The latest on Covid-19 vaccines for children

By Meg Wagner, Melissa Mahtani, Melissa Macaya and Veronica Rocha, CNN

Updated 6:43 p.m. ET, October 26, 2021
19 Posts
Sort byDropdown arrow
6:34 p.m. ET, October 26, 2021

FDA advisers vote to recommend Covid-19 vaccines for children 5 to 11

From CNN's Maggie Fox

This October 2021 photo provided by Pfizer shows an example of kid-size doses of its COVID-19 vaccine in Puurs, Belgium.
This October 2021 photo provided by Pfizer shows an example of kid-size doses of its COVID-19 vaccine in Puurs, Belgium. (Pfizer/AP)

Vaccine advisers to the US Food and Drug Administration voted 17-0 with one abstention Tuesday to recommend emergency use authorization of Pfizer’s Covid-19 vaccine in children 5 to 11.

Members of the FDA’s Vaccines and Related Biological Products Advisory Committee agreed that the benefits of vaccinating younger children appeared to outweigh the risks, but some members appeared troubled about voting to vaccinate a large population of younger children based on studies of a few thousand. 

“It is reassuring to me that we are giving a lower dose,” said Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. Pfizer has cut its vaccine to one-third of the adult dose for the children under 12. 

“I am just worried that if we say yes, then the states are going to mandate administration of this vaccine for children to go to school and I do not agree with that,” said Dr. Cody Meissner, a professor of pediatrics at Tufts University School of Medicine. “I think that would be an error at this time.”

But Dr. Amanda Cohn of the US Centers for Disease Control and Prevention reminded the committee that children have died of Covid-19. According to CDC, more than 700 children 18 and under have died of Covid-19. “We don’t want children dying of Covid,” she said. “And we don’t want children in the ICU.”

The FDA had said that, under most of the scenarios it projected, the benefits of vaccinating younger children would outweigh any risks and Pfizer said clinical trials showed the vaccine was more than 90% effective in preventing symptomatic infection in children.  

What happens next: The FDA will take the committee’s vote into consideration and then make the final decision about whether to authorize it.  Then, the US Centers for Disease Control and Prevention's independent advisory committee meets Nov. 2 and 3, and will vote on whether to recommend the vaccine for this age group.

Finally, CDC Director Dr. Rochelle Walensky will decide whether to accept or modify the committee's recommendation.

Once Walensky signs off, younger children could start getting Covid-19 shots immediately.

The US federal government has a plan in place for delivering the smaller-sized vaccines to pediatricians’ offices, pharmacies and other venues across the country.

5:51 p.m. ET, October 26, 2021

"We may have vaccines for children 5 to 11, possibly as soon as next week," Chicago health official says

From CNN’s Raja Razek

Chicago Department of Health Commissioner Allison Arwady
Chicago Department of Health Commissioner Allison Arwady (WLS)

Chicago Department of Health Commissioner (CDPH) Allison Arwady said they may have vaccines for children ages 5 to 11, "possibly as soon as next week."

“If everything moves as expected, we may have vaccines for children 5 to 11, possibly as soon as next week," she said in a news conference Tuesday. 

Her comments come after vaccine advisers to the US Food and Drug Administration voted 17-0, with one abstention, to recommend emergency use authorization of Pfizer’s Covid-19 vaccine in children ages 5 to 11.

Given that the FDA approval was expected, all federally qualified health centers serving children across the state have already placed orders, according to Arwady. 

"This is not going to be the hunger games," she said. "We estimate that there are 210,448 children living in Chicago between the ages of 5 and 11. I would like to reassure you that nearly 100,000 pediatric doses are tentatively scheduled to arrive in Chicago in the first week of pediatric vaccine alone." 

"There will be vaccine available. The best place to go is your pediatrician, and we will make available the lists of which pediatricians will have vaccine right from the beginning," she said. As for pharmacies, all local Walgreens would be offering pediatric vaccines "right away."

Children will also have the option to be vaccinated at school, according to Arwady. 

Chicago Public Schools (CPS) said they would provide access to the vaccine through the District’s regional clinics, school-based health centers and school-based mobile events across the for those 5 to 11, according to a news release by CDPH. 

“In addition to providing access to the vaccine for our eligible younger students, we will be implementing a robust public information campaign to communicate that the vaccine is safe, effective, and crucial to protect the health of CPS parents, students, staff, and all of our school communities," CPS CEO Pedro Martinez said.

Separately, Arwady gave an update on Chicago's travel advisory, saying, "We continue to see improvement across the U.S. with the Delta variant. As of today, Georgia, Louisiana, Maryland, and Mississippi are all being removed from the travel advisory."

5:13 p.m. ET, October 26, 2021

Pfizer reacts to FDA vaccine advisers meeting

From CNN's Amanda Sealy

Vaccine advisers to the US Food and Drug Administration voted 17-0 with one abstention Tuesday to recommend emergency use authorization of Pfizer’s Covid-19 vaccine in children 5 to 11. 

Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer, reacted to the news, saying:

We appreciated the opportunity to present our clinical data demonstrating the safety and high efficacy of our Covid-19 vaccine in children 5 to under 12 years of age.”

“COVID-19 is an ongoing threat for the more than 28 million young children in this age group in the U.S., as they remain at risk for this infection. About 10% of all weekly U.S. cases occur in children 5 to under 12 years of age with a potential risk of complications. In addition, immunizing children will help to get us closer to herd immunity, with the potential to stem the pandemic sooner. We thank the FDA advisory committee for their review and positive recommendation in support of Emergency Use Authorization to help protect this young population,” she added.

Following today's meeting, the FDA will take the committee’s vote into consideration and make a final decision about whether to authorize it.  Then, the US Centers for Disease Control and Prevention's independent advisory committee meets Nov. 2 and 3, and will vote on whether to recommend the vaccine for this age group.

Finally, CDC Director Dr. Rochelle Walensky will decide whether to accept or modify the committee's recommendation.

Once Walensky signs off, younger children could start getting Covid-19 shots immediately.

4:42 p.m. ET, October 26, 2021

FDA vaccine advisory meeting on Covid-19 vaccine for children is over

From CNN's Maggie Fox

The Vaccines and Related Biological Products Advisory Committee meeting has ended.

The committee voted 17-0, with one abstention, to recommend emergency use authorization of Pfizer’s Covd-19 vaccine for children 5-11. The FDA will now consider the committee’s vote in deciding EUA for the vaccine.

 

4:18 p.m. ET, October 26, 2021

NOW: FDA advisers are voting on Covid-19 vaccines for children 5 to 11

From CNN's Maggie Fox

Vaccine advisers to the US Food and Drug Administration are voting on the question of whether to recommend emergency use authorization of Pfizer’s one-third dose vaccine for children ages 5-11.

There is only one question:

“Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech Covid-19 vaccine when administered as a 2-dose series (10 microgram each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age?”

The FDA will take the committee’s vote into consideration, and then the question goes to the US Centers for Disease Control and Prevention next week.

3:18 p.m. ET, October 26, 2021

FDA vaccine advisers are in the final stage of discussions before a vote

From CNN's Maggie Fox

The FDA's Vaccines and Related Biological Products Advisory Committee has moved into the final, general discussion before voting on whether the risks of Pfizer’s vaccine in younger children outweigh the benefits.

They are running about 15 minutes late.

This is the single question they are voting on, and members may discuss the reasons for their votes:

“Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech Covid-19 vaccine when administered as a 2-dose series (10 microgram each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age?"

 You can watch the live stream here.

4:21 p.m. ET, October 26, 2021

FDA says benefits likely to outweigh risks for Pfizer's Covid-19 vaccine in younger kids

From CNN's Jamie Gumbrecht and Maggie Fox

(Shutterstock)
(Shutterstock)

The benefits of Pfizer’s Covid-19 vaccine are likely to outweigh the risks for children ages 5 to 11, the US Food and Drug Administration said Tuesday.

FDA vaccine advisers are meeting to discuss the evidence for and against emergency use authorization of a one-third dose of Pfizer’s vaccine for these younger children.

The FDA laid out several possible scenarios with various levels of pandemic spread, and various levels of vaccine efficacy among younger children. Under most scenarios, the benefits of vaccinating children clearly outweigh the risks, Hong Yang, senior adviser for benefit-risk assessment at FDA’s Office of Biostatistics and Epidemiology, told the meeting.

One consideration, Yang said, is the theoretical risk of a heart inflammatory condition called myocarditis in boys. The condition is elevated among people who get the vaccine, mostly young men. But even considering this risk, she said, the benefits appear to be strong. Myocarditis is usually mild and easily treated.

“FDA’s assessment is conservative,” Yang said.

Earlier, Pfizer’s Dr. William Gruber said he believed the pandemic had the potential to worsen this winter – something that would make the vaccine even more beneficial for children.

“If you just look at our track record in terms of predicting the epidemic … we've not done particularly well. Given that the winter season is coming, the Delta virus is still out there, you still have a large number of susceptible children, there's every reason to believe that the rate will not be at the nadir,” Gruber told the meeting.

 

1:07 p.m. ET, October 26, 2021

FDA vaccine advisers resume with public hearing

From CNN's Maggie Fox

The FDA's Vaccines and Related Biological Products Advisory Committee has resumed its meeting after a lunch break and is listening to public comments for the next hour about the issue of authorizing Pfizer’s Covid-19 vaccine for children ages 5 to 11.

The advisers' meeting is scheduled to run until 5 p.m. ET. You can watch the live stream here.

1:20 p.m. ET, October 26, 2021

Pfizer says there's future potential to lower the dose of its Covid-19 vaccine for children ages 12 to 15

From CNN's Jacqueline Howard

Sherri Trimble, 15, receives a shot of the Pfizer Covid-19 vaccine in Melbourne, Florida, in May.
Sherri Trimble, 15, receives a shot of the Pfizer Covid-19 vaccine in Melbourne, Florida, in May. (Paul Hennessy/SOPA Images/LightRocket via Getty Images)

A lower dose of the Pfizer/BioNTech coronavirus vaccine could be considered for children ages 12 to 15 in the future, a Pfizer official told vaccine advisers to the US Food and Drug Administration in a meeting Tuesday.

FDA's Vaccines and Related Biological Products Advisory Committee is meeting to vote on whether its members recommend the FDA authorize 10-microgram doses of Pfizer/BioNTech's Covid-19 vaccine for children ages 5 to 11. The FDA has already authorized 30-microgram doses of the Pfizer/BioNTech vaccine for adolescents ages 12 to 15, and approved that dosage for people age 16 and older.

"There is the potential, although we don't have the data to show it, for a 10-microgram dose to provide antibody response and we have some possibility of looking at that in the future. But we don't have that data today," Dr. William Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development, told members the FDA panel.

"We are thinking about that as a potential option, particularly as we move out of the pandemic period," Gruber said. "The key goal right now is obviously providing protection with a safe and effective vaccine."