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 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.

CDC recommends Pfizer COVID-19 vaccine for kids 5-11, shots ...

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 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."

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 vaccine for kids: FDA panel likely to recommend Pfizer ...

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.

Those ‘free’ COVID-19 tests? Labs rake in millions in tax dollars, study says

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.

FDA authorizes COVID vaccines for kids as young as 6 months old

America's youngest children could soon have access to two COVID-19 vaccines.

An expert panel on Wednesday unanimously found Moderna's vaccine safe for children 6 months to 6 years old, providing protection against COVID-19. The committee voted to support a Pfizer-BioNTech vaccine for children ages 6 months to 5 years.

Friday, the Food and Drug Administration's commissioner gave emergency authorization to both vaccines, and an advisory panel for the Centers for Disease Control and Prevention began two days of hearings on how the shots should be used. If they sign off and then the head of the CDC, vaccines will be available for young children as soon as Tuesday.

Although young children have largely been spared the worst of COVID-19, they can become seriously ill, and more than 200 have died from infections, according to data presented by the FDA.

Half of the young children hospitalized with COVID-19 did not have any preexisting conditions before they fell ill, the FDA said.

Because risks from COVID-19 infection in young children are relatively low, the risk of side effects from the vaccines must also be low to justify their use.

Committee members said they want to give parents the option to vaccinate their youngest children.

"We've got to be transparent about the real risks of COVID-19 for children. Tens of millions of children in this age group have been infected and have done just fine," said Dr. James Hildreth Sr., CEO of Meharry Medical College in Nashville, Tennessee. "For those parents who choose to do so, especially those parents of kids that have underlying conditions, this is a choice they should have, and I'm pleased that they'll have it."

Dr. Jay Portnoy, an allergist at Children’s Mercy Hospital in Kansas City, Missouri, said he hopes the committee's decision will help parents who have lived in fear of their child catching COVID-19. "This will certainly alleviate a lot of their concerns," said Portnoy, the patient representative on the committee. "I think it was the right vote."

Every other age group of Americans has long had access to the vaccines, except babies younger than 6 months old, who can get protection from the parent's vaccination during pregnancy.

The committee voted almost 18 months ago to approve vaccines for adults, first from Pfizer, then from Moderna.

"Essentially all of the American population can now choose to get vaccine," said Arnold Monto, an infectious disease epidemiologist at the University of Michigan in Ann Arbor, who chaired each of the meetings.

The committee voted 21-0 that Moderna's vaccine met the FDA's criteria for safety and effectiveness in the youngest children and that its benefits outweigh its risks. It voted the same way to support the Pfizer-BioNTech vaccine.

Adding a layer of confusion for parents, Moderna studied its vaccine in two doses; Pfizer-BioNTech found three doses of its vaccine were needed to provide adequate protection during a wave of infections caused by the omicron variant of the coronavirus.

Moderna recipients will probably need a third shot to receive protection against circulating variants, committee members, FDA staff and the company said, although the review covered only two doses.

Because the two vaccines were studied separately, they cannot be compared directly.

Committee members said they worry the Pfizer-BioNTech vaccine won't provide much protection until after the third dose; Moderna's shot may provide more protection faster.

Moderna's shots are given four weeks apart, meaning a child could have some protection against infection and severe disease by midsummer. A child would have to wait until two doses of Pfizer-BioNTech's vaccine three weeks apart and a third dose eight weeks later – roughly three months – to get protection.

Dr. Paul Offit, a vaccine expert at the Children's Hospital of Philadelphia, said Pfizer-BioNTech may have chosen too low of a dose for young children. He said he's worried parents will think their child is protected after two doses and will take fewer precautions to prevent COVID-19.

Before either vaccine can be made available, the FDA commissioner must sign off on them, which he is likely to do almost immediately.

A second expert advisory panel, this time for the CDC, is scheduled to consider the vaccines Saturday. If the CDC director approves the shots, they are set to roll out Tuesday.

The Biden administration allowed preorders of up to 10 million vaccine doses for young children, half of Moderna and half of Pfizer-BioNTech, which would be made available at pediatricians' offices, pharmacies, clinics, some libraries, children's museums and other venues.

The government pre-purchased vaccines, so parents won't have to pay for them.

Tuesday, parents are likely to have access to Moderna's vaccine for older children. Until now, only Pfizer-BioNTech could be provided to children, but this week, the FDA advisory committee said the benefits of Moderna's vaccine outweighed its risks. The FDA commissioner is likely to sign off on the vaccine and the CDC advisory committee to review it on Friday.

Vaccines available to children are the same as those for adults but in lower doses.

Adults receive two 30 microgram doses of the Pfizer-BioNTech vaccine three weeks apart, followed by a booster at least five months later. Adolescents receive the same dose, children 5 to 11 receive three 10-microgram doses on the same schedule and children 6 months to 5 years would get three 3-microgram doses.

Adults receive two 100-microgram doses of the Moderna vaccine a month apart, followed by a 50-microgram booster at least six months later. Adolescents would have the same dose and schedule, once shots and boosters are authorized.

Children 6 to 11 would receive two 50-microgram initial doses and a 25-microgram booster, and younger children would receive two 25-microgram doses, followed by a 10-microgram booster.

Committee members spent much of the question-and-answer period Wednesday trying to understand whether one COVID-19 vaccine is more effective in small children than the other, but they were frustrated by the lack of data.

Both vaccines appear to be safe. Short-term side effects such as fever and fatigue are fairly common, but there's been no evidence of the more serious side effects seen rarely in adults: severe allergic reactions and myocarditis, a swelling of the heart muscle.

Like adults, young children generally had more side effects after a second dose, except if they had previously been infected with COVID-19, in which case they felt more effects from the first dose. Otherwise, there were no safety differences noted in children infected with COVID-19 before vaccination, and they appeared to have greater protection against the virus, based on their levels of protective antibodies.

As the studies in small children were relatively small – 5,000 who received at least one dose of the active vaccine in Moderna's trials and 3,000 in Pfizer-BioNTech's – those rare side effects or others could turn up as more children are vaccinated.

As with adults and older children, it's unclear how long COVID-19 vaccines will be protective or whether boosters will be needed.

Both companies will continue to study the effects of their vaccines in young children, including those with immunocompromising health conditions.

Committee member Dr. Archana Chatterjee, a pediatric infectious disease specialist and dean of the Chicago Medical School, said the data analyzed by the FDA convinced her that both vaccines are safe and effective.

"As a pediatrician, today is a red-letter day for me," Chatterjee said. "To be able to vote for authorization of two vaccines that will protect children down to 6 months of age against this deadly virus is a very, very important thing."

Contributing: Elizabeth Weise

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 authorizes Covid-19 vaccines for younger children | CNN

(CNN) The Moderna and Pfizer/BioNTech Covid-19 vaccines are now authorized for emergency use in young children. The US Food and Drug Administration expanded the authorizations for the vaccines Friday to include children as young as 6 months.

However, shots can't be given until the US Centers for Disease Control and Prevention's vaccine advisers have voted on whether to recommend them -- a vote is scheduled for Saturday -- and CDC Director Dr. Rochelle Walensky has signed off on that recommendation. The White House has said vaccinations for younger children may begin next week.

Moderna's vaccine is now authorized for use in children 6 months through 17 years and Pfizer/BioNTech's for children 6 months through 4 years. About 17 million kids under the age of 5 are now are eligible for Covid-19 vaccines.

"Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age. As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death," FDA Commissioner Dr. Robert M. Califf said in a news release . "Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data."

Previously, the Pfizer/BioNTech vaccine was authorized for people 5 and older and approved for 16 and up, and Moderna's vaccine was authorized only for adults.

Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, called Covid-19 vaccines for younger age groups a "milestone."

"It is a bit of a milestone to bring down the age range for these vaccines as we work through this," Marks said Wednesday in a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee.

In that meeting, the committee members voted unanimously in favor of expanding the authorizations to include children as young as 6 months.

"To be able to vote for authorization of two vaccines that will protect children down to 6 months of age against this deadly disease is a very important thing," said committee member Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University.

She compared the day to December 2020, when the first Covid-19 vaccines were authorized for adults and older teens.

"I'm really pleased that we've reached this kind of milestone," said committee member Dr. Ofer Levy, of the Precision Vaccines Program at Boston Children's Hospital, who also likened the moment to when Covid-19 vaccines previously were authorized for other age groups.

"I recall our first vote a year ago or more on the first Pfizer authorization," Levy said. "I was one of the 17 votes in favor. I remember those early discussions -- even then, should the 16- and 17-year-olds be included? At that point, that was a controversial topic that was being discussed. And here we are now, as a committee unanimously recommending authorization down to 6 months of age. So we've come a long way."

Will the youngest children get vaccinated?

Many public health experts worry that even though the Covid-19 vaccines are now authorized for younger age groups, parents of these children might not take their kids to receive the vaccinations.

There is already slow uptake of Covid-19 vaccines among children in the United States.

"Having vaccine options for the youngest children is very important; however, we have seen a relatively low uptake of Covid vaccines in children in the 5- to 12-year-old group, and so my concern is that uptake in the youngest children under 5 years old might also be lower than we would like," Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told CNN on Wednesday.

Barouch, who is not involved in the FDA's decision, helped develop and study the Johnson & Johnson Covid-19 vaccine.

He said there were "striking" differences in how many adults are fully vaccinated compared with children and teens.

Children 5 to 11 were the most recent group to become eligible for vaccination, in November. But just 29% of these children are fully vaccinated with their two-dose primary series in the United States, according to the CDC , compared with about:

60% of adolescents 12 to 17

64% of adults 18 to 24

67% of adults 25 to 39

75% of adults 40 to 49

82% of adults 50 to 64

94% of adults 65 to 74

88% of adults 75 and older

"We are planning and preparing for the rollout of pediatric vaccines. Of course, there's a lot of work to be done to look at uptake of this vaccine. Some of the polls and surveys that have gone out to the public have indicated an ongoing lessening of parents considering giving their children these vaccines over time," said Lori Tremmel Freeman, chief executive officer of the National Association of County and City Health Officials.

According to a Kaiser Family Foundation's Vaccine Monitor survey , published in May, only 18% of parents of children under 5 said they would vaccinate their child against Covid-19 as soon as a vaccine was available.

"I think the more the pandemic is in the rearview mirror for some people -- or they believe it is -- then the less compelled they will be to do this, and so we have a big public health education campaign ahead of us," Freeman said. "Also, health departments at the local level will be looking to understand the landscape of their community in terms of how many providers, pediatricians and pharmacies have actually signed up to give out the vaccine."

'Benefits seem to clearly outweigh the risks'

Under the FDA's authorization, the Moderna vaccine can be given as a two-dose primary series, at 25 micrograms each dose, to infants and children 6 months through 5 years of age. For older children, ages 6 to 11, the doses are administered at 50 micrograms.

Vials of Pfizer/BioNTech's vaccine for younger children being filled.

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 FDA's vaccine advisers have determined that the benefits of both vaccines outweigh the risks and that the vaccines have been "well-tolerated" among the children who received them in clinical trials.

"The benefits seem to clearly outweigh the risks, particularly for those with young children who may be in kindergarten or in collective child care," committee member Oveta Fuller, an associate professor of microbiology and immunology at the University of Michigan Medical School, said of the Moderna vaccine.

Committee member Dr. Art Reingold added that even though the risk of Covid-19 hospitalization and death is lower for young children than for adults, children already get vaccinations to protect them against diseases for which their risk is low.

"If we have a vaccine whose benefits outweigh the risks, then making it available to people is a reasonable choice. I would point out that we as a country continue to give a large number of vaccines to children where the risk of the child dying or being hospitalized of those diseases are pretty close to zero," such as polio and measles, said Reingold, of the University of California, Berkeley.

The number of Covid-19 hospitalizations and deaths in children is concerning and much higher when compared with influenza-related deaths and hospitalizations, Marks said.

"There still was, during the Omicron wave, a relatively high rate of hospitalization during this period," he said. "That rate of hospitalization actually is quite troubling, and if we compare this to what we see in a terrible influenza season, it is worse."

Marks said the number of deaths for children 4 and under during the first two years of the pandemic "also compares quite terribly to what we've seen with influenza in the past."

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.

"We are dealing with an issue where I think we have to be careful that we don't become numb to the number of pediatric deaths because of the overwhelming number of older deaths here. Every life is important," he said, adding that "vaccine-preventable deaths are ones we would like to try to do something about."

He added that the Covid-19 vaccines are an intervention similar to the influenza vaccine, which has been broadly and routinely used and accepted to prevent deaths in all ages.

FDA advisers vote in favor of authorizing Covid-19 vaccines for ...

(CNN) Vaccine advisers to the US Food and Drug Administration voted unanimously on Wednesday in favor of expanding the emergency use authorizations for the Moderna and Pfizer/BioNTech Covid-19 vaccines to include children as young as 6 months.

All 21 members of the FDA's Vaccines and Related Biological Products Advisory Committee voted "yes" in response to the question: "Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine when administered as a 2-dose series (25 micrograms each dose) outweigh its risks for use in infants and children 6 months through 5 years of age?"

And all the committee members voted yes in response to the question: "Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine when administered as a 3-dose series (3 micrograms each dose) outweigh its risks for use in infants and children 6 months through 4 years of age?"

The FDA, which typically follows the committee's decisions, will now decide whether to authorize the vaccines for emergency use in the youngest children.

However, shots can't be given until the US Centers for Disease Control and Prevention's own vaccine advisers have voted on whether to recommend them and CDC Director Dr. Rochelle Walensky has signed off on the recommendation.

The CDC's vaccine advisers are expected to vote Saturday. The White House has said shots could begin as early as next week.

Children younger than 5 are the only age group not currently eligible to be vaccinated against Covid-19. About 17 million kids will become eligible for Covid-19 vaccines once they're authorized for this age group.

"To be able to vote for authorization of two vaccines that will protect children down to 6 months of age against this deadly disease is a very important thing," said committee member Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University.

She compared the day to December 2020, when the first Covid-19 vaccines were authorized for adults and older teens.

'Benefits seem to clearly outweigh the risks'

"The benefits seem to clearly outweigh the risks, particularly for those with young children who may be in kindergarten or in collective child care," committee member Oveta Fuller, an associate professor of microbiology and immunology at the University of Michigan Medical School, said of the Moderna vaccine.

Committee member Dr. Art Reingold added that even though the risk of Covid-19 hospitalization and death is lower for young children than for adults, children already get vaccinations to protect them against diseases for which their risk is low.

"If we have a vaccine with benefits that outweigh the risks, then making it available to people is a reasonable choice," said Reingold, of the University of California, Berkeley.

"I would point out that we as a country continue to give a large number of vaccines to children where the risk of the child dying or being hospitalized of those diseases are pretty close to zero," he said, such as polio and measles.

The number of Covid-19 hospitalizations and deaths in children is concerning and much higher when compared with influenza-related deaths and hospitalizations, FDA official Dr. Peter Marks said at Wednesday's meeting.

"There still was, during the Omicron wave, a relatively high rate of hospitalization during this period," said Marks, director of the FDA's Center for Biologics Evaluation and Research. "That rate of hospitalization actually is quite troubling, and if we compare this to what we see in a terrible influenza season, it is worse."

Marks said the number of deaths for children 4 and under during the first two years of the pandemic "also compares quite terribly to what we've seen with influenza in the past."

"We are dealing with an issue where I think we have to be careful that we don't become numb to the number of pediatric deaths because of the overwhelming number of older deaths here. Every life is important," he said, adding that "vaccine-preventable deaths are ones we would like to try to do something about."

Marks said the Covid-19 vaccines are an intervention similar to the influenza vaccine, which has been broadly and routinely used and accepted to prevent deaths.

Moderna vaccine 'well-tolerated' in youngest children

The Moderna vaccine is already authorized for adults. In a meeting Tuesday, the FDA's advisers voted unanimously in favor of expanding the emergency use authorization to include older children and teens, ages 6 to 17, saying it would also offer more benefits than risks.

Moderna's Covid-19 vaccine, when given as a 25-microgram dose, is "well-tolerated" in children ages 6 months to 5, said Dr. Rituparna Das, Moderna's vice president of Covid-19 vaccines clinical development, during Wednesday's meeting as she described the safety profile of the vaccine among this age group and adverse reactions.

"Pain was the most common event," Das said. "Young children's events included fever, headache, fatigue, myalgia, arthralgia, nausea, vomiting and chills. For infants and toddlers, events included fever, irritability, crying, sleepiness and loss of appetite."

These reactions were more common after the second dose of vaccine and resolved within two or three days, Das said, adding that fever was an important assessment of the vaccine's safety for this age group.

Fever after any dose of vaccine happened in about a quarter of the children, but more often after the second dose, and one incident of febrile seizure was considered to be related to vaccination, Das told the committee members. The child who had the seizure remained in the vaccine study and got a second dose of vaccine with no serious events.

No deaths or cases of myocarditis or pericarditis were reported among vaccine recipients, Das said.

"In summary, mRNA-1273 was well tolerated," she said, using the technical name of Moderna's vaccine. "Local and systemic reactions were seen less frequently in these youngest groups."

Concern over number of doses

VRBPAC member Dr. Paul Offit said in Wednesday's meeting that children who get the Pfizer/BioNTech vaccine will have to complete a three-dose series to get sufficient protection.

" 'Do the benefits outweigh the risks' is something I can support, but I do have some concerns about this vaccine," said Offit, director of the Vaccine Education Center at Children's Hospital of Pennsylvania.

Committee member Dr. Jeannette Lee of the University of Arkansas for Medical Sciences also mentioned concern that some children might not complete all three doses and that uptake of the vaccine will be slow.

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

Data from a phase 2/3 trial of the Pfizer vaccine included 1,678 children who had received a third dose during the period when the Omicron coronavirus variant dominated. The vaccine appeared to be safe and had a strong immune response. The data has not been peer-reviewed or published in a medical journal.

Antibody levels tested one month after the third dose showed that the vaccine produced a similar immune response as two doses in 16- to 25-year-olds, the companies said.

In FDA briefing documents, it was noted that among young children who had received the vaccine in trials, there were no cases of anaphylaxis, myocarditis or pericarditis, and the most common adverse reactions among children 6 months to 23 months were irritability, drowsiness, decreased appetite and tenderness at the injection site. For children 2 to 4 years old, the most common adverse reactions were fatigue and pain and redness at the injection site.

Will these children get vaccinated?

There is already slow uptake of Covid-19 vaccines among children in the United States.

"Having vaccine options for the youngest children is very important; however, we have seen a relatively low uptake of Covid vaccines in children in the 5- to 12-year-old group, and so my concern is that uptake in the youngest children under 5 years old might also be lower than we would like," Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told CNN on Wednesday.

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.

Barouch, who is not a member of the FDA advisory committee, helped develop and study the Johnson & Johnson Covid-19 vaccine.

He said there were "striking" differences in how many adults are fully vaccinated compared with children and teens.

Children 5 to 11 were the most recent group to become eligible for vaccination, in November. But just 29% of these children are fully vaccinated with their two-dose primary series in the United States, according to the CDC , compared with about:

FDA advisers to weigh expanding Covid-19 vaccines to younger kids

(CNN) Several months after older children became eligible to get vaccinated against Covid-19, the United States might be just days away from offering vaccines to those younger than 5.

The US Food and Drug Administration's independent Vaccines and Related Biological Products Advisory Committee is set to meet Tuesday and Wednesday to discuss amending the emergency use authorization (EUA) of Moderna's and Pfizer/BioNTech's Covid-19 vaccines to include younger ages.

Children under 5 -- about 18 million people -- are the only US age group that isn't eligible to get a Covid-19 vaccine.

The Moderna vaccine is authorized for use in adults, but on Tuesday, the advisers will discuss including children 6 through 17; on Wednesday, they will consider expanding the authorization to infants and children ages 6 months through 5.

The Pfizer/BioNTech vaccine is approved for people 16 and older, and it's authorized for use in children as young as 5. At Wednesday's meeting, advisers will discuss amending the EUA to include child-size doses of the vaccine for infants and children ages 6 months through 4.

According to FDA briefing documents posted Sunday, an agency review found that data supports the effectiveness of the Pfizer/BioNTech Covid-19 vaccine, given as a three-dose series, in preventing the disease in children 6 months through 4 years old. According to another document , a FDA review found that Moderna's Covid-19 vaccine is also safe and effective in younger kids.

In their meetings Tuesday and Wednesday, VRBPAC members will vote on whether the benefits of the Moderna and Pfizer/BioNTech vaccines outweigh risks for younger children.

What's next after vaccine advisers meet

After the FDA vaccine advisers vote, the agency will consider their decision and weigh whether it should authorize the vaccines.

However, shots can't be given until the US Centers for Disease Control and Prevention's vaccine advisers have voted on whether to recommend them and CDC Director Dr. Rochelle Walensky has signed off on the recommendation.

The White House has said vaccines for the youngest children could start next week.

The rollout of vaccines for this group could mirror that for older children, as pediatricians' offices will play a significant role in helping get shots into arms.

Some in-pharmacy clinics also are preparing to administer more vaccines.

"We plan to provide COVID-19 vaccinations to children 18 months through four years of age at our national network of 1,100 MinuteClinic locations once the FDA and CDC have provided guidance and inventory is received," CVS spokesperson Matt Blanchette said in an emailed statement Monday.

"Our MinuteClinic clinicians comprised of board-certified Family Nurse Practitioners, Physician Associates, and Nurses, have significant experience providing vaccinations to a younger population as well as private exam rooms, which will make the process easier for kids, parents, and guardians," the statement says.

Children under 5 typically have lower Covid-19 case rates than other age groups. But in the first week of June, hospitalization rates among these kids were slightly higher than among adults under the age of 50 and four times higher than those of other children.

At least 481 US children under the age of 5 have died of Covid-19, according to the CDC

Pfizer's data

People 5 and older are already eligible for Pfizer/BioNTech's two-dose Covid-19 vaccine and a booster dose -- but in Wednesday's meeting, VRBPAC members will discuss whether to add younger children to the emergency use authorization.

According to a briefing document, Pfizer's three-dose Covid-19 vaccine for children younger than 5 appears to be safe and generated an immune response in trials that's comparable to the response in older people.

One trial included more than 4,500 children ages 6 to 23 months and 2 to 4 years. Some got three 3-microgram shots, with the second shot coming three weeks after the first and the third shot given at least eight weeks after the second. The rest got a placebo.

The FDA briefing document says the Pfizer vaccine for this age group induced responses comparable to what has been seen in 16- to 25-year-olds. There weren't enough Covid-19 cases to establish vaccine efficacy in the study, but the FDA noted that this vaccine is known to be less protective against the Omicron variant.

A preliminary analysis put vaccine efficacy for children younger than 5 at 80.4%, with three Covid-19 cases in the vaccine group and seven in the placebo group. All the cases happened while the Omicron variant was dominant in the United States.

"Given the uncertainty of the COVID-19 pandemic and likelihood of continued SARS-CoV-2 transmission during the ensuing months, deployment of the vaccine for use among children 6 months through 4 years of age will likely have a beneficial effect on COVID-19 associated morbidity and mortality in this age group," the FDA said in its analysis.

There were no cases of anaphylaxis. There were also no cases of myocarditis or pericarditis -- inflammation of the heart muscle and inflammation of tissue surrounding the heart -- reported among more than 3,000 vaccine recipients in the trial, but it wasn't a large enough group to rule out the risk.

The most common adverse reactions among children 6 to 23 months were irritability, drowsiness, lack of appetite and tenderness at the injection site. For children 2 to 4 years old, the most common adverse reactions were pain or redness at the injection site and fatigue.

It's not clear how long the vaccine will be effective; the agency noted that the evaluation period was limited and that protection is known to wane over time in older ages. The agency also said it's "likely that a booster dose will be needed in addition to the three-dose primary series to increase robustness, breadth, and duration of protection."

Moderna's data

The immune response and safety profile of Moderna's Covid-19 vaccine also appear to be favorable for the youngest children, according to the FDA briefing documents.

VRBPAC members will discuss Moderna's vaccine on Tuesday and Wednesday, evaluating whether it should be authorized for younger ages.

In trials evaluating more than 6,000 children 6 months to under 6 years old, Moderna scientists found that two 25-microgram doses of vaccine, given 28 days apart, yielded a similar immune response as the two-dose vaccine series does in adults 18 to 25.

For children and teens ages 6 to 17, Moderna found that two doses of its vaccine provided a similar immune response as two doses in adults.

The vaccine was also found to be safe in all age groups, with adverse reactions described as "mostly mild to moderate in severity, generally of short duration," and happening more frequently after the second dose than the first, according to the document. Injection site pain was the most commonly reported adverse reaction. As for serious adverse events, the document described them as infrequent and didn't raise any concerns. No deaths were reported.

Although there were no known cases of myocarditis or pericarditis associated with the vaccine, it is acknowledged as one of the known risks and has been reported mostly in males ages 18 to 24.

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.

The FDA did not require the vaccine makers to submit vaccine efficacy data for emergency use authorization for young children, but Moderna's vaccine has been estimated to be 93.3% effective against symptomatic Covid-19 among teens ages 12 to 17 when the original coronavirus and the Alpha variant were dominant.

The vaccine was estimated to be 76.8% effective against symptomatic Covid-19 for children ages 6 to 11 when the Delta variant was predominant. However, the FDA also noted that for children in that age group, the "vaccine efficacy could not be reliably determined due to the small number of COVID-19 cases accrued during the study."

The vaccine was tested during a time when the Omicron variant was dominant. It was estimated to be 36.8% effective against symptomatic Covid-19 for children ages 2 to 5 and 50.6% protective for children 6 months to 23 months.

Vaccine efficacy estimates "were generally consistent" with what has been seen in adults, according to the FDA briefing document.