If you've been holding your breath in anticipation of an updated timeline for COVID-19 vaccines for kids under age 12, you can let it out now: We've got news—and we'll keep updating this story as developments occur.
The CDC has officially approved Pfizer's vaccine for kids 5 to 11
November 2: Just hours after the Centers for Disease Control and Prevention's (CDC) advisory panel unanimously voted to recommend Pfizer's vaccine for kids ages 5 to 11, CDC Director Dr. Rochelle Walensky issued her endorsement, clearing the way for shots to be distributed immediately.
President Biden released a statement marking the decision, calling it "a turning point in our battle against COVID-19," and declaring it "a major step forward for our nation in our fight to defeat the virus."
The Biden administration has been working on a rollout plan in partnership with 25,000 pediatric offices, children's hospitals, pharmacies and schools in order to make shots available without delay after FDA and CDC approval.
Fifteen million shots have already been shipped to vaccination sites around the country, and the administration said they have purchased enough of the Pfizer low-dose vaccine "for every child in America."
While some shots may be available starting Wednesday this week, health officials expect the federal rollout program to be fully up and running by Nov. 8.
For every 1 million doses delivered to kids, experts at the CDC expect vaccinations to prevent 58,000 cases and 226 hospitalizations in the pediatric group. Vaccinating the 28 million kids in this age group is expected to prevent 600,000 new cases in general across the country between now and March 2022, reports The New York Times.
"COVID-19 vaccines have undergone—and will continue to undergo—the most intensive safety monitoring in U.S. history," the CDC says in a media statement. Officials from both the FDA and the CDC have rigorously reviewed the data from Pfizer's clinical trials, and determined the vaccine to be safe and effective for the 5 to 11 age group.
Addressing the safety concerns some parents have, Dr. Walensky remarked, "As a mom, I encourage parents with questions to talk to their pediatrician, school nurse or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated.”
CDC panel recommends Pfizer’s vaccine for kids 5 to 11
November 2: A scientific advisory panel to the Centers for Disease Control and Prevention (CDC) has cleared the Pfizer-BioNTech vaccine for kids ages 5 to 11, meaning we may be just days away from the release of pediatric vaccines.
If the agency’s director signs off on the advisory panel’s endorsement, shots could be available for distribution as soon as this week. The final approval from Dr. Rochelle Walensky, director of the CDC, is expected to come very soon.
Earlier in today’s panel meeting, Dr. Walensky called today “a monumental day,” and shared that it was “one that many of us have been very eager to see.” The Covid pandemic has taken a significant toll on children, as the most recent CDC data show that more than 8,300 in the 5 to 11 age group have been hospitalized and 172 children have died as a result of the virus. Children in this age group also have the highest case numbers of MIS-C.
"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," said Dr. Walensky to the advisory panel. "It is our ongoing responsibility to make sure as many people as possible are vaccinated and protected from COVID 19."
The CDC's panelists discussed the general need for a children’s vaccine, given the fact that Covid in kids is not typically as severe or deadly as it is in adults. But, as NPR reports, the current prevalence of Covid nationwide and the large number of hospitalizations and deaths in children led to the panel’s recommendation of universal use of the vaccine in this age group.
The FDA authorizes Pfizer’s vaccine for kids 5 to 11
October 29: Pfizer's vaccine for kids ages 5 to 11 has been authorized for emergency use by the Food and Drug Administration (FDA).
Shots are expected to become available next week at hundreds of pediatricians' offices, family practices, pharmacies and children's hospitals around the country, but before that can happen, The Centers for Disease Control and Prevention (CDC) must sign off on the vaccine's usage.
The CDC's advisory panel has a meeting set for Nov. 2 and Nov. 3 to vote on guidelines for vaccine administration, and after that, CDC Director Dr. Rochelle Walensky will give the final verdict.
As the White House has already started rolling out plans for vaccine distribution in anticipation of FDA and CDC authorization, shots could become available as soon as Wednesday next week.
This is the first Covid vaccine to be authorized by the FDA for use in young children, who have not been spared by the highly contagious Delta strain. Cases in the 5 to 11 group make up 9% of all Covid cases in the U.S., and 40% of all pediatric Covid cases.
"As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today's authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy," Janet Woodcock, M.D., acting FDA commissioner said in a statement.
Though no vaccine is completely without side effects, the FDA's advisory panel ruled on Tuesday this week that the Pfizer vaccine's benefits (including protection against hospitalization and severe disease from Covid) outweighed the low risks of potential side effects from vaccination.
The FDA recommends Pfizer’s vaccine for kids 5 to 11
October 26: The Food and Drug Administration (FDA) endorses the Pfizer-BioNTech Covid vaccine for use in kids ages 5 to 11.
This could mean that shots may be available for the nation’s 28 million children in this age group as early as next week.
The advisory panel to the FDA voted 17 in favor with one abstension. The FDA committee reviewed the agency’s own analysis and found that the benefits of vaccination to prevent Covid outweighed the risks of possible side effects from the vaccine for this age group.
Data presented by Pfizer shows that their vaccine is 90.7% effective in preventing symptomatic Covid. The vaccine will be delivered in two 10-microgram doses, three weeks apart, and will be given in smaller vials (marked with an orange cap to differentiate them from the adult dose) and will feature a smaller needle.
The FDA committee’s endorsement is not the final say, however—the Centers for Disease Control and Prevention (CDC) will vote next week on their guidelines, after which, if approved, shots will become available.
Pediatricians and family doctors around the country have already been eligible to start placing orders for the shots, however, in anticipation of a favorable recommendation by the FDA and CDC, and to start getting shots in arms as quickly as possible for school-aged kids, who have seen an uptick in cases and hospitalizations since August.
In today’s meeting, Dr. Peter Marks, head of vaccine approvals for the FDA, shared that Covid is now one of the top 10 causes of death among children between the ages of 5 to 11.
Moderna reports their vaccine is safe and highly effective in kids 6 to 11
October 25: In a statement released Monday, Moderna announced that their vaccine for kids ages 6 to 11 had produced a powerful antibody response in clinical trials.
The results showed that two 50-microgram shots (half of the adult dose) 28 days apart led to a “robust” antibody response in kids that was 1.5 times higher than that seen in young adults.
The side effects reported were “generally well tolerated,” and primarily included fatigue, fever, headache and pain at the injection site. The company plans to submit the trial results to the Food and Drug Administration (FDA) soon.
“We are encouraged by the immunogenicity and safety profile of [the vaccine] in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” says Stéphane Bancel, Chief Executive Officer of Moderna. “We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.”
Pfizer's vaccine is 90.7% effective in kids 5 to 11, even at a lower dose
October 22: Pfizer-BioNTech reported to the Food and Drug Administration (FDA) today that their vaccine for kids ages 5 to 11 is 90.7% effective at reducing symptomatic Covid.
The findings are promising, as the 5 to 11 age group will receive a much smaller dose than the 12 and up age group, at 10 micrograms versus 30 micrograms. The companies also report a high rate of safety and that only mild side effects were seen in the trial participants.
The FDA will be releasing its own report analyzing the vaccine makers' clinical trial data later today.
The New York Times states that of the 2,268 children in the vaccine clinical trials, 16 kids who received the placebo got Covid-19, as compared to three who received the vaccine. While no vaccine is 100% effective, the mRNA technology used in the Pfizer-BioNTech shot is very successful at preventing illness in many and protecting against severe forms of the disease.
White House rolls out plan to vaccinate kids ages 5 to 11 against Covid
October 20: In a news conference held this morning, the White House Covid-19 Response Team unveiled a plan to move quickly on getting shots in arms for kids ages 5 to 11.
The Biden administration is aiming to set up a “kid-friendly experience that makes sure that we’re getting shots in arms with trusted providers in ways that makes parents feel comfortable,” says Sonya Bernstein, a senior policy adviser for the White House Covid-19 Response Team in The New York Times.
That looks like coordinating with more familiar settings for kids and families, like pediatricians' offices, primary care offices, pharmacies, children’s hospitals and schools—but no mass vaccination sites will be used, which means shorter lines (and hopefully fewer tears).
The needles and vaccine vials used will be smaller, too.
Officials are working to put plans in motion now so that vaccine distribution can start rolling out quickly—within days after the shot becomes authorized.
While the Pfizer/BioNTech vaccine has not yet been authorized by the Food and Drug Administration (FDA), a meeting is set for October 26 to review the decision, with potential recommendations by the Centers for Disease Control and Prevention (CDC) shortly after.
"We will be ready to begin getting shots in arms in the days following a final CDC recommendation," the White House said, which could come in the next two weeks.
AAP says pediatricians can start preparing to vaccinate kids 5 to 11 against COVID-19
October 15: The American Academy of Pediatrics (AAP) announced that pediatricians may be able to start ordering vaccines for kids ages 5 to 11 within the next two weeks for distribution to their patients once the vaccine is authorized for emergency use.
The authorization timeline is now looking like early November, if all goes to plan.
The Centers for Disease Control and Prevention (CDC) is encouraging states and large cities to allocate large portions of their vaccine supply to providers who work closely with kids, like pediatricians.
"We know from all of our research … that a person's health care provider, pediatricians, are a parent's most trusted source of health care information," Amanda Cohn, MD, FAAP, deputy incidence manager for vaccines for the CDC's COVID-19 emergency response, said in a call with AAP directors Wednesday. "And a strong recommendation by a pediatrician for their child to get a COVID vaccine is directly related to uptake in that person."
The vaccines for this younger group of kids will be a smaller dosage (10 micrograms) of Comirnaty, the Pfizer-BioNTech formula that has been authorized for kids age 12 and up. The Food and Drug Administration (FDA) has set a meeting on Oct. 26 to review the manufacturer's authorization request for the 5 to 11 age group. Full FDA emergency use authorization from the acting commissioner may come soon after.
But as soon as next week, jurisdictions will know how many doses they'll be allocated, and pediatricians can then request the shots through their local jurisdiction and start preparing their distribution plans. However, health professionals will not be able to give out the shots until after the CDC director makes an official recommendation. The CDC's vaccine committee has set a meeting for that purpose Nov. 2 and 3.
Federal authorities assure that there will be enough shots to vaccinate all children between the ages of 5 and 11, but it remains unclear how many parents will rush to vaccinate their kids. One recent survey found that 2 out of 3 parents plan to vaccinate their children against the virus, but that still leaves one-third of kids in this age group unprotected.
FDA sets a meeting for October 26 to review authorization of Pfizer's vaccine in kids ages 5 to 11
October 7: Pfizer and BioNTech have officially asked regulators today at the Food and Drug Administration to authorize their vaccine for children ages 5 to 11 for emergency use. The FDA has assured that they'll act quickly and has tentatively set a meeting for October 26 for authorization consideration.
The agency's ruling could then come between Halloween and Thanksgiving, The New York Times reports.
This updated timeline could mean that shots for many kids over 5 may be available later in November or December, but likely not around Halloween. As pediatric case numbers rise, the FDA is under immense pressure to approve the authorization request. The most recent data from The American Academy of Pediatrics (AAP) says that pediatric cases make up 26.7% of all Covid cases now—more than 1 in 4—and 22.2% of the population.
If authorized, this would be the first Covid vaccine available for younger children. "With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19," the manufacturers said on Twitter.
Pfizer and BioNTech submit vaccine trial data for FDA review
September 28: Pfizer and BioNTech announced that they have submitted data to the U.S. Food and Drug Administration for authorization of their COVID-19 vaccine to be used in children ages 5 to 11. This news is in keeping with the timeline proposed by numerous health experts of shots being available to this age group by Halloween.
FDA emergency use authorization could be granted in the coming weeks. In our recent interview with Dr. Fauci, the nation's top infectious disease expert mentioned that "it will usually take a couple of weeks for [the FDA] to carefully go over the data, so that would mean sometime in October we'll get Pfizer approval."
The FDA has previously mentioned that they will review the data as quickly as possible, and that they're "working around the clock to support the process for making COVID-19 vaccines available for children."
Study data on kids younger than 5 should be available by the fourth quarter of this year, and the companies plan to submit trial data for publication in a peer-reviewed journal once Phase 3 of the vaccine trials are complete.
Covid vaccine elicits a strong immune response in kids ages 5 to 11, say Pfizer and BioNTech
September 20: In an announcement, representatives from Pfizer and BioNTech state that their COVID-19 vaccine is safe and effective in kids ages 5 to 11. The companies plan to submit their clinical trial data to the FDA for regulatory review by the end of the month.
If all goes according to plan, that means millions of children could be vaccinated against the virus by Halloween, The New York Times reports.
Data for kids under age 5 is not expected until later this fall. However, at a time when 1 in 5 new cases affect children, the news of the vaccine's effectiveness is very promising—and likely comes as a great relief to many parents.
The Pfizer trial studied the immune response in 2,268 children ages 5 to 11, two-thirds of whom received two doses of the vaccine three weeks apart, and one-third of whom received a placebo saltwater injection. The vaccine was found to produce a comparable level of antibodies to those seen in the 16-to-25 age group; even though the dosage in the 5-to-11 group was only 10 micrograms—one-third the size of the 16-to-25 group's dose. At higher doses, researchers saw more side effects, such as fever and fatigue after receiving the shot. At the lower dose, these side effects were greatly diminished.
"You want to hit the sweet spot, where you're giving the lowest dose that might elicit reactions, but also high enough to get you a good, sustainable antibody response," said Dr. Yvonne Maldonado, chair of the American Academy of Pediatrics' infectious disease committee and who led the vaccine trial at Stanford University, to the Times.
In children under 5, one-tenth (3 micrograms) of the adult dose is being tested, with strong results so far, Dr. Maldonado says.
Pfizer and BioNTech plan to ask for vaccine approval for ages 5 to 11 in the coming weeks
September 10: The founders of German vaccine maker BioNTech, which developed an mRNA vaccine in partnership with Pfizer, announced today in German newspaper Der Spiegel that the company intends to ask regulators to approve the Pfizer-BioNTech vaccine for usage in kids ages 5 to 11 very soon.
"We will be presenting the results from our study on 5- to 11-year-olds to authorities around the world in the coming weeks," said Dr. Ozlem Tureci, chief medical officer and co-founder of BioNTech, The New York Times reports.
BioNTech is also preparing to make smaller doses of the vaccine for kids younger than age 5.
The co-founder and chief executive of BioNTech, Dr. Ugur Sahin, understands that time is of the essence when it comes to reducing the number of infections.
"There are still about 60 days left for us as a society to avoid a tough winter," he said, and urged anyone who is eligible to get their doses as soon as possible.
COVID-19 vaccines for kids under 12 may be available as soon as this fall
August 19: Pfizer expects to have enough data collected by the end of September to support an application for emergency use authorization for its vaccine in kids ages 5 to 11, according to NPR, but full authorization may not be granted until year-end.
For kids ages 12 to 15, shots became available in May 2021 after the vaccine-maker applied to the FDA for emergency use authorization in April. Given that timeline as a model, we can hopefully expect shots to be available for kids ages 5 to 11 sometime in October.
"We're hoping to have authorization—depending on both results and, of course, a few decisions—not too long after the school year starts," Dr. Phil Dormitzer, chief scientific officer for viral vaccines at Pfizer, told NPR.
Full FDA approval isn't expected until the end of the year
In a recent interview with NPR, Dr. Francis Collins, director of the National Institutes of Health (NIH), said that this September timeline is still accurate, but added, "I've got to be honest, I don't see the approval for kids—5 to 11—coming much before the end of 2021." Full FDA approval may empower more schools to require the COVID-19 vaccine for eligible students.
Vaccine safety data for kids under 5 is coming soon, too
Pfizer has also shared that the data for children between the ages of 2 and 5 should be available shortly after the data is collected for kids ages 5 to 11. They expect data on kids ages 6 months to 2 years to be available by year-end.
Moderna, the maker of another mRNA-based COVID-19 vaccine, is also collecting data on its use of the vaccine in children between the ages of 6 and 11. Currently, the Moderna vaccine is only available to people over the age of 18, but Moderna hopes to apply for emergency use authorization for ages 6 to 11 by year-end, as well.
Cases are increasing among children
With approximately 50 million children under 12 in the U.S., that's a significant portion of the population walking around unvaccinated. According to the American Academy of Pediatrics, children now make up 26% of COVID cases. And given the fact that the Delta variant now makes up 98.8% of COVID cases and is more than twice as contagious as previous strains, time is of the essence in getting shots in kids' arms.
Because so many children are ineligible for the vaccine, we're seeing pediatric cases—and hospitalizations—rising across the country. Currently, the best tool we have for fending off infections is to have as many adults and teens get vaccinated as soon as possible.
Hold on a little longer
With school already in session for thousands of kids across the country, the timing isn't great—but stay hopeful. It's also important to remember that both the Pfizer and Moderna vaccines require two shots spaced three or four weeks apart, and that immunity isn't fully built up until two weeks after the second shot. If shots become available for the 5 to 11 age group in October, that could mean many kids would have full immunity by Thanksgiving—something to be thankful for, indeed.
In the meantime, keeping up with kids' masking, hand-washing, social distancing and frequent testing can help curb the spread, plus encouraging vaccination for any and all teens and adults in your orbit.
This post was originally published on August 19, 2021. It has been updated.