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

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.

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.