CDC recommends coronavirus vaccine for kids 5-11; shots set to ...

Children ages 5 to 11 are now eligible for the Pfizer-BioNTech COVID-19 vaccine, after the director of the Centers for Disease Control and Prevention signed off Tuesday night on an expert panel's recommendation.

Children in this age group could begin getting shots as soon as this week, as health providers can start vaccinating them "as soon as possible," the CDC said in a release.

Last week the Food and Drug Administration authorized Pfizer-BioNTech's vaccine for children 5 to 11, and the CDC's recommendation now clears the vaccine for those ages.

President Joe Biden called the news "a turning point in our battle against COVID-19," in a written statement Tuesday night.

Presidential adviser Jeffrey Zients said Monday that the Biden administration ordered enough vaccine to cover all 28 million American children in the age group. The administration’s distribution program will be “running at full strength” the week of Nov. 8, he said.

Though the vaccines carry some risk for children, their benefits are greater, concluded the CDC's Advisory Committee on Immunization Practices, made up of vaccine and immune system experts from universities and medical schools across the country.

"We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine," a Tuesday release quotes CDC Director Dr. Rochelle Walensky. "As a mom, I encourage parents with questions to talk to their pediatrician, school nurse or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated."

Vaccines will be available at 100 children's hospitals, temporary clinics in the community and at schools, as well as pharmacies and pediatricians' offices. Shots will be free, at one-third the dose of the adult vaccine and will be delivered in two shots at least three weeks apart.

A number of professional groups added their support Tuesday for childhood vaccination, including the American Academy of Pediatrics, the American Medical Association, the American Academy of Family Physicians, the National Association of Pediatric Nurse Practitioners and the Pediatric Infectious Disease Society.

In several small trials, Pfizer-BioNTech, which makes the vaccine, saw no serious side effects connected with the shots.

It is likely, committee members acknowledged, that some potentially dangerous side effects will become apparent once the shots are delivered to millions of children, just as rare side effects not seen in clinical trials of adults turned up with widespread vaccinations.

"We need to acknowledge the unknown," said Dr. Matthew Daley, a committee member and senior investigator at the Institute for Health Research at Kaiser Permanente Colorado in Aurora.

Daley said he was more concerned about the risk of waiting to vaccinate kids. "If we wait, we miss the chance to prevent many cases of COVID-19 in this age group, and that includes some very severe cases."

Data from the CDC suggests that vaccinations can prevent 600,000 infections in the age group by March, including a number of hospitalizations and a few deaths.

Fully vaccinating 1 million children in the age group would prevent about 57,000 cases of COVID-19 and about 200 hospitalizations, the CDC said.

“The data that was presented really speaks volumes in terms of the safety and effectiveness of the vaccine,” said Dr. Pablo Sánchez, a professor of pediatrics at Nationwide Children’s Hospital in Columbus, Ohio.

“Children are dying, and we can reduce hospitalization and death with this safe and effective vaccine that will benefit the community,” said Dr. Oliver Brooks, chief medical officer for the Watts HealthCare Corporation in Los Angeles.

Parents who have concerns about the shots should speak with their pediatrician, CDC and committee members said.

Kid shots Q and A: Everything to know about COVID-19 vaccine and children

The potential vaccine side effect of biggest concern is a swelling of the heart muscle, known as myocarditis, which has been seen particularly among young men who received vaccine.

Out of every one million 16- and 17-year-old boys vaccinated, 69 have developed the condition, compared with two out of every million men in their 40s, government statistics show. None has died, and most cases appear to be mild without long-term consequences.

Matthew Oster, a pediatric cardiologist at Children’s Healthcare of Atlanta, said he expects the side effect will be even rarer in children.

Before COVID-19, myocarditis was most common among adolescents and young men probably because of their relatively high levels of the hormone testosterone, Oster told the committee. Children younger than 12 typically have low levels.

Infection with COVID-19 can cause myocarditis that appears to be more serious than swelling seen with vaccination, he said.

Many children who receive the shots will, like adults and teens, feel side effects in the first 48 hours or so. The most common side effects in the trials were fatigue, headaches, joint pain, pain at the injection site and vomiting, nausea or diarrhea.

The CDC monitors vaccine recipients, including children, for serious vaccine reactions through several different systems. One involves self-reporting of symptoms, another is reported mainly by doctors and two others collect data from hospitals, the CDC's Dr. Tom Shimabukuro told the committee.

The Food and Drug Administration has a separate vaccine surveillance system, as does the Department of Defense, which first identified myocarditis as a risk among service members.

Rush is on: With vaccine orders placed, doctors, pharmacies prepare for a flood of young children

Last week, the Food and Drug Administration authorized vaccines for use in this age group after a signoff by an independent group of vaccine experts who determined that the benefits outweighed the risks.

Of the three vaccines available to adults in the USA, only Pfizer-BioNTech has completed studies in minors. Moderna said Sunday that the FDA asked for more information about its shots in adolescents, which probably will defer its authorization until January.

Johnson & Johnson is further behind in its trials in adolescents and children.

Typically, companies test vaccines in adults, then move down in age as the shots are proved safe. Pfizer-BioNTech continues to study even younger children, down to 6 months of age.

Though fully approved for use in adults and older teens, the Pfizer-BioNTech vaccine is authorized only for emergency use in children and younger adolescents. The collaborating companies will probably request full authorization for these age groups next year, once they have longer-term data and more details on manufacturing.

Vaccines are somewhat more controversial in children than adolescents and adults, because children are less likely to suffer severe COVID-19 infections.

Still, 94 American children ages 5-11 have died from COVID-19 since the pandemic began – the eighth leading cause of death in this age group – and about 8,300 have been hospitalized.

Although at lower rates than adults, children ages 5 to 11 can suffer from lingering symptoms of COVID-19 infections, so-called long COVID – including months-long fatigue, pain, headaches, insomnia and trouble concentrating.

All children, regardless of age, can catch and pass on COVID-19, one study confirmed.

Pfizer-BioNTech's COVID-19 vaccine is clearly effective in children 5-11, preventing more than 90% of infections, according to a company-run study in about 2,500 children.

Questions remain about the effectiveness and safety of the shots because of the relatively small number of children who have received them so far – fewer than 3,500 across three company-run studies. It is not clear how long this protection against COVID-19 will last or whether booster shots will be needed.

Data from the CDC suggests that nine children would have needed to be vaccinated to protect one of them from contracting COVID-19 in September during the peak of the last wave, and about 26 today when rates are lower. About 2,200 kids would have needed protection six weeks ago to prevent one hospitalization and about 8,200 more recently.

Children who are immunocompromised or have health issues such as obesity and metabolic disease are at higher risk for serious COVID-19 infections. Two-thirds of children hospitalized for COVID-19 had preexisting health conditions, while one-third were previously healthy according to the CDC.

The CDC's recommendation for vaccination includes all children, regardless of their underlying medical conditions.

Childhood vaccinations will help families in which parents are fighting cancer, said Dr. Gwen Nichols, chief medical officer of the Leukemia & Lymphoma Society. Vaccination will allow "children to interact with more freedom, including with their parents and grandparents," she said. "This is particularly important for immunosuppressed patients, including those with blood cancers who have been in an impossible situation with their younger children returning to school in-person.”

Children of color have been hospitalized at three times the rate of white children, data shows.

About 38% of American children have been infected with COVID-19, according to data presented to the committee.

Children who have already had COVID-19 will get some protection against severe disease but should still get vaccinated, according to the recommendation, because the shots provide more consistent protection than infection.

An FDA analysis of infections presented to a different advisory committee last week found that the benefits of vaccination generally outweigh risks among children. If COVID-19 cases are extremely low – less than 10% of the rates seen in mid-September – the benefits of vaccination are less clear, the report concluded.

Vaccines take about five weeks to come to full effectiveness, two weeks after the second shot, so parents will not have time to provide vaccine protection in the face of a sudden outbreak or a fast-spreading new variant.

COVID-19 has already caused substantially more misery than other childhood diseases, CDC data showed. COVID-19 led to at least three times more hospitalizations and deaths than hepatitis A, meningococcal disease, varicella, rubella and rotavirus did before vaccines were introduced against those diseases.

Dr. Katherine Poehling, a professor of pediatrics at the Wake Forest School of Medicine in Winston-Salem, North Carolina, said that information helped convince her to strongly support COVID-19 vaccines for elementary school children.

"We can now make these COVID-19 hospitalizations and deaths vaccine preventable," she said.

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

Covid-19 vaccinations begin for US children under 5 - CNN

Vaccines for children under 5 a turning point for many US families

CNN —

Dr. Sarah Schaffer DeRoo described in one word how she felt after getting her 7-month-old son vaccinated against Covid-19: thrilled.

Her active baby boy sat in her lap at a vaccine clinic hosted by Children’s National Hospital in Washington, DC, while receiving his first dose of Covid-19 vaccine. The shot was administered in his thigh. He cried for a few seconds but then his attention turned toward a golden retriever that was on site as a comfort dog provided by the hospital.

“I’m feeling really thrilled that we have this opportunity,” DeRoo, a pediatrician at Children’s National Hospital in Washington, DC, told CNN’s Suzanne Malveaux on Tuesday about her son’s vaccination.

DeRoo added that her family now will feel more comfortable participating in certain activities, knowing that their youngest son has started his Covid-19 vaccine series.

“It will certainly allow us to have more freedom with our personal lives and what we do,” DeRoo said. “And for the baby, we’ll feel like we have cloaked him in as much protection as we can.”

Covid-19 vaccinations for children younger than 5 are beginning Tuesday across the United States, marking a milestone in the nation’s fight against the disease.

Last week, the US Food and Drug Administration expanded the emergency use authorizations for Moderna’s vaccine to include children 6 months through 17 years and Pfizer/BioNTech’s for children 6 months through 4 years.

Then on Saturday, US Centers for Disease Control and Prevention Director Dr. Rochelle Walensky signed off on Covid-19 vaccinations for children under 5, clearing the way for vaccinations to be administered in that age group.

About 17 million kids under the age of 5 are now eligible for Covid-19 vaccines.

“This is a big day. We’ve been waiting a long time for children to have access to the vaccine. We now have every age group, 6 months and above, in the country which is now eligible to get protection from the Covid-19 vaccine. And I’ll tell you as a dad of a 4-year-old, this is a big deal for my family as well,” US Surgeon General Dr. Vivek Murthy told CNN’s Brianna Keilar on Tuesday morning.

As of the end of Tuesday, the US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) has delivered approximately 2.7 million doses of vaccine for children under 5 nationwide.

“Another 1 million doses have been shipped and will soon be received by administration sites,” Tim Granholm, an HHS spokesperson, wrote in an email to CNN on Wednesday morning.

“HHS has received orders for approximately 4.2 million doses to date,” Granholm wrote. “We will continue to deliver vaccines expeditiously as we fulfill orders and take new ones. We made 10 million doses of vaccine available for ordering initially, with millions more available soon, so supply should not be a barrier to someone getting their young child vaccinated.”

Vaccines given in child-sized doses

Under the FDA’s authorization, the Moderna vaccine can be given as a two-dose primary series, with doses given four weeks apart, at 25 micrograms each dose, to infants and children 6 months through 5 years of age.

While the FDA has authorized Moderna’s vaccine for children ages 6 to 17, the CDC has not yet recommended it for that age group, so those shots can’t be administered yet. The FDA authorization would allow children ages 6 to 11 to receive doses are 50 micrograms each. For those ages 12 and older, it would be administered as 100-microgram doses.

The Pfizer/BioNTech vaccine now can be given as a three-dose primary series, at 3 micrograms each dose, for use in infants and children 6 months through 4 years. The vaccine is administered as a two-dose primary series at 10 micrograms per dose for children 5 to 11 and at 30 micrograms per dose for adolescents and adults ages 12 and older.

Completing the Pfizer/BioNTech vaccine series is a longer process, as the first two doses are administered three weeks apart, and then the third dose is given eight weeks later.

Dr. Jeannette Lee of the University of Arkansas for Medical Sciences, who serves on the FDA’s vaccine advisory committee, expressed concern about children not completing all three doses.

“Three doses will certainly benefit. I have a lot of concern that many of these kids will not get a third dose,” Lee said. “My concern is that you have to get the three doses to really get what you need.”

As for children who might turn from age 4 to 5 at any point while completing their Pfizer/BioNTech vaccine series, the CDC recommends two options. The child could complete the two-dose primary series authorized for children ages 5 to 11, or they could complete the three-dose series for younger kids, but each of doses 2 and 3 may be either the dosage for younger children or ages 5 to 11.

The FDA’s Vaccines and Related Biological Products Advisory Committee determined that the benefits of both vaccines outweigh the risks and noted that the vaccines have been “well-tolerated” among the children who got them in clinical trials.

According to clinical trial data, common side effects for both vaccines include pain at the injection site, headache, fever, chills and fatigue. The vaccines appeared to elicit similar immune responses in children as has been seen in adults.

Where young children can get vaccinated

Pediatricians’ offices and pharmacies are the main sites where young children could get vaccinated.

“We know that parents are going to want to get their children vaccinated in pediatricians’ offices. Some people will go to a pharmacy, some people will go to a children’s hospital or some sort of a community health center,” Dr. Ashish Jha, the White House’s Covid-19 response coordinator, said Monday on CBS.

“But the bottom line is, I think a majority of parents are going to want to get their child vaccinated in their pediatrician’s office,” Jha said. “So, many pediatricians are going to be offering the vaccine.”

As for the pharmacy locations offering these child-sized vaccines, CVS and Walgreens have announced plans to provide vaccinations.

CVS will begin administering Pfizer’s Covid-19 vaccines to children under five on Tuesday, a communications representative told CNN.

“We will begin administering the Pfizer-BioNTech Covid-19 vaccine for eligible children 18 months through four years of age at our 1,100 MinuteClinic locations starting on Tuesday,” Matt Blanchette, senior manager of retail communications with CVS Pharmacy, told CNN in an email.

“MinuteClinic is located inside select CVS Pharmacy stores in 35 states and Washington, DC,” Blanchette said. Appointments will be available on a rolling basis according to vaccine supply.

Blanchette said children over 5 will still be able to access Covid-19 vaccines in CVS pharmacies.

On Saturday, Walgreens announced in a news release that appointments for vaccinations in young children will be available starting June 25. Walgreens will be vaccinating children 3 and older at “select” locations, and appointments can be scheduled online.

Get CNN Health's weekly newsletter Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team.

Hy-Vee pharmacies will have Covid-19 vaccinations available for children under 5 once doses are available, a communications representative told CNN on Monday.

“Hy-Vee anticipates receiving its allocations for the newly approved age groups in the coming days,” Tina Potthoff, senior vice president of communications, wrote in an email.

“As soon as we receive vaccine and our appointment scheduler is open for these age groups, we will post an update on our COVID-19 vaccine landing page, post on our Hy-Vee store Facebook pages, and contact media outlets in our eight-state region to make them aware of our pediatric hubs that are accepting appointments.”

Due to federal regulations, she wrote, Hy-Vee will only be providing vaccinations to children 3 and older.

“Under the PREP Act, retail pharmacies, including Hy-Vee pharmacies, are only authorized to administer vaccines to patients ages 3+,” Potthoff wrote in the email. “Patients younger than age 3 should visit their pediatrician or health care provider to receive the COVID-19 vaccine.”

COVID vaccine for kids coming in weeks, Biden says. Pfizer says fall.

President Joe Biden is optimistic that vaccines for children under 12 years old could be available as early as August.

Biden made the statement during a town hall Wednesday in Cincinnati hosted by CNN. After speaking with scientists, Biden said, he wasn't promised a specific date, but he did have an expectation.

"My expectation talking to the group of scientists we put together, over 20 of them, plus others in the field, is that sometime maybe in the beginning of the school year, at the end of August, beginning of September, October, they'll get a final approval," he said.

That's an unlikely timeline. Trials began in March for the Moderna and Pfizer-BioNTech vaccine for younger children. The results of the trials are expected in the fall, not within weeks.

Dr. Alejandra Gurtman, vice president of the Vaccine Clinical Research and Development at Pfizer, said an emergency use authorization was planned for the 5-to-11 age group in September or October during a presentation at a Johns Hopkins-University of Washington symposium on June 30. She said the 2- to 5-year-old group would follow soon after.

Children under 12 are still ineligible to receive the vaccine in the U.S., and Biden said the Center for Disease Control and Prevention probably will recommend that children who are not vaccinated wear masks in school.

'It's limbo':Parents stuck between two COVID-19 worlds as young kids remain unvaccinated

"It's going to get a little bit tight in terms of, well, are Mom or Dad being honest that Johnny did or did not get vaccinated? That's going to raise questions," Biden said. "It's a matter of community responsibility."

On July 9, the CDC recommended that fully vaccinated children did not need to wear masks at school.

"Students benefit from in-person learning, and safely returning to in-person instruction in the fall 2021 is a priority," a press release from the CDC said.

On Monday, the American Academy of Pediatrics had a different opinion and recommended that all children older than 2, regardless of their vaccinations, should wear a mask.

Coronavirus cases have nearly tripled in the U.S. over the past two weeks. The delta variant of the virus, scientists say, is more contagious. A lambda variant was recently identified at a Houston-area hospital, but health experts said it doesn't appear as contagious.

“I know there’s great interest in lambda, but I think people really need to be focused on delta,” said Dr. S. Wesley Long, Houston Methodist’s medical director of diagnostic biology. “Most importantly, regardless of the variant, our best defense against all these variants is vaccination.”

Our World Data reports that 49.3 % of Americans are fully vaccinated. During the town hall, Biden urged people to get the vaccine.

“We have a pandemic for those who haven’t gotten the vaccination – it’s that basic, that simple,” Biden said.

Fauci to Sen. Paul:'You do not know what you are talking about'

'Hard choice doesn't amount to coercion':Judge sides with Indiana University in student challenge to COVID-19 vaccine mandate

Contributing: Ryan Miller

Follow reporter Asha Gilbert @Coastalasha. Email: agilbert@usatoday.com.

COVID-19 in Iowa: State reaches 500000 total cases; new cases rising

More than half a million Iowans have contracted COVID-19 since the start of the pandemic, according to data released Wednesday by the Iowa Department of Public Health.

The 9,067 new cases reported this week brought the state's total to 500,119 individual Iowans who have tested positive for the disease since it first reached the state last year. That means the coronavirus has infected about one in six Iowans at some point in the past two years.

Iowa's number of cases is again on the rise, with the state reporting an increase in new confirmed cases for the third week in a row. This week's average of 1,295 new reported cases per day was up 19% over the previous week.

While cases are climbing, the state has an additional tool to curb the virus after federal regulators approved a COVID-19 vaccine for children as young as 5.

More:US COVID-19 map: Tracking cases and deaths

COVID-19 hospitalizations, which had declined each of the previous four weeks, also increased, according to Wednesday's data. There were 524 Iowans hospitalized with COVID-19, including 113 in intensive care and 52 on ventilators. More than 70% of the patients hospitalized with COVID-19 were not fully vaccinated against the disease, including 85% of those in the ICU.

The share of the state's population that is fully vaccinated against COVID-19 increased just two-tenths of a percentage point in Wednesday's update, a slight decline from previous weeks. About 53% of the state's population is fully vaccinated, according to the Iowa Department of Public Health. Additional data from the U.S. Centers for Disease Control and Prevention shows that nearly one-fifth of those fully-vaccinated Iowans have also now received a booster dose — the extra shot now available to some at-risk populations.

The state also reported 97 additional COVID-19 deaths this week, some dating back to mid-September. COVID-19 has now caused or contributed to the deaths of 7,166 Iowans.

How many Iowa children have received the vaccine?

As has been the case for the last several months, children made up just under a quarter of the new COVID-19 cases reported this week, or about 2,000. Eight were hospitalized with the disease as of Wednesday's update.

Last week, the Pfizer-BioNTech vaccine became available for children ages 5 to 11. Wednesday's data update did not yet show the number of doses that have been administered to children in that age group so far.

More:'We feel like we can move forward.' COVID-19 vaccines for children 5 to 11 years old now available

However, about 7,000 Iowa children were able to start their vaccination process by the end of the weekend, according to Ken Sharp, an Iowa Department of Public Health administrator helping coordinate the vaccination campaign. On Wednesday, he called that "good news," and promised the number of doses administered would rise.

Biden administration officials have promised it would have its pediatric vaccination distribution program fully running this week after the Pfizer vaccine was approved for young children last week. In Iowa, the doses started being administered in many locations on Thursday, albeit with limited slots available. Many pharmacies that provide the adult vaccine were still getting their programs up and running through the weekend.

More:'We feel like we can move forward.' COVID-19 vaccines for children 5 to 11 years old now available

"There are some, I think, frustrations we're hearing that the parents weren't able to get the vaccine where they would normally go to get the vaccine, and I think it's just a matter of timing," Sharp told the State Board of Health at its regular meeting Wednesday. "We're still taking that as positive news of parents are excited about getting their kids vaccinated and looking for that vaccine."

There are about 284,000 children ages 5 to 11 in Iowa, and the state received about 99,000 doses from the federal government, not including those shipped directly to pharmacies. Sharp said all 99 counties should have pediatric doses available by this week. The state has also ordered another 24,000 doses.

CDC assumptions on vaccine take rates show about 30% of parents would want their child vaccinated immediately, Sharp said, which covers about 95,000 newly eligible children. Another 20% to 30% would likely wait a little bit or until it's more convenient, such as during other scheduled vaccinations. The remaining are hesitant, Sharp said.

"CDC has assured us that there will not be any supply chain issues for the pediatric vaccine, and right now, we feel like things are going as smoothly as they could be given the rollout of that new product," he told the board.

Meanwhile, board member Dr. Donald Macfarlane, with University of Iowa Health Care, asked for a stronger pushback on anti-vaccine rhetoric.

Macfarlane said he was concerned about how vaccine opponents are misusing the CDC's vaccine adverse event reporting system, known as VAERS. The data, he said, is made up of unverified, self-reported events that aren't necessarily associated with any vaccine.

Sharp said the state receives regular updates from the CDC about VAERS reports, and there have been zero Iowans who have died because they received the COVID-19 vaccine. Sharp told Macfarlane that the state health department would discuss how to better communicate that message.

"I think there is a very difficult message for the general public to understand what those data elements are and to understand that literally anyone can report into VAERS on a perceived correlation between a negative impact or adverse effect from a vaccine," Sharp said.

Read more on COVID-19 in Iowa:

The latest COVID-19 numbers in Iowa

The latest data, as of 11 a.m. Wednesday, Nov. 10, compared to the previous Wednesday.

Confirmed cases: 500,119, an increase of 9,067

Deaths: 7,166, an increase of 97

Total tested: 2,141,764

Total recovered: 465,549

Statewide 14-day positivity rate: 8.9%

How many Iowans are hospitalized with COVID-19?

Hospitalizations: 524, up from 483 one week ago

Patients in ICU: 113, up from 111

Patients on ventilators: 52, down from 53

How many people in Polk and Dallas counties are vaccinated?

In Polk County, 288,796 (59%) residents are fully vaccinated, an increase of 1,330 (0.3 percentage points) since last week.

In Dallas County, 54,760 (59%) residents are fully vaccinated, an increase of 272 (0.3 percentage points).

The five counties in Iowa with the highest percentage of their population fully vaccinated as of Nov. 10 are Johnson (63%), Buena Vista (61%), Linn (59%), Polk (59%) and Dallas (59%) counties.

For a county-by-county look at the vaccination rollout, see our COVID-19 vaccine tracker, which is updated weekly.

Tim Webber is a data visualization specialist for the Register. Reach him at twebber@registermedia.com, 515-284-8532, and on Twitter at @HelloTimWebber.

Everything to know about COVID-19 vaccine and children: Where to ...

An advisory committee to the Centers for Disease Control and Prevention on Tuesday voted to recommend Pfizer-BioNTech's COVID-19 vaccine for children 5 to 11, and CDC director Dr. Rochelle Walensky has signed off on the committee's recommendations.

Now vaccines will be available to eligible children across the country, and some locations have already begun offering shots.

At a news conference Wednesday, Walensky assured parents the science behind the decision to recommend the vaccine for younger kids is sound, and said the shots will protect them and others from getting sick.

“In clinical trials, vaccination was found to be nearly 91% effective in preventing COVID-19 among children ages 5 to 11. In clinical trials, vaccine side effects were mild, self-limiting,” she said. "The most common side effect was a sore arm."

Although younger children are now able to get vaccinated, many parents still have questions. Here's everything health experts want them to know about the vaccine.

Do kids need a COVID-19 vaccine? Is the COVID-19 vaccine safe for kids?

The American Academy of Pediatrics on Tuesday issued a release supporting the CDC advisory committee's decision.

"Vaccinating children will protect children’s health and allow them to fully engage in all of the activities that are so important to their health and development," the release says.

"The AAP recommends COVID-19 vaccination for all children and adolescents 5 years of age and older who do not have contraindications using a vaccine authorized for use for their age."

Many health experts are going on the record recommending children ages 5 to 11 get the Pfizer-BioNTech vaccine as soon as it becomes available.

“As pediatricians, our sole purpose is to take care of children and protect them,” said Dr. Stan Spinner, vice president and chief medical officer at Texas Children’s Pediatrics and Texas Children’s Urgent Care. “We feel very comfortable (with this vaccine). If we didn’t, we wouldn’t be recommending it.”

More:Parents were confused about kids and COVID. The American Academy of Pediatrics stepped in.

Hundreds of children ages 5 to 11 have been hospitalized with COVID-19, and 94 have died this year, the FDA has reported. It was the eighth-leading cause of death in the age group over the past year, after accidents, cancer, malformations, murder, heart disease, chronic lower respiratory disease, and flu or pneumonia.

Children appear to be just as likely as adolescents and adults to catch COVID-19 and pass it on, health experts say. Though they seem to be less likely to become seriously ill, health experts urge parents not to take that chance.

“A third of our pediatric patients admitted to the hospital ended up in the ICU with COVID,” Spinner said. “So it’s not a benign disease for anybody. ... Kids need the vaccine.”

Why should my kid get a COVID-19 vaccine?

Even with a mild infection, children are still at risk for developing a dangerous immune overreaction called multisystem inflammatory syndrome in children. COVID-19 has led to more than 5,000 cases of the condition; the average age is 9.

Children are less likely to have long-term symptoms of COVID-19 than adults, experts say, but they still can suffer from so-called long-haul COVID.

Recent data shows children are as likely to get infected by the delta coronavirus variant as adults, and about 50% of infections in children are asymptomatic, said Dr. Anthony Fauci, Biden’s chief medical adviser and the nation’s top infectious disease expert.

Fauci told reporters that vaccinating millions of children ages 5 to 11 will also stifle community transmission and nudge the country closer to herd immunity.

“If we can get the overwhelming majority of those 28 million children vaccinated, that would play a major role in diminishing the spread of infection in the community,” Fauci said.

If the pandemic is contained, health experts say, children will have more freedom to enjoy a sense of pre-pandemic normalcy, like going back to school with minimal restrictions and safely attending family events.

“The last point for why to vaccinate children now is to really allow kids the freedom to be kids,” said Dr. Emmanuel Walter Jr., professor of pediatrics at Duke University School of Medicine and chief medical officer of the Duke Human Institute.

More:Scientists examine the unique immune systems of kids as more get COVID-19

Where to get the COVID-19 vaccine for kids — Are pharmacies accepting appointments?

Pediatricians and primary care doctors, children's hospitals, pharmacies and clinics at schools are among the places where kids can get the vaccine.

The Biden administration said it has purchased enough vaccine to cover the 28 million American children in the 5 to 11 age group, and about 15 million doses will be available within the first week.

Those locations include more than 25,000 pediatricians’ offices and primary care sites, more than 100 children’s hospitals and health systems, tens of thousands of pharmacies, and hundreds of schools and community-based clinics. Administration officials say they are working with states and localities to enroll more sites.

CVS and Walgreens, the two largest pharmacy chains in the country, are accepting appointments for COVID-19 vaccines for children ages 5 through 11.

Did America’s schools open safely?We crunched the latest data on COVID and kids.

However, some sites are waiting until they have vials of vaccine before opening their appointment books.

By the end of the week, the government website Vaccines.gov will list places where kids can get vaccinated in their neighborhood, Zients said at a news conference Wednesday.

At that point, parents and guardians can go to the website, type in their ZIP code, click a box specifying they're looking for the Pfizer-BioNTech pediatric COVID-19 vaccine and get a list of clinics, physicians and pharmacies that have it available. The list is expected to expand over time as more sites open appointments.

When will the COVID-19 vaccine be available for kids?

Some locations around the country have already begun administering first doses to kids, and hundreds more sites are expected to open in the coming days as the national push to vaccinate about elementary school children ramps up.

Presidential advisor Jeffrey Zients said Monday the Biden administration's distribution program will be "running at full strength" to cover all 28 million American children in the age group the week of Nov. 8.

On Tuesday, President Joe Biden repeated the date in a statement, saying "the program will ramp up over the coming days, and fully up and running during the week of November 8."

Has the FDA approved the COVID vaccine for children?

On Friday, the Food and Drug Administration authorized Pfizer-BioNTech's vaccine for children 5 to 11.

However, this does not mean the vaccine is "approved" for kids.

Emergency use authorization allows Pfizer-BioNTech to provide safety and effectiveness data after tracking trial participants for an average of two months instead of the usual six months.

In the middle of a pandemic, it was more important to get vaccines to people faster, the FDA said, and vaccine side effects generally occur within the first four to six weeks after a shot.

The only age group that has official approval from the FDA is people 16 and older. Teenagers and children ages 12 to 15 have also been authorized to get the vaccine under emergency use.

An FDA official explains:Why don't COVID-19 vaccines have full authorization?

Where do children's vaccines from Moderna and Johnson & Johnson stand?

Moderna released its own study Monday finding that its COVID-19 vaccine at half the original adult dose is safe and effective in children 6 to 11. The company has not yet asked for authorization to provide its vaccine to this age group.

A Johnson & Johnson spokesperson told USA TODAY the company has started the first phase 3 study in adolescents ages 12 to 17 years and anticipates results for dose and regimen in the coming months.

What's the vaccine schedule and dose information for kids?

The vaccine would be given to children ages 5 to 11 in two shots, administered three weeks apart, at one-third of the dose given to adults and adolescents.

The adult dose of the Pfizer-BioNTech vaccine is 30 micrograms; the companies propose a 10-microgram dose in children ages 5 to 11.

The only difference in the children's Pfizer-BioNTech vaccine is the addition of one chemical called tri-sucrose. Tri-sucrose already is used in several other vaccines and makes the vaccine easier to dilute and remain stable in a refrigerator for up to 10 weeks, a Pfizer executive said.

What were the results of Pfizer’s vaccine study?

The FDA's Vaccines and Related Biological Products Advisory Committee met last Tuesday to hear information on the Pfizer-BioNTech vaccine from company officials as well as government experts who had reviewed the data.

Pfizer presented the results of several studies it has done among about 5,000 5- to 11-year-olds, which showed the vaccine was found to be safe with no severe vaccine-related side effects or dangerous allergic reactions.

In a subset of the children, the Pfizer-BioNTech vaccine was found to be more than 90% protective against contracting symptomatic COVID-19. Of the 19 children in the study found to be infected with the coronavirus, only three received the active vaccine, compared with 16 who received a placebo.

In one of the studies, of about half the children, more than 11% had obesity and nearly 8% had asthma. Both groups appeared just as well protected from the vaccine as children without those conditions.

"Those are the people who are at the highest risk of getting infected," Spinner said. "When we look at the children who have gotten sick, most of them had underlying conditions. Those are the ones that should be the first in line to get vaccinated."

Phase 3 clinical data presented last year showed the vaccine was 95% effective in adults. But new research that has not yet been peer-reviewed suggests efficacy may be closer to 84% after six months.

More on underlying conditions:CDC adds mental health disorders to list of conditions linked to higher risk of severe COVID-19. Here's why.

What are the vaccine side effects for kids?

The trials showed children experienced the same types of mostly minor side effects seen in adolescents and young adults.

Many of those ages 5 to 11 had sore arms, fatigue, headaches, muscle pain, chills and low-grade fevers that lasted a day or two.

One of the reasons researchers decreased the normal vaccine dose from 30 to 10 micrograms in children is to reduce the severity of side effects, said Jason Gallagher, clinical professor at Temple University’s School of Pharmacy and a clinical pharmacy specialist in infectious diseases at Temple University Hospital.

“A lot of the side effects that people complain about after getting the vaccine is related to the immune response,” he said. “Pfizer went back to the drawing board on dosing and found out that a lower dose (in children) is effective and safe than the dose we’ve been giving to teenagers and adults.”

What can I give my child if they don't feel well after getting vaccinated?

Health experts say parents can give their children over-the-counter medicine like acetaminophen, aspirin or ibuprofen to relieve any mild to moderate side effects after vaccination.

But the CDC does not recommend taking those medications before getting vaccinated in anticipation of side effects, because they might affect how well the vaccine works.

Walter also suggests preparing your child before vaccination to expect these mild side effects.

“Parents can have that discussion with their child that they may get a fever, they may feel a little achy or not feel as good the next day following vaccination and that’s to be expected,” he said.

Could schools require children to be vaccinated?

The Pfizer-BioNTech vaccine is available to children ages 12 to 18, and vaccine mandates for school vary by state.

The board of the Los Angeles Unified School District – which oversees the second-largest public school system in the country – voted to require students age 12 and up to be fully vaccinated. Those who take part in sports and other extracurricular activities should have taken both shots by the end of October and all other students by Dec. 19.

New York City’s school system, the nation’s largest, has required vaccinations only for 20,000 student-athletes in certain sports considered at high risk of spreading the virus.

More:California becomes first state to announce plans to mandate COVID-19 vaccine for schoolchildren

While some districts mull over COVID-19 vaccine mandates, some states have banned schools from requiring vaccines.

Health experts say it’s too soon to say if schools will mandate COVID-19 shots after authorization or approval, but vaccines in schools have helped eradicate some diseases in the U.S. like smallpox and polio.

“It’s to prevent disease in children themselves and prevent outbreaks in communities," said Dr. Sean O’Leary, a pediatric infectious disease specialist at Children’s Hospital Colorado. "And those school requirements have been longstanding for many decades and they’ve led to very successful control of vaccine-preventable diseases."

Will vaccinated children still need to wear masks?

Until a vaccine is available to children, public health experts, including the FDA's Peter Marks, have said that the best thing parents can do to protect their children – besides getting vaccinated themselves – is to encourage children to wear masks while indoors in public.

CDC guidance recommending fully vaccinated people to wear masks inside could remain in place even after children 5 to 11 can get their shots, health experts say.

“We’ve seen so much COVID-19 circulating in our communities, it will be critical to get the amount of transmission down before it’s likely the CDC might relax those guidelines,” said Dr. Evan Anderson, a physician at Children’s Healthcare of Atlanta and associate professor of pediatrics and medicine at Emory University School of Medicine.

He reminds parents that children may not have the full intended protection against COVID-19 until two weeks after their second dose and encourages them to continue following CDC and local school guidance regarding masks.

When will children under 5 years old be vaccinated?

The companies are also studying their vaccine in children ages 2 to 5, and 6 months to age 2, but those trials are not yet complete. Younger children are being tested on a 3-microgram dose.

Pfizer has reported it may have data by the end of the year. Before the vaccine becomes available to younger children and infants, the company will have to submit the data for FDA and CDC review.

The timing "is going to depend on what the data show,” O'Leary said. “I think that people’s best guess is early 2022, but there’s a lot of uncertainty around that guess.”

Contributing: Karen Weintraub, Elizabeth Weise and Nathan Bomey, USA TODAY. Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

COVID-19 vaccines for children under 12: When are they coming?

Eight months after adult Americans began receiving COVID-19 vaccines, children under 12 are still not eligible for the shots.

That's left a lot of parents worried their children might get sick – and might get others around them sick, as well.

Children can catch COVID-19 and pass it on to others. Luckily, they are less likely than adults to become seriously ill. Roughly 4.5 million American children have become infected with COVID-19 since the beginning of the pandemic, according to the American Academy of Pediatrics.

That number has risen lately, however, with children making up a higher proportion of the seriously ill. Many adults are protected by vaccines and the highly contagious delta variant now accounts for most of the infections in the U.S. Across the country. About 180,000 children have been infected in the past week, the American Academy of Pediatrics says.

We pose and answer several common questions about young children and COVID-19 vaccines:

What age group can currently get COVID-19 vaccines?

Adults and children 12 and up are eligible to receive the Pfizer-BioNTech vaccine, now called Comirnaty.

Only adults are eligible to receive the Moderna and Johnson & Johnson vaccines because their studies in children have not yet been completed.

Why aren't COVID-19 vaccines available yet for kids under 12?

Traditionally, drugs are studied first in adults and then move to adolescents, then children, then younger children, as they are proven safe and effective in each group.

With COVID-19 vaccines, large clinical trials in adults (and in the case of Pfizer-BioNTech, older teens) took place in the second half of last year and studies in teens and then younger children began earlier this year.

Read more:Pfizer's vaccine is FDA-approved for adults, but it's still a 'no-no' to vaccinate kids under 12

More colleges are requiring the COVID-19 vaccine. Some are starting to kick out unvaccinated students.

What's the status of clinical trials on younger children?

All three companies are studying their vaccines in children, first in adolescents, then 5- to 11-year-olds, then 2- to 5-year-olds followed by infants, 6 months and up. Younger babies are believed to have some protection from their vaccinated mothers. Last week, the Centers for Disease Control and Prevention recommended that pregnant people get vaccinated to protect themselves because they are at higher risk for a serious COVID-19 infection, and their unborn child would receive some protection.

Because the vaccines were already proven safe and effective in tens of thousands of adults, the studies in children have been allowed to be smaller – on the order of 3,000-4,000, instead of 30,000-40,000.

Children are less likely to become seriously ill with COVID-19 than older adults, with risks generally declining with age. So regulators want to make sure that vaccines are safe enough to justify use in each age group.

Advisory panels to the CDC and the Food and Drug Administration decided that the benefits outweigh the risks of the Pfizer-BioNTech vaccine for adolescents age 12 to 15.

Pfizer-BioNTech has said its study in children ages 5 to 11 should be completed early this fall, and in younger children early next year.

Moderna began its trials several months after Pfizer-BioNTech, so it is likely to complete its trials some time later, though it has not released a detailed timetable.

In May, the company showed its vaccine was safe and extremely effective in adolescents. Out of 3,700 12- to 17-year-old volunteers, no one who was fully vaccinated with the active vaccine developed the virus, the study found.

J&J hasn't yet started its studies in minors, though it is in active discussions with the FDA to begin four trials with a minimum of 4,500 children. The first trial, in adolescents 12 to 17, is expected to begin this fall with the others to follow.

When will the COVID-19 vaccine be available for kids under 12?

The FDA requires longer-term follow-up data on children than adults, "to make sure that the safety is adequate," according to Dr. Peter Marks, who heads the FDA division tasked with reviewing vaccines.

The FDA has not given a sense of how long it would take to review the research, but previous emergency use authorization requests have taken as long as eight weeks, suggesting that vaccines are unlikely to be available to grade schoolers until very late this year or early next.

Two- to 5-year-olds should be able to get shots by the end of winter or early spring 2022.

Is the vaccine dosage the same for children as adults?

The dose is the same for 12- to 15-year-olds as for adults, but dosage for younger children is likely to be lower. That's one of the things being worked out in the trials.

In early trials, Pfizer-BioNTech said 112 children received doses of 10, 20, or 30 micrograms, with an option for 3 micrograms in the youngest children.

Currently, they are testing 10 micrograms in 5- to 11-year-olds and 3 micrograms in children under 5. Adults and adolescents get 30 micrograms.

Is the COVID-19 vaccine safe for kids?

In adolescents, the vaccines seem to be as safe as they are in adults, though teens may be more likely to suffer side effects like post-vaccine pain, fatigue and fevers.

The risk of heart inflammation, called myocarditis, also appears to be higher in younger people, particularly males, after vaccination.

'Keep your guard up': CDC studies show waning COVID vaccine efficacy as delta variant sweeps US

Why shouldn't parents try to vaccinate their younger children now?

Legally, now that the Pfizer-BioNTech vaccine has received full FDA approval, doctors can prescribe it to anyone, including young children.

But the FDA and leading pediatricians warned this week that it's a terrible idea to give shots designed for adults to children under 12.

The dose is likely to be more than they need, causing unnecessary side effects, according to the American Academy of Pediatrics, which has urged the FDA to expedite the process of authorizing shots for younger children.

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

COVID vaccine for kids 5-11 are coming: What we know and what ...

The Pfizer-BioNTech COVID vaccine could become available for children ages 5 to 11 as soon as next week.

Serious COVID-19 infections have been rare among the 28 million American children ages 5-11.

Younger children will be given a Pfizer-BioNTech vaccine dose one-third as large as the dose given to those over 12, to minimize side effects while maintaining effectiveness.

Corrections & clarifications: An earlier version of this story incorrectly reported the estimated number of children who received the Pfizer-BioNTech active vaccine in clinical trials.

The evidence supporting COVID-19 vaccines in adults is clear. In August, an unvaccinated adult was six times more likely to test positive and 11 times more likely to die from COVID-19 than someone who was vaccinated.

The story, though, isn't as clear-cut with children ages 5 to 11, according to data presented Tuesday by the Food and Drug Administration and the Centers for Disease Control and Prevention.

After listening for hours to government experts and officials from Pfizer-BioNTech, an advisory panel to the FDA concluded the benefits of vaccination outweigh the risks for this age group.

A similar discussion will take place next week at an all-day meeting of a CDC advisory panel. If they sign off, along with FDA and CDC officials, as seems likely, vaccines could become available for children ages 5 to 11 as soon as the middle of next week.

How does COVID-19 affect me? Don’t miss an update with the Coronavirus Watch newsletter

That means parents are likely soon to be faced with a choice: Would they rather take the small chance of their child falling seriously ill from COVID-19, or the even smaller chance that they will be harmed by the shots intended to protect against it?

To help with that decision, USA TODAY has summarized the data presented to the FDA panel, including what is known and what remains unknown.

Even without vaccination, it's possible to protect children by wearing masks indoors and vaccinating the adults in their lives, CDC Director Dr. Rochelle Walensky said at a White House briefing Wednesday.

COVID-19 in younger children

Serious COVID-19 infections have been rare among the 28 million American children ages 5-11.

According to one study, as many as 42% of children in this age group have been infected since the start of the pandemic, leading to more than 8,000 hospitalizations and just under 100 deaths.

Cases in children spiked this summer, because of the delta variant, though children do not appear to be getting sicker from this variant than from others.

Although at substantially lower rates than in adults, children ages 5-11 can also suffer from lingering symptoms of COVID-19 infections – including monthslong fatigue, pain, headaches, insomnia and trouble concentrating.

All children, regardless of age, can catch and pass on COVID-19, a recent Harvard study confirmed.

It's also become clear over the past year how important it is to keep children in school, and vaccinating kids would undoubtedly reduce the number of school closures, which have kept more than 1 million children away from their classrooms this fall.

In the 2019-2020 flu season, considered a bad year for the virus, 107 children ages 5 and older died of flu. More children have been hospitalized with COVID-19 than were hospitalized with flu in 2017-2018. Millions of parents choose to vaccinate their kids against flu to protect them and elders.

Pfizer, Moderna and Johnson & Johnson:Comparing the COVID-19 vaccines

Risks of vaccination for kids 5-11

Every vaccine brings some risks.

In this case, the risks are theoretical. None of the roughly 3,500 children who received the Pfizer-BioNTech vaccine in clinical trials suffered a serious side effect tied to the shots, according to company data reviewed by the FDA.

Those who oppose vaccination in kids, who flooded the inboxes of advisory panel members last weekend, argued vaccines are unnecessary in this age group, because so few children have been seriously harmed by their COVID-19 infection.

Benefits of COVID-19 vaccination

Pfizer-BioNTech's COVID-19 vaccine is clearly effective in children 5-11, preventing more than 90% of infections, according to one study in about 2,500 children.

The vaccine appears to be safe, with most side effects in line with those experienced by adolescents and adults, including temporary pain at the injection site, headache, fatigue and low-grade fevers.

Younger children will be given a Pfizer-BioNTech vaccine dose one-third as large as the dose given to those over 12, to minimize side effects while maintaining effectiveness.

The only member of the Vaccines and Related Biological Products Advisory Committee to abstain from the vote, Dr. Michael Kurilla, expressed concern in a later statement about the duration and strength of protection.

Children in the trial were only followed for a few months, he noted, and since at least half of children in this age group see no symptoms when infected with COVID-19, he thought the studies overestimated the risk of infection and therefore the benefit of vaccination.

What we still don't know

There remain unanswered questions about how children ages 5-11 will respond to vaccines:

What about rare side effects? Pfizer-BioNTech's safety trials included about 5,000 children, which is not enough to identify rare side effects.

The potential side effect of greatest concern is called myocarditis, a swelling of the heart muscle that can also be caused by COVID-19. Myocarditis after vaccination has been seen mainly in adolescents and young adults, mostly male, after their second dose of vaccine.

Out of every million 16- and 17-year-old boys who have been vaccinated, 69 have developed the condition, compared to just two out of every million men in their 40s. None has died.

Tracking COVID-19 vaccine distribution by state:How many people have been vaccinated in the US?

Myocarditis is more common generally in older teenagers and young adults and lower in the 5- to 11-age group, but it's not clear whether that would be true if caused by the vaccine.

"We're worried about a side effect that we can't measure yet, but it's probably real," said committee member Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine and an infectious disease expert at Brigham and Women's Hospital and the Harvard T.H. Chan School of Public Health.

"We're never going to learn how safe it is until we start giving it," he added.

What about long-term effects and benefits? As with adults, vaccines in children are unlikely to cause long-term health effects not seen within the first weeks after the shots. In one of two studies, children were followed for an average of two months; in the other, just a few weeks so far.

The Pfizer-BioNTech vaccine, like the one from Moderna, triggers the body to produce a harmless protein found on the surface of the virus that causes COVID-19, so the immune system will recognize it and respond if it sees the complete virus.

This production does not last long and the messenger RNA used to deliver the vaccine does not stick around long or get into the cell nucleus where the DNA is stored, so it cannot make fundamental changes to the cell's activities.

As with the adult vaccines, it's unknown how long a COVID-19 vaccine will protect a child ages 5 to 11 against infection or whether boosters will be needed.

Committee member Dr. Paul Offit said he always wishes he had more information, but felt he had enough in this case to decide in favor of vaccinations.

"It's always nerve-wracking when you're asked to make a decision for millions of children based on studies of only a few thousand," said Offit, an infectious disease expert at The Children’s Hospital of Philadelphia. "For me, I think I know enough to move forward with a 'yes' vote."

Other factors to consider for parents

Infection rates:An FDA analysis of the vaccine's safety and effectiveness in kids concludes that the benefits outweigh the risks until infection rates fall below 5% of those at their height in September.

Infection rates are falling right now throughout most of the country, but is not clear whether they will climb again with the winter (respiratory viruses like COVID-19 tend to increase in winter) or whether a new variant will pop up that will make vaccination more important.

Previous infection: A child who has already been infected with COVID-19 carries some protection against the virus and is less likely to fall seriously ill. Generally, a vaccine provides more predictable protection than infection, but an infection may offer broader protection against variants, studies in adults have shown.

A child's vulnerability: Children who are immunocompromised or have health issues like obesity and metabolic disease are at higher risk for serious cases. Two-thirds of children hospitalized for COVID-19 have had preexisting health conditions. A child in this category may benefit more from vaccination than a healthy child.

Also, children of color – Black, brown or Native American – have been hospitalized at three times the rate of white children, CDC epidemiologist Fiona Havers told the committee Tuesday. Perhaps because of their family's exposures and their own health risks, they may benefit more from vaccination.

Mapping coronavirus:Tracking U.S. cases and deaths

"I do believe that children at highest risk do need to be vaccinated," said Dr. James Hildreth, a committee member and president and CEO of Meharry Medical College in Nashville, Tennessee.

Hildreth voted along with the majority of the committee, supporting vaccines, but said he struggled with the decision, because he doesn't think all children need to be vaccinated.

"In some ways we're vaccinating children to protect adults, and it should be the other way around," he said. "Our focus should be on vaccinating adults to protect the children."

The vulnerability in the child's life: If the child lives with an immunocompromised parent or an older relative, vaccination may make more sense. Though it's not clear whether vaccines reduce transmission, a child who is vaccinated may be less likely to pass on the virus.

A parent's anxiety level: There are no known serious risks from vaccination and its effectiveness is clear, so a parent who would feel better if their child is vaccinated can easily justify their decision.

"Parents are terrified of sending their kids to school," said Dr. Jay Portnoy, a pediatric immunologist and allergist at Children's Mercy Hospital in Kansas City, Missouri, who said he wanted to give them a chance to decide whether to get their child vaccinated.

"The evidence is pretty clear that this vaccine is worthwhile," he concluded.

Kurilla came to a different conclusion. In his statement about abstaining, he ended by saying: "While there are clearly high risk groups in the 5-11 age group for which the vaccine would significantly reduce serious disease, I do not expect protection from infection to last more than a few months and this may negatively affect public perception of vaccines."

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

Covid-19 vaccine for children under 5 could come as early as June ...

(CNN) Covid-19 vaccines could be authorized for the United States' youngest children as early as June, according to the US Food and Drug Administration's latest meeting schedule .

The agency announced Friday it is reserving dates in June for its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to meet to discuss updates to vaccine makers Moderna and Pfizer/BioNTech's emergency use authorizations that would include making younger ages eligible for Covid-19 vaccination.

Tentative meeting dates for VRBPAC are June 8, 21 and 22.

Following the advisory committee's deliberations, FDA officials could consider authorizing vaccines for younger children — with that decision also hinging on the agency's reviews of the vaccine data.

"As we continue to address the ongoing COVID-19 pandemic, there are a number of anticipated submissions and scientific questions that will benefit from discussion with our advisory committee members," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in Friday's announcement

"We are providing a tentative schedule for discussion of these submissions, as these meetings will cover a number of topics that are of great interest to the general public," Marks said. "The agency is committed to a thorough and transparent process that considers the input of our independent advisors and provides insight into our review of the COVID-19 vaccines. We intend to move quickly with any authorizations that are appropriate once our work is completed."

It has been more than a year since adults first became eligible to receive Covid-19 vaccines in the United States, and currently, children 5 and older are eligible to get vaccinated. But no Covid-19 vaccines have been authorized yet for children younger than 5 in the US -- about 18 million people -- and, even though FDA advisers plan to meet in June, an exact timeline for potential authorization is still not clear.

Moderna officials have said the FDA is expected to move fast, and a Pfizer official suggested its vaccine for younger children could be available in June, if it's authorized.

Why is it taking so long to get vaccines for children under 5?

The timeline for making Covid-19 vaccines available for children under 5 hit somewhat of a delay earlier this year when a VRBPAC meeting to discuss the Pfizer/BioNTech vaccine in February was postponed so that additional data on vaccines for this age group could be reviewed.

At the time, the FDA was waiting for Pfizer and BioNTech to submit data from an ongoing trial on a three-dose regimen in these younger children before moving forward with consideration of an emergency use authorization, allowing the FDA to review all data available on the efficacy of each regimen option: two doses or three doses.

If the original meeting had occurred in February, the committee would not have seen all available data to have an informed discussion. The latest clinical trial data from Pfizer/BioNTech suggests that in this age group, two doses seemed to work well against the Delta coronavirus variant but not against the Omicron variant.

As for Moderna's Covid-19 vaccine, the company announced Thursday that it is seeking emergency use authorization from the FDA for children 6 months through 5 years of age.

Just recently, in late March, Moderna announced results of a clinical trial that included 2,500 children ages 6 months through 24 months and 4,200 children ages 2 through 5. The company said that two 25-microgram doses of its vaccine led to a similar immune response in young children as two 100-microgram doses for adults ages 18 to 25. And it said this should predict protection from Covid-19 and severe Covid-19 down to 6 months of age.

While Moderna has shared some data on two doses of Covid-19 vaccine for younger children, Pfizer and BioNTech's data on three doses for younger children is not yet available.

The FDA is weighing whether to consider emergency use authorization for both the Pfizer/BioNTech and Moderna Covid-19 vaccines for young children at the same time, rather than considering them separately, Dr. Anthony Fauci, chief medical adviser to President Biden, said last week.

"Two products that are similar but not identical, particularly with regard to the dose, and what the FDA wants to do is to get it so that we don't confuse people to say 'this is the dose. This is the dose regimen for children within that age group of 6 months to 5 years,' " Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN's Kasie Hunt.

The Pfizer vaccine was made to protect against the original strain of the coronavirus, and the initial series of two 3-milligram doses tested in kids under 5 wasn't powerful enough to keep them safe from the more infectious Omicron variant.

"It didn't meet the criteria for efficacy," Fauci said. "There was never a safety issue, but it didn't meet the criteria, which then had them go back and do a study with a third dose as a part of the primary regimen."

Pfizer CEO Albert Bourla said publicly that the company's goal is to have its Covid-19 vaccine available for young children by summer.

How long would it be for my child to get the vaccine after authorization?

If the FDA authorizes the shots, vaccine advisers to the US Centers for Disease Control and Prevention next will vote on whether the vaccine should be recommended for young children. The CDC director will then need to sign off on a vaccine recommendation before shots can be administered.

That process could happen as quickly as within just a few days.

How many kids 5 and older have already received a Covid-19 vaccine?

The youngest group eligible to be vaccinated against Covid-19 in the US, children ages 5 to 11, is also the least vaccinated one, according to the latest CDC data

Just over a third of 5- to 11-year-olds are fully vaccinated.

But vaccination rates are twice as high among adolescents, and overall, about 43% of currently eligible children ages 5 to 17 are fully vaccinated -- about 23 million in all.

Overall, as of Friday, about 66% of the US population is fully vaccinated, including 76% of adults and 90% of seniors. Among adolescents ages 12 to 17, the vaccination rate is 69%.

What's the risk to kids under 5 if they get Covid-19?

Even though children are far less likely than adults to be hospitalized or to die from Covid-19, it is not a benign disease in young ages, according to the American Academy of Pediatrics (AAP).

The number of new Covid-19 cases among children in the US grew nearly 12% last week from the week before, the AAP announced Monday , but they made up a smaller share of all new cases than they did the week before.

About 37,073 kids tested positive for Covid-19 during the week ending April 21, the second consecutive week of increasing child cases after months of declines.

However, this was 16.3% of all new Covid-19 cases in the US last week, 10 percentage points less than the week before.

Overall, during the Omicron surge, more children were sent to the hospital than in earlier waves. Among states that report hospitalization information by age, kids were 1.2% to 4.6% of the total cumulative hospitalizations, a number that has remained consistent for the past four weeks and has stayed relatively steady throughout the pandemic.

Among states that reported mortality data, kids were up to 0.27% of all Covid-19 deaths, a number that has also remained steady.

For now, how can I protect my child until the Covid-19 vaccine is available?

While parents are waiting to vaccinate their little ones, there is something they can do to protect the children.

All adults who interact with the children should be vaccinated, the experts say, and ideally boosted. Adults are also advised to use masks around unvaccinated children, even as many mandates have fallen away.

Get CNN Health's weekly newsletter Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team.

Dr. Doran Fink, who oversees the FDA's clinical and toxicological review of investigational and US-licensed vaccines, said in a meeting of the CDC's Advisory Committee on Immunization Practices this month that he understood parents' concerns. He also promised that the FDA would work "diligently" to verify any data submitted.

"We know that many parents and caregivers and health care providers are anxious to have Covid vaccines available for this age group," Fink said. "I do want to reassure the committee and the public that we understand this concern, and we want to have available safe and effective vaccines for all age groups who will benefit from them."

Pfizer COVID vaccine: Next phase of trials in young children to begin

Pfizer released details Tuesday about the progress of its COVID-19 vaccination trials in children, showing that they have completed early testing and are moving forward with lower-dose trials in younger kids.

Children are less likely than adults to have a serious case of COVID-19, so drug companies are trying to minimize vaccine side effects while maximizing benefits.

For now, Pfizer, which collaborates with German biotech BioNTech, is testing its vaccine at lower doses in grade schoolers than adolescents and still lower doses in younger children.

Pfizer and BioNTech already have studied their vaccine in 2,260 adolescents age 12 to and 15 and received authorization to provide them shots in the United States. Their vaccine trials showed that adolescents developed a strong antibody response to the virus. The vaccine prevented infections and did not lead to intolerable side effects.

The companies also have completed early trials in a small number of younger children to show safety and establish relevant vaccine doses. As is typical with trials in children, volunteers have been divided into three age groups: ages 5 to 11, 2 to 5, and 6 months to 2 years.

Vaccines 2.0: Next-generation COVID-19 shots will be cheaper, easier to deliver and protect against more viruses, industry leaders say

The 112 children in those trials received doses of either 10, 20 or 30 micrograms, with an option for 3 micrograms in the youngest children.

Larger trials to evaluate safety and immune response have already begun in 5- to 11-year-olds at 10 micrograms and are expected to begin in the younger age groups in the next few weeks, according to a statement from Pfizer. Children under 5 will receive the 3 microgram dose.

Those trials will include 4,500 volunteers across all three age groups in the U.S., Finland, Poland and Spain. Trial organizers are working to ensure a diversity of trial participants, the company said.

One child will receive a placebo for every two that get the active vaccine. Children who receive the placebo will be given the option to get the active shots if the vaccine is authorized within six months of their participation.

More:How does COVID-19 end in the US? Likely with a death rate Americans are willing to 'accept'

If those trials prove safety and immune response, the companies expect to request federal authorization in September or October to provide the vaccine to children ages 5 to 11, and a little later in the fall for younger children.

At a later date, the companies may consider vaccinating infants once they confirm safety in older children.

As with adults and older teens, the Pfizer-BioNTech vaccine will be given to children with two shots, spaced about three weeks apart.

Unlike adults, the companies will not be required to prove that the vaccines prevent most infections – which is no longer practical because of low rates of infection in the U.S. and even lower rates among children. Instead, vaccine makers will have to show that their shots produce an equivalent or better immune response than in young people 16 to 25.

Moderna and Johnson & Johnson, which also make authorized COVID-19 vaccines, are testing their shots in children as well.

To volunteer your child for a Pfizer-BioNTech trial, click here.

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

FDA advisers to review, likely recommend COVID-19 vaccines for ...

An FDA expert advisory panel meets this week and will likely recommend two COVID vaccines for the youngest children.

The vaccines under review are Moderna's for ages 6 months to 17 years and Pfizer-BioNTech's for children ages 6 months to 5 years.

If the vaccines are authorized this week, they would become available as soon as June 21, the Biden administration has said.

A federal advisory panel is likely this week to recommend two COVID-19 vaccines for the youngest children, as well as a second option for older kids whose access has been limited to Pfizer-BioNTech shots.

According to detailed information made public Friday and Sunday, Food and Drug Administration staff reviewed safety and effectiveness data for the Moderna vaccine for people ages 6 months to 17 years and for the Pfizer-BioNTech vaccine for children ages 6 months through 4 years.

The review was positive, raising no new safety issues or concerns about trial data, most of which had been released by the companies.

An FDA expert advisory panel will hold all-day meetings Tuesday and Wednesday to discuss the data, but the staff review suggests that there will be no major surprises and that the panel will recommend authorization of both vaccines.

If that happens and the FDA commissioner signs off on the shots, the Centers for Disease Control and Prevention will follow the same process, and a different expert advisory panel will do a review Friday and Saturday. The CDC director would have to endorse the vaccines before the companies would be allowed to provide them.

The Biden administration said that if the vaccines are authorized this week, they would become available as soon as June 21 (a day after the federal Juneteenth holiday) at pharmacies, pediatricians' offices, libraries, children's museums, health centers and other outlets.

The federal government pre-purchased vaccine doses, which will be provided at no cost to families.

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Advocates are eager for vaccines to finally be extended to young children, the only major group of Americans left unprotected by vaccines.

"This moment is bittersweet," said Fatima Khan, co-founder of Protect Their Future, a grassroots group of physicians, parents and activists. "We're grateful to access a safe vaccine but also troubled by how long it took. … We must learn from this experience and fix root bureaucratic issues that caused the delays so that our children are never left behind again."

The only vaccine available for children has been Pfizer-BioNTech's, authorized for those 5 and up. Traditionally, drugs and vaccines are studied first in adults, then in adolescents and progressively younger children, moving down in age as safety and effectiveness are proved in older groups.

Babies younger than 6 months are not expected to receive a COVID-19 vaccine. Instead, vaccination during pregnancy, which has been safe, passes on protection that lasts for about the first six months of life.

Companies determined the most effective doses of COVID-19 vaccines for each eligible age group, while minimizing side effects.

Pfizer-BioNTech offers adults and adolescents a two-dose initial vaccine series, with 30 micrograms of active ingredients in each shot. Children ages 5-11 receive 10 micrograms of the vaccine, and the youngest children would get a 3-microgram dose.

Pfizer and its German partner, BioNTech, found that two doses were not adequately protective against the omicron variant of the coronavirus, so they asked the FDA and CDC to authorize a three-dose series for children ages 6 months through 4 years old. Older children are authorized to receive a booster dose to protect against the latest variants.

Adults get two 100-microgram doses of the Moderna vaccine, which is based on the same mRNA technology as Pfizer-BioNTech's, for their initial series. The company proposed the same dosage for teens, two 50-microgram shots for younger children and two 25-microgram doses for the youngest children.

Moderna tested its vaccine in two doses only, and it appears less effective in the youngest children.

On Tuesday, the FDA advisory panel, called the Vaccines and Related Biological Products Advisory Committee, will review data on Moderna's vaccine for children 6 to 17.

On Wednesday, the panel will decide whether to recommend Moderna and Pfizer-BioNTech's vaccines for children as young as 6 months.

Vaccine side effects, dosage for children and what studies have found

Vaccine side effects in the youngest age groups were similar to those in older children, including short-term fever and redness at the injection site, studies showed.

Neither vaccine trial in young children found any cases of allergic reactions to the shots or myocarditis, the swelling of the heart muscle occasionally seen among adolescent boys and young men after vaccination.

In the Pfizer-BioNTech trial, three shots – the third given at least eight weeks after the second – protected more than 75% of children ages 6 months to 2 years and 82% of those ages 2 to 5, and there was no significant increase in side effects. The trial included about 4,500 children in five countries; twice as many participants got the active vaccine than got a placebo.

The Pfizer-BioNTech trial had been designed to wait for results until 21 children in either the placebo or active vaccine group contracted COVID-19. Although cases have risen in recent weeks, only 10 had tested positive for the coronavirus this month, so technically, the effectiveness results are considered preliminary.

In Moderna's trial of 6,700 children ages 6 months to under 6, company researchers found that two 25-microgram doses led the children to develop levels of virus-fighting antibodies comparable to young adults who received two full-strength shots.

In the study, which took place during the omicron wave, researchers found the vaccine was 51% effective among children 6 months to under 2 and 37% effective among children 2 to under 6.

Among older children, a 50-microgram dose appeared to be safe and effective, according to company data and the FDA analysis.

Moderna filed a year ago for authorization of its vaccine in adolescents, but the FDA held the application, awaiting more information on the risks of myocarditis after vaccination. The committee will review more recent data and decide whether the benefits of the vaccine outweigh the risks of myocarditis in that age group.

Teens and young adults, particularly males, appear to be at the highest risk for this side effect, though it is generally milder than the myocarditis caused by infection with COVID-19.

5 million doses of each vaccine available by June 21

The FDA advisory panel is likely to make a recommendation at the end of each day's meeting: Tuesday on Moderna's vaccine for children ages 6-17 and Wednesday on both vaccines for young children.

Administration officials said last week they started accepting state and local orders for the shots and expect to have 5 million doses each of Pfizer-BioNTech and Moderna vaccines for young children available on June 21 and millions more soon thereafter.

"If the FDA and the CDC recommend these vaccines, this would mark an important moment in the pandemic," Dr. Ashish Jha, the White House COVID-19 response coordinator, said at a news conference last week. "It would mean that for the first time, essentially every American – from our oldest to our youngest – would be eligible for the protection that vaccines provide."

Contributing: Adrianna Rodriguez

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.