(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.
(NEW YORK) — In the spring of 2020, U.S. airlines started touting electrostatic spraying, more frequent cleaning, and advanced filtration systems onboard in an attempt to convince passengers that flying is safe amid the pandemic.
But as the nation battles new variants of the virus and people consider buying tickets for the holidays — do these measures help prevent the spread of COVID-19?
“The evidence is pretty good with respect to cleaning materials that airlines use for the most part it’s going to kill a lot of the virus, and hopefully all of it,” Dr. Jay Bhatt, an internal medicine physician, an instructor at the University of Illinois School of Public Health and an ABC News contributor, said in an interview with ABC News. “But that still doesn’t take away the issue of being in close proximity to others, as you’re traveling, getting out of planes getting seated, getting up and leaving grabbing your bag. There’s a lot of different exposure risk and possibility there.”
While there are no longer any distancing policies on planes, carriers say the HEPA filtration systems on flights help curb the spread of the virus by making the air quality comparable to that of an operating room.
“Planes are using hyperfiltration and are requiring masking — those are both really good things to help reduce the risk of infection,” Bhatt said.
But the best way to mitigate any potential risk is by getting vaccinated, masking up, and resisting dropping your mask to eat or drink. And not all masks are created equal, Bhatt said.
“The difference between a high-grade quality mask or double masking compared to one blue surgical mask is about 10 to 12% more protective,” Bhatt.
Bhatt said it’s still important to be cautious while traveling over the holidays and recommends getting tested three days before a trip for those who are fully vaccinated.
“There’s higher risk during the holidays because of the amount of people traveling, the in and out of people in colleges and universities, and as well as in school with adolescence and younger kids,” he said. “The other issue is that in many parts of the country, there are folks that think the pandemic is over. And let’s be clear, we are still very much in a pandemic.”
The holiday travel season also comes on the heels of comments made by Dr. Anthony Fauci, the nation’s top infectious disease expert, who said he would support a vaccine requirement for air travel.
“I would support that,” Dr. Fauci told The Skimm podcast last week. “If you want to get on a plane and travel with other people … you should be vaccinated.”
Bhatt said a vaccine requirement would decrease the risk of infection while traveling even further.
“It’s certainly something important to think about and given that we’ve seen certain actions be taken around accelerating vaccinations via mandates employer, actions, and even airlines employees are being mandated to be vaccinated,” Bhatt said.
The U.S. Travel Association responded to Fauci’s comments, saying while it supports people getting vaccinated, it has “long maintained that there should be no mandatory vaccination requirement for domestic travel.”
The group said the current federal mask mandate is enough to keep passengers safe — pointing to a study conducted by the Department of Defense in partnership with United Airlines.
The study found that the risk of COVID-19 exposure onboard an aircraft is “virtually non-existent,” and when masks are worn, there is only a 0.003% chance particles from a passenger can enter the breathing space of a passenger sitting beside them.
“My advice is get vaccinated if you’re not, I would say look at the level of community transmission, and think about places you might be able to go and outdoors when you’re traveling, and most importantly, have your mask,” Bhatt said.
(NEW YORK) — Data shows the Pfizer and BioNTech COVID-19 vaccine is safe and effective for children ages 5 to 11, the companies announced Monday morning.
“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the delta variant and the substantial threat it poses to children,” Pfizer chairman and CEO Albert Bourla said in a statement. “Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination.”
There were 2,268 participants ages 5 to 11 in the trial, which, while it still followed a two-dose regimen, used a lesser dose than the amount given to people ages 12 and older, for the “safety, tolerability and immunogenicity” of younger children.
“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.
Pfizer and BioNTech plan to share their data with the U.S. Food and Drug Administration, the European Medicines Agency and other regulators soon and will submit a request for emergency use authorization in the United States.
The FDA approved the Pfizer vaccine, which is marketed as Comirnaty, for people ages 16 and older in August. It is currently authorized for emergency use in children ages 12 to 15.
“These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” Bourla 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, the companies said.
Pfizer has also received emergency use authorization from the FDA to give a third dose of vaccine to those 12 years of age and older who have been determined to have certain kinds of immunocompromise.
However, a panel advising the federal government on vaccines recently rejected President Joe Biden’s suggestion to roll out booster shots for all Americans, recommending that for now, a third dose should only be given to those 65 and older or those at high risk of severe COVID-19.
(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.
