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

By Melissa Mahtani, Adrienne Vogt, Aditi Sangal, Meg Wagner and Melissa Macaya, CNN

Updated 10:36 PM ET, Tue November 2, 2021
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1:10 p.m. ET, November 2, 2021

Side effects from Covid-19 vaccine are less common in younger children than in teens and adults, Pfizer says

From CNN’s Maggie Fox

A person receives a bandage after their first dose of the Pfizer Covid-19 vaccine in Los Angeles in August.
A person receives a bandage after their first dose of the Pfizer Covid-19 vaccine in Los Angeles in August. Patrick T. Fallon/AFP/Getty Images

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.

“There are many people who choose to either not get vaccinated or to delay vaccine because they frequently will hear either from clinicians or the media that your common side effects are fever, chills or body aches,” Stinchfield said. “And when you look at the data, that is actually not correct.”

11:59 a.m. ET, November 2, 2021

How long will it take for kids to have full immunity once vaccinated?

From CNN's Maggie Fox

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.

"We looked at 10 micrograms, 20 micrograms and 30 micrograms in adults," Frenck told reporters last month. "We found in 18- to 55-year-olds a 10-microgram dose gives a very good immune response," he added. "But the 65 and above, they did not respond as well to the lower doses and so that's why we chose that 30-microgram dose across the adult age range from 18 to above."

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.

11:50 a.m. ET, November 2, 2021

CDC director makes hard case for vaccinating younger kids against Covid-19

 From CNN’s Maggie Fox

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 review the data today, it will be key to keep in mind the specific risks to children from this virus and the pandemic, and to put that risk into context of other vaccine-preventable diseases,” she said, noting that children are routinely vaccinated against diseases such as chickenpox, which kill far fewer children and put far fewer of them into the hospital than Covid-19 does.

“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.

“We have watched as the education gap that exists in this country has widened as this virus has disproportionately impacted racial and ethnic minority communities. Pediatric vaccination has the power to help us change all of that and to let us move toward school as we once knew it and hope it can be – a safe and enriching environment for all of our children," she 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.

11:05 a.m. ET, November 2, 2021

NOW: CDC advisers meet to discuss Covid-19 vaccines for kids

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.

10:10 a.m. ET, November 2, 2021

Pfizer expects initial data of its Covid-19 kids' vaccine at the end of the year

From CNN’s Naomi Thomas

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.

9:49 a.m. ET, November 2, 2021

CDC adviser predicts "vote will be overwhelmingly in favor" to recommend Pfizer's Covid-19 vaccine for kids

From CNN's Jen Christensen and Elizabeth Cohen

Pfizer COVID-19 Pediatric vials packaging & labelling.
Pfizer COVID-19 Pediatric vials packaging & labelling. (Pfizer)

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."

9:16 a.m. ET, November 2, 2021

The FDA already authorized Pfizer's Covid-19 vaccine for children ages 5 to 11. Now it's up to the CDC.

From CNN's Maggie Fox

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.

8:50 a.m. ET, November 2, 2021

Covid-19 kids' vaccine program "will be running at full strength" the week of Nov. 8, White House says

From CNN's Jacqueline Howard

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.

"So, starting the week of Nov. 8, the kids' vaccination program will be fully up and running," Zients said. "Parents will be able to schedule appointments at convenient sites they know and trust to get their kids vaccinated. And the number of sites will continue to increase throughout the month as more vaccine sites open their doors to administer vaccine."

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.

10:45 a.m. ET, November 2, 2021

Key things to know about the CDC vaccine advisers' meeting today

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:

  • The committee will meet from 11 a.m. ET to 5 p.m. ET Tuesday.
  • It will hear presentations about Covid-19 in children, the vaccine rollout for younger children and about vaccine safety and myocarditis.
  • A voting period is scheduled to begin at 4:15 p.m.
  • Tomorrow's ACIP meeting deals with vaccines other than those for Covid-19.

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.