Doctor weighs in on how safe it is to get kids back in school
2:16
What we covered
The FDA’s independent vaccine advisory board voted to recommend emergency use authorization of Pfizer’s one-third dose vaccine for children ages 5-11.
On Friday, Pfizer released documents on the efficacy of its Covid-19 vaccine, saying it was 90.7% effective against symptomatic disease in children in this age group.
Once the FDA makes its authorization, the issue goes to the US Centers for Disease Control and Prevention’s vaccine advisory group, which is set to meet Nov. 2 and 3. From there, it’s up to the CDC director to sign off on the recommendation.
Our live coverage of this story has ended. Read the latest here.
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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.
((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.
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.
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"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
(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.
“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.”
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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.”
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.
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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.
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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:
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.
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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:
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)
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.
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.
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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.
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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.
(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.
“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.”
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The FDA advisers meeting is on a lunch break
From CNN's Jacqueline Howard
A meeting of the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee has paused for lunch and will reconvene around 1 p.m. ET. When they come back, there will be an hour-long open public hearing.
The committee is meeting to vote on whether its members recommend the FDA authorize Pfizer/BioNTech’s Covid-19 vaccine for children ages 5 to 11. The committee’s recommendation is then sent to the FDA to make the final decision on an authorization.
The advisers’ meeting is scheduled to run until 5 p.m. ET. You can watch the live stream here.
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CDC official: Myocarditis after Covid-19 vaccination is rare, and more study is needed on long-term outcomes
The FDA’s Vaccines and Related Biological Products Advisory Committee is meeting to consider whether to recommend the agency authorize Pfizer’s Covid-19 vaccine for people ages 5 to 11.
Rare incidents of myocarditis – inflammation of the heart muscle – have previously been linked to Pfizer’s Covid-19 vaccine.
Myocarditis is generally more common among young men, and that has been the case following Covid-19 vaccination, as well, Dr. Matthew Oster, a pediatric cardiologist, told the panel; the theory is that it’s linked to testosterone and hormone levels, which may explain why risk peaks in adolescence and young adulthood. If that pattern holds, Oster said, it would be expected that the risk would be lower for children ages 5 to 11, even following vaccination.
But presentations and outcomes for myocarditis can differ, Oster told the FDA’s advisers, and it’s not clear how easily the types of myocarditis can be compared. “Classic” myocarditis, like what was seen before Covid-19, is often linked to infections, but many times a cause is not identified, and it can be serious. Myocarditis can also occur after Covid-19, or from multisystem inflammatory syndrome in children, or MIS-C, a rare and serious Covid-19 complication that impacts children.
People who experienced myocarditis following Covid-19 vaccination tended to recover quickly, but data on potential long-term effects is limited, Oster said.
Among 1,640 reports of potential myocarditis in people age 29 or younger in the CDC’s Vaccine Adverse Event Reporting System through Oct. 6, 877 cases had been investigated and met the decision of myocarditis and another 637 cases were still under review, Oster said. Among the 877 confirmed cases, 829 resulted in hospitalization and 789 have been discharged. Seventeen cases remain hospitalized, with five in the intensive care unit.
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CDC officer: Covid-19 in kids less likely to be reported, but they are as likely as adults to be infected
From CNN's Jacqueline Howard
Dr. Fiona Havers, a medical officer at the US Centers for Disease Control and Prevention, speaks during a meeting on October 26.
(Food and Drug Administration)
Coronavirus infections in children are less likely to be reported — even though children seem to be as likely as adults to be infected, according to data from the US Centers for Disease Control and Prevention.
The data — presented to the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee in a meeting Tuesday — showed that about six times as many children have Covid-19 antibodies compared with how many cases have been reported among kids.
Children “consistently have higher seroprevalence estimates than adults,” Dr. Fiona Havers, a medical officer at the CDC, told the VRBPAC members in Tuesday’s meeting.
Seroprevalence refers to the percentage of people in a certain population who have antibodies against SARS-CoV-2, the coronavirus that causes Covid-19. Antibodies can be a sign of a previous infection and serology, or antibody, testing is used to detect antibodies in a person’s blood.
The seroprevalence of Covid-19 antibodies among children ages 5 to 11 appeared to increase from about 13% in November to December last year to 42% in May to June of this year, according to data that Havers presented to the VRBPAC members Tuesday.
“Investigators also use seroprevalence to estimate the cumulative number of infections and compare that with the number of reported cases by age. Overall, for the general population, the jurisdiction-level infections-to-case ratio had a median of 2.4, with a range of 2.0 to 3.9,” Havers said.
“For children, the infections-to-case ratio was substantially higher, with a median of 6.2 cases per every one infection, with a range of 4.7 to 8.9,” Havers said. “These seroprevalence data suggest that infections in children are less likely to be reported compared with adults. But children are at least as likely as adults to be infected with SARS-CoV-2.”
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CDC officers are presenting data on Covid-19 in children
From CNN's Jacqueline Howard
Dr. Fiona Havers with the US Centers for Disease Control and Prevention is presenting data on coronavirus infections in children right now during the meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.
Dr. Matthew Oster, also of the CDC, is scheduled to present next, and share data on myocarditis in adolescents and young adults with the VRBPAC members.
The VRBPAC meeting is scheduled to run until 5 p.m. ET.
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FDA official asks advisers to "keep our discourse today civil" on Covid-19 vaccine for kids
From CNN's Jacqueline Howard
Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, speaks during a meeting on October 26.
(Food and Drug Administration)
As the US Food and Drug Administration’s vaccine advisory committee meets to discuss Pfizer’s Covid-19 vaccine for children ages 5 to 11, one FDA official urged the panel to “keep our discourse today civil” and focus on the science.
“To be clear, today’s discussion is going to be about the scientific data that are presented and it’s not about vaccine mandates, which are left to other entities outside of FDA,” Marks said. “I ask that we keep our discourse today civil and focus on the science related to this issue, so that we can get through a productive discussion.”
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FDA vaccine advisers' meeting on Pfizer Covid-19 vaccine for kids ages 5 to 11 has started
The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee is meeting now to decide whether to recommend authorizing the Pfizer/BioNTech Covid-19 vaccine for children ages 5 to 11.
The discussion and voting period begins at 2:55 p.m. ET. The meeting is scheduled to adjourn at 5 p.m. ET.
What would happen next: If the FDA committee votes in its favor of emergency use authorization for the vaccine, the FDA will then make the final decision about whether to authorize it. The committee will consider evidence submitted by Pfizer that shows the vaccine is safe and works to protect this age group.
Then, the US Centers for Disease Control and Prevention’s independent advisory committee meets next week on 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.
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NIH director: Vaccinating kids would be "one significant step forward" to getting US in a better place
From CNN's Naomi Thomas
Dr. Francis Collins, director of the National Institutes of Health, said on ABC’s Good Morning America on Tuesday that getting children ages 5 to 11 vaccinated would be a “significant step” toward getting the US in a better place when it comes to coronavirus.
Asked about parents who are hesitant about getting their children vaccinated, who argue that children are less likely to get seriously ill from Covid-19 than adults and so might not need the vaccine, Collins said, “I totally understand that. And I think parents need to be listened to, they’re usually pretty smart about their kids. And I think there’ll be a lot of conversations going on between parents and pediatricians about this very issue.”
“But one shouldn’t actually discount the fact that kids can get pretty sick with Covid-19,” he said, adding that over 700 children have died from it since the pandemic began, and that they can also face long Covid, even without a severe case of Covid-19 — “another reason to try to provide the protection.”
The vaccine data to be discussed at the US Food and Drug Administration’s Vaccine and Related Biological Products Advisory Committee on Tuesday “looks really good,” Collins said.
“It still is the case that lots of kids are getting infected, especially with Delta because it is so contagious,” Collins said when asked about the argument made by some that because child cases are going down, there may be no need for them to get vaccinated. “That’s one more reason why I think it’s going to be difficult, in many instances, to keep schools completely open, so dealing with the vaccination as means of preventing that is going to be a good step forward.”
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FDA advisers are meeting today. Here's what to expect.
The US Food and Drug Administration’s independent vaccine advisory committee is meeting today to discuss if the Pfizer/BioNTech Covid-19 vaccine should be authorized for children ages 5 to 11.
Pfizer’s vaccine is already authorized under emergency use for children 12 to 15 and is approved for people 16 and older.
The committee will listen to and discuss presentations from the US Centers for Disease Control and Prevention about the impact Covid-19 has had on children and will also discuss any potential safety issues with the vaccine.
Here’s what to expect from the meeting:
The advisory panel will hear presentations from the CDC on how Covid-19 presents in children, and the known safely signals that have been documented among children who have received Covid-19 vaccines.
Pfizer will present its rationale for requesting emergency use of its vaccine.
In the late afternoon, the panel will vote on whether to authorize the vaccine under emergency use conditions.
If recommended, the FDA will next have to approve the authorization. Then the CDC will decide whether to recommend the vaccine to the public.
If all goes as expected, Dr. Anthony Fauci says parents could expect to begin vaccinating their children ages 5 to 11 within the first two weeks of November.
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Child vaccinations will help tame pandemic, health official says
From CNN's Susannah Cullinane
Overall in the US, Covid-19 case numbers are declining. As of Sunday, the seven-day average of new daily cases was 72,843, according to Johns Hopkins University, about 10,000 fewer than a week prior. The seven-day average of daily deaths was 1,690.
Dr. Ashish Jha, the dean of the Brown University School of Public Health, told CNN last week being able to vaccinate younger children will help tame the pandemic in the US.
“Kids need to get vaccinated because it’s going to be good for them. It’s going to protect them,” Jha said. “Obviously, it’s also going to add population immunity to our broader population. … It is going to be one more important step towards getting to the end of this pandemic.”
Currently, 57.4% of the total US population is fully vaccinated, according to the US Centers for Disease Control and Prevention. More than 66% have received at least one dose of vaccine.
US Surgeon General Dr. Vivek Murthy said Friday, while there are still 65 million unvaccinated Americans, the fact vaccines are now available will likely prevent the coming winter from seeing as much Covid-19 transmission as last winter.
But even with all those vaccinated residents and falling case numbers, the threat is still significant. More than 90% of counties – home to more than 319 million people – still have “high” or “substantial” community transmission, according to thresholds set by the CDC.
Because of the stubbornly high transmission rates, Walensky said it’s important to get vaccinated ahead of holiday gatherings, but Halloween can proceed with precautions, even if kids are too young for vaccination.
“I would put on those costumes, stay outside and enjoy your trick-or-treating,” CDC Director Rochelle Walensky told Fox News’ Chris Wallace on Sunday. “If you are spread out doing your trick-or-treating, that should be very safe for your children.”
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The FDA could authorize a Covid-19 vaccine for kids by this week
From CNN's Susannah Cullinane
As the number of new daily cases of Covid-19 continues to fall in the US, the country awaits a major milestone that could provide another critical tool in the fight against the pandemic – the first vaccine for children ages 5 to 11.
And Dr. Scott Gottlieb, a former US Food and Drug Administration commissioner and current Pfizer board member, said the company is ready to ship out doses for children as soon as the agency signs off.
The FDA’s independent vaccine advisory board is meeting Tuesday to discuss whether the Pfizer/BioNTech Covid-19 vaccine should be authorized for younger kids.
On Friday, Pfizer released documents on the efficacy of a children’s dose of its Covid-19 vaccine, saying the company found the vaccine was 90.7% effective against symptomatic disease in children ages 5 to 11.
Once the FDA makes its authorization, the issue goes to the US Centers for Disease Control and Prevention’s vaccine advisory group, which is set to meet Nov. 2 and 3, and from there the CDC director signs off on the recommendation.
“It will be available for use once there’s a hopefully positive vote from CDC. So, it could be as early as November fourth or fifth, that you can go into some locations and get your child vaccinated,” he said.
Expanding the age groups eligible for vaccination couldn’t come soon enough, as Covid-19 cases among children represent about a quarter of all weekly reported cases in the US, according to the American Academy of Pediatrics. About 131,000 new cases were reported among children in the week ending Oct. 14, the group said.
CDC Director Dr. Rochelle Walensky said since many children are vulnerable to the virus in school settings, it’s vital to use preventative measures.
“In my mind, the most important thing right now as we work to get our cases down, as we work to get our children vaccinated, is that we continue the masking to keep our kids in school,” she said on NBC’s “Meet the Press” on Sunday.
