CDC recommends Pfizer’s Covid-19 vaccine for kids 5 to 11

Stickers for children are seen ahead of full approval from the CDC for children to receive the Pfizer-BioNTech Covid-19 vaccine at Hartford Hospital in Hartford, Connecticut on November 2.

President Biden is calling the CDC’s authorization of Pfizer’s vaccine for children age 5-11 “a turning point in our battle against COVID-19.”

The President also said that his administration is prepared to meet this moment, having already secured enough vaccine doses for every child in America. Some of those doses have already been delivered to locations across the country and by the week of Nov. 8, the distribution program for these vaccines will be fully up and running according to Biden.

“A vaccine for children age 5 to 11 will allow us to build on the extraordinary progress we’ve made over the last nine months. Already, more than 78 percent of Americans age 12 and older have gotten at least one shot, including millions of teenagers — and the vaccines have proven to be incredibly safe and effective,” he concluded.

The director of the US Centers for Disease Control and Prevention, Dr. Rochelle Walensky, said Tuesday evening she was endorsing a recommendation for vaccinating children ages 5-11 against Covid-19, clearing the way for immediate vaccination of the youngest age group yet in the United States.

“Together, with science leading the charge, we have taken?another important step?forward?in our nation’s fight against the virus that causes COVID-19,” Walensky said.

“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. 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.”?

Vaccine advisers to the US Centers for Disease Control and Prevention spent considerable time Tuesday explaining their votes in support of Pfizer’s Covid-19 vaccine for children ages 5 to 11, saying it’s safe and will protect children form an infection that can hurt them.

“As you’ve heard, we all have a lot of enthusiasm for this vaccine in this age group,” added Dr. Beth Bell, a clinical professor of global health at the University of Washington.

She continued: “But we also understand that parents have legitimate concerns and legitimate questions, and that our vote is a way of telling the American public that, based on our expertise and the information that we have, we’re all very enthusiastic. We were all talking about how we’re getting our kids and our grandkids vaccinated. But I think another point that we made to the American public is that we do understand that people have legitimate concerns and that they have lots of questions. We really encourage people to ask their providers, to visit the CDC website, to talk to their friends, their parents, and do what they need to do to feel comfortable with their decision.”

It’s now up to CDC Director Dr. Rochelle Walensky to recommend the vaccine, and she has signaled she will do so. After that, vaccination of the younger children may begin immediately.

Bridgette Melo, 5, holds onto the hand of her dad Jim Melo as she gets the first of two Pfizer COVID vaccinations on September 28 during a clinical trial for children at Duke Health.

Vaccine advisers to the US Centers for Disease Control and Prevention voted unanimously Tuesday to recommend giving Pfizer’s Covid-19 vaccine to children ages 5-11.

Members of the CDC’s Advisory Committee on Immunization Practices spent close to an hour commenting in support of the recommendation before they voted.

The question now goes to CDC Director Dr. Rochelle Walensky, who signaled in opening remarks to the committee’s meeting that she strongly supports vaccinating children in this age group to protect them against Covid-19 and its complications, and to help school get back to normal.

Vaccination could begin as soon as Walensky issues her decision.

Vaccine advisers to the US Centers for Disease Control and Prevention spoke in strong favor Tuesday of recommending Covid-19 vaccines for children ages 5-11.

CDC’s Advisory Committee on Immunization Practices was discussing whether to recommend Pfizer’s one-third sized vaccine for children, after the US Food and Drug Administration issued emergency use authorization last week.

Members of ACIP’s working group, which went over efficacy and safety data, told the meeting they felt strongly the benefits of the vaccine outweighed the risk.

Voting and non-voting members of ACIP took turns speaking in favor of vaccinating children Tuesday before the vote.

Members of the American Academy of Pediatrics, the Pediatric Infectious Diseases Society and the National Association of Pediatric Nurse Practitioners all spoke in favor of recommending the vaccine.

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will vote on whether to recommend Pfizer’s Covid-19 vaccine for children ages 5 to 11.?

The US Food and Drug Administration gave their green light for the vaccine on Friday. However, shots cannot be administered until after ACIP make a recommendation on the use of the vaccine and the CDC director signs off.

Earlier Tuesday CDC Director Dr. Rochelle Walensky made a hard case for vaccinating younger children against Covid-19, pointing to the disruption nearly two years of pandemic has made to their lives, and reminding CDC vaccine advisers about the risks of the virus.

Walensky sent a clear signal about where she stands.?“We have been asking when we will be able to expand this protection to our younger children,” she said in opening comments to the committee.

Many vaccine clinics, children’s hospitals and pediatricians’ offices across the United States have received shipments of Pfizer/BioNTech coronavirus vaccine doses for ages 5 to 11 and are ready to put shots into arms as early as Wednesday – or even Tuesday night — if the Walensky recommends it.

This October 2021 photo provided by Pfizer shows kid-size doses of its COVID-19 vaccine in Puurs, Belgium.

Many vaccine clinics, children’s hospitals and pediatricians’ offices across the United States have received shipments of Pfizer/BioNTech coronavirus vaccine doses for ages 5 to 11 and are ready to put shots into arms as early as Wednesday – or even Tuesday night — if the US Centers for Disease Control and Prevention recommends it.

The company Viral Solutions, which organizes Covid-19 vaccine and testing clinics in Georgia,?confirmed that it has received Pfizer’s child vaccine, and if the CDC gives the green light, vaccinations could start as early as Tuesday evening at a location in Decatur.

Children’s Hospital Los Angeles in California and Nationwide Children’s Hospital in Columbus, Ohio both confirmed to CNN that they received their vaccine shipments Tuesday and are planning to administer vaccine Wednesday, pending CDC sign-off.

And MiDoctor Urgent Care in New York confirmed to CNN that child vaccine doses have arrived and are ready to be administered on-site Wednesday morning.

Pfizer’s vaccine for children ages 5 to 11 received emergency use authorization from the US Food and Drug Administration on Friday, and the CDC’s Advisory Committee on Immunization Practice is meeting now to consider whether recommending use of the vaccine in that age group. Shots can be administered after CDC Director Dr. Rochelle Walensky signs off on that recommendation.

The Biden administration has secured enough vaccine supply to vaccinate the 28 million children ages 5 to 11 in the United States who are eligible for vaccination, according to the White House.?Pfizer’s vaccine for younger kids is a smaller dose of 10 micrograms, rather than the 30 micrograms used for people 12 and older.

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is meeting now to discuss the US Food and Drug Administration’s emergency use authorization for Pfizer’s Covid-19 vaccine for children ages 5-11.

A vote is scheduled to begin at 4:15 p.m. ET.

If ACIP recommends the vaccines and the CDC director signs off, vaccination could begin immediately for that age group.

Where can kids get vaccines?

The same places they get flu vaccines – their pediatricians’ offices, at local pharmacies and perhaps at some schools.

“This is the pediatrician’s wheelhouse,” Dr. David Kimberlin, who helps lead the pediatric infectious diseases division at the University of Alabama at Birmingham, told CNN.

“We’re trying to get pediatricians enrolled and that’s a major strategy,” Claire Hannan, executive director of the Association of Immunization Managers, told CNN’s Jacqueline Howard.

One potential pinch point is the smaller dose of vaccine, which means the younger children cannot be given doses in stock for adults and teens.

The kids’ vaccine is expected to be shipped in packages of 100 doses, which is much smaller than the packages of 1,170 doses used for the adult vaccines.

“The fact that they’re moving to smaller packaging and smaller shipping amounts is really great news,” Hannan said. That will be easier for doctors’ offices to manage.

The CDC notes that government websites help people find places to get vaccinated.

“Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233 to find locations near you,” the CDC advises.

In addition, White House Coronavirus Response Coordinator Jeff?Zients said the country’s Covid-19 vaccination program for children ages 5 to 11 will be fully up and running next week.

“While vaccinations may start later this week, the program will still be ramping up to its full strength, with millions more doses packed, shipped and delivered and thousands of additional sites coming online each day,” Zients said at a briefing Monday, noting that 15 million doses are being shipped.

About six US children were infected with coronavirus for every case diagnosed in September – meaning most cases went undetected, a US Centers for Disease Control and Prevention researcher said Tuesday.

CDC estimates show that about 38% of US children ages 5-11 have been infected with coronavirus — more than adults, overall, and about the same as among children and teens ages 12 to 17, the CDC’s Dr. Jefferson Jones told a meeting of CDC vaccine advisers. But this varies — from 11% in some states to 61% in others, he said.

The CDC looked at data taken from people who had blood drawn for a number of reasons not related to Covid-19, but who were tested for antibodies against coronavirus.

And while about half of all infections among adults are going undiagnosed now, many more are being missed among younger children, Jones told the Advisory Committee on Immunization Practices. In September, among children 5 to 11, the CDC estimates 6.2 were infected in September for every case diagnosed.

“Infections resulting in mild or no symptoms appear to be much more common in children than adults,” Jones told the meeting.

The CDC’s ACIP is meeting now to consider a one-third dose of Pfizer’s vaccine for children ages 5-11 and will vote later Tuesday.

A person receives a bandage after their first dose of the Pfizer Covid-19 vaccine in Los Angeles in August.

Side effects from Pfizer’s Covid-19 vaccine, especially fever, were much less common among kids ages 5-11 than they were among 16-to-25-year-olds, the company told advisers to the US Centers for Disease Control and Prevention Tuesday.

The CDC’s Advisory Committee on Immunization Practices is considering a one-third dose of Pfizer’s vaccine for children ages 5-11 and will vote later Tuesday.

Pfizer’s Dr. Alejandra Gurtman told ACIP that fever was far less common among younger kids than among older people – with 6.5% of younger children experiencing fever in clinical trials of the vaccine, compared to 17.2% of 16-25-year-olds

“Systemic reaction less common than in 16-to-25-year olds,” Gurtman told the meeting. “Reactogenicity was mostly mild to moderate and short-lived.”

Patricia Stinchfield, a representative of the?National Association of Pediatric Nurse Practitioners to ACIP, who does not vote, said she was encouraged to hear this.

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is meeting now to discuss the US Food and Drug Administration’s emergency use authorization for Pfizer’s Covid-19 vaccine for kids ages 5-11. Once they recommend it and the CDC director signs off, vaccination could begin immediately for that age group.

However, it could still take another five weeks for kids to reach full immunity.

Here’s why:

Just as with adults, Pfizer is testing and proposing a two-dose series for kids. So that would mean?two doses of vaccine given three weeks apart.?And as with adults, immunity isn’t immediate, even after the second dose. People have been considered fully vaccinated two weeks after the second dose and the same will go for kids.

So at the very earliest, children would be advised to continue taking precautions for five weeks after they get the first dose of vaccine. That means wearing masks, keeping a physical distance from others and avoiding crowded indoor spaces when possible.

As for boosters, it’s far too soon to ask about them. It took several months of gathering real-world data before Pfizer asked FDA to authorize boosters in adults.

Will kids get the same dose as adults?

No. Pfizer has been testing a 1/3 dose in children 11 and under. But indications are that this smaller dose will protect kids just as well as a larger dose protects teens and adults – even if a particular 10- or 11-year-old is large for his or her age.

Vaccine makers test varying doses when they are doing clinical trials to try to get the best immune response possible from the lowest dose possible. This can reduce side effects and stretch supply.

Tests in children showed a strong response to a 10-microgram dose in the clinical trials, says Dr. Robert Frenck, who heads up vaccine trials at Cincinnati Children’s Hospital and who has been testing Covid-19 vaccines in children there.

A bigger initial dose did not seem to improve immunity, so even older children won’t miss out if they get the smaller dose.

“My guess is that if we gave a 12-year-old a 10-microgram dose that they would still have a similar immune response as a 30-microgram dose, but we don’t have the data for that,” Frenck said.

For the youngest children, children under 5, doctors are testing a 3-microgram dose of vaccine.

Dr. Rochelle Walensky, director of US Centers for Disease Control and Prevention, made a hard case for vaccinating younger children against Covid-19, pointing to the disruption nearly two years of pandemic has made to their lives, and reminding CDC vaccine advisers about the risks of the virus.

The CDC’s Advisory Committee on Immunization Practices is meeting now to discuss the US Food and Drug Administration’s emergency use authorization for Pfizer’s Covid-19 vaccine for kids ages 5-11.

ACIP will vote later Tuesday on whether to recommend use of the vaccine in children this age. It will then be up to Walensky to decide whether to accept ACIP’s decision. After Walensky decides, vaccination could begin immediately, and vaccines are already being deployed in preparation.

Walensky sent a clear signal about where she stands.?“We have been asking when we will be able to expand this protection to our younger children,” she said in opening comments to the committee.

“As you will all aware, in this most recent Delta wave, we saw pediatric admission rates higher than they had in any previous wave of the pandemic, reaching a rate of 25 hospitalizations per 100,000 per year in children between the ages of 5 to 11,” she said.

The CDC says 745 children under 18 have died. “The chance that a child will have severe Covid, require hospitalization or develop a long term complication like MIS-C remains low, but still the risk is too high and too devastating to our children, and far higher than for many other diseases for which we vaccinate children,” Walensky added.

“We also know that beyond the clinical impact of Covid on children, there have been detrimental social and mental health impacts that we are just beginning to fully understand. For almost two full years, school has been fundamentally changed. There are?children in second grade who have never experienced a normal school year. There are students in middle school who missed out on sports and extracurricular activities. There are missed proms and homecoming dances and too many missed graduations,” Walensky said.

Walensky said it’s also important to continue vaccinating adults.

“Looking at data from August through October of this year, as we saw Delta cases increasing sharply across the country, there were stark differences in pediatric cases based on community vaccination levels. In a stepwise fashion, as a percent of eligible population fully vaccinated increased, the number of pediatric hospitalizations decreased. It is our ongoing responsibility to make sure as many people as possible are vaccinated and protected from Covid-19,” she said.

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) is meeting now to discuss Pfizer’s Covid-19 vaccine for children ages 5 to 11.?

The vaccine received emergency use authorization from the US Food and Drug Administration on Friday. However, shots cannot be administered until after ACIP make a recommendation on the use of the vaccine and the CDC director signs off.

The ACIP committee is scheduled meet from 11 a.m. ET to 5 p.m. ET today and hear presentations about coronavirus in children, the vaccine rollout for younger children and issues relating to vaccine safety and myocarditis.

A voting period is scheduled to begin at 4:15 p.m.

You can see the full ACIP agenda here.

Pfizer is expecting initial data for use of its Covid-19 vaccine in 2- to 5-year-olds in the fourth quarter of 2021, the company’s chief scientific officer Dr. Mikael Dolsten said in prepared remarks ahead of a Tuesday earnings call.

Pfizer is also projecting that there will be an initial data readout for use of its vaccine in children ages 6 months to 2 years old in the first quarter of 2022.

Pfizer has projected US Food and Drug Administration emergency use authorization for the vaccine in 2- to 5-year-olds in the first half of 2022, and for children ages 6 months to 2 years old in the second half of the year.

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is meeting today to discuss Pfizer’s Covid-19 vaccine for children ages 5 to 11.?Once ACIP makes a recommendation on the use of the vaccine and the CDC director signs off, shots can start to be administered.

Pfizer COVID-19 Pediatric vials packaging & labelling.

The US Centers for Disease Control and Prevention’s vaccine advisers, the Advisory Committee on Immunization Practices, is schedule to vote Tuesday whether to recommend Pfizer’s Covid-19 vaccine for children ages 5 to 11. It’s the last step before CDC Director Dr. Rochelle Walensky will make a final decision on the vaccine.

In the meeting that will run from 11 a.m. to 5 p.m. ET, Pfizer will present its data to the advisers in the morning. In the afternoon, the committee will hear from the CDC, which will discuss the overall need young children have for this vaccine, as well as any potential side effects.

One side effect under discussion is the risk of myocarditis – an inflammatory heart condition. It’s rare but has been seen in some?adolescents?and adults?who got the Pfizer/BioNTech and Moderna vaccines.??

Dr. Grace Lee, the chair of the committee, told CNN while data is limited, the?surveillance?systems in place are doing a good job picking up on vaccine safety signals. She said the CDC is also doing a long-term study of people who develop myocarditis after vaccination.?

Dr. William Schaffner, the chair of the department of preventative medicine at Vanderbilt University School of Medicine and a committee liaison who does not vote,?said he thinks?a couple voting members may voice concern about myocarditis, but he thinks the committee will vote overwhelmingly in favor of the vaccine.?

Noting that generally myocarditis occurs less often in this younger population,?Schaffner said?he?thinks that?the theoretical risk of myocarditis is outweighed by the benefits of the vaccine.

“It outweighs it enormously,” Schaffner told CNN. “I think there isn’t any doubt.”?

Lee said the committee members will have to make a decision about the vaccine for children even though they don’t have all the data about the impact of Covid-19 on children.?For example, it’s unclear what the impact of long-haul Covid-19?is?on?children or?the?full?impact of missing school when?children?are out sick with Covid-19.?

“I think decision making under uncertainty creates many challenges,” Lee, a professor of pediatric infectious diseases at Stanford University, told CNN. “For much of the pandemic, what we’ve seen ACIP do is struggle with the data that exists and the data we would like to have.”

But she thinks ultimately, a decision has to be made.

“Not making a decision is in and of itself a decision,” Lee said.

“At the end of the day, we will get to endorsing this vaccine and recommending its use in children ages 5-11, but I think there will be a little bit of this discussion off to the side,” Schaffner said. “I think the vote will be overwhelmingly in favor. I can’t predict that it will be unanimous.”

The US Food and Drug Administration issued emergency use authorization?on Friday?for Pfizer’s Covid-19 vaccine for children ages 5 to 11. This is the first Covid-19 vaccine authorized in the United States for younger children.?

Last Tuesday, the FDA’s vaccine advisers voted 17-0, with one abstention, to recommend?EUA?for the vaccine, which is formulated at one-third the dose of the vaccine used for people 12 and older.??

Pfizer says a clinical trial showed its vaccine provides more than 90% protection against symptomatic disease among children, even at one-third the dose, and the company hopes the lower dose will reduce the risk of any side effects.

What happens next: The question now goes to the US Centers for Disease Control and Prevention. The CDC’s vaccine advisers, the Advisory Committee on Immunization Practices, is meeting today to discuss whether to recommend use of the vaccine among US children. Then the CDC director, Dr. Rochelle Walensky, makes the final decision on use of the vaccine.?

The White House says it has a plan already in place for distributing vaccines to children. Vaccines could be administered as soon as the CDC signs off.

Pfizer’s Covid-19 vaccine was previously authorized for children ages 12 to 15. The vaccine is approved for people age 16 and older.

The United States’ Covid-19 vaccination program for children ages 5 to 11 will be fully up and running next week,?White House Coronavirus Response Coordinator Jeff?Zients said during a virtual White House briefing Monday.

“While vaccinations may start later this week, the program will still be ramping up to its full strength, with millions more doses packed, shipped and delivered and thousands of additional sites coming online each day,” Zients said, noting that 15 million doses are being shipped.

Zients added that the White House has been planning for this moment and will be ready to roll out vaccinations as soon as the US Centers for Disease Control and Prevention recommends doing so.

Pfizer’s vaccine for children ages 5 to 11 received emergency use authorization from the US Food and Drug Administration on Friday, and the US Centers for Disease Control and Prevention’s vaccine advisers meet today to consider whether to recommend its use in that age group.

Shots can only be administered after CDC Director Dr. Rochelle Walensky signs off on the recommendation.

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices has posted the?final agenda?for its Nov. 2-3 meeting, which includes a discussion and vote on Tuesday about Pfizer’s Covid-19 vaccine for children ages 5 to 11.?

Here’s what we know:

Some background: The Pfizer vaccine for children ages 5 to 11 has already received an emergency use authorization from the US Food and Drug Administration. Shots cannot be administered until after ACIP make a recommendation on the use of the vaccine and the CDC director signs off.

You can see the full ACIP agenda here.