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| Meta Title | Pfizer CEO: When to Expect Vaccines for Children 2-4 - The Atlantic |
| Meta Description | Pfizerâs CEO set a timeline for when Americans can expect the earliest news about shots for young children. |
| Meta Canonical | null |
| Boilerpipe Text | Pfizerâs CEO set a timeline for when Americans can expect the earliest news about shots for young children.
Drew Angerer / Getty ; The Atlantic
September 28, 2021
Editorâs Note:
This article is part of our coverage of The Atlantic Festival. Learn more and watch festival sessions
here
.
The vaccine timeline for young kids is looking a little more solid. This morning, Pfizer
submitted data to the FDA
showing that its COVID-19 vaccine is effective and safe for children ages 5 to 11. And this afternoon, the companyâs CEO, Albert Bourla, said that trial results for even younger kids, aged 2 to 4, will be available in a couple monthsâ time. âBefore the end of the year,â he confirmed in an interview with Craig Melvin, the
Today
news anchor and MSNBC anchor, at The Atlantic Festival. Submission to the FDA will follow soon thereafter, Bourla said.
The wait for COVID-19 vaccines comes during an ongoing
surge of cases among children
. Vaccines are taking this
long to reach kids
because the trials follow the classic strategy of age de-escalation. Manufacturers first tested their shots in adults, then teens, and most recently kids as young as 2. Pfizer is also running a pediatric trial for the youngest children, aged six months up to 2 years old. Bourla did not specify a timeline for this cohort, but expect results sometime after those from the 2-to-4-year-old group.
Once the results for each age cohort are collected, Pfizer will submit them to the FDA to review for safety and efficacy. The agency doesnât work on a set timeline, but for context, emergency use of Pfizerâs vaccine took 21 days from filing to authorization for adults and 31 days for teens age 12 to 15. If that precedence holds, then kids 5 to 11 will likely be able to get shots
around Halloween
and those 2 to 4 will be eligible by early next year. (Donât be surprised if those
timelines stretch
, however.)
All eyes are on Pfizerâs vaccine because its pediatric trials are furthest along. Moderna and Johnson & Johnson, the two other companies whose COVID-19 vaccines have been authorized in the United States, havenât yet released any data from their trials running in children under 12. (Like Pfizerâs trial, these also go down to children as young as six months.) The first shot available to kids will almost certainly come from Pfizer.
The adult and pediatric trials of COVID-19 vaccines do differ in a couple of key ways. First of all, Pfizer is testing a smaller dose in kids. For adults and teens, each shot of Pfizerâs two-dose regimen contained a 30-microgram dose. For kids 11 and under, the dose was reduced to only
10 micrograms a shot
, and then reduced even further to
3 micrograms
for kids six months up to 2 years of age. Based on Pfizerâs announcements, the data the company has collected so far suggest that the smaller dose is indeed safe and coaxes a strong immune response out of the 5-to-11-year-old cohort; their antibody responses are similar to that of adults who got the higher dose.
Speaking of that immune response, scientists are evaluating the vaccineâs efficacy in kids somewhat indirectlyâthis is another way these adult and kid trials differ. The COVID-19 vaccine is already known to be effective in adults, so researchers are looking at antibody responses rather than counting the number of vaccinated versus unvaccinated people who get COVID-19, as they did in the original adult trial. Studying efficacy by waiting for enough kids in a trial to get COVID-19 would require a much larger trialâand much more time to complete it. These trials that focus on antibody response are called
âimmunobridgingâ studies
and are standard in studying vaccines.
Even when young kids are able to be vaccinated, howeverâand
polls right now
suggest that many parents are still hesitantâthe coronavirus is
unlikely to go away
. This is why pharmaceutical companies including Merck, Roche, and Pfizer are also racing to develop antivirals to treat patients with COVID-19. This week,
Pfizer announced
that it is studying an oral pill that could block the replication of the coronavirus. Trials are âongoing right nowâ to see whether the pill can mitigate or prevent COVID-19, Bourla told Melvin, and the first results are expected before the end of the year. The world is heading into a third year with the coronavirus, but this time with many more pharmaceutical defenses in the arsenal. |
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# Vaccine Data for Kids Under 5 Are Coming âBefore the End of the Yearâ
Pfizerâs CEO set a timeline for when Americans can expect the earliest news about shots for young children.
By [Sarah Zhang](https://www.theatlantic.com/author/sarah-zhang/)

Drew Angerer / Getty ; The Atlantic
September 28, 2021
Share
Save
Editorâs Note: This article is part of our coverage of The Atlantic Festival. Learn more and watch festival sessions [here](http://www.theatlanticfestival.com/).
The vaccine timeline for young kids is looking a little more solid. This morning, Pfizer [submitted data to the FDA](https://www.npr.org/sections/coronavirus-live-updates/2021/09/28/1041100773/pfizer-fda-kids-covid-coronavirus-vaccine-authorization-results) showing that its COVID-19 vaccine is effective and safe for children ages 5 to 11. And this afternoon, the companyâs CEO, Albert Bourla, said that trial results for even younger kids, aged 2 to 4, will be available in a couple monthsâ time. âBefore the end of the year,â he confirmed in an interview with Craig Melvin, the *Today* news anchor and MSNBC anchor, at The Atlantic Festival. Submission to the FDA will follow soon thereafter, Bourla said.
The wait for COVID-19 vaccines comes during an ongoing [surge of cases among children](https://www.cidrap.umn.edu/news-perspective/2021/09/pediatric-covid-19-case-surge-continues-across-us). Vaccines are taking this [long to reach kids](https://www.theatlantic.com/health/archive/2021/08/covid-vaccination-timeline-children/619729/) because the trials follow the classic strategy of age de-escalation. Manufacturers first tested their shots in adults, then teens, and most recently kids as young as 2. Pfizer is also running a pediatric trial for the youngest children, aged six months up to 2 years old. Bourla did not specify a timeline for this cohort, but expect results sometime after those from the 2-to-4-year-old group.
Once the results for each age cohort are collected, Pfizer will submit them to the FDA to review for safety and efficacy. The agency doesnât work on a set timeline, but for context, emergency use of Pfizerâs vaccine took 21 days from filing to authorization for adults and 31 days for teens age 12 to 15. If that precedence holds, then kids 5 to 11 will likely be able to get shots [around Halloween](https://www.bloomberg.com/news/articles/2021-09-20/fauci-says-children-could-get-shots-by-halloween-virus-update) and those 2 to 4 will be eligible by early next year. (Donât be surprised if those [timelines stretch](https://www.wsj.com/articles/pfizers-covid-19-vaccine-for-kids-may-not-be-fda-authorized-before-november-11632856430), however.)
All eyes are on Pfizerâs vaccine because its pediatric trials are furthest along. Moderna and Johnson & Johnson, the two other companies whose COVID-19 vaccines have been authorized in the United States, havenât yet released any data from their trials running in children under 12. (Like Pfizerâs trial, these also go down to children as young as six months.) The first shot available to kids will almost certainly come from Pfizer.
The adult and pediatric trials of COVID-19 vaccines do differ in a couple of key ways. First of all, Pfizer is testing a smaller dose in kids. For adults and teens, each shot of Pfizerâs two-dose regimen contained a 30-microgram dose. For kids 11 and under, the dose was reduced to only [10 micrograms a shot](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results), and then reduced even further to [3 micrograms](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-initial-data-us-fda-pivotal) for kids six months up to 2 years of age. Based on Pfizerâs announcements, the data the company has collected so far suggest that the smaller dose is indeed safe and coaxes a strong immune response out of the 5-to-11-year-old cohort; their antibody responses are similar to that of adults who got the higher dose.
Speaking of that immune response, scientists are evaluating the vaccineâs efficacy in kids somewhat indirectlyâthis is another way these adult and kid trials differ. The COVID-19 vaccine is already known to be effective in adults, so researchers are looking at antibody responses rather than counting the number of vaccinated versus unvaccinated people who get COVID-19, as they did in the original adult trial. Studying efficacy by waiting for enough kids in a trial to get COVID-19 would require a much larger trialâand much more time to complete it. These trials that focus on antibody response are called [âimmunobridgingâ studies](https://www.reuters.com/business/healthcare-pharmaceuticals/global-quest-underway-speed-covid-19-vaccine-trials-2021-07-20/) and are standard in studying vaccines.
Even when young kids are able to be vaccinated, howeverâand [polls right now](https://www.theatlantic.com/ideas/archive/2021/09/how-many-vaccinated-parents-will-vaccinate-their-kids/620191/) suggest that many parents are still hesitantâthe coronavirus is [unlikely to go away](https://www.theatlantic.com/science/archive/2021/08/how-we-live-coronavirus-forever/619783/). This is why pharmaceutical companies including Merck, Roche, and Pfizer are also racing to develop antivirals to treat patients with COVID-19. This week, [Pfizer announced](https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-begins-study-covid-19-antiviral-drug-2021-09-27/) that it is studying an oral pill that could block the replication of the coronavirus. Trials are âongoing right nowâ to see whether the pill can mitigate or prevent COVID-19, Bourla told Melvin, and the first results are expected before the end of the year. The world is heading into a third year with the coronavirus, but this time with many more pharmaceutical defenses in the arsenal.
### About the Author
[](https://www.theatlantic.com/author/sarah-zhang/)
[Sarah Zhang](https://www.theatlantic.com/author/sarah-zhang/)
Follow
[Sarah Zhang](https://www.theatlantic.com/author/sarah-zhang/) is a staff writer at *The Atlantic.*
Explore More Topics
[COVID-19 vaccine](https://www.theatlantic.com/tag/general/covid-19-vaccine/), [vaccine](https://www.theatlantic.com/tag/general/vaccine/), [Pfizer](https://www.theatlantic.com/tag/organization/pfizer/)
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| Readable Markdown | Pfizerâs CEO set a timeline for when Americans can expect the earliest news about shots for young children.

Drew Angerer / Getty ; The Atlantic
September 28, 2021
Editorâs Note: This article is part of our coverage of The Atlantic Festival. Learn more and watch festival sessions [here](http://www.theatlanticfestival.com/).
The vaccine timeline for young kids is looking a little more solid. This morning, Pfizer [submitted data to the FDA](https://www.npr.org/sections/coronavirus-live-updates/2021/09/28/1041100773/pfizer-fda-kids-covid-coronavirus-vaccine-authorization-results) showing that its COVID-19 vaccine is effective and safe for children ages 5 to 11. And this afternoon, the companyâs CEO, Albert Bourla, said that trial results for even younger kids, aged 2 to 4, will be available in a couple monthsâ time. âBefore the end of the year,â he confirmed in an interview with Craig Melvin, the *Today* news anchor and MSNBC anchor, at The Atlantic Festival. Submission to the FDA will follow soon thereafter, Bourla said.
The wait for COVID-19 vaccines comes during an ongoing [surge of cases among children](https://www.cidrap.umn.edu/news-perspective/2021/09/pediatric-covid-19-case-surge-continues-across-us). Vaccines are taking this [long to reach kids](https://www.theatlantic.com/health/archive/2021/08/covid-vaccination-timeline-children/619729/) because the trials follow the classic strategy of age de-escalation. Manufacturers first tested their shots in adults, then teens, and most recently kids as young as 2. Pfizer is also running a pediatric trial for the youngest children, aged six months up to 2 years old. Bourla did not specify a timeline for this cohort, but expect results sometime after those from the 2-to-4-year-old group.
Once the results for each age cohort are collected, Pfizer will submit them to the FDA to review for safety and efficacy. The agency doesnât work on a set timeline, but for context, emergency use of Pfizerâs vaccine took 21 days from filing to authorization for adults and 31 days for teens age 12 to 15. If that precedence holds, then kids 5 to 11 will likely be able to get shots [around Halloween](https://www.bloomberg.com/news/articles/2021-09-20/fauci-says-children-could-get-shots-by-halloween-virus-update) and those 2 to 4 will be eligible by early next year. (Donât be surprised if those [timelines stretch](https://www.wsj.com/articles/pfizers-covid-19-vaccine-for-kids-may-not-be-fda-authorized-before-november-11632856430), however.)
All eyes are on Pfizerâs vaccine because its pediatric trials are furthest along. Moderna and Johnson & Johnson, the two other companies whose COVID-19 vaccines have been authorized in the United States, havenât yet released any data from their trials running in children under 12. (Like Pfizerâs trial, these also go down to children as young as six months.) The first shot available to kids will almost certainly come from Pfizer.
The adult and pediatric trials of COVID-19 vaccines do differ in a couple of key ways. First of all, Pfizer is testing a smaller dose in kids. For adults and teens, each shot of Pfizerâs two-dose regimen contained a 30-microgram dose. For kids 11 and under, the dose was reduced to only [10 micrograms a shot](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results), and then reduced even further to [3 micrograms](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-initial-data-us-fda-pivotal) for kids six months up to 2 years of age. Based on Pfizerâs announcements, the data the company has collected so far suggest that the smaller dose is indeed safe and coaxes a strong immune response out of the 5-to-11-year-old cohort; their antibody responses are similar to that of adults who got the higher dose.
Speaking of that immune response, scientists are evaluating the vaccineâs efficacy in kids somewhat indirectlyâthis is another way these adult and kid trials differ. The COVID-19 vaccine is already known to be effective in adults, so researchers are looking at antibody responses rather than counting the number of vaccinated versus unvaccinated people who get COVID-19, as they did in the original adult trial. Studying efficacy by waiting for enough kids in a trial to get COVID-19 would require a much larger trialâand much more time to complete it. These trials that focus on antibody response are called [âimmunobridgingâ studies](https://www.reuters.com/business/healthcare-pharmaceuticals/global-quest-underway-speed-covid-19-vaccine-trials-2021-07-20/) and are standard in studying vaccines.
Even when young kids are able to be vaccinated, howeverâand [polls right now](https://www.theatlantic.com/ideas/archive/2021/09/how-many-vaccinated-parents-will-vaccinate-their-kids/620191/) suggest that many parents are still hesitantâthe coronavirus is [unlikely to go away](https://www.theatlantic.com/science/archive/2021/08/how-we-live-coronavirus-forever/619783/). This is why pharmaceutical companies including Merck, Roche, and Pfizer are also racing to develop antivirals to treat patients with COVID-19. This week, [Pfizer announced](https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-begins-study-covid-19-antiviral-drug-2021-09-27/) that it is studying an oral pill that could block the replication of the coronavirus. Trials are âongoing right nowâ to see whether the pill can mitigate or prevent COVID-19, Bourla told Melvin, and the first results are expected before the end of the year. The world is heading into a third year with the coronavirus, but this time with many more pharmaceutical defenses in the arsenal. |
| Shard | 21 (laksa) |
| Root Hash | 13119341252700813021 |
| Unparsed URL | com,theatlantic!www,/science/archive/2021/09/pfizer-ceo-vaccine-young-children-2-4/620236/ s443 |