as soon as later this year.
3. Why do kids need to be vaccinated against COVID-19?
While there have not been as many deaths from COVID-19 among children as adults, particularly adults in high-risk categories, kids can still get the virus and just as importantly, they can transmit the virus to adults.
“There are really two big reasons why kids need to get the vaccine,” explained Dr. Jennifer Ashton, ABC News chief medical correspondent.
“One of them is that it is possible that they could be infected and then unknowingly pass COVID-19 to someone with a serious or underlying, pre-existing medical condition,” she said. “And also, though it’s very uncommon and unlikely, it is still possible that children infected with COVID-19 could become seriously ill or worse. We have seen that.”
“It’s important to think in ripple effects, outside the box,” Ashton added. “It’s not just your home environment that you need to worry about.”
4. Will kids experience the same vaccine side effects as adults?
In announcing its trial results, Pfizer and BioNTech said the vaccine was “well-tolerated” in kids ages 5 to 11.
Adolescents experienced a similar range of side effects to the vaccine as seen in older teens and young adults — generally seen as cold-like symptoms in the two to three days after the second dose — and had an “excellent safety profile,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in August.
Moderna has said its COVID-19 study with teens ages 12 to under 18 identified no “significant safety concerns.” The most common side effects from the vaccine were injection site pain, headache, fatigue, muscle pain and chills, according to the company.
The FDA will scrutinize Moderna’s clinical data before authorizing the use in anyone under 18.
5. Have there been vaccine complications reported for teens and young adults?
There have been more than 300 confirmed cases of heart inflammation in teens and young adults who have received COVID-19 vaccines, but the nation’s leading health experts say the Pfizer and Moderna vaccines remain safe for use.
Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), said on “Good Morning America” in June the benefits of the vaccine for young people “overwhelmingly outweigh the risk,” echoing the findings of researchers at a CDC advisory committee meeting in June on vaccines.
The rare instances of heart inflammation occurred about 12.6 times out of every million second dose administered and were mostly among younger males about a week after the second dose of the Pfizer or Moderna vaccines, according to researchers at the CDC advisory committee.
6. How effective are the vaccines in children?
Pfizer announced in late March that its clinical trials showed the vaccine was safe and 100% effective in children ages 12-15, similar to the 95% efficacy among adult clinical trial participants.
Marks confirmed on May 10 that after a trial with over 2,000 children, Pfizer found no cases of infection among the children who had been given the vaccine and 16 cases of infection among the children who received a placebo.
No cases of COVID occurred in the 1,005 adolescents that received the vaccine, while there were 16 cases of COVID among the 978 kids who received the placebo, “thus indicating the vaccine was 100% effective in preventing COVID-19 In this trial,” said Marks.
Moderna’s COVID-19 vaccine is 100% effective in children ages 12 to under 18, the company said last month, in announcing results of their latest clinical trials.
In addition to its efficacy, the vaccine showed “no significant safety concerns” in the trial of more than 3,700 adolescent participants, according to Moderna.
7. Will kids get the same dose of the vaccines as adults?
Children ages 5 to 11 in the Pfizer and BioNTech trial still received two doses of the vaccine, but received a lesser dose than the amount given to people ages 12 and older, for the “safety, tolerability and immunogenicity” of younger children, according to the companies.
For 12- to 15-year-olds, the FDA has authorized the same dosing as adults with the Pfizer two-dose vaccine.
8. Could COVID-19 vaccines impact puberty, menstruation?
There is currently no clinical evidence to suggest the vaccines can have long-term effects on puberty or fertility, according to Ashton, a practicing, board-certified OBGYN.
Ashton noted that while there has been anecdotal discussion of the emotional event of finally receiving the vaccine temporarily impacting menstruation for adult women, the idea of the cause being from the vaccine itself “defies science and biology.”
It is really important to understand basic biology here,” Ashton said. “Women can have changes in their menstrual cycle and also have gotten the vaccine, that does not mean that one caused the other.”
“Right now there is no puberty concern. There is no fertility concern,” she added.
9. Will the Johnson & Johnson COVID-19 vaccine be available for kids?
Johnson & Johnson announced in April that it had begun vaccinating a “small number of adolescents aged 16-17 years” in a Phase 2a clinical trial.
As of April, the trial was enrolling participants only in Spain and the United Kingdom, with plans to expand enrollment to the U.S., the Netherlands and Canada, followed by Brazil and Argentina.
10. Will COVID-19 vaccines be required by schools?
It is up to each state’s government to decide whether a COVID-19 vaccine is required for school entry. Many colleges and universities in the U.S. are already requiring students to be vaccinated from COVID-19.
ABC News’ Sasha Pezenik, Anne Flaherty, Eric Strauss, Cheyenne Haslett and Jade A. Cobern, MD, a member of the ABC News Medical Unit, contributed to this report.
